Feasibility Study of Caregiver-Assist Strategy Training

NCT06741475 | Recruiting

• 1 other identifier: N202407030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

Stroke rehabilitation; Caregiver; Strategy training; Activity function

Outcome Measures

Primary Outcomes (1)

• Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms

  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.

  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)

Secondary Outcomes (7)

• Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)

  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)

• EuroQol-5D-3L (EQ-5D-3L)

  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)

• Stroke Self-Efficacy Questionnaires (SSEQ)

  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)

• Fugl-Meyer Assessment (FMA)

  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)

• Montreal Cognitive Assessment (MoCA)

  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)

Other Outcomes (4)

• National Institutes of Health Stroke Scale (NIHSS)

  At baseline, within 4 weeks after enrollment

• Berg Balance Scale (BBS)

  At baseline, within 4 weeks after enrollment

• Hospital Anxiety and Depression Scale (HADS)

  At baseline, within 4 weeks after enrollment

Study Arms (2)

Caregiver-Assisted Strategy Training

EXPERIMENTAL

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.

Behavioral: Caregiver-Assist Strategy Training

Education

SHAM COMPARATOR

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

Behavioral: Education

Interventions

Caregiver-Assist Strategy Training 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.

Also known as: CaST

Caregiver-Assisted Strategy Training

Education 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.

Education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (3)

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

MeSH Terms

Conditions

Stroke

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Feng-Heng Chang, ScD

  Graduate Institute of Injury Prevention and Control, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Heng Chang, ScD

CONTACT

+886-2-66202589; ipc@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher is responsible for the randomization process and the results are coded with predefined IDs that investigators and outcomes assessors are unaware of the meaning.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 19, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)