Ireland
--:--IST
Recruiting Not applicable

Feasibility Study of Caregiver-Assist Strategy Training

NCT06741475 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2025-02-04
Last updated
2025-02-17

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

Caregiver-Assist Strategy TrainingEducation

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms — 4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)
    The AM-PAC measures the difficulty is performing three activity domains: Basic Mobility (18 activities), Daily Activity (15 activities), and Applied Cognition (19 activities) on a 4-point scale. In this trial, Applied Cognition domain is viewed as a secondary outcome. A trained research assistant performs AM-PAC face-to-face with participants. We determine the AM-PAC as the primary outcome due to its effect size from the between-group comparison will be used in developing the further efficacy trial.

Trial sites (3)

FacilityCityRegionStatus
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare New Taipei City Taiwan Recruiting
Taipei Medical University Hospital Taipei Taiwan Recruiting
Taipei Municipal Wanfang Hospital Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06741475 on ClinicalTrials.gov ↗ ← All trials in Taiwan