Improving Participation After Stroke Self-Management-Rehabilitation

NCT06588647 | Recruiting

• 2 other identifiers: 21086061R01HD114732-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Canadian Occupational Performance Measure (COPM) Performance

  Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

• Canadian Occupational Performance Measure (COPM) Satisfaction

  Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

  Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

• 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.

  Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

Secondary Outcomes (4)

• In home activity level as measured by sensor system

  Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)

• Community engagement as measured by sensor system

  Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)

• Stroke Impact Scale participation domain

  Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

• Assessment of Life Habits (LIFE-H)

  Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

Study Arms (2)

Improving Participation after Stroke Self-Management Program (IPASS)

EXPERIMENTAL

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.

Behavioral: Improving Participation after Stroke Self-Management Program (IPASS)

Chronic Disease Self-Management Program (CDSMP)

ACTIVE COMPARATOR

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

Behavioral: Chronic Disease Self-Management Program (CDSMP)

Interventions

Improving Participation after Stroke Self-Management Program (IPASS) BEHAVIORAL

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).

Improving Participation after Stroke Self-Management Program (IPASS)

Chronic Disease Self-Management Program (CDSMP) BEHAVIORAL

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.

Chronic Disease Self-Management Program (CDSMP)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of Washington: collaborator
• National Institutes of Health (NIH): collaborator
• University of Illinois at Chicago: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

Related Publications (7)

• Jette DU, Latham NK, Smout RJ, Gassaway J, Slavin MD, Horn SD. Physical therapy interventions for patients with stroke in inpatient rehabilitation facilities. Phys Ther. 2005 Mar;85(3):238-48.

  PMID: 15733048 BACKGROUND

• Sakakibara BM, Kim AJ, Eng JJ. A Systematic Review and Meta-Analysis on Self-Management for Improving Risk Factor Control in Stroke Patients. Int J Behav Med. 2017 Feb;24(1):42-53. doi: 10.1007/s12529-016-9582-7.

  PMID: 27469998 BACKGROUND

• Fryer CE, Luker JA, McDonnell MN, Hillier SL. Self management programmes for quality of life in people with stroke. Cochrane Database Syst Rev. 2016 Aug 22;2016(8):CD010442. doi: 10.1002/14651858.CD010442.pub2.

  PMID: 27545611 BACKGROUND

• Chen L, Chen Y, Chen X, Shen X, Wang Q, Sun C. Longitudinal Study of Effectiveness of a Patient-Centered Self-Management Empowerment Intervention During Predischarge Planning on Stroke Survivors. Worldviews Evid Based Nurs. 2018 Jun;15(3):197-205. doi: 10.1111/wvn.12295.

  PMID: 29878691 BACKGROUND

• Cadilhac DA, Hoffmann S, Kilkenny M, Lindley R, Lalor E, Osborne RH, Batterbsy M. A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program. Stroke. 2011 Jun;42(6):1673-9. doi: 10.1161/STROKEAHA.110.601997. Epub 2011 Apr 14.

  PMID: 21493910 BACKGROUND

• Wolf TJ, Baum CM, Lee D, Hammel J. The Development of the Improving Participation after Stroke Self-Management Program (IPASS): An Exploratory Randomized Clinical Study. Top Stroke Rehabil. 2016 Aug;23(4):284-92. doi: 10.1080/10749357.2016.1155278. Epub 2016 Mar 16.

  PMID: 27077987 BACKGROUND

• Lee D, Fischer H, Zera S, Robertson R, Hammel J. Examining a participation-focused stroke self-management intervention in a day rehabilitation setting: a quasi-experimental pilot study. Top Stroke Rehabil. 2017 Dec;24(8):601-607. doi: 10.1080/10749357.2017.1375222. Epub 2017 Sep 28.

  PMID: 28956721 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna E Boone, PhD, OTR/L

  University of Missouri Occupational Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna E Boone, PhD, OTR/L

CONTACT

5738827023; booneae@umsystem.edu

Juliana H. Earwood, OTD, OTR/L

CONTACT

5738846681; jmhudson@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes assessors will be blinded to participant study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)