Feasibility Study of Caregiver-Assist Strategy Training

NCT ID: NCT06741475

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this study is to examine the feasibility of delivering an innovative intervention, caregiver-assisted strategy training (CaST), targeting enhancing activity functions in community-dwelling adults after stroke. The main questions it aims to answer are:

• Is CaST acceptable to stroke survivors with functional limitations?
• Does CaST show positive effects on functional outcomes?

Researchers will compare the CaST program to a control education program to investigate the interventional effect size for the selected stroke participants.

Participants will:

• Receive CAST or an education program 1 to 2 sessions per week until finishing 10 sessions.
• Be assessed clinical outcomes at 4 times: pre-intervention, post-intervention, 3-month, and 6-month follow-up.
• Be interviewed once after finishing their intervention.

Detailed Description

To address post-stroke activity limitations, intensive task-oriented rehabilitation is widely recommended across clinical guidelines. The caregiver is potentially able to play a facilitative role during the rehabilitation process. However, the best way to integrate caregivers into task-oriented rehabilitation is largely unknown. To address this gap, this preliminary study aims to assess the feasibility of a newly developed intervention, caregiver-assisted strategy training (CaST), in enhancing the activity performance of stroke survivors.

A mixed-methods (quantitative and qualitative) design, including a repeated measures design, is used in this feasibility study. A procedure of randomization with minimization will be conducted by a researcher who is independent of the investigation and outcome assessments. Eligible stroke survivors and their caregivers will be recruited from collaborative hospitals in Northern Taiwan and randomly assigned with even possibility. Longitudinal evaluations will be conducted at baseline (T1), post-intervention (T2), 3-month (T3), and 6-month (T4) follow-ups. Standardized assessments such as the Activity Measure for Post-Acute Care (AMPAC), the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), EuroQol-5D (EQ-5D), Stroke Self-Efficacy Questionnaires (SSEQ), Fugl-Meyer Assessment (FMA), Montreal Cognitive Assessment (MoCA), and Goal Attainment Scaling (GAS) will be used to assess outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. The feasibility indicators, such as recruitment rates and intervention attendance and adherence, will be evaluated by questionnaires, field notes, and qualitative interviews after the interventions are completed. Quantitative data will be analyzed using multiple linear regression models and mixed-effects regression models. Furthermore, qualitative in-depth interviews with participants, caregivers, and therapists will be conducted post-intervention. These interviews will explore experiences, satisfaction, and perceived effectiveness of the intervention. Transcribed data will undergo coding by two independent coders and subsequent analysis through the thematic analysis method.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Caregiver-Assisted Strategy Training

Trained therapists visit each participant once or twice weekly for 60 minutes per visit. In a total of 10 sessions over a maximum of 10 weeks, CaST program includes the following active ingredients: self-selected activity-based goals, dynamic performance analysis, global strategy ("Goal-PlanDo-Check"), massed practice, variable practice, increasing task difficulty, explicit and implicit feedback, guided discovery, action observation, and social interaction.

Group Type: EXPERIMENTAL

Caregiver-Assist Strategy Training

Intervention Type: BEHAVIORAL

CaST is a home-based rehabilitation that guides both stroke survivors and their caregivers to implement strategy training for addressing real-life limitations after stroke. During the intervention, the caregiver not only supervises the participant but also co-participates in the practice by instructing on when and how to be an assistant and facilitator when the stroke survivor executes their practice plan.

Education

Participants receive a dose-matched stroke education with 10 visits by well-trained research staff through face-to-face talks.

Group Type: SHAM_COMPARATOR

Education

Intervention Type: BEHAVIORAL

Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequela, and adaptive skills for impaired functions are provided.

Interventions

Caregiver-Assist Strategy Training

CaST is a home-based rehabilitation that guides both stroke survivors and their caregivers to implement strategy training for addressing real-life limitations after stroke. During the intervention, the caregiver not only supervises the participant but also co-participates in the practice by instructing on when and how to be an assistant and facilitator when the stroke survivor executes their practice plan.

Intervention Type: BEHAVIORAL

Education

Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequela, and adaptive skills for impaired functions are provided.

Intervention Type: BEHAVIORAL

Other Intervention Names

CaST

Eligibility Criteria

Inclusion Criteria

• Being willing to provide informed consent
• Diagnosis with ischemic and/or hemorrhagic stroke
• Modified Rankin Scale (mRS) ranges from 2 to 4
• Rehabilitation frequency less than 3 days per week
• Having a healthy caregiver

Exclusion Criteria

• Undergoing palliative care
• Major diseases or severe conditions influencing study participation, such as global aphasia, dementia, multiple organ failure, immobilization due to fracture, etc Moderate post-stroke cognitive impairment, with Montreal Cognitive Assessment score <22
• Pre-stroke mRS > 1
• Participating in other interventional study concurrently.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng-Hang Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng-Heng Chang, ScD

Role: PRINCIPAL_INVESTIGATOR

Graduate Institute of Injury Prevention and Control, Taipei Medical University

Locations

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, , Taiwan

Site Status: RECRUITING

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Feng-Heng Chang, ScD

Role: CONTACT

ipc@tmu.edu.tw

+886-2-66202589 ext. 16040

Facility Contacts

Chen, MD

Role: primary

b8601084@tmu.edu.tw

Kang, MD

Role: primary

jhk@tmu.edu.tw

Lin, MD

Role: primary

solin1103@tmu.edu.tw

Other Identifiers

N202407030

Identifier Type: -

Identifier Source: org_study_id