An interventional study of Dyad-focused strategy training intervention and Attention-control intervention in Stroke, sponsored by Taipei Medical University. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
The purpose of this study is to examine the efficacy of a newly developed dyad-focused strategy training intervention on enhancing participation of stroke survivors and their caregivers.
To address this purpose, a single-blinded, parallel-group randomized controlled trial will be implemented to assess the efficacy of the dyad-focused strategy training intervention in comparison to the control group. An expected sample of 138 stroke survivor-caregiver dyads will be recruited from our collaborative hospitals in Northern Taiwan.
Data will be analyzed using multiple linear regression models and mixed-effects regression models. Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention.
Findings of this study will provide important evidence on whether this newly-developed program has immediate and long-term effect on improving and maintaining participation for both stroke survivors and their caregivers. These findings will together support the application of the dyad-focused strategy training intervention in rehabilitation practice and inform future study development.
Stroke is the leading cause of death and adult disability. Stroke survivors and their caregivers often experience an overwhelming sense of social isolation and experience a wide range of participation restrictions after stroke, leading to frustration and adverse health outcomes. To address both the survivor and caregiver needs, dyad-focused interventions are necessary to be implemented in the transitioning process. However, very few interventions were designed to address the needs of the dyad and place an equal emphasis on both survivors' and caregivers' outcomes. The purpose of this study is to examine the efficacy of a newly developed dyad-focused strategy training intervention on enhancing participation of stroke survivors and their caregivers.
To address this purpose, a single-blinded, parallel-group randomized controlled trial will be implemented to assess the efficacy of the dyad-focused strategy training intervention in comparison to the control group. An expected sample of 138 stroke survivor-caregiver dyads will be recruited from our collaborative hospitals in Northern Taiwan. These participants will be randomly assigned to the intervention group and the control group at a 1:1 ratio. Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), General Self-Efficacy Scale (GSES), Activity Measure for Post-Acute Care (AM-PAC), and other standardized assessment tools and questionnaires will be administered to the participants at baseline (T1), post-intervention (T2), and 3-month (T3), and 6-month (T4) follow-ups. Data will be analyzed using multiple linear regression models and mixed-effects regression models.
Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method.
Findings of this study will provide important evidence on whether this newly-developed program has immediate and long-term effect on improving and maintaining participation for both stroke survivors and their caregivers. The mechanism of whether and how this intervention program impacts the dyad's self-efficacy and the functions of stroke survivors in addition to participation will also be identified. These findings will together support the application of the dyad-focused strategy training intervention in rehabilitation practice and inform future study development.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 138 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Stroke survivors
Family caregivers include that the caregiver
Exclusion Criteria:
The survivor-caregiver dyad will be excluded if any of them:
The dyad-focused strategy training intervention will be delivered to the treatment group. The intervention protocols of the dyad-focused strategy training were developed based on the strategy training guideline outlined by Skidmore et al, Bodenmann's framework of dyadic coping, and the self-efficacy theory.
Behavioral: Dyad-focused strategy training intervention
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 provide in-person education to the dyad using an illustrated manual developed based on the stroke rehabilitation guidelines suggested by the American Heart Association/American Stroke Association .
Behavioral: Attention-control intervention
The program consists of five critical ingredients: shared decision making, self-selected goals, self-evaluation of performance, strategy development and implementation, and therapeutic guided discovery. Trained research therapists will deliver the intervention to the survivor-caregiver dyads on a one-to-two base at the participants' home or in a quiet room at our collaborative hospitals. The therapist will ask the dyad to identify 3 to 5 shared participation goals and provide them the global strategy (also called guided discovery strategy), which involves (1) setting a goal to address the barriers, (2) developing a plan to address the goal, (3) doing the plan, and (4) checking if the plan worked or required revising. This procedure will be repeated iteratively until the dyad's goal is met, and the next goal can be moved on to.
The topics of the education will cover: (1) secondary stroke prevention; (2) prevention and management of comorbidities; (3) managing emotions and behaviors; (3) medications and personal care; (4) finances and transportation; and (5) home and community-based participation.
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time frame: From baseline to up to 6 weeks
World Health Organization Quality of Life (WHOQOL-Brief)
The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".
Time frame: From baseline to up to 6 weeks
World Health Organization Quality of Life (WHOQOL-Brief)
The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".
Time frame: From baseline to up to 18 weeks
World Health Organization Quality of Life (WHOQOL-Brief)
The WHOQOL-BREF (Taiwan ver.) is a self-administered questionnaire comprising 28 questions on individuals' perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely".
Time frame: From baseline to up to 30 weeks
General Self-Efficacy Scale (GSES)
The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."
Time frame: From baseline to up to 6 weeks
General Self-Efficacy Scale (GSES)
The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."
Time frame: From baseline to up to 18 weeks
General Self-Efficacy Scale (GSES)
The GSES, sometimes seen as GSE, is a 10-item psychometric scale created to assess perceived self-efficacy regarding coping and adaptation abilities in daily activities and isolated stressful events. Responses to questions are on a 1-4 Likert scale where 1 represents "Not at all true" and 4 represents "Exactly true."
Time frame: From baseline to up to 30 weeks
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Time frame: From baseline to up to 6 weeks
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Time frame: From baseline to up to 18 weeks
Activity Measure for Post-Acute Care (AM-PAC) Short Forms
The AM-PAC consists of three subscales that assess three activity domains: basic mobility, daily activity, and applied cognitive. The inpatient short consists of 6 items per domain, and the outpatient short consists of 15-19 per domain. Each item asks the respondent to rate the difficulty of performing specified activities using a 4-point scale. The summary scores for each subscale will be transformed into standardized scores on the t-score scale.
Time frame: From baseline to up to 30 weeks
Montreal Cognitive Assessment (MoCA)
MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health. The score ranges from 0 to 30. A score of 26 and higher is considered normal.
Time frame: From baseline to up to 6 weeks
Montreal Cognitive Assessment (MoCA)
MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health. The score ranges from 0 to 30. A score of 26 and higher is considered normal.
Time frame: From baseline to up to 18 weeks
Montreal Cognitive Assessment (MoCA)
MoCA is a 30-question test. It checks different cognitive or thinking abilities to help people quickly assess a patient's cognitive health. The score ranges from 0 to 30. A score of 26 and higher is considered normal.
Time frame: From baseline to up to 30 weeks
Stroop Test
The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.
Time frame: From baseline to up to 6 weeks
Stroop Test
The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.
Time frame: From baseline to up to 18 weeks
Stroop Test
The Stroop test assesses the ability to inhibit cognitive interference that occurs when processing a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants will be asked to read out the word's ink color as accurately as soon as possible. The ink color of the word could be congruent or incongruent with the written color name. Each participant's time to complete the task will be calculated and recorded.
Time frame: From baseline to up to 30 weeks
TMT Test
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
Time frame: From baseline to up to 6 weeks
TMT Test
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
Time frame: From baseline to up to 18 weeks
TMT Test
The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.
Time frame: From baseline to up to 30 weeks
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time frame: From baseline to up to 18 weeks
Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
The PM-3D4D is a 24-item measure that was designed to evaluate three domains of participation: Productivity, Social, and Community.
Time frame: From baseline to up to 30 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taipei Medical University