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



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 7, 2013
End Date:December 31, 2020

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

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.

Stroke Self-Management: Effect on Function and Stroke Quality of Life Anticipated Impacts on
Participant's Healthcare: This planned evaluation of the investigators' stroke
self-management program may improve the patient's healthcare by establishing an
evidence-based program for which VA case managers may implement to improve patient
self-management and the health-related quality of life of stroke survivors. This program
produced standardized manuals for case managers and stroke survivors that may be used in the
field, in the patient medical care home and via telehealth.

Project Background: Stroke is prevalent and associated with increased morbidity and
mortality. Stroke is the leading cause of long-term disability in the US. Within the VA,
approximately 60,000 patients had a primary outpatient encounter for stroke during fiscal
year 2010 (FY10). Data from the Office of Quality and Performance (OQP) Stroke Special Study
demonstrate that more than 5,000 Veterans were admitted to a VA facility for acute ischemic
stroke in FY07 and another 5000 Veterans with a transient ischemic attack (TIA) or
mini-stroke, were admitted in a VA facility or received care at an urgent clinic or emergency
department in VA. The total VA cost of stroke treatment was almost $315 million in FY05, with
a cost per patient of over $18,000. Stroke/TIA survivors are at elevated risk for future
vascular events and yet, there are no systematic post stroke programs offered widely in VA
designed to reduce this risk and increase stroke specific quality of life in Veterans. The
investigators recently developed and pilot tested a stroke self-management program that
adapted the Stanford Chronic Disease program for stroke.

Project Objectives: The objectives of this project were to: 1. Conduct a randomized trial
comparing stroke survivors randomly assigned to receive a stroke self-management program on
patient functioning, stroke self-management, and stroke specific quality of life compared to
stroke survivors assigned to usual care; and 2. Conduct a summative evaluation among VA
clinical providers, patients with stroke and their caregivers to understand the barriers and
facilitators of implementing the stroke self-management program.

Project Methods: To accomplish these aims, the investigators employed mixed methods. For the
first aim, the investigators conducted a randomized controlled trial comparing subjects
randomly assigned to the stroke self-management intervention to subjects randomly assigned to
usual care. Subjects from both groups were assessed at baseline, 3, 6, and 12 months. We
delivered the stroke self-management program over 6 months (12 weeks biweekly sessions
followed by 12 weeks of bimonthly telephone and group support sessions). Usual care
participants received written stroke risk factor materials. The primary outcomes were stroke
specific quality of life and the secondary outcomes were stroke self-management,
self-efficacy, functioning, and post stroke depression. We are evaluating clinical risk
factor management after stroke.

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 < 7;

- Significant language comprehension (NIH Stroke Scale commands score > 0); or

- Receptive language deficits (NIH Stroke Scale aphasia score > 2).
We found this trial at
2
sites
Indianapolis, Indiana 46202
Phone: 317-988-2722
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