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

University of Missouri (MU)

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Chronic Disease Self-Management Program (CDSMP); Behavioral: Improving Participation after Stroke Self-Management Program (IPASS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06588647

2108606

1R01HD114732-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Improving Participation after Stroke Self-Management Program (IPASS)

Experimental group

Description:

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.

Treatment:

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

Chronic Disease Self-Management Program (CDSMP)

Active Comparator group

Description:

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

Treatment:

Behavioral: Chronic Disease Self-Management Program (CDSMP)