Improving Participation After Stroke Self-Management-Rehabilitation

NCT ID: NCT06588647

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2029-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Improving Participation after Stroke Self-Management Program (IPASS)

Intervention Type 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).

Chronic Disease Self-Management Program (CDSMP)

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

Group Type ACTIVE_COMPARATOR

Chronic Disease Self-Management Program (CDSMP)

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Anna Boone

Assistant Professor of Occupational Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna E Boone, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Occupational Therapy

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna E Boone, PhD, OTR/L

Role: CONTACT

5738827023

Juliana H. Earwood, OTD, OTR/L

Role: CONTACT

5738846681

Facility Contacts

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Juliana Earwood, OTD

Role: primary

573-884-6681

References

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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.

Reference Type BACKGROUND
PMID: 15733048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27469998 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27545611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29878691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21493910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27077987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28956721 (View on PubMed)

Other Identifiers

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1R01HD114732-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2108606

Identifier Type: -

Identifier Source: org_study_id

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