Clinical trial NCT06741475: Feasibility Study of Caregiver-Assist Strategy Training
Official title: Optimizing Activity Performance of Stroke Patients Through Caregiver-Assisted Rehabilitation With Strategy Training: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke rehabilitation
Caregiver
Strategy training
Activity function
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
timeFrame: 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:
measure: Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: 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)
measure: EuroQol-5D-3L (EQ-5D-3L)
timeFrame: 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)
measure: Stroke Self-Efficacy Questionnaires (SSEQ)
timeFrame: 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)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 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)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 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)
measure: Goal Attainment Scale
timeFrame: 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)
measure: Client Satisfaction Questionnaire
timeFrame: At the end of intervention, 5 to 10 weeks from the baseline
Other outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At baseline, within 4 weeks after enrollment
measure: Berg Balance Scale (BBS)
timeFrame: At baseline, within 4 weeks after enrollment
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, within 4 weeks after enrollment
measure: modified Rankin Scale (mRS)
timeFrame: 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)
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
Study officials:
affiliation: Graduate Institute of Injury Prevention and Control, Taipei Medical University
name: Feng-Heng Chang, ScD
role: PRINCIPAL_INVESTIGATOR
References: