Clinical trial NCT06588647: Improving Participation After Stroke Self-Management-Rehabilitation
Official title: Efficacy of the Improving Participation After Stroke Self-Management-Rehabilitation (IPASS-R) Program in Sub-acute Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Self-Management
Telehealth
Activities of daily living
Community engagement
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Washington
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Illinois at Chicago
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM) Performance
timeFrame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
measure: Canadian Occupational Performance Measure (COPM) Satisfaction
timeFrame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
measure: Participation Strategies Self-Efficacy Scale (PS-SES)
timeFrame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Secondary outcomes:
measure: In home activity level as measured by sensor system
timeFrame: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
measure: Community engagement as measured by sensor system
timeFrame: Duration of study (from baseline assessment (week 0) to 6-month follow-up assessment)
measure: Stroke Impact Scale participation domain
timeFrame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
measure: Assessment of Life Habits (LIFE-H)
timeFrame: Pre-intervention (week 0), post-intervention (week 6), and 6-month follow-up (week 32)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri Occupational Therapy
name: Anna E Boone, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.