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StrokeNCT05571150

A Novel Rehabilitation Approach: Dyadic Strategy Training for Stroke Survivors and Their Caregivers

A study testing Dyad-focused strategy training intervention in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Dyad-focused strategy training intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteTaiwan
Study dates
5 Oct 2022to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Stroke survivors
  • ages 20 years and older;
  • has been diagnosed with a first-time stroke within the past two year;
  • speaks Mandarin;
  • has an identified primary caregiver who provides care or assistance of any kind and taking responsibility for the survivor;
  • is able to provide informed consent.
Show all 12Show fewer
  • Family caregivers include that the caregiver
  • ages 20 years and older;
  • speaks Mandarin;
  • is the primary caregiver recognized by the survivor;
  • is available to participate in the intervention sessions with the survivor;
  • is able to provide informed consent.

Who cannot join

  • The survivor-caregiver dyad will be excluded if any of them:
  • requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;
  • has severe aphasia;
  • is unable to participate in a 1-hour discussion session;
  • has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from participating in the study.

Trial locations and contacts

1 site in 1 country.

Feng-Hang Chang, Sc.D. contact

886-2-2736-1661 ext. 6573

fhchang@tmu.edu.tw

Taiwan1 site, 1 recruiting
  • Taipei Medical University

    Taipei

    Feng-Hang Chang, 886-2-2736-1661 ext. 6573, fhchang@tmu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: A Novel Rehabilitation Approach for Optimizing Dyadic Outcomes of Stroke Survivors and Their Caregivers: Dyadic Strategy Training

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.

Read more

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.

Read the detailed description

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.

Conditions
Stroke
Being tested
Dyad-focused strategy training intervention, Attention-control intervention
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dyad-focused strategy training interventionBehavioural

    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.

  • Attention-control interventionBehavioural

    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.

Study groups in NCT05571150
Study groupRoleWhat they receive
Experimental intervention groupExperimentalThe 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.
Receives: Behavioral: Dyad-focused strategy training intervention
Control intervention groupActive comparatorParticipants 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 .
Receives: Behavioral: Attention-control intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to up to 6 weeks

Secondary outcomes (20)
  1. 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".

    Measured: From baseline to up to 6 weeks

  2. 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".

    Measured: From baseline to up to 18 weeks

  3. 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".

    Measured: From baseline to up to 30 weeks

  4. 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."

    Measured: From baseline to up to 6 weeks

  5. 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."

    Measured: From baseline to up to 18 weeks

  6. 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."

    Measured: From baseline to up to 30 weeks

  7. 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.

    Measured: From baseline to up to 6 weeks

  8. 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.

    Measured: From baseline to up to 18 weeks

  9. 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.

    Measured: From baseline to up to 30 weeks

  10. 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.

    Measured: From baseline to up to 6 weeks

  11. 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.

    Measured: From baseline to up to 18 weeks

  12. 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.

    Measured: From baseline to up to 30 weeks

  13. 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.

    Measured: From baseline to up to 6 weeks

  14. 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.

    Measured: From baseline to up to 18 weeks

  15. 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.

    Measured: From baseline to up to 30 weeks

  16. TMT Test

    The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.

    Measured: From baseline to up to 6 weeks

  17. TMT Test

    The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.

    Measured: From baseline to up to 18 weeks

  18. TMT Test

    The TMT test measures sustained attention, sequencing, mental flexibility, and visual tracking.

    Measured: From baseline to up to 30 weeks

  19. 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.

    Measured: From baseline to up to 18 weeks

  20. 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.

    Measured: From baseline to up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2022
  2. Study start5 Oct 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05571150
Sponsor's protocol ID
N202203083
Status last verified
Jul 2024
First submitted
5 Oct 2022
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin YN, Hsu SP, Kang JH, Liou TH, Han DS, Ni P, Chiu V, Rodakowski J, Chang FH. Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial. BMJ Open. 2025 May 21;15(5):e090751. doi: 10.1136/bmjopen-2024-090751.

    PubMed 40398954

Questions about this trial

What is this clinical trial studying?

A study testing Dyad-focused strategy training intervention in people with Stroke, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Feng-Hang Chang, Sc.D. (886-2-2736-1661 ext. 6573, fhchang@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D) (time frame: From baseline to up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05571150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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