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Improving Participation After Stroke Self-Management-Rehabilitation

Efficacy of the Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R) Program in Sub-acute Stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06588647
Acronym
IPASS-R
Enrollment
100
Registered
2024-09-19
Start date
2024-12-16
Completion date
2029-12-15
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Self-Management, Telehealth, Activities of daily living, Community engagement

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.

Interventions

BEHAVIORALImproving 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).

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.

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER
University of Washington
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Illinois at Chicago
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

All outcomes assessors will be blinded to participant study group assignment.

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Canadian Occupational Performance Measure (COPM) PerformancePre-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) SatisfactionPre-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

MeasureTime frameDescription
In home activity level as measured by sensor systemDuration 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 systemDuration 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 domainPre-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.

Countries

United States

Contacts

CONTACTAnna E Boone, PhD, OTR/L
booneae@umsystem.edu5738827023
CONTACTJuliana H. Earwood, OTD, OTR/L
jmhudson@health.missouri.edu5738846681
PRINCIPAL_INVESTIGATORAnna E Boone, PhD, OTR/L

University of Missouri Occupational Therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026