Improving Participation After Stroke Self-Management-Rehabilitation
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-85
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Improving Participation after Stroke Self-Management Program (IPASS)
BehavioralThe IPASS-R program is a group-based self-management intervention that aims to improve problem-solving, action-planning, and resource utilization skills for improved community living and participation. The Activity-Barriers-Changes-Doing-Evaluation (ABCDE) framework is a user friendly problem-solving and goal setting framework that is used repetitively in each session throughout the program. Participants are guided to identify (1) an activity that they want to improve or re-engage in (A); (2) individual and environmental barriers that hinder their engagement (B); (3) changes that they can make to deal with the barriers and improve their engagement (C); and (4) an action plan to pursue (D). After the action plan, participants come back in the next session and evaluate their performance in following through on their plans (E).
Chronic Disease Self-Management Program (CDSMP)
BehavioralThe program is facilitated by two trained leaders in small groups in a community setting with individuals who have chronic health problems and will follow the CDSMP protocol. Participants receive education on various health-related topics applicable to a range of chronic conditions, share experiences, and support one another.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Improving Participation after Stroke Self-Management Program (IPASS)Experimental treatment 1 intervention
Group B: Chronic Disease Self-Management Program (CDSMP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Canadian Occupational Performance Measure (COPM) Performance
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time frame
Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)2
Canadian Occupational Performance Measure (COPM) Satisfaction
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Time frame
Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)3
Participation Strategies Self-Efficacy Scale (PS-SES)
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.
Time frame
Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)Secondary outcomes
1
In home activity level as measured by sensor system
average hourly percentage of time spent engaged in activity
Time frame
Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)2
Community engagement as measured by sensor system
Time outside the home as measured by time between door sensor activations
Time frame
Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)3
Stroke Impact Scale participation domain
Measures perceived stroke recovery/quality of life. Range of scores 0-100. Higher scores indicate higher performance.
Time frame
Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)4
Assessment of Life Habits (LIFE-H)
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.
Time frame
Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)Sponsors and contacts
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University of Missouri-Columbia
Lead sponsor
University of Washington
Collaborator
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Illinois at Chicago
Collaborator
Source ClinicalTrials.gov