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Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life

NCT01507688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2023-07-27

Study results available
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Summary

The experience of a stroke event may result in a disruption to the survivor's daily life. Patients with stroke have reported fears of permanent disability and major concerns over their ability to recover and be productive and engaged with family, friends and coworkers. To enhance recovery from stroke, the investigators designed a stroke self-management program and have pilot tested the program among Veterans recovering from stroke/TIA. The study is a three-site, randomized controlled trial designed to test the efficacy of a stroke self-management program. The intervention program includes 6 bi-weekly sessions over months 1-3 followed by monthly telephone calls as the investigators administered in the investigators' pilot study during months 4-6 for a total length of program duration of 6 months. The investigators have added 3 monthly group support sessions during months 4-6 for additional peer support. Thus, participants will receive bi-monthly support during months 4-6. The three intervention sites include the Jesse Brown VAMC in Chicago, the Roudebush VAMC in Indianapolis, and the IU Health Methodist Hospital in Indianapolis, Indiana. The three hospitals represent facilities with a small, moderate, and large volume of acute stroke care, respectively. Additionally, Methodist Hospital includes a greater proportion of women which enables us to study the patterns and preferences of women with stroke/TIA and tailor the investigators' future programs to prepare for the increasing female Veteran population.

Conditions

Interventions

BEHAVIORAL

Stroke Self-Management

Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Teresa M. Damush, PhD · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-07
Primary Completion
2017-03-31
Completion
2019-08-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507688 on ClinicalTrials.gov