Clinical trial NCT05571150: A Novel Rehabilitation Approach: Dyadic Strategy Training for Stroke Survivors and Their Caregivers
Official title: A Novel Rehabilitation Approach for Optimizing Dyadic Outcomes of Stroke Survivors and Their Caregivers: Dyadic Strategy Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Stroke survivors

  1. ages 20 years and older;
  2. has been diagnosed with a first-time stroke within the past two year;
  3. speaks Mandarin;
  4. has an identified primary caregiver who provides care or assistance of any kind and taking responsibility for the survivor;
  5. is able to provide informed consent.
* Family caregivers include that the caregiver

  1. ages 20 years and older;
  2. speaks Mandarin;
  3. is the primary caregiver recognized by the survivor;
  4. is available to participate in the intervention sessions with the survivor;
  5. is able to provide informed consent.

Exclusion Criteria:

* The survivor-caregiver dyad will be excluded if any of them:

  1. requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;
  2. has severe aphasia;
  3. is unable to participate in a 1-hour discussion session;
  4. has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from participating in the study.

Primary outcomes:
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to up to 6 weeks
Secondary outcomes:
measure: World Health Organization Quality of Life (WHOQOL-Brief)
timeFrame: From baseline to up to 6 weeks
measure: World Health Organization Quality of Life (WHOQOL-Brief)
timeFrame: From baseline to up to 18 weeks
measure: World Health Organization Quality of Life (WHOQOL-Brief)
timeFrame: From baseline to up to 30 weeks
measure: General Self-Efficacy Scale (GSES)
timeFrame: From baseline to up to 6 weeks
measure: General Self-Efficacy Scale (GSES)
timeFrame: From baseline to up to 18 weeks
measure: General Self-Efficacy Scale (GSES)
timeFrame: From baseline to up to 30 weeks
measure: Activity Measure for Post-Acute Care (AM-PAC) Short Forms
timeFrame: From baseline to up to 6 weeks
measure: Activity Measure for Post-Acute Care (AM-PAC) Short Forms
timeFrame: From baseline to up to 18 weeks
measure: Activity Measure for Post-Acute Care (AM-PAC) Short Forms
timeFrame: From baseline to up to 30 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to up to 6 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to up to 18 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to up to 30 weeks
measure: Stroop Test
timeFrame: From baseline to up to 6 weeks
measure: Stroop Test
timeFrame: From baseline to up to 18 weeks
measure: Stroop Test
timeFrame: From baseline to up to 30 weeks
measure: TMT Test
timeFrame: From baseline to up to 6 weeks
measure: TMT Test
timeFrame: From baseline to up to 18 weeks
measure: TMT Test
timeFrame: From baseline to up to 30 weeks
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to up to 18 weeks
measure: Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: From baseline to up to 30 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Feng-Hang Chang
role: PRINCIPAL_INVESTIGATOR
References: