Improving Participation After Stroke Self-Management-Rehabilitation

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Behavioral: Improving Participation after Stroke Self-Management Program (IPASS); Behavioral: Chronic Disease Self-Management Program (CDSMP)

• Registration Number: NCT06588647
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

The overall goal of this proposed study is to evaluate the efficacy of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-efficacy, activity performance, and quality of life in individuals with sub-acute stroke.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-12-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2029-12-15
• Study Completion: 2029-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• less than 6 months post-stroke
• age 45-85 years
• completed inpatient rehabilitation services (if recommended)
• living in the community with or without caregiver support (i.e., not living in a skilled nursing facility)
• ability to read, write, and speak English
• diagnosis of mild or moderate stroke (National Institutes of Health stroke score <16)
• able to use videoconferencing independently or with caregiver support

Exclusion Criteria

• severe depressive symptoms as indicated by a score ≥21 on the Patient Health Questionnaire
• dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment
• additional neurological diagnoses (e.g., brain malignancy, previous severe stroke)
• (4) moderate or severe aphasia as indicated by a National Institutes of Health Stroke Scale aphasia score of ≥ 2
• inability to provide informed consent
• any other condition not otherwise specified that the PI determines would render participation in this study as unsafe for the participant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Improving Participation after Stroke Self-Management Program (IPASS)	Improving Participation after Stroke Self-Management Program (IPASS)	The IPASS-R intervention consists of 6 weekly 90-minute sessions delivered by an occupational therapist and stroke survivor peer facilitator. All sessions will be delivered remotely via videoconferencing.
Chronic Disease Self-Management Program (CDSMP)	Chronic Disease Self-Management Program (CDSMP)	The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing.

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM) Performance	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)	Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Canadian Occupational Performance Measure (COPM) Satisfaction	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)	Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Participation Strategies Self-Efficacy Scale (PS-SES)	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)	Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources. Range of scores from 35-350. Higher scores indicate greater self-efficacy.

Secondary Outcome Measures

Name	Time	Method
In home activity level as measured by sensor system	Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)	average hourly percentage of time spent engaged in activity
Community engagement as measured by sensor system	Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)	Time outside the home as measured by time between door sensor activations
Stroke Impact Scale participation domain	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)	Measures perceived stroke recovery/quality of life. Range of scores 0-100. Higher scores indicate higher performance.
Assessment of Life Habits (LIFE-H)	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)	Measures self-reported participation in daily activities by measuring total score across 6 domains. Score range of 0 to 9 with higher scores indicating better performance.

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States