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NCT Number: NCT06588647

Improving Participation After Stroke Self-Management-Rehabilitation

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.

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Key information

Conditions

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

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

Location status: Recruiting

Location contact

Anna Boone, PhD

PRINCIPAL_INVESTIGATOR

Juliana Earwood, OTD

CONTACT

[email protected]

573-884-6681

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM) Performance

    Time frame: Pre-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.

  2. Canadian Occupational Performance Measure (COPM) Satisfaction

    Time frame: Pre-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.

  3. Participation Strategies Self-Efficacy Scale (PS-SES)

    Time frame: 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 outcomes

  1. In home activity level as measured by sensor system

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

    average hourly percentage of time spent engaged in activity

  2. Community engagement as measured by sensor system

    Time frame: Duration 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

  3. Stroke Impact Scale participation domain

    Time frame: Pre-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.

  4. Assessment of Life Habits (LIFE-H)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna E Boone, PhD, OTR/L

CONTACT

[email protected]

5738827023

Juliana H. Earwood, OTD, OTR/L

CONTACT

[email protected]

5738846681

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • University of Illinois at Chicago
  • University of Washington

Registry information

Official study title

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

Acronym: IPASS-R

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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