Recruiting

Stroke Rehabilitation

Sponsor:

University of Missouri-Columbia

Code:

NCT06588647

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Improving Participation after Stroke Self-Management Program (IPASS)

Chronic Disease Self-Management Program (CDSMP)

Study Details

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.

Conditions

Stroke

Study ID

NCT06588647

Start date

Dec 16, 2024

Status verified date

Apr, 2026

Completion date

Dec 15, 2029

Anticipated

Primary completion date

Dec 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Chronic Disease Self-Management Program (CDSMP)

The CDSMP will consist of 6, weekly 90-minute sessions. All sessions will be delivered remotely via videoconferencing.

Interventions

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).

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 measure

  • Canadian Occupational Performance Measure (COPM) Performance [ Time Frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) ]
  • Canadian Occupational Performance Measure (COPM) Satisfaction [ Time Frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) ]
  • Participation Strategies Self-Efficacy Scale (PS-SES) [ Time Frame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32) ]

Central Contacts and Locations

Central contacts

Anna E Boone, PhD, OTR/L

5738827023booneae@umsystem.edu

Juliana H. Earwood, OTD, OTR/L

5738846681jmhudson@health.missouri.edu

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Juliana Earwood, OTD

573-884-6681jmhudson@health.missouri.edu

Principal Investigator:

Anna Boone, PhD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-04-28.