Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.
This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.
Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.
NCT05571150; Preresults.
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Stroke is a leading cause of long-term disability.1 According to the WHO, of the 15 million people who experience a stroke annually, 5 million die and another 5 million are left permanently disabled.1 In Taiwan, approximately 230 people experience a stroke each day,2 with a prevalence rate of about 19.3 per 1000 people.3
Participation is a primary recovery goal and health indicator for stroke survivors and their caregivers.4 5 According to the International Classification of Functioning, Disability and Health, participation is defined as ‘involvement in life situations’ 6(p10), which encompasses engagement in various life domains such as productivity, social life and community involvement.7 It also includes fulfilling social roles and cannot be separated from the context in which an individual lives.6 Participation enhances recovery by increasing a person’s motivation, competence and self-efficacy.8 Challenges an individual faces in participation are termed ‘participation restrictions’, referring to limitations in life situations and roles that are important to the individual.6 Restrictions in participation can contribute to a decreased quality of life and negative health outcomes.9
Both stroke survivors and their caregivers may face numerous restrictions in participation. Following a stroke, survivors and their caregivers must contend with challenges such as loss of employment, marital breakup and difficulties managing family care responsibilities following a stroke.10 Most survivors give up leisure activities they enjoyed before their stroke, spending more time on passive and solitary activities.11 12 Similarly, family caregivers often sacrifice their personal time to care for the survivors, resulting in a substantial reduction in their participation in valued activities.13 Consequently, both survivors and caregivers may experience a profound sense of social isolation and changes in their relationships,14 potentially leading to severe physical and mental health conditions.15–19
Although participation outcomes are important to both stroke survivors and caregivers, the current healthcare system predominantly focuses on the needs of stroke survivors, often neglecting caregivers, who are commonly viewed merely as resources for the survivors.20 As a result, caregivers frequently report stress, isolation, emotional distress and various physical and psychological health issues,21–23 which negatively impact both caregiver and stroke survivor outcomes.23–25 Therefore, services and programmes designed to address the needs of survivor-caregiver dyads during care transitions are essential.
Dyadic interventions are designed to target both the survivor and their family caregiver as active participants.26 These interventions typically aim at dyadic outcomes, such as the health, quality of life, physical and psychological conditions, knowledge, service use and satisfaction of both survivors and caregivers.27 Some studies also examine specific outcomes for survivors, such as physical functions, and for caregivers, such as preparedness, burden, stress and strain.27 While the dyadic approach has been explored in stroke, dementia, oncology and other chronic conditions,28–31 the body of literature remains limited.28
Three types of dyadic interventions are commonly found in the literature: psychoeducational (providing survivors and caregivers with knowledge and resources), support (focusing on peer interactions for support) and skill-building (training in problem-solving, goal-setting and functional skills such as mobility and activities of daily living).26 Among these, skill-building interventions that emphasise goal-setting and problem-solving have shown potential in enhancing the quality of life and reducing depression and anxiety in both survivors and caregivers, as well as improving survivors’ physical functions.26 31 However, the evidence is still unclear and mixed.27 Most of these interventions have been dyad-based (involving both survivors and caregivers in the intervention) rather than dyad-focused (targeting dyadic outcomes), often placing a majority of emphasis on either survivors or caregivers.26 27 31 Very few interventions are designed to address the needs of both survivors and caregivers equally.27 Without an equal emphasis on both individuals in a dyad, the needs of either survivors or caregivers can be neglected, potentially resulting in negative effects on dyadic outcomes.26 31
Strategy training is a complex intervention aimed at improving the occupational performance of individuals with specific needs.32 This approach guides clients in identifying and analysing real-life problems and in generating and implementing problem-solving strategies.33 While strategy training has shown promising effects in reducing disability among stroke survivors,32 34 35 little is known about its effectiveness for caregivers. Given that strategy training aims to help individuals develop problem-solving strategies to address real-life challenges, it has the potential to meet the needs of both survivors and caregivers, facilitating their return to community life.
To address this research gap, our team developed a dyad-focused strategy training intervention. The feasibility of this intervention was tested in stroke survivor-caregiver dyads in Taiwan,36 demonstrating that dyad-focused strategy training is feasible and potentially beneficial for both survivors and caregivers. Based on the findings from this feasibility study, we designed the present randomised controlled trial (RCT). The purpose of this trial is to examine the efficacy of the dyad-focused strategy training intervention in enhancing the participation of stroke survivors and their caregivers. The following hypotheses will be tested in this project:
Improvement in both the survivor’s and the caregiver’s participation will be positively correlated with improvements in their self-efficacy and the survivor’s functional abilities.
The intervention effects on the survivor-caregiver dyad’s participation will be sustained at 3 months and 6 months following the intervention.
This multicentre, parallel-group RCT employs allocation concealment and assessor blinding. Conducted in the rehabilitation departments of six hospitals in northern Taiwan (Taipei Medical University Hospital; Wan Fang Hospital, Taipei Medical University; Shuang Ho Hospital, Taipei Medical University; National Taiwan University Hospital; National Taiwan University Hospital Bei-Hu Branch; and Taipei Tzu Chi Hospital), data collection commenced on 5 October 2022 and is projected to continue until 31 July 2026.
Participants will be randomly allocated to either the experimental intervention group or the control group in a 1:1 ratio at each site. Assessments of outcomes will take place at baseline, and at 3 months and 6 months following the intervention. The study design is depicted in a flow diagram (figure 1). This protocol is prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013. The SPIRIT checklist, along with the schedule for enrolment, interventions and assessments, is available in the online supplemental additional file 1 and figure 2.
To participate in this study as a dyad, both the stroke survivor and their caregiver must meet specific inclusion criteria. The inclusion criteria for stroke survivors include: (1) age 20 years or older; (2) diagnosed with a first-time stroke within the past 2 years; (3) speaks Mandarin; (4) has an identified primary caregiver who provides care or assistance, and assumes responsibility for the survivor; and (5) is able to provide informed consent.
The inclusion criteria for family caregivers include: (1) age 20 years or older; (2) speaks Mandarin; (3) recognised as the primary caregiver by the survivor; (4) available to participate in the intervention sessions with the survivor; and (5) is able to provide informed consent.
The survivor-caregiver dyad will be excluded if any of them: (1) requires significant medical treatment (eg, chemotherapy, radiation therapy or haemodialysis/peritoneal dialysis) that may impede participation in the study; (2) has severe aphasia; (3) is unable to participate in a 1-hour discussion session; and (4) has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede participation in the study.
Based on the inclusion criteria, our trained research staff will regularly visit our collaborating clinical sites to screen for eligible participants through medical chart reviews and personal interviews. Additionally, the research staff will post advertisements for this study (eg, posters and flyers) at the collaborating sites and online, providing contact information. Informed consent will be obtained from all participants who agree to join the study.
Eligible participants at each recruitment site will be randomly assigned to either the experimental intervention group or the control group using a computerised central randomisation scheme generated by a biostatistician. A minimisation randomisation technique will be employed to balance the number of dyads in the two intervention arms based on potential confounders such as survivors’ disability level, sex, age, dyadic relationship and enrolment site. Each dyad will be randomised as a unit. The research staff will inform eligible participants of their group allocation by phone. Subsequently, the baseline assessment and intervention will be administered sequentially within a maximum of 4 weeks after randomisation.
The nature of the intervention does not allow for blinding of participants or therapists to group assignment. However, outcome assessors, the statistician and the principal and coprincipal investigators will remain blinded to group assignment. The allocation results (intervention or control group) will be replaced with the Roman numerals ‘I’ or ‘II’ in the blind code. The grouping code will be revealed only after the completion of the statistical analyses.
Experimental intervention group
The dyad-focused strategy training will be delivered to participants in the experimental intervention group. The intervention protocols were developed based on the strategy training guidelines outlined by Skidmore et al,34 Bodenmann’s framework of dyadic coping 37 and the self-efficacy theory,38 with input from stroke survivors and their caregivers, ensuring the intervention addressed their real-world needs and priorities. Participants will engage in this intervention in addition to their routine outpatient rehabilitation. Trained research therapists will deliver the intervention to the survivor-caregiver dyads either at the participants’ homes or in a quiet room at our collaborating hospitals, on a one-to-two basis.
The programme comprises five critical components: shared decision-making, shared goal-setting, shared self-evaluation of performance, strategy development and implementation, and therapeutic guided discovery. The therapist will ask the dyad to identify 3–5 participation goals using the Goal Attainment Scale and provide them with the global strategy (also called the guided discovery strategy),39–41 which involves: (1) setting a goal to address the barriers, (2) developing a plan to achieve the goal, (3) executing the plan and (4) evaluating whether the plan worked or requires revision (see figure 3). This procedure will be repeated iteratively until the dyad’s goal is met, and they can move on to the next goal. Each intervention session will last approximately 45 min, with participants receiving two sessions per week for a total of 12 sessions over 6 weeks.
Control intervention group
Participants in the control group will receive a dose-matched stroke education provided by a trained research therapist as an attention-control intervention. The therapist will deliver inperson education to the dyad using an illustrated manual developed based on the stroke rehabilitation guidelines recommended by the American Heart Association/American Stroke Association.42 The educational topics will include: (1) secondary stroke prevention; (2) prevention and management of comorbidities; (3) managing emotions and behaviours; (4) medications and personal care; (5) finances and transportation; and (6) home and community-based participation. The frequency and duration of the control intervention sessions will match those of the experimental group sessions.
For both the experimental and control intervention groups, the same research therapists—serving as the intervention provider—will deliver all 12 sessions for each dyad to ensure consistency and continuity of the intervention. Each research therapist must complete training prior to delivering the dyad-focused strategy training and/or education. This training consists of reviewing standardised materials (eg, manuals, slides and demonstration videos) and participating in at least two discussions with experienced therapists who have previously implemented similar research interventions.
Participation in the trial will be terminated under the following circumstances: (1) the participant is unwilling or unable to continue the trial, (2) the participant exhibits illness deterioration or any other physical or mental condition that may impede their continued participation or (3) the participant experiences serious adverse events (AEs).
Participant adherence to the intervention will be evaluated based on attendance rates, engagement in intervention sessions (measured using the Pittsburgh Rehabilitation Participation Scale,43 a 6-point scale assessing effort and motivation of participating in the intervention) and adherence to the intervention protocol (measured using the Dyad-focused Strategy Training Fidelity Checklist, modified from the Strategy Training Fidelity Checklist32 developed by Skidmore et al). To ensure fidelity, 20% of the sessions will be randomly selected for assessment by two trained independent raters. These raters will not be present during the sessions but will complete the fidelity checklist based on session records, including written notes, worksheets and audio recordings. The checklist is used to evaluate the therapists’ adherence to intervention principles (yes or no) and their competence in delivery (rated as inadequate, adequate or exceptional).
During the intervention, research therapists will develop a rapport with the participants, encourage their continued participation and monitor their adherence to the study protocol. Following the intervention, our research staff will maintain monthly phone contact with the participants to sustain the relationship. Incentives will be provided to participants who complete all assessments and intervention sessions to encourage active participation.
Primary outcome
The primary outcome of this study is the change in participation performance, measured using the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D).44 This 24-item measure assesses three domains of participation: productivity, social and community.44 45 For each domain, respondents rate items on four dimensions: (1) diversity, (2) frequency, (3) desire for change and (4) perceived difficulty.44 For the purposes of this study, the frequency and difficulty dimensions will be used to reflect the objective and subjective participation performance of the dyad, respectively. The reliability, validity, and responsiveness of the PM-3D4D have been validated in a stroke population in Taiwan.44–47
Secondary outcomes
The quality of life for the dyads will be measured using the Taiwanese version of the The World Health Organization Quality of Life bref (WHOQOL-BREF).48 This self-administered questionnaire includes two items related to overall quality of life (question 1) and general health (question 2), along with 26 items assessing satisfaction with quality of life across four domains: physical health (seven items), mental health (six items), social relationships (four items) and environmental health (nine items). Each item is scored on a 5-point Likert scale, with higher scores indicating a better quality of life.48
The self-efficacy of the dyads will be measured using the General Self-Efficacy Scale (GSES).49 This 10-item measure evaluates the perceived self-efficacy of both survivors and caregivers on a 4-point scale, ranging from 1 (‘not at all true’) to 4 (‘exactly true’). The total score of the GSES ranges from 10 to 40, with higher scores indicating greater self-efficacy.49 The reliability of the GSES has been validated in Chinese-speaking populations.50
Survivors’ functional independence will be evaluated using the Activity Measure for Post-Acute Care (AM-PAC) Generic Outpatient Short Forms.51 The AM-PAC assesses difficulty in performing activities across three domains: basic mobility (18 items), daily activity (15 items) and applied cognitive (19 items). Each item is rated on a 4-point scale. Summary scores for each subscale are transformed into standardised scores on a t-score scale.51 The Chinese version of the AM-PAC has demonstrated strong psychometric properties in patients undergoing rehabilitation in Taiwan.52
Survivors’ general cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA),53 a 30-item tool that evaluates various cognitive domains. The MoCA has demonstrated promising reliability and higher sensitivity compared with the Mini-Mental State Examination in detecting cognitive deficits in stroke survivors.53 54 Executive function will be evaluated using the Stroop Test55 and the Trail Making Test (TMT A and B).56 The Stroop Test assesses inhibition, set-shifting and selective attention.55 Participants will be asked to name the ink colour of a word as accurately and rapidly as possible, where the ink colour may be congruent or incongruent with the written colour name. The time taken to complete the task will be recorded.57 58 The Stroop Test has shown validity in patients with traumatic brain injury.59 The TMT A and B will measure sustained attention, sequencing, mental flexibility and visual tracking. In TMT A, participants link a series of 25 numbered circles on a test paper as quickly as possible. In TMT B, participants switch alternately between a set of numbers (1–13) and a set of letters (A–L).56 The time taken to complete TMT A and B will be recorded, with longer completion times indicating poorer performance. This instrument has been validated in diverse populations.60–62
At baseline, demographic characteristics of the dyad will be collected using a questionnaire developed by the research team. Clinical variables will be retrieved from medical charts. Stroke severity will be characterised using the National Institutes of Health Stroke Scale.63 The modified Rankin Scale64 will be used to assess the participant’s disability level. The HEAL Positive Outlook questionnaire65 will measure participants’ positive attitudes. The Dyadic Relationship Scale66 will describe the relationship between the survivor and the caregiver. The Hospital Anxiety and Depression Scale67 will be used to measure the levels of anxiety and depression in both the survivor and the caregiver.
Qualitative data
Qualitative data will be collected through structured interviews with survivors, caregivers and research therapists to capture their experiences, satisfaction with the intervention and perceived effectiveness. Trained interviewers will conduct these interviews at the end of each participant’s intervention programme. All interviews will be audio-recorded and transcribed verbatim. Additionally, field notes and research team meeting notes will be meticulously documented.
Any unexpected AEs that occur during the study period will be documented and reviewed by the study team to determine if they are related to the study. Serious AEs will be promptly reported to the research ethics committee.
In our feasibility studies on strategy training for stroke survivors or survivor-caregiver dyads, the standard response means (SRMs) for the PM-3D4D’s frequency and difficulty scales from baseline to the postintervention ranged from 0.58 to 1.25.39 68 With a two-group t-test, different SRMs between T1 (preintervention) and T2 (postintervention) are expected in the intervention group, with no changes anticipated in the control group. A sample size of 48 dyads per group will provide 80% power to detect an SRM as low as 0.58.
For the second aim, a multiple regression model with 96 dyads (48 per group) will have 80% power to detect correlations of 0.3 or higher between score changes in secondary outcomes, assuming 10% variance explained by other characteristics. To detect a 0.4 difference in the correlation of change scores between survivors and caregivers (medium correlation of 0.6 in the intervention group vs small correlation of 0.2 in the control group), 55 dyads per group are needed. Allowing for a 20% loss to follow-up, 69 dyads per group are required.
Quantitative data will be analysed using SAS V.9.3 (SAS Institute, Cary, North Carolina, USA). All analyses will follow an intention-to-treat approach, meaning all participants will be analysed in their assigned groups regardless of compliance. Missing data will be handled using multiple imputation. We will make every effort to obtain follow-up assessments for all enrolled participants. Sensitivity analyses will be performed to examine differences between complete and incomplete data sets.
Descriptive statistics will be used to summarise the frequency, percentage distribution, mean and SD of all variables. Baseline differences between treatment and control groups will be assessed using the χ2 test, the Mann–Whitney U-test or t-test, depending on the measurement scale and data distribution.
For our primary aim of evaluating the intervention’s efficacy in improving participation for the dyads, changes in PM-3D4D scores from T1 to T2 will be compared between the experimental and control groups using a two-group t-test. Multiple linear regression models, akin to analysis of covariance, will adjust for background characteristics to examine group differences. Constrained longitudinal data analysis (cLDA) will further assess group differences in score changes from T1 to T2.
For our secondary aim, to determine if improvements in survivors’ participation correlate with caregivers’ participation, we will use correlation analysis followed by multiple regression to control for background characteristics and examine the relationship between changes in PM-3D4D scores.
For assessing whether changes in participation correlate with changes in survivors’ functions and both survivors’ and caregivers’ self-efficacy and quality of life, we will calculate score changes from T1 to T2. Multiple linear regression models will analyse these associations, including interaction terms to assess differences between intervention and control groups.
To evaluate intervention effects over time, cLDA will model PM-3D4D, GSES, AM-PAC, MoCA, Stroop Test and TMT scores at T1 (preintervention), T2 (postintervention), T3 (3-month follow-up) and T4 (6-month follow-up). Both baseline and follow-up outcomes will be treated as dependent variables. The model will include fixed effects of time, group, differences between study groups at each time point and background characteristics. An unstructured variance-covariance matrix will account for repeated measures. Mean differences and p values will be reported, with significance set at p<0.05.
Thematic analysis will be used to analyse qualitative data, combining inductive and deductive coding. Two independent coders will code the transcriptions, and a third researcher will review the coding for quality and consistency.
The intervention protocols were developed with input from stroke survivors and their caregivers to ensure that the intervention addresses their real-world needs and priorities.
The sponsor principal investigator (FHC) holds responsibility for securely storing and safeguarding all study data. Study documents will be securely stored and labelled with unique study identification numbers, which will be linked to subject identifiers through a master code. Access to the master code will be restricted to the principal investigator and a select number of research staff. This master code will be kept in an encrypted file separate from the study data.
Data entry will be conducted by research assistants using unique identification numbers, and the data will be stored in a secure, password-protected drive. Two research assistants will perform data checks and audits to ensure accuracy. All computers and electronic systems will be housed in locked offices, and access will be limited to Institutional Review Board (IRB)-approved study team members.
Given the minimal risks associated with this study and the absence of new drugs, biologics or devices, a data monitoring committee is deemed unnecessary. The Office of Human Research at Taipei Medical University, National Taiwan University Hospital and Taipei Tzu Chi Hospital will oversee data monitoring of each corresponding site and auditing for this study every 12 months. Following study completion, all pseudonymisation data will be archived for 10 years. Publications or presentations derived from this project will refrain from including identifying information about participants.
This study represents a pioneering effort in evaluating the efficacy of dyad-focused strategy training for enhancing the participation of stroke survivors and their caregivers. The methodologically rigorous approach of collecting both quantitative and qualitative data at various time points, along with the robust study design and close monitoring of fidelity, strengthens the validity and reliability of the findings.
While the strengths of the study are notable, it is essential to acknowledge potential limitations. As a single-blind RCT, blinding of participants and interventionists is not feasible, but efforts have been made to blind outcome assessors and data analysts to minimise bias. Additionally, longitudinal studies such as this one face challenges in participant recruitment and retention. Strategies to address these challenges, including collaboration with clinical staff and regular communication with participants, have been implemented.
Despite these limitations, this study is poised to determine the immediate and long-term effects of the intervention on participation outcomes for stroke survivors and their caregivers. The empirical evidence generated will contribute to the enhancement of stroke rehabilitation services and inform decision-making regarding payer coverage.
In conclusion, this research holds the potential to significantly impact the quality of care provided to stroke survivors and their caregivers. By elucidating the efficacy and treatment mechanisms of the intervention, this study will pave the way for improved rehabilitation practices and ultimately enhance the well-being of those affected by stroke.
This study protocol adheres to the principles outlined in the Declaration of Helsinki. Ethics approval for the study protocol and consent forms was granted by the Taipei Medical University-Joint Institutional Review Board (approval number: N202203083; protocol version/date: V1/2022.01.06), National Taiwan University Hospital Research Ethics Committee (approval number: 202207096RINA; protocol version/date: V5/2025.02.01) and Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Institutional Review Board (approval number: 11-M-107; protocol version/date: V2/2022.08.23). Primary reason for amendments was personnel change. Prior to enrolment, participants will receive detailed explanations regarding the study background, objectives and potential benefits and risks. Informed consent will be obtained from all participants before their involvement in the study. The study protocol has been registered and is accessible on the Clinical Trial Registry website (trial registration number: NCT05571150). Any significant modifications to the protocol will necessitate approval from the ethics committee, with approved changes promptly updated on the Clinical Trial Registry website.
Study findings will be disseminated to participants and shared with researchers, healthcare providers and individuals with disabilities through presentations at scientific conferences, professional platforms and peer-reviewed journal publications.
Consent obtained directly from patient(s).
We thank our collaborating therapists, including Yi-Hsuan Wu, OTR/L (National Taiwan University Hospital), Jui-Chi Lin, OTR/L (Shuang Ho Hospital), Ya-Ling Tseng (Shuang Ho Hospital), Shih-Shan Chen, OTR/L (Taipei Medical University Hospital), Yen-Ting Liu, OTR/L (Wan Fang Hospital), Chi-Tzu Feng, OTR/L (Taipei Tzu Chi Hospital) and Yi-Chun Lu, OTR/L (Taipei Tzu Chi Hospital).
