Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Improving Participation after Stroke Self-Management Program (IPASS); Behavioral: Chronic Disease Self-Management Program (CDSMP)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana H. Earwood, OTD, OTR/L; Phone Number: 5738846681; Email: jmhudson@health.missouri.edu
• Study Contact Backup: Name: Anna E Boone, PhD, OTR/L; Phone Number: 5738827023; Email: booneae@umsystem.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri
      • Contact: Juliana Earwood, OTD; Phone Number: 573-884-6681; Email: jmhudson@health.missouri.edu
      • Principal Investigator: Anna Boone, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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).
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
In home activity level as measured by sensor system	average hourly percentage of time spent engaged in activity	Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
Community engagement as measured by sensor system	Time outside the home as measured by time between door sensor activations	Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
Stroke Impact Scale participation domain	Measures perceived stroke recovery/quality of life. Range of scores 0-100. Higher scores indicate higher performance.	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
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.	Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Illinois at Chicago; National Institutes of Health (NIH); University of Washington
• Investigators: Principal Investigator: Anna E Boone, PhD, OTR/L, University of Missouri Occupational Therapy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): December 15, 2029

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Activities of daily living; Telehealth; Self-Management; Community engagement
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2108606; 1R01HD114732-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No