N/A
N=258
Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01507688 ↗Enrolled (actual)
258
Serious AEs
30.6%
Results posted
Apr 2019
Primary outcome: Primary: Total Stroke Specific Quality of Life — 3.80; 3.82; 4.01; 3.94 units on a scale — p=0.0500
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stroke Self-Management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Stroke Specific Quality of Life |
3.80; 3.82; 4.01; 3.94; 4.07; 3.95 | 0.0500 |
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.
Eligibility Criteria
Inclusion Criteria
Patient eligibility criteria include:
- age 18 or older;
- acute diagnosis of ischemic stroke or TIA within past 12 months;
- able to speak and understand English;
- no severe cognitive impairment;
- access to a telephone;
- willing to follow-up in VA/IU Health outpatient care;
- had a previous outpatient primary care visit during the past 12 months in VA/IU Health outpatient care;
- willing to attend all individual phone and group meetings during the 6 month intervention; and
- life expectancy of at least 6 months as defined by the patient's neurologist at stroke event.
Exclusion Criteria
- Short Portable Mental Status score 0); or
- Receptive language deficits (NIH Stroke Scale aphasia score > 2).
Data sourced from ClinicalTrials.gov (NCT01507688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.