NCT06588647 · University of Missouri-Columbia
Improving Participation After Stroke Self-Management-Rehabilitation
(IPASS-R)
What this study is about
The overall goal of this proposed study is to evaluate the effectiveness of a small-group, stroke-specific, self-management program delivered via telehealth to improve self-effectiveness, activity performance, and quality of life in individuals with sub-acute stroke.
View original scientific description
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.
Interventions
BEHAVIORAL
Improving Participation after Stroke Self-Management Program (IPASS)
The 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).
BEHAVIORAL
Chronic Disease Self-Management Program (CDSMP)
The 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.
Primary outcome measures
Canadian Occupational Performance Measure (COPM) Performance
Time frame: 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
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbia, Missouri
Collaborators
University of Washington, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois at Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations