Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers

NCT05185271 | Completed

• 1 other identifier: N202106087
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases. In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads. A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited. The participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. Quantitative data will be analyzed descriptively.

Conditions

Stroke

Keywords

Caregiver; Stroke; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Rehabilitation Participation Scale (PRPS)

  The PRPS, a clinician-rated instrument, measures patients' participation on a 6-point Likert-type scale. A higher point reflects better participation in each intervention session.

  During intervention, up to 2 months

• Client Satisfaction Questionnaire (CSQ)

  The CSQ is an 8-item measure of client satisfaction with the intervention. It allows clients to rate on a 4-point scale where 1 represents "Not at all" and 4 represents "Extremely ." A higher score reflects higher satisfaction and acceptability of the intervention.

  Immediately after intervention

• Qualitative data

  Qualitative data will be collected through field notes taken by therapists after each intervention session and in-person qualitative interviews with participants and their therapists using semi-structured questionnaires.

  After intervention

Secondary Outcomes (34)

• Goal Attainment Scaling (GAS)

  Change from baseline to immediately post-intervention

• World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version

  Change from baseline to immediately post-intervention

• World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version

  Change from post-intervention to 3-month follow-up

• World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version

  Change from 3-month to 6-month follow-up

• General Self-Efficacy Scale (GSES)

  Change from baseline to immediately post-intervention

Other Outcomes (9)

• National Institutes of Health Stroke Scale

  At baseline

• Modified Rankin Scale (MRS)

  Change from baseline to immediately post-intervention

• Modified Rankin Scale (MRS)

  Change from post-intervention to 3-month follow-up

Study Arms (1)

Dyad- focused strategy training intervention

EXPERIMENTAL

The dyad-focused strategy training intervention protocol will be developed to help dyads manage the needs that they have as transitioning to the community. The following theoretical frameworks and guidelines will be used to guide the development of the intervention: (1) the strategy training guideline outlined by Skidmore et al; (2) Bodenmann's framework of dyadic coping; and (3) Self-efficacy theory.

Behavioral: Dyad-focused strategy training

Interventions

Dyad-focused strategy training BEHAVIORAL

Rehabilitation therapists will be hired to deliver the intervention to the stroke survivors-caregiver dyads on a one-to-two base. The therapist will ask the dyad to identify their shared goals and provide them the global strategy "Goal-Plan-Do-Check" (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.

Dyad- focused strategy training intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors include that the survivor:
• ages 20 years and older;
• has been diagnosed with stroke;
• speaks Mandarin;
• is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;
• has an identified primary caregiver;
• is able to provide informed consent.
• Caregivers include that the caregiver:
• ages 20 years and older;
• speaks Mandarin;
• is the primary caregiver recognized by the survivor (living with the survivor or providing daily care to the survivor for at least 10 hours per week);
• is available to participate in the intervention sessions with the survivor;
• is able to provide informed consent.

You may not qualify if:

• 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 continually participating in the study.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

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  PMID: 28489044 BACKGROUND

• Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.

  PMID: 18192628 BACKGROUND

• Orsulic-Jeras S, Whitlatch CJ, Powers SM, Johnson J. A dyadic perspective on assessment in Alzheimer's dementia: Supporting both care partners across the disease continuum. Alzheimers Dement (N Y). 2020 Aug 28;6(1):e12037. doi: 10.1002/trc2.12037. eCollection 2020.

  PMID: 32885021 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feng-Hang Chang

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 11, 2022
• Study Start: November 16, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)