A feasibility and pilot study of a “lifelong learning” intervention for people with dementia

doi:10.21203/rs.3.rs-2231616/v1

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A feasibility and pilot study of a “lifelong learning” intervention for people with dementia

https://doi.org/10.21203/rs.3.rs-2231616/v1

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published 30 Apr, 2024

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Background:

Developing evidence for the use of psychosocial interventions for people with dementia is a priority for research. This pilot study aimed to provide estimates of variability for a set of outcome measures considered for a larger controlled study of the effect of attending a lifelong learning intervention for people with dementia, compared to receiving treatment as usual. In the study it was also explored how datacollectors and researchers evaluated the use of the outcome measures in a sample of people with mild to moderate dementia.

Methods:

Initially, a participant consultation, with participants and their teachers at a dementia school, was carried out to identify important research outcomes which were Mini-Mental State Exam (MMSE), Quality of Life Alzheimer’s Disease (QoL-AD), General Self-Efficacy Scale (GSE), Rosenberg Self-esteem scale, Friendship Scale). The following study was divided into two steps. In step 1 participants included were people with dementia attending a dementia school (intervention group) or usual services (control group). The participants were tested at baseline and at 6-month follow-up. Data were collected between November 2018 and July 2019. In step 2 feasibility and acceptability issues in step 1 with the recruitment of participants, data collection process and outcome measures were evaluated and analysed qualitatively.

Results:

Fifty-five people with dementia were included in the analysis of follow-up. Step 1 provided estimates of changes from baseline to follow-up and ancillary standard deviations were provided for all outcome measures. Step 2 provided reflections about feasibility and acceptability of the intervention itself, the data collection, and the outcome measures. This including views on how people with dementia experience participating in the test situation.

Conclusions:

This study provided estimates of change and variability in the outcome measures. Additionally, issues regarding data collection were identified and should be addressed in future studies. It was demonstrated how people with dementia can participate in research which is meaningful to them.

Trial registration:

Registration with a database of clinical studies was according to national legislation, not required, as the study was evaluating existing activities and thus no clinical intervention.

Dementia

cognitive stimulation

lifelong learning

feasibility

1) What uncertainties existed regarding the feasibility? In order to inform sample size in a larger randomised study of the lifelong learning service it was needed to establish a) if people with dementia could participate in choosing outcome measures which were meaningful to them b) estimates of variability for a set of outcome measures used in a sample of people with dementia c) the ability to recruit participants meeting inclusion criteria, participants ability to complete the set of tests, d) how data collectors assessed the burden on people with dementia when carrying out the tests and collecting data.

2) What are the key feasibility findings? People with mild to moderate dementia can participate in research about themselves and contribute with outcome measures meaningful to them. Additional resources may be considered at the individual sites to evaluate eligibility of all possible participants as usual staff has to prioritise daily activities. In the lifelong learning group 30 participants of 43 participants were analysed and in the control group 25 participants of 45 participants were analysed. The data collectors presented a variety of experiences with the different outcome measures from the importance of using pen and paper rather than pc or tablet extending to outcome measures opening for meaningful conversations. All data collectors believe the outcome measures to be feasible yet also suggests other or additional outcome measures.

3) What are the implications of the feasibility findings for the design of the main study? The feasibility findings of the pilot study suggests that a larger randomised study of the effect of a lifelong learning intervention compared to usual services for people with dementia is feasible. Additionally, calculations on power and sample size can draw on estimates of variability for five outcome measures. Future studies should involve people with dementia in defining important outcomes of psychosocial interventions yet be cautious of the direct impact of the research on its participants. It is planned to use the findings from this study in a fully powered randomised study

Being diagnosed with dementia has far-reaching and serious consequences physically, emotionally, and psychologically for patients, family, and carers, and thus effective interventions relieving these consequences are required for [1], [2]. Psychosocial interventions are becoming an integral part of the treatment of people with dementia in Europe, and globally, where the focus is on supporting those living with dementia, delaying its progression [3], and providing evidence-based non-pharmacological interventions [4].

Ward et al. suggest that an innovative lifelong learning approach to provide “education in the classroom”, tailored for people with dementia, can stimulate cognition and memory [5]. In this context, researchers emphasize the underlying philosophy of “lifelong learning” and its potential benefits for empowerment and dignity in later life [6] .Lifelong learning means to continually learn and develop, to remain socially engaged and maintain a life offering the experience of joy [7] .In Denmark, there is a strong tradition for lifelong learning which goes back to N.F.S. Grundtvig (1783–1872), a theologist, who in the aftermath of the time of enlightenment, brought out the idea of providing all people free access to cultural and scientific knowledge [8], [9]. It is on that historic background that a Dementia School in Northern Denmark offers education for people with dementia, in a school environment. Lessons are specially developed to support cognitive function, quality of life, problem solving, self-esteem and social engagement, and this model has been inspired by cognitive training (CT) and cognitive stimulation therapy (CST) [10]. Qualitative research of the school-participants’ experiences with the service supports the lesson aims as participants emphasize self-perceived impacts in these domains [11]–[14]. There is a growing body of evidence about the effect and impact of psychosocial interventions, which has also emphasized the need to distinguish between hallmarks of the various approaches. Examples of such approaches are cognitive stimulation (CS), cognitive stimulation therapy (CST) and cognitive training (CT) [15]. CS is a psychological intervention that enhances cognition through targeting cognitive and social functioning [16]. For example, CS incorporates reality orientation, attention, memory, language and problem-solving [3]. A variant of CS is CST, which is an evidence-based programme that was developed following a Cochrane review and a systematic review of the use of Reality Orientation Therapy for people with dementia [10], [17], [18]. CST consists of 14 x 45-minute group sessions with a manual to guide the sessions [19]. In contrast to CST, CT is often defined as ‘guided practice on a set of standard tasks designed to reflect particular cognitive functions’ for example memory or executive function [20].

Research suggests the benefits of CS can be wide reaching, affecting cognition and socialisation, including communication and quality of life [21], [22]. However, the number of high-quality randomised controlled trials are still low [23]. Comparisons between different studies using CS may also be difficult due to heterogeneity in the study design, including lack of consistency in use of validated measures, sample sizes and use of comparison groups [14].

Much evidence on effectiveness of interventions aimed at dementia is focused on reducing the burden of symptoms characterizing the condition rather than what is experienced as important by those living with dementia [24]. Research is now embracing the patients and their carers in determining important outcomes in dementia research [25]. The emphasis on involving patients, and in some cases their carers, in randomised controlled studies of good quality will require valid and reliable estimates of effects and variability in outcome measures as well as evaluating the feasibility of undertaking such trials.

This pilot study sought to provide estimates of variability for a set of outcome measures considered for a larger controlled study of the effect of attending a lifelong learning intervention for people with dementia, compared to receiving treatment as usual. The pilot study also investigated how data collectors and researchers experienced the feasibility of using the outcome measures in a population of people with mild to moderate dementia.

STUDY DESIGN AND SETTING

Prior to the pilot study, a participant consultation involving students and teachers from the Dementia School. The pilot study fell in two steps. In step 1 the pilot study participants were people with dementia who attended a lifelong learning (intervention) or dementia day service (control). These services are not time-limited but are offered for as long as the person with dementia experiences it as meaningful and staff consider it beneficial. Therefore, length of attendance varied between participants. The activities for both intervention and control groups were in a similar timeframe. Individuals in the control and intervention groups were assessed at the beginning and end of a 6-month period with measures of cognition, quality of life, self-efficacy, self-esteem, and socialisation. Thus, there is no clear baseline as participants were already engaged in the different services. However, the pilot study does not seek to estimate any effect sizes – only variability of outcome measures. In step 2 of the pilot study, feasibility, and acceptability issues with the recruitment of people with mild to moderate dementia, data collection process and outcome measures were evaluated in a focus group interview and analysed qualitatively. Participants in the focus group interview were data collectors and the research team. An overview of the study phases is shown in Fig. 1. This pilot study was carried out in accordance with the CONSORT Extension to Pilot and Feasibility Trials checklist where possible.

Insert [Figure 1 Overview of the study]

Participant consultation

The participant consultation before the pilot study included interviews with two teachers and focus groups with 23 people with dementia attending a dementia school (9 women;14 men). Teachers supported the process, as advocates during this consultation. The consultation explored how people with dementia experienced the lifelong learning and asked what would be important to research for those receiving and delivering the programme. The following factors were identified as important by those with dementia: socialising with peers; wellbeing; learning and learning environment; having an insight into own life situation. The teachers identified the following areas to investigate assessment of cognition and memory; quality of life; verbal fluency and stress and wellbeing. From these findings and two previous qualitative studies conducted with this service the research team identified the measures to be included in the study [11], [12]. This ensured that the outcome measures were important experiences of those attending the lifelong learning programme.

STEP 1 OF THE PILOTSTUDY

PARTICIPANTS

Recruitment for the intervention group was undertaken from four Dementia Schools, located in four municipalities in Northern Denmark. Participants in the control group were recruited from six different dementia services across five municipalities. Prior to recruitment, the researchers conducted an introductory meeting with staff at each service to ensure consistency in the process. Recruitment was conducted between November 2018 to February 2019 where participants were assessed at inclusion and again after six months from April 2019 to July 2019. Participants were recruited if they 1) had a diagnosis of dementia, 2) attended a service providing the lifelong learning programme or another dementia service and 3) were able to provide informed consent. Participants were excluded if they attended fewer than ten times during the data collection period. Allocation was determined by which service was offered in the individual/included municipalities.

TEACHERS

Staff at the Dementia School are, true to the setting, referred to as “teachers”. The teachers’ professional backgrounds varied, but all had health or education backgrounds. Staff at the facilities providing the usual services for people with dementia had health backgrounds.

DATA COLLECTION

In step 1 of the pilot study, tests were conducted by an associate professor (PhD) with experience in dementia and nursing, and two assisting professors in nursing. The associate professor was also a member of the research group.

Prior to the start of the project, the data collectors were trained in the process of data collection to ensure consistency in the assessment approach across the team. The data collectors were not blinded as they attended different services. All tests were conducted according to an agreed protocol and in the same order. To ensure that the tests were administered with consistency, the team met on two occasions to review the process.

ETHICS

The Ethics Committee of Northern Denmark confirmed no further approvals were required due to the national rules for health science research projects. The study adhered to the Data Protection and Privacy Regulations (GDPR) with the research teams’ institution. Registration with a database of clinical studies was not required as the study was evaluating existing activities and thus no clinical intervention. Participants were provided with dementia-friendly information and asked to provide informed written consent. The recruitment process was based upon a collaboration with the participant, their relatives, and service staff. The aim with this process was to provide participants the opportunity to engage in the research, understand what taking part would mean, and provide informed consent to participate.

No incidents of harm to the participants were observed in either the intervention or control groups.

INTERVENTION

Lifelong Learning (LL) group

These were people with dementia receiving a lifelong learning intervention. Participants attend 1–2 days a week and take part in cognitive classes for 3–4 hours a day depending on the progression of dementia. Details of the classes and the aims of the dementia school can be found in previously published papers [5], [11], [12]. This program is designed for people with early-stage dementia to provide ongoing education to support a person with dementia’s cognitive function, decision making and activities of daily living, supporting them to retain their independence for as long as possible. The core focus of the intervention is on the delivery of cognitive stimulation, with a supplementary curriculum that changes according to the interests of those attending [5], [11], [12], [26]. The intervention has been designed into three tiers to support changes and declines in dementia. The intervention sites work closely with their local dementia coordinators and nurses to assess people’s stage of dementia and ensure they are in the most appropriate tier for their level of functioning, and to provide a service for people to move onto when the intervention is mutually agreed to no longer be of interest or benefit. Running since 2000, the intervention is delivered by qualified teachers and has been based on theories derived from cognitive stimulation therapy [10], neuropsychology [27], and education [28].

Control group

The control group engaged in activities delivered via dementia services at day-care centres or other social places that include activities such as dementia cafés, social activities, physical activities with instructors. Activities included crafts, reading newspapers and seasonal activities such as making Christmas and Easter decorations. People with dementia attend 1–3 days a week for 3–5 hours.

OUTCOME MEASUREMENTS

The outcome measures chosen were based on results of the consultation process, qualitative literature in this field and a narrative literature review of existing research of CS, CST, CT, and rehabilitation [14]. A review of these sources identified the following domains: Cognition; Friendship; Quality of life; Self-esteem; Self-efficacy. Accessibility of validated tests in Danish and the level of expertise required to administer the measures was considered when selecting appropriate measures. Following an extensive review of the measures available, five tests were chosen. In order not to over burden the participants, the research team aimed to limit the amount of time for each assessment to a maximum of one hour. The following measures were used:

1) Mini-Mental State Exam (MMSE) [29]. The MMSE is used to support diagnosis of dementia and to assess cognitive decline in patients with dementia. It consists of a series of questions to test mental abilities, memory, language, and attention. This is a well-established validated measure used in dementia research to assess changes in cognition over time. Decline in cognition may be a consequence of dementia, however, an increased or stabilised score on the MMSE could indicate an intervention response [30].

2) Quality of Life Alzheimer’s Disease (QoL-AD) [31], [32]. This is a 13-item measure using a 4-point Likert scale and is a patient self-administered and caregiver-administered measure. Only the patient version was used in this study. The purpose of the measure is to provide psychometric data on perceived quality of life in patients with Alzheimer’s disease.

3) General Self-Efficacy Scale (GSE) [33]. This is a 10-item scale to measure self-efficacy, i.e. an individual’s belief in their own capacity to behave or act in a certain way[34], which relates to emotion, optimism, and work satisfaction. Items are answered on a 4-point Likert scale. Previous research has shown that self-efficacy for those with a diagnosis of dementia is associated with greater control over life situations, improving confidence and a sense of feeling more positive [35].

4) Rosenberg Self-esteem scale [36]. This is a 10-item scale to measure global individual self-esteem, including positive and negative feelings of the self. Items are answered on a 4-point Likert scale. Self-esteem has been associated with happiness and improved relationships [37]. For people with dementia, a diagnosis can have a negative impact on an individual’s self-esteem and can indirectly impact on their health and the way that they manage their diagnosis [38].

5) Friendship Scale [39]. This is a 6-item measure using a 5-point Likert scale. The measure was developed to explore issues of isolation in older adults. Friendship was an important theme emerging from the work of Thoft [11] and Ward [5] in relation to experiences of being a student at the Dementia School in Northern Denmark.

Tests were carried out face-to-face in a quiet room at each service or at the individual’s home, depending on personal preferences. All the participants were able to complete all tests. Time was provided for breaks if needed, and participants were provided with tea/coffee/water.

DATA ANALYSIS

Statistical analysis was carried out using the IBM SPSS version 26. The study sample demographic characteristics were presented using descriptive statistics. Estimates of change and variability were given as mean and standard deviation for each outcome measure for both the LL-group and the control group.

Step 2 Of The Pilot Study

PARTICIPANTS

Participants in the interview group were data collectors and the research group. One data collector was also member of the research group. Otherwise there was no further overlap between the two groups.

FEASIBILITY

Feasibility was evaluated by the data collectors and the research team in a focus group interview. The focus was on feasibility and acceptability of the outcome measures for both the participants, data collectors and the research team administrating the study. Items assessed were the process of recruitment, acceptability of the data collection process, and the acceptability and relevance of outcome measures. Finally, the methodological questions of completeness of data and appropriateness of choice in outcome measures were addressed.

DATA ANALYSIS

One interviewer carried out the focus group interview and is also first author on the manuscript (ALS). The interviews were recorded in Microsoft Teams. The applied analysis technique was deductive in approach as there were initial codes driving the interview. The focus group was structured according to a discussion guide informed by normalisation process theory (NPT) [40]. NPT core constructs are coherence (how people “make sense” of the challenges they face), cognitive participation (the relational work people are willing to invest in the intervention to make the intervention work), collective action (how people operationalise the intervention and which resources are needed to make the intervention work) and reflexive monitoring (how people appraise and understand the intervention) [40]. See Appendix 1 for the discussion guide applied in the focus group interviews. The applied analysis technique was deductive in approach, based on the NPT approach, as there were initial codes driving the interview. This enabled a focus on the data to respond to the aims of the project [41]. A thematic approach was used to conduct the analysis, based on Braun and Clarke [42]. Using their six-stage approach the data was read and coded in line with the identified codes. These initial codes were presented to and discussed with the rest of the research group and the groups’ discussion steered the forming of themes.

Step 1 Of The Pilot Study

PARTICIPANT DEMOGRAPHICS

Staff from the control and intervention services were recruited through a convenience sample. The staff recruited 88 participants (43 in the LL-group and 45 in the control group). Following attrition and exclusions, the final numbers of participants was 55, 30 in the LL-group and 25 in the control group (see flowchart shown in Fig. 1 for details).

Insert [Figure 2 Participant flowchart]

There were statistically significant differences between the groups for age where the LL-group was younger on average (median 72.5 years compared with 76.0 years for the controls) and for MMSE score where the LL group had higher score on average (LL group had mean of 21.83 compared with 18.44 for the control group). Participant demographics can be seen in Table 1. The analysis did not show other significant differences in participant demographics.

Table 1

Baseline data
Characteristics	Control group	LL-group
	n = 25	n = 30
Age in years (median, IQR)	76.0 (72.5–82.5)	72.5 (62.8–74.5)
Gender, n (%)
Male	16 (64.0)	19 (63.3)
Female	9 (36.0)	11 (36.7)
Dementia type, n (%) (2 missing in the control group)
Alzheimer’s disease	17 (73.9)	19 (63.3)
Other types of dementia	6 (26.1)	11 (36.7)
Level of education, n (%) (1 missing in the control group and 1 missing in the LL-group)
Elementary	12 (50.0)	9 (31.0)
Skilled work/short education	11 (45.8)	12 (41.4)
Shorter college/University degrees	1 (4.2)	8 (27.6)
Long university degrees	0 (0)	0 (0)
Participates in other activities, n (%) (5 missing in control group)
No	8 (40.0)	18 (60.0)
Yes	12 (60.0)	12 (40.0)
Housing, n (%)
Care home or other facility	0 (0)	0 (0)
Own home	25 (100)	30 (100)
Other	0	0 (0)
Number of sessions (median, IQR)	25 (17-35.5)	22 (15–25)
Baseline for outcome measures
MMSE mean (SD)	18.44 (5.17)	21.83 (3.44)
QOL-AD mean (SD)	37.24 (5.52)	37.7 (4.04)
GSE mean (SD)	30.46 (6.26)	28.81 (7.10)
Self-esteem scale mean (SD)	19.05 (5.75)	20.74 (4.84)
Friendship scale mean (SD)	20.02 (3.90)	20.22 (3.23)

[insert Table 1 about here]

The mean changes and standard deviation for the outcome measures can be seen in Table 2.

Table 2

Changes in outcome measures (mean, sd) for LL and control groups
	Control group (n = 25)			LL- group (n = 30)
	Baseline	Follow-up	Change (SD)	Baseline	Follow-up	Change (SD)
MMSE mean (SD)	18.44 (5.17)	18.52 (5.64)	0.08 (2.84)	21.83 (3.44)	22.13 (4.23)	0.30 (4.19)
QOL-AD mean (SD)	37.24 (5.52)	37.08 (6.30)	-0.16 (5.01)	37.7 (4.04)	37.33 (5.13)	-0.37 (3.57)
GSE mean (SD)	30.46 (6.26)	29.56 (6.18)	-0.90 (4.71)	28.81 (7.10)	28.96 (5.31)	0.16 (4.62)
Self-esteem scale mean (SD)	19.05 (5.75)	19.72 (5.37)	0.67 (3.62)	20.74 (4.84)	19.97 (5.74)	-0.77 (4.49)
Friendship scale mean (SD)	20.02 (3.90)	19.36 (4.60)	-0.66 (3.65)	20.22 (3.23)	20.97 (3.21)	0.74 (2.35)

[insert Table 2 about here]

OUTCOME MEASURES

The estimates of mean and standard deviations of the outcome measures provided in Table 2 can inform sample size calculations to be carried out in future efficacy studies.

Step 2 Of The Pilot Study

Results

Feasibility And Acceptability Of The Intervention

Recruitment of people with dementia

The number of potential participants varied across the LL and dementia services due to the progressive nature of dementia and the different ways the services are organized (with varying attendance). Recruitment was undertaken by staff at each of the services, and challenges were experienced in relation to participant recruitment. When DCs arrived at the sites, there were instances where a participant did not fulfil the criteria for participation (for example they had a diagnosis of MCI). Entry criteria had been discussed at the introduction meetings, however additional training on recruitment could have mitigated this. It has not been possible to contact the services for follow-up interviews on the recruitment process. The following quote is from the NPT focus group:

“I don’t think the resources were there (at the sites) but with lots of time and resources, a better structure and recruitment could have been established... so recruitment forms could have been filled out correctly from the beginning.” (DC2)

This suggests that future studies could benefit from having resources available for recruiting a research assistant in each site who can document and facilitate the recruitment process in collaboration with the staff to ensure it is managed effectively. The sites were encouraged to contact the research team if they had any questions, or problems occurred. In a couple of situations, a member of the research team supported the sites to complete the registrations.

Feasibility And Acceptability Of The Data Collection Process (Dup: Abstract ?)

The introduction to the tests and the collaborative discussion on how to ensure reliability in the data collection was considered satisfactory. The data collectors agreed unanimously that the data collection was best carried out with pen and paper. It provided a convenient way of introducing the tests for the participants and it was thought that participants would have found it challenging to answer on a tablet or PC. One DC reported:

“Well… In the relation (to the participant) and being able to read their signals and for them to read our signals clearly... I think it (tablet or pc) would have been a disturbance…” (DC3).

The other DCs supported this statement spontaneously.

“Because we realized the importance of the paper... that they needed to see the paper and touch it…and we talked about it. I also needed it as a “prop” when I needed to collect my thoughts”.

This approach could be used in similar studies as it appears to prompt and ensure focus and attention on the assessment for both participant and DCs.

The DCs reported that carrying out the tests was not too difficult. However, on occasion the DCs were hesitant about how to interpret the response to certain questions and the strategy was to write down the answer and then discuss where to “put the mark” with the other data collectors to ensure it was done according to the test guidelines. As an example, on the MMSE a participant was asked which floor they were on, the participant answered, “first floor”. In reality, it was the ground floor, however the building was split level and raised from the ground, giving the appearance of being on the first floor. In this case a point was given. Whether this form of “consensus” process is an advantage is uncertain but might indicate that new data collectors need to pilot test their understanding of the tests before data collection commences. The tests were piloted, however not with people with dementia which might have revealed some of these issues earlier. Discussing whether points should be given or not happened on no more than four occasions.

The data collection process was organised according to the work schedule of the DCs. For future studies, it would be preferable for DCs to collect pre and post data from the same individuals and sites to ensure consistency, but in this study, it was not always possible:

“We could have avoided this (…that different DCs collected pre and post data) if there had been a planned period of time where resources were available for the three of us to handle things because the (data collecting) was competing with other work-related tasks”. (DC1)

The collection of demographic characteristics proved challenging. It was suggested by one member of the research team (RT) that it should have been easy to fill out pre-recorded forms where DC1 noted that:

“It is not that simple…some of these sites do not have a tradition for registering anything… it is like “come when you feel like it” … They (the sites) are asked to do something new… they will find it difficult…or think they don’t have the resources because it is an extra thing to do” (DC1)

The collection of participant characteristics needs to be addressed in a more structured way and with more emphasis on reliability and validity. For example, through a designated staff member supporting the registration of this data. A structured recruitment process and collection of demographic data requires appropriate resources and funding. Staff at the sites were, however, very supportive and engaged in the study.

The DCs were asked about length of time to undertake the tests. The DCs could not give an estimate but said it varied between participants. Overall, it was thought not to be too exhausting for the participants. Perhaps because the participants mostly forgot it was a test situation and acted more like it was a conversation situation. Yet, five tests were perceived as a maximum for one session according to the DCs. The DCs felt that the choice of outcomes was relevant in evaluating a school setting for people with dementia. However, they also felt that it would have been relevant to supplement the chosen outcomes by testing for example communication skills and reading skills.

“I missed some scales that showed if they were better or had maintained communication level, their reading skills, that sort of things – to evaluate a school course… however, that was not what people with dementia saw as important. They focused on being social, trusting oneself and living a life with dementia” (DC1)

Feasibility And Acceptability Of Outcome Measures (Dup: Abstract ?)

The QOL-AD and MMSE are validated to be used with people with dementia, yet DCs did not think these tests were any easier or difficult than the other three tests used in this study, and none of the five tests caused an unacceptable level of stress. The DCs found the outcome measures to be both feasible and acceptable but did express that the process of undertaking the measures was more challenging, and ethically nuanced, than they anticipated.

“We experienced that it does require thought not to exhaust participants or give them a negative experience, so for us… we were challenged on the relational aspect” (DC1) and was seconded:

it was important that they (the participants) did not feel they were being interrogated or felt tested in whether they were “good” or “bad” (DC2)

The DCs and participants found the scoring system of the measures could result in lower scores where they were not able to account for other physical or health conditions that could influence the way a participant answered, for example, one participant had challenges answering questions because of his hearing loss, rather than due to his dementia. The impact caused by normal age-related cognitive decline and the impact of dementia related cognitive deficit should be considered, as this may confound results. As well as health issues confounding potential scores, participant’s everyday skills were also identified as having a potential impact, as one DC reflects on the MMSE:

“If you have been a math teacher or just good with numbers you may ace that question where you count backwards or if you have dyslexia, you can’t write a sentence. I mean, there are other tests that would be better…”. (DC3)

The Rosenberg Self-esteem scale also posed a challenge with the questions “I feel I do not have much to be proud of” and “At times I think I am no good at all”. These questions, in the Danish version of the test, were perceived as double negatives (with subsequent confusion), although the translation is grammatically correct. DCs found that participants could be supported to answer these questions by first establishing what a “positive” answer was and then what a “negative” answer was:

“We often needed to break down for instance four possible questions into two categories; positive and negative – and then break it down further.” (DC1).

An important part of the process, DCs reported, was planning sufficient time to undertake the tests with pe to ensure an ethical process was followed. The DCs found participants needed time to understand some questions, and for DCs to support facilitation of this understanding. For example, to provide the alternative wording the measures suggest, or as already noted, to support a dementia friendly approach to identify ‘positive’ or ‘negative’ responses.

Questions on the QOL-AD, Friendship scale, Rosenberg’s self-esteem scale and GSE scale had the unforeseen effect of prompting people with dementia to share elements of their life-story. It was also noted that these tests could give the foundation for meaningful conversations with people with dementia. DCs suggested that the structure and level of instruction in the MMSE (with its focus on correct answers rather than experiences) could be the reason why conversation was not encouraged. The MMSE test was perceived as the most emotionally uncomfortable test for both people with dementia and the DCs.

“They knew it had something to do with the disease. They had tried it a thousand times before and they may not have remembered when they did it the last time, but they remembered this is not a nice feeling. Here I (the participant) felt like… here I am being confronted – and I (the DC) did not like it either”. (DC2)

The DCS agreed that very few participants were excluded due to any emotional toll. Emotional responses were identified as relating to participant’s frustrations with their declining abilities and skills. Some participants even expressed gratefulness and appreciation for the conversations which touched upon memories and allowed for conversations about past and present life.

Dementia is inevitably a progressive illness. Psychosocial interventions, such as LL, which aim to support people with dementia, delay dementia’s progression and provide meaningful activities, might be part of the answer. Research is crucial in understanding the benefit of these interventions. This paper highlights the implications of different study designs and implementation decisions. It also explores how these can support future study design choices, particularly in examining the feasibility of a larger study of the LL approach for people with dementia to inform sample sizes and optimise choices of effect measures that are reflective of and suitable for people with dementia.

Feasibility And Acceptability Of The Study Design

The pragmatic choice of evaluating existing LL services introduced its own set of challenges. Firstly, randomisation is often considered the best foundation for effect evaluation, however, this was not possible within the existing frames and how the services were organised. Participants had spent variable amounts of time in the services before participating in the study, possibly affecting the outcomes. Participants were also not matched. While the authors recognise that a future study would benefit from ensuring randomisation and comparable times in the service, this study also highlights the challenges of working pragmatically with existing services, where study design, meeting the needs of the service, and people with dementia need to be balanced. Such pragmatics are a part of conducting research in clinical or community settings, and form part of a continuum of research from explanatory to pragmatic [43]. As randomised controlled studies require economic resources and rigorous preparatory work, this study served to establish criteria, which will make an RCT possible and help define the intervention reliably.

The current results underline the need to not only understand cause and effect, but also the influences of how and where the intervention is implemented. people with dementia and their carers show great interest in participating in research about dementia. What is becoming increasingly important is that they give input into what is being researched. Holtrop and Glasgow discuss that research which falls within the pragmatic paradigm of research should consider exploring ‘what works in a typical clinical care setting’ and ensuing that the research questions are focused on issues that patients want to explore [43]. This paper presents one way in which this focus can be achieved, as it drew from previous qualitative research on LL-learning and included a consultation process with those attending and delivering the service.

Feasibility And Acceptability Of The Data Collection Process

Review of the data collection process has provided some areas for future consideration. Following an investigation of data, only three participants (4.4%) were not able to complete the tests. The focus of using a limited number of measures, five in this study, was identified as an appropriate number so as not to over burden the participants. The approach of using paper and pen to complete the measures also provided a focus point and was perceived to aid the process.

One aspect of data collection that could be improved, related to the participant demographic information. Firstly, three participants had MCI and not dementia. This raises a question about potential misdiagnosis and how/what diagnostic information is shared/collected by services. Missing demographic data was also identified e.g., dementia type, level of education, and engagement with other services. This indicates the different approaches in documenting patient characteristics across the different services and municipalities. While entry criteria were discussed at the project meetings, additional staff training on recruitment, or funding may have mitigated this. To further improve completeness and validity of collecting participants’ background information, consideration could be given to involving carers, general practitioners and/or secondary care in this process. Furthermore, the potential to include project costs for staff time may also support this process in enabling staff to dedicate hours to the task.

Feasibility And Acceptability Of Outcome Measures

Key findings in this study were the estimates and variability of measures used to explore the potential effect of attending a lifelong learning intervention for people with dementia and to inform sample sizes for a larger future study. All tests used in this study were chosen based on qualitative input from people with dementia about what they found to be important constructs. However, the concrete, individual tests for the constructs described by people with dementia were chosen by researchers. The choices by the researchers also involved using tests not specifically validated for people with dementia although had been used with people in later life, e.g., the GSE scale, Rosenberg’s self-esteem scale, and the Friendship scale. While some challenges were experienced with the phrasing of reverse questions [13], there is precedent set by other studies for using tests not validated for use with people with dementia, as exemplified in a multicentre randomised controlled trial which used the GSE scale as a secondary measure for evaluating a cognitive rehabilitation programme for people with early-stage dementia [44], and a study of the relationship between self-efficacy and depression with people with dementia [45], [46].

A review of measures was undertaken and those used in this study were identified as the most appropriate at the time, given the requirements to meet the criteria set by those with dementia and the need for validated Danish translations. Since conducting this research, new measures are emerging that address some of these areas, for example, the Engagement and Independence in Dementia Questionnaire [47], and the Positive Psychology Outcome Measure [48] – these offer ways to explore hope, resilience, and social engagement, and are validated for use with people with dementia. The offer of a wider range of validated tests is encouraging, although, many remain as English versions, and so challenges exist in identifying measures that have been translated and validated for use in other countries and across cultures [13].

The MMSE test was completed by all participants, but in the light of the comments by the DCs it may be worth considering using a cognitive test which does not convey the same feeling of “passing or failing” for people with dementia [13]. This poses an interesting challenge as the MMSE is one of the most widely used cognitive assessment in dementia research [45]. However, the MMSE has been found reliable in showing decline, and is a test that can be administered by clinical staff in a short time and has clear guidance for its use [25]. Other studies have also shown that some emotional distress can be experienced for people with dementia when completing the MMSE test [49], and that sensitivity issues apply to the outcomes, which may stem from the shift in its use from a screening test to as a research tool [45]. Decisions on which measure would be most appropriate is a challenge for researchers and needs to be weighed in terms of the intended use, sensitivity, time to complete, and the qualifications required to deliver each measure.

The QOL-AD test has been validated in several countries and appears to have good validity and reliability [45], This test and the GSE scale’s feasibility and acceptability were demonstrated with no missing data and a general acceptance by the DCs who identified these tests’ ability to spark a meaningful conversation about everyday life with the participants. However, there were challenges in using measures that had not been validated for use with people with dementia, particularly in terms of the phrasing of reverse questions. These were reported to cause potential confusion for the participants, thus requiring time, empathy, and explanations of the measures. The Rosenberg self-esteem scale proved to be both a positive and challenging test. It opened some emotional yet meaningful conversations about life with dementia, but it also challenged understanding as the questions alternated between positive and negative statements related to self-esteem. The Friendship scale was more straightforward. All questions appeared to be understandable to the participants and brought thoughts and reflection forward about their social life when living with dementia.

The study was developed pragmatically to enable participation from people in existing groups. This raised several issues, firstly, it was not possible to randomize or match the control and intervention groups and subsequently may have had an impact on the study findings. Secondly, the higher MMSE score in the intervention group may indicate that those participating in LL have a higher level of cognitive functioning. Thirdly, those measures not validated for people with dementia, may measure other constructs than anticipated. However, the measures changed little over time showing reliability, if assuming the participants level of functioning was relatively stable. Further limitations are noted in the capture of participant demographic and participant service engagement information. Service staff were supportive of this project but found it difficult to balance the requirements of the research with the delivery of their normal activities. Further training and financial support for a dedicated liaison between services and research team may support this in future research.

This study is, to the best of the authors’ knowledge the first feasibility and pilot study of the LL programme for people with mild to moderate dementia using more than one method. This study has provided variability and feasibility for the chosen outcome measures which provide inference for researchers and clinicians planning interventions for people with dementia. Additionally, future studies should investigate the positive reception by many participants of measures such as the Rosenberg self-esteem scale, the GSE scale and the Friendship scale for providing background for meaningful conversation, as well as providing translations of existing measures in other languages than English. It was shown that people with dementia can support decisions on what to research to ensure that the research is meaningful and useful for the target group.

CT: Cognitive therapy

CST: Cognitive stimulation therapy

CS: cognitive stimulation

LL: Lifelong Learning

MCI: mild cognitive impairment

DC: Data collectors

MMSE: Mini-Mental State Exam

QoL-AD: Quality of Life Alzheimer’s Disease

GSE: General self-efficacy scale

Acknowledgements

We would like to thank all the participants in the study for their interest and effort in completing each measure. We also want to thank all the professionals in the municipalities in Northern Denmark for their great effort in informing and recruiting the participants for the study and providing us with demographic data of each participant. The team would like to thank Graeme Hawthorne, Principal Research Fellow, Faculty of Medicine Dentistry and Health Sciences, University of Melbourne for the use of and approval for the translation of the Friendship Scale.

Funding

The authors report no funding for this study

Author information

Authors and affiliations

University College of Northern Denmark, Aalborg, Denmark

Ann Lykkegaard Sørensen (corresponding author)

Diana Schack Thoft

University of Northampton, Northampton, United Kingdom

Alison Ward

Jackie Campbell

Authors’ contributions

Ann Lykkegaard Soerensen has made first draft of the paper, contributed to the paper and conducted the statistical analysis in collaboration with Professor Jackie Campbell. Diana Schack Thoft has conducted the tests together with two assisting professors in nursing, organized data and contributed to the paper. Alison Ward has quality checked the registered data and contributed to the paper. Jackie Campbell has quality checked the data and conducted the statistical analysis in collaboration with Ann Lykkegaard Sørensen. She has contributed to the paper.

Ethics declaration

The study was approved by the participating institutions and the participants provided their written consent

Consent for publication

Not applicable

Competing interests

The authors have none to declare

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A feasibility and pilot study of a “lifelong learning” intervention for people with dementia

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Abstract

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Key Messages Regarding Feasibility

Background

Aim

Method

STUDY DESIGN AND SETTING

Participant consultation

STEP 1 OF THE PILOTSTUDY

PARTICIPANTS

TEACHERS

DATA COLLECTION

ETHICS

INTERVENTION

Lifelong Learning (LL) group

Control group

OUTCOME MEASUREMENTS

DATA ANALYSIS

Step 2 Of The Pilot Study

PARTICIPANTS

FEASIBILITY

DATA ANALYSIS

Results

Step 1 Of The Pilot Study

PARTICIPANT DEMOGRAPHICS

OUTCOME MEASURES

Step 2 Of The Pilot Study

Results

Feasibility And Acceptability Of The Intervention

Recruitment of people with dementia

Feasibility And Acceptability Of The Data Collection Process (Dup: Abstract ?)

Feasibility And Acceptability Of Outcome Measures (Dup: Abstract ?)

Discussion

Feasibility And Acceptability Of The Study Design

Feasibility And Acceptability Of The Data Collection Process

Feasibility And Acceptability Of Outcome Measures

Limitations

Conclusion

Abbreviations

Declarations

References

Supplementary Files

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