This is a single-blind, two-arm parallel randomized controlled trial of a nurse-led health coaching program for stroke survivors versus routine care situated in the First Affiliated Hospital and the Third Affiliated Hospital of Army Medical University in Chongqing, China (Fig. 2). These hospitals are chosen as they are nearly identical regarding patient population and staff profiles. They serve for the same civilian population in a large metropolitan area and are administered by a similar governance body, policies, standards; and have same staffing levels and education and training for staff. The intervention will last 12 weeks. Data collection will be at three time points: the baseline (after the consent form is signed), immediately after the intervention (at 12 weeks), and 24 weeks from the baseline. Stroke survivor-caregiver dyads will participate in the study and will be recruited from the hospitals mentioned above. Four stroke wards from these tertiary hospitals (two from each hospital) will participate in the study. The care services provided to stroke patients in these wards are similar. The nurse-led health coaching program will be conducted at stage 1 in the hospital and stage 2 in the community after discharge from hospital. The trial follows the Recommendations for Intervention Trials (SPIRIT) that is presented in Additional file 1.
[Insert figure 2 about here]
Ethical approvals and consent to participant
The protocol was approved by the Southern Adelaide Clinical Human Research Ethics Committee (Approval Number: 230.18) and the Institutional Review Boards of the First Affiliated Hospital and the Third Affiliated Hospital of the Army Medical University, China. Informed consent will be obtained from all participants. Any information provided by participants will be collected in a de-identifiable form. Each participant and participating health facility will be given a unique numerical code to represent them on data collection forms used throughout the project. Any information provided to the study will be treated in strict confidence, and none of the participants will be individually identifiable in research reports. All paper-based questionnaire surveys and patients and caregivers files will be locked in a safe cabinet in the research office and only the co-investigator will have access to it.
Eligibility: Inclusion criteria and exclusion criteria
Inclusion criteria and exclusion criteria for stroke survivors
Participants will meet all of these inclusion criteria: (1) aged 18 or over; (2) first-time stroke survivors (ischemic or haemorrhagic stroke); (3) will be discharged to home-care setting within a week; (4) have no cognitive impairment (Montreal cognitive assessment score ≥23) (24); (5) not participating in other clinical trials at the same time; (6) can speak Chinese without aphasic; and (7) willing to participate in this study.
Participants will be excluded if they have (1) comorbidities such as severe circulation, digestive, immune, blood and endocrine systems disorders; (2) existing cerebrovascular disease with impaired limb function; (3) mental illness (such as Panic disorder, PTSD, Psychosis, Schizoaffective disorder, Schizophrenia); or (4) existing cognitive impairment (depression and delirium) and disabilities prior to stroke .
Inclusion criteria and exclusion criteria for caregivers
Caregivers will meet all these inclusion criteria: (1) aged 18 or over; and (2) be the primary caregiver. Caregivers will be excluded if they (1) are under 18 years old; or (2) have mental or cognitive disabilities. Inclusion criteria for health coaches
Health coaches will be trained intervention nurses from each participating ward of the two hospitals, and they will conduct all interventions in this study. The eligibility criteria for health coaches are (1) a registered nurse; (2) at least a bachelor’s degree in nursing; and (3) at least 5-years work experience in the care of stroke survivors.
We will allocate eligible participant dyads to the intervention group or the control group using simple randomization, with an equal allocation ratio of 1:1, using IBM SPSS Statistics version 25 random sampling and allocation methods. A research associate who is not involved in recruitment, intervention allocation or outcome assessment will generate the random numbers. Allocation concealment will be ensured by the research associate putting the group allocation into sequentially numbered, opaque, sealed envelopes to inform the intervention nurse after baseline data collection for each dyad.
Participant dyads and intervention nurses will not be blinded due to the nature of the intervention. However, the researcher, who will collect the outcome assessments and undertake data entry and analysis, will remain blinded to treatment allocations. Intervention nurses, who will conduct the telephone and outpatient clinic follow-ups, will not be blinded as they will need to update participant information and maintain the intervention and service.
Description of the interventions
Interventions that will be implemented in this study are based on effective health coaching components identified in a systematic review and meta-analysis conducted by the research team prior to this RCT study (25) and other systematic reviews and studies on health coaching in chronic condition management (26-29). A two-stage intervention for the intervention group will be conducted as described in the following.
Stage I: Interventions while in hospital
An intervention nurse will provide participant dyads with individualized health coaching within one week prior to discharge from hospital.
Individualized health coaching: intervention nurses will provide participant dyads with two face-to-face individualized health coaching sessions (20-30 minutes each). All health coaching sessions will be based on the “Health Coaching Intervention Program Guide” (Table 1) to standardize interventions in the study.
[Insert table 1 about here]
Outline of health coaching activities:
- Participant dyads will establish their transition care goals and develop personal action plans.
- An intervention nurse will demonstrate self-care and other skills required by participant dyads when providing Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADL) and participating in social engagements.
- Participant dyads will discuss a safe home environment including safe toileting, walking and sleeping. Home environment modifications will be undertaken prior to discharge when needed.
- An individualized functional recovery and physical exercise plan will be developed based on the recommendation from the stroke survivor’s medical specialist. An intervention nurse will discuss the plan and demonstrate skills when appropriate. The functional recovery and physical exercise plan will be recorded in the “Stroke Health Coaching Diary” (Additional file 2).
- Stroke survivors will be given an individualized treatment and rehabilitation plan provided by medical specialists, have opportunities to discuss and clarify the plan and receive medication education from an intervention nurse. The treatment and rehabilitation plan will be recorded in the “Stroke Health Coaching Diary”.
- An intervention nurse will demonstrate how to prevent, identify and manage stroke-related complications.
Stage II: Follow-up interventions in the first 12 weeks after discharge to home
Intervention nurses will provide participant dyads with phone support and face-to-face meetings in outpatient clinics over a 12-week period as follows:
- Weekly telephone support: Participant dyads will receive a weekly telephone call at home from an intervention nurse. Participants will be encouraged to discuss concerns and problems arising from transition care. They will also be provided with resources and strategies to resolve problems. An intervention nurse will motivate participants to monitor their care activities and outcomes towards their transition care goals. Each phone call will last about 10-15 minutes. Participants can also seek additional phone help from an intervention nurse when necessary.
- Bi-weekly face-to-face coaching activities at an outpatient department: Stroke survivors will engage in rehabilitation or have an appointment with specialists at the outpatient clinic bi-weekly. An intervention nurse will use this opportunity to meet with participant dyads. Participant dyads will be asked to bring their coaching diary to this meeting to lead discussion about any concerns and problems they have encountered. An intervention nurse will coach participants to develop problem-solving skills based on their needs, introduce resources to them, reinforce self-care knowledge and skills, and motivate them to self-monitor progress and outcomes towards care goals.
Participants in the usual care group will receive the usual transitional discharge plan that includes verbal stroke-related education and a follow-up telephone call at the end of the first and the fourth week after discharge to home. For usual care, other registered nurses, who are not intervention nurses, will conduct the discharge plan and follow-up.
Outcome measures are based on hypotheses of this RCT. The effects of the intervention will be measured at baseline, 12 weeks and 24 weeks. The general procedure of data collection and assessments is presented in Figure 3 (the SPIRIT figure).
[Insert figure 3 about here]
Outcomes of stroke survivors
- Primary outcomes
1.1 Self-efficacy: This outcome will be measured using the Stroke Self-efficacy Questionnaire (SSEQ). The SSEQ consists of 13 items to test self-efficacy in two dimensions: activity domain (7 items) and self-management (5 items) (30). It has been translated into Chinese and proven to be reliable and valid for the Chinese population with the Cronbach’s α 0.972, and a test-retest reliability coefficient of 0.806 (31).
- Secondary outcomes
2.1 Quality of life: This outcome will be measured using the short version of the Stroke-Specific Quality of Life Scale (SSQoL-12). The SSQoL-12 is a self-assessment scale comprising physical domain (6 items) and psychosocial domain (6 items) (32). The SSQoL-12 has good criterion validity and internal consistency (Cronbach’s α 0.77-0.89).
2.2 Functional ability: This outcome will be measured using (1) the Chinese version of the Barthel Index (BI) for ADL, (2) the Multilevel Lawton Instrumental Activities of Daily Living (Lawton IADL), and (3) the Social Support Rating Scale (SSRS). The BI comprises 10 items and is a valid tool to evaluate the ADL of stroke survivors (33, 34). It has been translated into Chinese with acceptable internal consistency (Cronbach’s α of 0.916) (35). The Lawton IADL is an appropriate instrument with eight categories to assess independent living skills (36). It has been used and proven in the Chinese population with a satisfactory Cronbach’s alpha of 0.739 (37). The SSRS was developed in China and is widely used with high validity (Cronbach’s alpha 0.83 to 0.90) and reliability (test–retest reliability 0.92) (38, 39).
2.3 Stroke-related health knowledge: This outcome will be measured using the Chinese Stroke Prevention Knowledge Questionnaire (SPKQ). The SPKQ comprises 25 items using close-ended questions to assess patients’ stroke-related knowledge. It has been used in the Chinese population with a validity index of 0.89 and Cronbach’s α of 86 (40).
2.4 The number of deaths, adverse events and unplanned hospital admissions: The adverse events will be limited to secondary strokes, falls, ulcers and urinary tract infections to reflect the nurse-led intervention to prevent post-stroke associated complications. These outcomes will be recorded by participants on the “Adverse Events Form” and verified by an intervention nurse.
Outcomes of Caregivers
- Self-efficacy: This outcome will be measured using the Generalized Self-Efficacy Scale (GSES). It contains 10 items to measure people at risk for coping deficiencies. With its highly validity, the GSES has been widely used around the world. It has been used in the Chinese population with a Cronbach’s α of 0.89. Higher scores indicate better self-efficacy (41, 42).
- Caregiver-related burden: This outcome will be measured using the Chinese version of the Modified Caregiver Strain Index (CSI). The CSI contains 13 items including financial, physical, psychological, social and personal domains. It is rated on a scale from 0 (No) to 2 (Yes). The total score ranges from 0 to 26 points, with higher scores indicating greater caregiver burden (43). It was validated in the Chinese population with a Cronbach's alpha of 0.91 (44).
The sample size is estimated on the basis of the primary outcome, stroke survivors’ self-efficacy, measured by the SSEQ (30). We generated the estimated effect size of 0.5 based on a 7.5 point between-group change in SSEQ from baseline reported in a similar RCT by Lo et al. (45). We also estimated a pooled SD of 6.42 based on the 95% confidence interval of the SSEQ score reported in the study. A type I error of alpha 0.05 and a power of 80% were used in the sample size calculation. We expect a 10% dropout rate. Therefore, we will require 70 dyads per treatment group. In total, we will recruit at least 140 participant dyads into the study.
Stroke survivors and their primary family caregivers will be recruited together as participant dyads from participating wards. A recruitment poster will be displayed at the nursing station of each ward and a secure participant response drop-box placed underneath. Participant dyads who are interested in this project will be asked to fill in a response slip that includes their contact details and place it in the drop-box. Upon receiving the response slip, a research recruiter (the secretary in each ward), who is blinded to group allocation and has no interest in the outcome of the study, will contact participant dyads to confirm their participation. On confirmation of participation, an intervention nurse will check the eligibility of participant dyads, explain the project to them and seek informed consent. An intervention nurse will also allocate each participant dyad to either the intervention group or the usual care group after baseline data collection using the sequentially numbered, opaque, sealed envelopes.
Data collection methods
Baseline data collection will be conducted at the hospitals through self-administered questionnaires. The researcher (SLL) will prepare a drop box for each ward. Participants will be instructed to place their completed questionnaire in a sealed envelope to maintain confidentiality and to put the envelope into the drop box. The researcher will collect completed baseline questionnaires on a weekly basis. For 12-week and 24-week follow-up data collection, the researcher (SLL) will mail a questionnaire to participants with pre-paid and pre-addressed envelopes. Participants will be instructed to return the completed questionnaire to the researcher by post.
The intention-to-treat (ITT) approach will be adopted for data analysis. Statistical analysis will be performed using IBM SPSS Statistics version 25 and STATA software version 15. The normality of data will be assessed using normality plots. Percentages will be presented to summarise category data. Means and standard deviation, or medians and IQR, will be presented to describe countinous data with normal distribution and non-normal distribution respectively. Two group comparisons of demographic and clinical characteristics at baseline will be performed using Chi-square tests for category data and independent t-tests or non-parametric Mann-Whitney U-tests for data with normal distribution or non-normal distribution respectively.
The researcher will determine changes in outcome measures at baseline, and 12-week and 24-week follow-ups. To estimate mean changes over time in primary and secondary outcomes, linear mixed effect models for repeated measures will be used to assess differences between the two groups. Fixed effects in the model will include time, group, covariate(s) and the two-way interaction of group and time. The model will also include participant-level random effects to account for correlation between participants’ repeated measures over time. Value and confounders that include age, gender, educational level, insurance type, and number of comorbidities at baseline will be adjusted in this model. A p<0.05 will be regarded as statistically significant for all statistical tests. Estimated mean differences, including 95% confidence intervals and p-values, will be reported for (time × group) interaction effects.
Data monitoring will be overseen by the Southern Adelaide Clinical Human Research Ethics Committee (Approval Number: 230.18). The Committee is independent from the project team and has no competing interests. Researchers are required to provide annual and/or final report to the Committee regarding data monitoring. Detailed requirements can be accessed via the Committee website (46).
Prior to commencing the project, the researcher (SLL) will introduce the intervention study to each participating ward through a one-hour presentation. The purpose of the presentation is to inform health professionals about the study, gain their support and allow them to ask questions in relation to the study.
Four intervention nurses from participating wards (one from each ward) will participate in two workshops (two hours each) to standardize health coaching interventions throughout the project. The workshops will enable intervention nurses to practice health coaching skills, gain feedback from the researcher and their peers, and ask any questions they may have. The workshops will be provided by the researcher (SLL) who is a qualified academic member of the Nursing College of Chongqing Medical University and a specialist in chronic disease management including the care of stroke survivors. Intervention nurses will also be provided with written “Health Coaching Intervention Program Guidelines” (Table 1).
The researcher (SLL) will recruit 3-5 hospital volunteers (laypersons) for a workshop to test whether they understand the questionnaires and measure the time taken to complete. Each intervention nurse will undertake a pilot coaching activity with workshop volunteers and receive feedback from the researcher. To ensure data quality, double data entry will be conducted by four master’s students who are not involved in this study.
Standardized training and written guidelines for intervention nurses will enhance adherence to the study protocol. A “Stroke Health Coaching Diary” and a written education booklet to reinforce health coaching activities for stroke survivor-caregiver dyads in the intervention group will be used to help them adhere to the intervention protocol.
Dealing with contingencies
The first possible contingency in the study is the unforeseen withdrawal of a trained intervention nurse. The strategy to deal with this will be to train another nurse to replace them. The second possible contingency is difficulties in recruiting enough stroke survivor-caregiver dyads to meet the sample size requirement. If required, we will extend the recruitment period to gain enough participants.