Step 1: Needs assessment
To develop an intervention that could be tailored to effectively target physical activity and sedentary behaviour after stroke, and subsequently implement this intervention in to the stroke rehabilitation care pathway, we conducted a needs assessment. This involved: systematically reviewing the literature; consulting with healthcare professionals and stroke survivors and identifying local community stroke care pathways (where they existed) to determine how a new intervention could integrate with and/or complement what was already available.
Systematic review
A systematic review of randomised controlled trials was undertaken to explore the characteristics and promise of existing intervention components targeting free-living physical activity and/or sedentary behaviour after stroke. (9)
Key findings of systematic review
The findings of the systematic review have been published previously. (9) All nine studies (N=719 participants) included in the systematic review targeted physical activity behaviour, and none targeted sedentary behaviour. Six of the interventions evaluated were rated as promising – i.e. interventions with statistically significant between- or within-group improvements in outcomes greater than those of the comparator group. (21) All of these interventions involved an element of supervised support that was tailored to individual needs. Both face-to-face and telephone contact were identified as promising modes of intervention delivery to engage stroke survivors in physical activity behaviour change. The number of contacts for promising interventions ranged from a single contact to 36 contacts, with the duration of interventions ranging from one single contact to twelve consecutive weeks. Nine promising behaviour change techniques were identified with reference to the BCT Taxonomy V1 (22) and considered for inclusion in our intervention: information about health consequences; information about social and environmental consequences; goal setting behaviour; problem-solving; action planning; feedback on behaviour; biofeedback; social support unspecified; and credible source.
Qualitative focus group discussions
To complement and add context to the findings of our systematic review, a series of interactive focus group discussions were conducted with stroke survivors and healthcare professionals involved with their care. The overall aim of the focus groups was to identify determinants of behavioural change for both stroke survivors and healthcare professionals and to explore the barriers and enablers to engagement in long-term physical activity and reduction in sedentary behaviour post-stroke. Focus group discussions were conducted in person, audio- recorded and transcribed verbatim. Transcripts were read, re-read and analysed following the conduct of each focus group discussion and any unsubstantiated issues or points were further explored during subsequent group discussions (i.e. topic guides were revised accordingly).
Data were analysed using the Theoretical Domains Framework (TDF) (23), to facilitate an exploration of behavioural determinants likely to predict and impact upon behaviour and behaviour change. Three researchers independently read, re-read and analysed transcripts of stroke survivor and healthcare professional focus groups. The first researcher has a background in stroke physiotherapy and rehabilitation research (SAM), the second is a chartered health psychologist with expertise in health behaviour change and qualitative research methods (LA), and the third was a master’s degree student. The skill mix of the researchers ensured appropriate questions were asked and responses were further probed to generate a comprehensive understanding of what was required from an intervention. Analyses of the data involved assigning text segments to one or more domains of the TDF and generating themes within each domain. Given the explicit nature of the TDF, all focus group transcripts with healthcare professionals and stroke survivors were coded and analysed by hand and no qualitative software was required. Common themes across the stroke survivors and healthcare professionals were subsequently established. Regular meetings were held with all three researchers to discuss their independent coding and analyses and to discuss any discrepancies until a consensus on the final domains and domain-specific themes was reached.
Findings of focus groups discussions
Eighteen stroke survivors and twenty-four healthcare professionals (HCPs) (physiotherapists n=14, technical instructors n=8, physiotherapy assistants n=2) participated across seven focus groups. All 14 of the theoretical domains of the TDF were identified from the data generated from stroke survivor focus groups. The TDF domains and themes are presented in Table 1. The most commonly populated domains were ‘environmental context and resources’, ‘beliefs about consequences’ and ‘beliefs about capabilities’ (Stroke survivor TDF domains themes and related change objectives are presented in Table 2, Step 2).
Data generated from HCP focus groups populated seven theoretical domains: ‘knowledge’, ‘skills’, ‘social/professional role and identity’, ‘belief about consequences’, ‘beliefs about capabilities’, ‘reinforcement’ and ‘environmental context and resources’. The most populated domains were ‘environmental context and resources’ and ‘skills’ (HCP TDF domains themes and related change objectives are presented in Table 3, Step 2).
Although the aim of the focus group discussions with stroke survivors was to explore the determinants of behavioural change in relation to long-term physical activity and reduction in sedentary behaviour post-stroke, participants focused their discussions on physical activity. This highlighted a potential lack of understanding and awareness about sedentary behaviour and the importance of this in the context of stroke and stroke rehabilitation.
Lack of sustainable physical activity options were identified as a key barrier by stroke survivors to engagement in long-term physical activity post stroke. A lack of timely information and long-term support was also reported. Enablers to increasing physical activity and reducing sedentary behaviour were identifying meaningful, accessible, sustainable activities with social support and developing skills for self-monitoring physical activity and well-being. HCPs also identified environmental context and access to resources as barriers to promoting physical activity and reducing sedentary behaviour of stroke survivors, as well as a lack of skills to effectively support behaviour change.
Exploration of intervention opportunities within existing pathways
To identify current stroke rehabilitation services and explore potential for delivering the intervention within existing pathways, a questionnaire was sent to local community stroke teams in the North East of England. Questions explored current and future staffing, current service provision, practices around promoting and supporting physical activity and sedentary behaviour post-stroke and potential for participation in a future study. Community stroke services at seven NHS trusts in the North East of England were considered for inclusion in the exercise. Four of these trusts were already involved in another rehabilitation study led by the research team, therefore it was agreed that they would not be approached so not to over burden the teams.
Key findings of exploration of existing pathways
Service and capacity mapping and interest and ability to take part in a future feasibility study of the intervention were determined (Appendix A). All three trusts did not report any specific interventions or resources already in place to target free-living physical activity and sedentary behaviour and reported having an interest, capacity, and manager agreement to take part in a future feasibility study.
Key findings of needs assessment
The needs assessment highlighted that physical activity and sedentary behaviour are not adequately addressed post-stroke and HCPs do not feel equipped to target these behaviours effectively. The systematic review of randomised controlled trials targeting long-term physical activity and sedentary behaviour after stroke identified promising behaviour change techniques and intervention components to incorporate into a new intervention. The qualitative focus group discussions explored physical activity and sedentary behaviour of stroke survivors, and the promotion and long-term support of post-stroke physical activity behaviour by HCPs. Data were analysed using the TDF which enabled further identification of potential BCTs and selection of theory alongside the findings of the systematic review. The needs assessment indicated that to increase physical activity and reduce sedentary behaviour after stroke, the intervention should be person-centred and adaptable to individual needs and preferences. A supported self-management approach was identified as a possible approach to target these requirements. Mapping of existing stroke rehabilitation pathways revealed there was potential to incorporate a physical activity and sedentary behaviour intervention and training for HCP into current practice.
Step 2: Identification of behavioural outcomes, and specification of performance and change objectives
The needs assessment conducted in Step 1 identified the behaviours to be targeted by our intervention. Target behaviours were identified as physical activity and sedentary behaviour of stroke survivors and HCPs knowledge about physical activity and the promotion of physical activity in the context of stroke, and skills to support behaviour change to optimise consultation behaviour. The two behavioural outcomes of the PARAS intervention and related performance objectives are reported in Table 1.
Table 1. Behavioural outcomes and related performance objectives of PARAS
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Stroke survivor behavioural outcomes: To develop knowledge to raise awareness of the importance of physical activity in the context of stroke, and skills to increase and sustain activity levels and reduce sedentary behaviour in order to perform activities of daily living.
Performance objectives
· Understands benefits of physical activity and reducing sedentary behaviour after stroke
· Requests support to increase physical activity and reduce sedentary behaviour at the most appropriate time
· Selects and safely performs meaningful and sustainable physical activity and/or reduces sedentary behaviour
· Identifies and utilises social support to maintain physical activity behaviour and reduce sedentary time
· Applies behavioural goal setting, action planning, and coping planning to selected physical activities and/or reducing sedentary behaviour
· Selects methods of self-monitoring physical activity and sedentary behaviour
· Self-monitors physical activity and sedentary behaviour, behavioural goal attainment and associated confidence and well-being
· Plans methods for maintaining physical activity or reducing sedentary behaviour
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HCP behavioural outcomes: To improve/increase knowledge about the benefits of physical activity in the context of stroke and to develop skills to promote and sustain activity levels and reduce sedentary behaviour to enable stroke survivors to perform activities of daily living.
· Accepts supporting physical activity and reducing sedentary behaviour after stroke is beneficial for stroke rehabilitation and part of the HCP role
· Supports stroke survivors to successfully engage in the PARAS intervention
· Appropriately uses PARAS intervention resources to support stroke survivor engagement in the PARAS intervention
· Appropriately uses behaviour change counselling techniques to support stroke survivor’s identify reasons for physical activity behaviour change and maintenance
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Change objectives (i.e. aspects of behaviour individuals are required to learn, do or change) that need to be accomplished by stroke survivors and HCPs in order to achieve the behavioural outcomes and performance objectives were developed related to the TDF domains and sub-themes identified in Step 1. These are described in Tables 2 and 3.
Table 2. Theoretical domains and associated themes identified from focus group data generated by stroke survivors and related change objectives
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TDF Domain
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Themes identified
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Stroke survivor change objectives
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Knowledge
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Timing of information provision is important but highly individual
Amount and intensity of physical activity has to increase to derive benefit
Lack of knowledge about physical activity opportunities and support available prevents engagement
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To have the knowledge and confidence t request information at the right time
To develop skills and mastery of tools and resources to safely self-manage physical activity and sedentary behaviour
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Skills
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Planning and self-monitoring can facilitate engagement in physical activity and help reduce sedentary time
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To have capacity and capability to master self-monitoring of physical activity
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Social/Professional role
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Past physical activity levels and engagement facilitates participation in physical activity and physical activity choices
Being physically active with people of a similar age and varying abilities provides confidence
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To identify meaningful physical activities
To identify and engage social support
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Beliefs about capabilities
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Confidence about ability is a barrier to increasing physical activity
Old age, comorbidities and fatigue limit ability to be active
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To develop knowledge and capability to confidently undertake physical activity. This involves articulating reasons for change.
To be able to describe personal barriers to physical activity and reducing sedentary behaviour and identify potential solutions.
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Optimism
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A positive attitude facilitates participation in physical activity and reduces sedentary behaviour when prompted
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To be able to set behavioural goals and actions and monitor well-being when goals are achieved
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Beliefs about consequences
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Too much physical activity too soon could lead to further health problems including stroke recurrence
Physical activity as a mechanism to return to pre-stroke self
Fear of falls is a barrier
Physical activity gets you out of the house
Physical activity fills time post stroke
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To be able to identify a physical activity that feels safe but is effective for achieving outcome goals
To be able to identify meaningful, safe physical activity outcomes and select appropriate activities likely to lead to these outcomes
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Reinforcement
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Sense of achievement can facilitate longer-term physical activity
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To identify and use appropriate tools to measure physical activity against behavioural and outcome goals
To monitor wellbeing in response to goal attainment
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Intentions
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Recognition of the importance of physical activity but HCP information provision not sufficient to enable physical activity
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To access appropriate physical activity information and advice and select meaningful activities that are more likely to lead to behavioural change
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Goals
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Planning physical activity in advance increases the likelihood it will be undertaken
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To set appropriate and realistic behavioural and outcome goals
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Memory, attention and decision processes
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Having to think about everything before doing it post-stroke makes engagement in physical activity more difficult
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To use appropriate tools to set realistic goals and action plan to aid memory
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Environmental context and resources
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Stroke specific groups provide emotional and physical support that can facilitate physical activity.
Modifying home environment can facilitate physical activity and reduce sedentary time
Restricted car use can impact on physical activity levels
Mixed ability and co-morbidity groups can facilitate physical activity
Knowledge and skills of professionals can affect uptake of physical activity
Lack of longer-term physiotherapy input can affect long-term physical activity
Lack of information provision, resources and available options is a barrier to physical activity
Dependence on others to be able to leave home is a barrier to increasing physical activity
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To identify and engage social support to enable PA
To understand and access resources available within the home and locally to increase physical activity and reduce sedentary time
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Social influences
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Peer support groups provide a means of support and can help to facilitate physical activity
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To identify and engage with social support
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Emotion
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Group based activities that are enjoyable and provide a means of support can facilitate physical activity
Anxiety and depression is a barrier to engaging on activities
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To select safe physical activities that lead to meaningful outcomes and a sense of well-being
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Behavioural regulation
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Planning and self-monitoring can facilitate engagement in physical activity and help reduce sedentary time
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To use planning and self-monitoring tools meaningfully and review physical activity and sedentary behaviour to support maintenance
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Table 3. Theoretical domains and associated themes identified from focus group data generated by healthcare professionals and change objectives
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Theoretical Domains
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Themes
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HCP change objectives
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Knowledge
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Training in the benefits and use of physical activity in the context of stroke would be beneficial
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To understand the benefits of physical activity and reducing sedentary behaviour post-stroke
To deliver person centred, personalised support to stroke survivors
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Skills
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Being able to promote physical activity tailored to individual needs is essential for promoting participation
Skills to help patients overcome barriers to physical activity will facilitate longer-term engagement
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Able to identify physical activity resources available to stroke survivors that meet their individual needs
To support stroke survivors to undertake barrier identification and coping planning
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Social/Professional role
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Promoting physical activity is part of the healthcare professional’s role
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Engage in training to use a range of behavioural tools to target physical activity
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Beliefs about capabilities
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Engaging patients in physical activity and reducing sedentary time is difficult when pre stroke activity levels were low
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To apply appropriate behaviour change counselling techniques to engage stroke survivor in behaviour change and maintenance
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Beliefs about consequences
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Being overweight can be a barrier to physical activity and reduction in sedentary time for stroke survivors
Motivational strategies will only work on a proportion of patients
Withdrawal of physiotherapy support makes promotion and support of long-term physical activity problematic
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Able to identify the different barriers to behaviour change and support the formulation of appropriate coping plans
Able to succeed with resistant or ambivalent stroke survivors
To understand how to support stroke survivor’s long-term physical activity within the context of individual service delivery, identifying meaningful, sustainable activities and social support
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Reinforcement
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Seeing patients succeed is an incentive to promoting physical activity
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Able to support stroke survivors to identify and achieve meaningful, sustainable physical activities and social support
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Environmental context and resources
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Increased availability of physical activity options for patients post stroke would be beneficial
Community physical activity groups are usually targeted at higher functioning stroke survivors
Promoting long-term engagement in physical activity can be difficult without an individual in the team to take on this role
Tools to tailor physical activity to individual needs would be beneficial
Self-monitoring tools and technologies could be useful to initiate and maintain physical activity.
Funding and time are barriers to physiotherapists participating in training to effectively target and support stroke survivors to be physically active
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To develop knowledge of physical activity resources available to stroke survivors
To be able to adapt physical activity support to individual needs of stroke survivors and enable identification of meaningful sustainable activities and goals
To be able to access and effectively apply tools to support engagement in physical activity and reduction in sedentary behaviour e.g. self-monitoring tools
To be able to access training on how to support physical activity and reduce sedentary behaviour post-stroke within restrictions of current job role
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Step 3: Selection of theory-based intervention content
Selection of the theories/models to underpin the behaviour change intervention were informed by the findings of steps 1 and 2.
Theoretical underpinning of stroke survivor component of intervention
Two theories were selected to underpin the stroke survivor component of the multifaceted intervention, they were the Health Belief Model (24) and Self-Regulation Theory. (25) The Health Belief Model assumes an individual’s belief in the personal threat of an illness together with their belief that the effectiveness of a health behaviour or action will determine whether they change their behaviour (or not).
Step 1 informed the selection of this model to target individual perceptions of stroke and stroke recurrence including the use and perceived benefits and disadvantages of physical activity and inactivity. It was felt that this model would be appropriate particularly around challenging beliefs about the consequences of physical activity/inactivity and as such formulate reasons/intentions for engaging in physical activity.
Self-Regulation Theory assumes that behaviour is goal-directed or purposive. Findings from our systematic review and focus group discussions supported the need for specific strategies to target volition as well as motivation in recognition that maintenance of physical activity for stroke survivors can be particularly challenging given the level of cognitive and physical effort required. Furthermore, inclusion of several specific BCTs that target self-regulation e.g. goal setting-behaviour; problem-solving; action planning; feedback on behaviour were identified from the systematic review as promising.
Behaviour change techniques (BCTs) are the irreducible active ingredients of interventions targeting behaviour change, and are useful to inform, describe, deliver and evaluate behaviour change interventions. (26) TDF domains were identified from the data generated from stroke survivor focus group discussions and BCTs were selected with reference to those domains, supported by evidence from the systematic review (i.e. BCTs identified by the review as promising). When discrepancies occurred between the findings of the qualitative study and the systematic review, members of the research team discussed these findings and reached a consensus in terms of inclusion/exclusion of specific BCTs. The outcome of the decision-making process is summarised in Table 4 which also describes how BCTs were operationalised to target increases in levels of physical activity and a reduction in sedentary behaviour.
Table 4. Theoretical intervention mapping targeting physical activity and sedentary behaviour of stroke survivors
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TDF Domain
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Behaviour change technique
(used/not used, promising/non-promising from systematic review findings)
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Selection rationale
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Theoretical constructs targeted and potential intervention components
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Knowledge
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5.1: Information about health consequences (used/promising)
Definition: Provide information (e.g. written, verbal,
visual) about health consequences of
performing the behaviour
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· Assessed as promising systematic review
· Supported by qualitative findings
· Expert consensus
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Appropriate theory: Health Belief Model (HBM)
Constructs: All constructs of HBM
Suggested/example intervention component(s):
· Booklet for patients and/or DVD containing information and patient narratives
· Access to repository of information via HCPs to obtain details of local activities, support and resources
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5.2: Salience of consequences (not used)
Definition: Use methods specifically designed to
emphasise the consequences of
performing the behaviour with the aim of
making them more memorable (goes
beyond informing about consequences)
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· Not supported by systematic review findings, but overruled based on small sample sizes
· Supported by qualitative findings
· Expert consensus
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3.1: Social support (unspecified)(used/promising)
Definition: Advise on, arrange or provide social
support (e.g. from friends, relatives,
colleagues,’ buddies’ or staff) or non-contingent praise or reward for performance of the behaviour. It includes
encouragement and counselling, but only
when it is directed at the behaviour
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· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
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9.1 Credible source (used promising)
Definition: Present verbal or visual communication
from a credible source in favour of or
against the behaviour
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· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
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Skills
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4.1: Instruction on how to perform the behaviour (used/non-promising)
Definition: Advise or agree on how to perform the
behaviour (includes ‘Skills training’)
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· Not supported by systematic review findings, overruled based on small sample sizes and the need for instruction on how to perform specific activities safely
· Supported by qualitative findings
· Expert consensus
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Relevant theory: Self-Regulation Theory (SRT)
Constructs: Action planning, problem solving
Suggested/example intervention component(s):
· Workbook (template to be completed/populated in discussion with a HCP) and/or DVD
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6.1: Demonstration of the behaviour (used/non-promising)
Definition: Provide an observable sample of the
performance of the behaviour, directly in
person or indirectly
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· Not supported by systematic review findings, overruled based on the need to demonstrate behaviour for safety
· Supported by qualitative findings
· Expert consensus
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|
Social/Professional role
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3.1: Social support (unspecified) (used promising)
Definition: Advise on, arrange or provide social
support (e.g. from friends, relatives,
colleagues,’ buddies’ or staff) or non-contingent
praise or reward for performance of the behaviour. It includes encouragement and counselling, but only
when it is directed at the behaviour
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Feedback; problem solving
Suggested/example intervention component(s):
· Access to repository of information via HCPs to obtain details of local support and resources. Constructs are targeted by social support (e.g., positive reinforcement and sharing of information to overcome barriers).
|
|
Beliefs about capabilities
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1.1: Goal setting (behaviour) (used/promising)
Definition: Set or agree on a goal defined in terms of
the behaviour to be achieved
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: HBM & SRT
Constructs: Individual perceptions; likelihood of action; goal setting; problem solving
Suggested/example intervention component(s):
· Information booklet and/or DVD concentrating on antecedents and pros and cons for changing behaviour. Booklet template to be completed in discussion with a HCP targeting goal setting and problem solving.
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1.2: Problem solving (used/promising)
Definition: Analyse, or prompt the person to analyse,
factors influencing the behaviour and
generate or select strategies that include
overcoming barriers and/or increasing
facilitators (includes ‘Relapse Prevention’
and ‘Coping Planning’)
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
|
4.2: Information about antecedents (not used)
Definition: Provide information about antecedents
(e.g. social and environmental situations
and events, emotions, cognitions) that
reliably predict performance of the
behaviour e.g. Advise to keep a record of
snacking and of situations or
events occurring prior to snacking
|
· Not used in systematic review, overruled based on strength of qualitative findings
· Supported by qualitative findings
· Expert consensus
|
|
Optimism
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5.4: Monitoring of emotional consequences (not used)
Definition: Prompt assessment of feelings after attempts at performing the behaviour
|
· Not used in systematic review, overruled based on strength of qualitative findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: HBM & SRT
Constructs: Modifying factors; self-monitoring
Suggested/example intervention component(s):
· Booklet to be completed/populated in discussion with a HCP, reviewed and feedback provided to provide positive reinforcement
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Beliefs about consequences
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5.1: Information about health consequences (used/promising)
Definition: Provide information (e.g. written, verbal,
visual) about health consequences of
performing the behaviour
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: HBM
Constructs: Individual factors; modifying factors
Suggested/example intervention component(s):
· Information booklet and/or DVD with patient and HCP narratives
|
|
|
5.3: Information about social and environmental consequences (used/promising)
Definition: Provide information (e.g. written, verbal,
visual) about social and environmental
consequences of performing the behaviour
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· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
|
Reinforcement
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10.4: Social reward (not used)
Definition: Arrange verbal or non-verbal reward if
and only if there has been effort and/or
progress in performing the behaviour
(includes ‘Positive reinforcement’)
|
· Not used in systematic review, overruled based on strength of qualitative findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Feedback
Suggested/example intervention component(s):
· Feedback from a HCP or social group relating to attainment of goals
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|
Intentions
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5.1: Information about health consequences (used/promising)
Definition: Provide information (e.g. written, verbal,
visual) about health consequences of
performing the behaviour
5.3: Information about social and environmental consequences (used/promising)
Definition: Provide information (e.g. written, verbal,
visual) about social and environmental
consequences of performing the behaviour
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· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: HBM
Constructs: Individual factors; modifying factors
Suggested/example intervention component(s):
· Information booklet and/or DVD with patient and HCP narratives
|
|
Goals
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1.1: Goal setting (behaviour) (used/promising)
Definition: Set or agree on a goal defined in terms of the behaviour to be achieved
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Goal setting
Suggested/example intervention component(s):
· Goal setting component within the booklet. Template to be completed in discussion with a HCP
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|
Memory, attention and decision processes
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8.3: Habit formation (not used)
Definition: Prompt rehearsal and repetition of the
behaviour in the same context repeatedly
so that the context elicits the behaviour
|
· Not used in systematic review, overruled based on strength of qualitative findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Goal setting; action planning
Suggested/example intervention component(s):
· Goal setting and action planning components within the booklet. Template to be completed in discussion with a HCP
|
|
Environmental context and resources
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3.1: Social support (Unspecified) (used/promising)
Definition: Advise on, arrange or provide social
support (e.g. from friends, relatives,
colleagues,’ buddies’ or staff) or non-contingent praise or reward for performance of the behaviour. It includes encouragement and counselling, but only
when it is directed at the behaviour
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Action planning; feedback
Suggested/example intervention component(s):
· Access to repository of information about physical activity options and support via a HCP
· A booklet showing examples of the physical environment that can be populated (tailored to the individual)
|
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12.1: Restructuring the physical environment (not used)
Definition: Change, or advise to change the physical
environment in order to facilitate
performance of the wanted behaviour or
create barriers to the unwanted behaviour
(other than prompts/cues, rewards and
punishments)
|
· Not used in systematic review, overruled based on strength of qualitative findings
· Supported by qualitative findings
· Expert consensus that it is not appropriate for everyone
|
|
Social influences
|
3.1: Social support (Unspecified) (used/promising)
Definition: Advise on, arrange or provide social
support (e.g. from friends, relatives,
colleagues,’ buddies’ or staff) or non-contingent
praise or reward for performance of the behaviour. It includes encouragement and counselling, but only
when it is directed at the behaviour
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Feedback; action planning; problem solving
Suggested/example intervention component(s):
· Access to repository of physical activity options and support via a HCP
· Use of booklet to plan support around physical activity
|
|
Emotion
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3.1: Social support (unspecified) (used/promising)
Definition: Advise on, arrange or provide social
support (e.g. from friends, relatives,
colleagues,’ buddies’ or staff) or non-contingent praise or reward for performance of the behaviour. It includes encouragement and counselling, but only
when it is directed at the behaviour
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Feedback; self-monitoring
Suggested/example intervention component(s):
· Access to repository of physical activity options (e.g., local groups) via a HCP to provide ongoing support
· Use of booklet to monitor effect of PA on emotions and mood followed by feedback from a HCP
|
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5.4 Monitoring of emotional consequences (not used)
|
· Not used in systematic review, overruled based on strength of qualitative findings
· Theme from qualitative research
· Expert consensus
|
|
Behavioural regulation
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1.1: Goal setting behaviour (used/promising)
Definition: Def: Set or agree on a goal defined in terms of the behaviour to be achieved
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
Relevant theory: SRT
Constructs: Goal setting; action planning; feedback; self-monitoring
Suggested/example intervention component(s):
· Booklet template to be completed with a HCP. Provision for self-monitoring and feedback (e.g., use of pedometers).
|
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1.4: Action planning (used/promising)
Definition: Prompt detailed planning of performance of the behaviour (must include at least one of context, frequency, duration and intensity).
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
|
2.2: Feedback on behaviour (used/promising)
Definition: Monitor and provide informative or evaluative feedback on performance of the behaviour (e.g. form, frequency, duration, intensity)
|
· Supported by systematic review findings
· Supported by qualitative findings
· Expert consensus
|
|
2.3: Self-monitoring of behaviour (used/non-promising)
Definition: Establish a method for the person to monitor and record their behaviour(s) as part of a behaviour change strategy
|
· Supported by qualitative findings
· Expert consensus overruled systematic review. Feedback on behaviour required undertaking of self-monitoring.
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Theoretical underpinning of the healthcare professional component of the intervention
Social Cognitive Theory (27) was selected to underpin the development and evaluation of the healthcare professional component of the multifaceted intervention to target consultation behaviour. This theory was considered appropriate with reference to the findings from the focus group discussions with HCPs during Step 1. For example, HCPs highlighted the need for specific knowledge and skills development training that would enable them to attain specific practice-related goals. These included promoting and supporting an increase in physical activity to enable improvements in specific functional outcomes of patients. Social Cognitive Theory provides specific examples of evidence based strategies for translating motivation/intentions into action/behaviour in healthcare professionals through the use of modelling to increase skills and self-efficacy. (28) Focus group data supported the need for modelling to facilitate skill acquisition and target beliefs about capabilities.
The selection of BCTs incorporated in to the HCP component of the intervention was also informed by findings from the qualitative focus group discussions conducted as part of step 1. The decision making process is summarised in Table 5 which also describes how BCTs were operationalised to support stroke survivors to engage in the PARAS intervention to engage in activities, improve their levels of physical activity and reduce sedentary behaviour.
Table 5. Theoretical intervention mapping targeting healthcare professional consultation behaviour
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TDF Domain
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BCTs identified by healthcare professionals in PARAS qualitative work
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Theoretical constructs targeted and potential intervention components
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Knowledge
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5.1: Information about health consequences
9.1: Credible source
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Relevant theory: Social Cognitive Theory
Constructs: Forethought capability, Vicarious learning capability
Suggested/example intervention component(s):
· A face-to-face training programme presenting research evidence supporting increased physical activity and reduced sedentary behaviour in the context of stroke
· Case studies of patients who have successfully increased their physical activity levels and/or reduced sedentary time and if possible
· Case studies from physiotherapists who have successfully supported stroke survivors to be more physically active
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Skills
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1.2: Problem solving
1.4: Action planning
3.1: Social support (practical)
3.3: Social support (emotional) – includes motivational interviewing
4.1: Instruction on how to perform the behaviour (Includes skills training)
5.1: Information about health consequences
6.1: Demonstration of the behaviour
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Relevant theory: Social Cognitive Theory
Constructs: Forethought capability, Self-regulation capability, vicarious learning capability, Self-efficacy
Suggested/example intervention component(s):
· A manual to accompany the face-to-face training programme which HCPs complete throughout as the training progresses
· Role play and demonstrations of intervention materials being used
· Encourage a buddy system among HCPs
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Social/Professional role
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5.2: Salience of consequences
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Relevant theory: Social Cognitive Theory
Constructs: Outcome expectancies); Forethought, Self-regulation
Suggested/example intervention component(s):
· Verbal delivery explaining the benefits of physical activity promotion and providing ongoing support.
· Patient narratives
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Beliefs about capabilities
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1.2: Problem solving
1.4: Action planning
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Relevant theory: Social Cognitive Theory
Constructs: Self-regulation
Suggested/example intervention component(s):
Problem solving and action planning in the context of practice (i.e. teaching how to complete action planning with patients).
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Beliefs about consequences
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1.2: Problem solving
1.4: Action planning
4.1: Instruction on how to perform the behaviour
6.1: Demonstration of the behaviour
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Relevant theory: Social Cognitive Theory
Constructs: Forethought, Self-regulation, Vicarious learning
Suggested/example intervention component(s):
· Completion of tasks within the training manual
· Teaching problem solving and action planning in the context of physiotherapy practice
· Instruction in the manual on how to action plan and problem solve
· A demonstration of action planning and problem solving
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Reinforcement
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2.5: Monitoring of outcomes of behaviour without feedback
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Relevant theory: Social Cognitive Theory
Constructs: Self-regulation
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Environmental context and resources
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1.2: Problem solving
4.1: Instruction on how to perform the behaviour (includes skills training)
5.2: Salience of consequences
6.1: Demonstration of the behaviour
9.1: Credible source
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Relevant theory: Social Cognitive Theory
Constructs: Forethought, Self-regulation, Vicarious learning, Self-efficacy
Suggested/example intervention component(s):
· Provision of face-to-face training programme with accompanying manual
· Repository of information providing details of local physical activity groups, support and resources
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Step 4: Development of the PARAS intervention
Following the intervention mapping exercise in Step 3, a prototype intervention was developed and presented to stroke survivors and HCPs to further engage them in an iterative co-design process.
Stroke survivor co-design workshops
We conducted three co-design workshops with stroke survivors (n=21). The aim of these workshops was to elicit views on intervention content, form and mode of delivery of the intervention. Prototypes of the intervention tools (workbook, physical activity diary, information on apps accessible on mobile phone) and a range of pedometers were circulated during workshops to facilitate discussion and generate feedback. During the first two workshops (n=13 stroke survivors) a feedback form was used to collate opinions/information (Appendix B). To support the involvement of stroke survivors with aphasia (impairment of language), the third workshop was delivered with the North East Aphasia Research User Group (https://www.neta.org.uk/) (n=8 stroke survivors). This workshop was delivered in an aphasia friendly format (i.e. using strategies to enable understanding of language) and verbal rather than written feedback was collated. To enable stroke survivors with aphasia and cognitive difficulties to take part in future testing of the intervention, aphasia friendly consent forms and information sheets (Appendix C and D) were developed specifically for the study and taken to the aphasia research group for feedback prior to use. All three workshops were audio-recorded and transcribed verbatim to capture feedback generated and facilitate the intervention development processes.
Key findings of stroke survivor co-design workshops
A detailed overview of workshop findings with stroke survivors is provided in Appendix E. In summary, participants reported a preference for the intervention to be supported by HCPs and delivered either at home or in a community outpatient setting. A preference was reported for at least two sessions, with the first session delivered face-to-face and subsequent sessions delivered either face-to-face or by telephone. The majority (>75%) of stroke survivors either strongly agreed or agreed that the content of the intervention workbook was well organised, easy to follow and appropriate. The physical activity diaries were reported to be well designed and considered easy to use by most participants. However, mixed views were received on whether other stroke survivors would use the diaries and the commercially available apps discussed, although it was agreed that this required further testing in a feasibility study. Eight commercially available pedometers that have been used successfully in other physical activity studies (29-31) were presented to stroke survivors during the workshop. The CSX 301S 3D simple pedometer was considered the most appropriate from those shown and was the only pedometer to be voted by all participants as easy to use and something they would be likely to use.
Healthcare professional feedback
An online questionnaire was completed by four North East community stroke teams (n=11 HCPs) to elicit feedback on the prototype intervention. These teams had previously expressed an interest in reviewing the intervention and taking part in a future feasibility study. The Template for Intervention Description and Replication (TIDieR) checklist (10) was used to present the components of the prototype intervention to the stroke teams.
Findings: Feedback in relation to the intervention design and content was largely positive (Appendix F). Team 2, 3 and 4 strongly agreed or agreed with the suitability of the intervention, tools and mode of delivery. Team 2 were uncertain about whether they could deliver the intervention within their team because they reported discharging patients to other rehabilitation services (i.e. follow-up reviews might not be possible). Team 4 raised concerns about their confidence in being audio-recorded delivering the intervention for fidelity assessment and feedback in the context of a feasibility study.
Team 1 were less certain about the content of the intervention in terms of delivery expressing a need for training. There were also some issues highlighted by Team 1 in terms of whether their patients would be suitable for the intervention because it was felt that patients may have been discharged from their service if they were sufficiently mobile to take part in the intervention. A further meeting was held with Team 1 to discuss concerns and provide more detail that could enable a more informed decision regarding potential participation in a feasibility study of the intervention (e.g. to further emphasise that the intervention was not aimed at ‘high functioning’ patients). Following this meeting, Team 1 agreed they could potentially deliver the intervention.
Step 5: Formulation of an implementation plan
An important consideration during the development of the PARAS intervention was implementation of the intervention and that it targeted all three pillars of high quality care: patient experience; safety and effectiveness. (32) To increase the likelihood of implementation, the APEASE criterion: affordability; practicability; effectiveness and cost-effectiveness; acceptability; side effects/safety and equity (33) were considered and applied in the final intervention design. The final intervention components and APEASE criteria are provided in Table 6.
Step 6: Development of an evaluation plan
In order to further develop and optimise the PARAS intervention within community stroke settings, the most appropriate next step was to undertake a feasibility study to inform the iterative development of the intervention (in accordance with the MRC Framework). A protocol was developed for a feasibility study and outlined objectives relating to the stroke survivor component of the intervention, including feasibility and acceptability of intervention components, mode of delivery and fidelity of delivery, receipt and enactment of the intervention. (34) The protocol also outlined outcomes relating to the healthcare professional training component of the intervention to assess their attitudes and skills pre-and post-training. The feasibility study is currently recruiting and is registered on the ISRCTN website (Trial identifier: ISRCTN35516780, date of registration: 24/10/2018 URL http://www.isrctn.com/ISRCTN35516780).
Table 6 PARAS intervention components described with the Template for intervention Description and replication (TIDieR) and APEASE criteria considered in development phase
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TIDieR component
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Description
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APEASE criteria considered
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Brief name: Provide the name or a phrase that describes the intervention
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Physical Activity Routines After Stroke (PARAS)
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Why: Describe any rationale, theory, or gaol of the elements essential to the intervention
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See needs assessment step 1-5
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What: materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (e.g. online appendix, URL).
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Components provided to/used by stroke survivors
· Consent form and participant information sheet
· Intervention toolkit including: stroke survivor workbook; repository of local/national information on PA choices; self-monitoring tools (activity diary, pedometer (3DFitBud-Counter-Walking-Pedometer, 3D active, UK) and instructions, app advice); laminated goal summary sheet and fridge magnet pen; laminated benefits, outcomes and activities cards to aid discussion between stroke survivor and HCP and support people with speech and language problems
Components provided to/used by healthcare professionals
· Consent form and participant information sheet
· HCP training brochure
· Dictaphone
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Affordability: Portable document format (PDF) files of all the intervention tools were created, printed out and stored in a workbook file meaning extra patient specific sheets could be added to individual’s files (e.g. physical activity diary). This process allowed iterative changes to be made without large costs of reprinting manuals. Rather than creating a website with large costs linked to maintenance and development, it was decided to trial a paper-based version of the intervention initially which could be developed online at a later date.
The pedometer selected had a relatively low price point (£16.99) to enable increased sued with NHS settings.
Practicability: HCPs were provided with a PARAS kitbag holding all the intervention tools so they could deliver the intervention then and there rather than having to for example find out information about available resources and get back to participants at a later date.
Acceptability: all components tested at co-design workshops and developed iteratively in response to feedback
Equity: The stroke survivor intervention tools were designed to be inclusive so individuals with speech and language or cognitive difficulties would not be excluded as is the case in the majority of stroke research studies.
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What: procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities.
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Stroke survivor procedures
Supported self-management programme involving goal setting, action planning, barrier identification, coping planning and feedback around PA and sedentary behaviour.
HCP procedures
Training programme aimed at developing physical/sedentary behaviour counselling skills of HCPs. Initial training before delivery of intervention then feedback provided on delivery.
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Acceptability, affordability and practicability: Supported self-management was identified as the most appropriate mode of delivery for the stroke survivor component following our needs assessment and co-design workshops. This type of intervention appears more sustainable than for example face-to-face structured group exercise which presents with a number of environmental and resource related barriers.
Acceptability and effectiveness: Although HCPs working in community stroke care will have some experience of goal setting etc. qualitative workshops identified there were training needs in this area and it was acceptable to target these needs.
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Who: For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given.
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Provider of stroke survivor component
A healthcare professional (HCP) who is a credible source (e.g. well informed on stroke rehabilitation) and plays a key role in the stroke survivors community rehabilitation e.g. physiotherapist, occupational therapist, nurse.
Provider of HCP component
Health psychologist with experience in delivering behaviour change interventions in long-term conditions, research physiotherapist with 20 years clinical experience and 10 years research experience in developing and delivery physical activity and rehabilitation stroke interventions
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Affordability, practicability and acceptability: PARAS focus groups identified delivery of the stroke survivor component should be by a healthcare professional with experience working in stroke. Using healthcare professionals embedded within community stroke teams meant these individuals already had specialist core stroke skills meaning training was not required in this area alongside training in PARAS delivery. As the intervention was designed to be delivered within usual care this meant there were not additional salary costs. Initially consideration was made to include technical instructors and rehab assistants however on discussion with these individuals it was felt they would prefer to support the delivery rather than lead on the delivery and that they were not happy to be audio-recorded as part of the fidelity assessment.
Acceptability and effectiveness: As the providers of the HCP training had developed the intervention and were experienced in this field from both a therapy and a psychology perspective they were thought to be the most credible source to deliver the training.
Practicability: At this feasibility stage it was decided that two members of the research team would deliver the HCP training face-to-face. This allowed the research team to highlight any iterative changes required to the training programme before scaling.
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How: Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group
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Stroke survivor component
First session face-to-face, follow-up sessions either face-to-face or remotely by phone dependent on patient choice.
HCP training component
Face-to-face for initial training, then email and phone contact to provide feedback
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Acceptability: The modes of delivery were assessed as acceptable from our needs assessment, co-design workshops and questionnaires.
Affordability and practicality: Our qualitative work indicted that this mode of delivery of the stroke survivor intervention was practical. As the community HCP involved in delivering the stroke survivor component were already working with the stroke survivors participating in the study it was practical for them to initially see the participants face-to-face. To lower travel costs the option of providing the review sessions by phone was provided
Acceptability, affordability and practicality: The HCPs were very clear that they wanted training face-to-face as they felt E-Learning was not effective. The HCP component was delivered in a group format to each of three community teams involved. This reduced costs of training individuals. Delivering three spate sessions rather than delivering the training to everyone at once meant that the training could be fitted around the needs of each service.
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Where: Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features.
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Stroke survivor component
UK NHS community stroke services. Delivered In patient’s homes or outpatient settings
HCP training component
Initial face-to-face training delivered at participating community stroke teams’ education centres.
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Acceptability: Our needs assessment, co-design workshops and resource capacity mapping exercise within services identified the acceptability of the intervention location.
Practicality: It was hypothesised that delivering the stroke survivor intervention within patients homes would allow the HCP to provide better support to the participants as they would have an increased understanding of the participants environmental circumstances. This was felt to outweigh costs associated with community visits.
Affordability: Although travelling to the community sites to deliver the HCP training had cost implications, it was believed more HCP would attend if the trainers travelled to the participants. In the future, it is thought that this training could be delivered online but at this stage to enable as much knowledge on delivery face-to-face training was deemed most appropriate.
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When and how much: Describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose.
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Stroke survivor component
At least two sessions. The first session/s targets goal setting using the workbook and other tools, there will then be a review session timed to coincide with review date for PA/sedentary behaviour goals. There is no upper limit to sessions the number is defined by patients’ support needs/availability of resources.
The programme to be initiated once ‘functional rehab’ goals have been achieved and the stroke survivor is moving towards supported self-management. The time from stroke will vary dependent on needs of participant/health care professional’s opinion on the best timing/availability of resources.
HCP training component
Three-hour face-to-face training session. Email and phone delivery support by study team. Email feedback on the delivery of the intervention after completion with two stroke survivors.
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Acceptability: Our needs assessment and co-design workshops identified what was acceptable in terms of timing and dose of delivery of the components of the intervention.
Side effects/safety: Our needs assessment and co-design workshops provided evidence that the intervention training and delivery methods would be safe with minimal side effects. As the stroke survivors were already being seen by a community stroke team with specialist skills it was felt that this team would be able to effectively identify any risks associated with taking part in the intervention and potential changes in physical/sedentary behaviour.
Effectiveness: It was hypothesised that all the components of the stroke survivor intervention could be delivered effectively within the two or more sessions.
It was also hypothesised that all elements of the stroke survivor intervention delivery could be taught effectively within three hours with email and phone contact for support during delivery
Affordability: The supported self-management approach for the stroke survivor component provided a more affordable but at the same time potentially effective method of delivery than for example a face-to-face exercise intervention.
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Tailoring: If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how
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Stroke survivor component
Support graded to individuals’ ability, preference, and values and progressed as able
HCP training component
The HCP training was tailored according to personal needs during the face-to-face training, email and telephone support. All participating HCPs received feedback on delivery that was tailored to their individual learning needs.
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Acceptability: The needs assessment, co-design workshops and questionnaires were used to assess the acceptability of tailoring.
Affordability: To enable effectiveness our needs assessment identified that a person centred individual tailored approach was required for the stroke survivors. This approach is potentially more expensive than a group based approach, however the increased potential for effectiveness should outweigh these costs.
Equity: the stroke survivor component was designed to allow a person-centred tailored approach that would not exclude any stroke survivor who has the potential to move more or sit less.
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How well: Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them.
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Treatment fidelity strategies for design of study
HCP training. Plan for implementation setbacks e.g. map out stroke team resources prior and during study and plan in case anyone is leaving, rotating etc.
Treatment fidelity strategies for monitoring and improving provider training
Face to face training and standardised training manual provided to HCP. Testing of HCP acquisition skills during training and delivery. Minimise drift in HCP skills during programme delivery e.g. monitor how work books are completed and delivery of sessions through audio recording and checklist completion. Programme leads available to provide training on aspects of delivery on request. Tailor training to needs of HCPs delivering programme
Treatment fidelity strategies for monitoring and improving delivery of programme
Assessment of delivery of programme through audio recording and analysis of sessions and completion of workbook to enable provision of feedback and training on delivery of programme to HCPs
Treatment fidelity strategies for monitoring and improving receipt of programme
Assess participants understanding of programme, use of cognitive skills and ability to perform behavioural skills through completion of workbook and analysis of audio-recorded sessions
Treatment fidelity strategies for monitoring and improving enactment of programme skills
Review workbook completion and achievement of goals.
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Practicability and effectiveness: Informed by previous delivery of physical activity interventions in diabetes and cardiovascular disease.
Fidelity assessment based upon Bellg, A. J., Borrelli, B., Resnick, B., Hecht, J., Minicucci, D. S., Ory, M., & Czajkowski, S. (2004). Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychology, 23(5), 443.
Acceptability: The main issue brought up by the HCPs during the devlopment phase was the need to audio-record the intervention delivery. When it was discussed that this approach was to detrmine whether our training programme was appropaite the HCPs stated they thought this was acceptable. Whether this was actually the case will be further tested in a feasbility study.
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