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

July 19, 2023 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center, Chicago, IL
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 SSM Intervention
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.
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.
No Intervention: Arm 2 Usual Care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Stroke Specific Quality of Life
Time Frame: Change from baseline to 6 months
A 49-item instrument that assesses 12 domains relevant to stroke patients' health-related quality of life including: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. A lower score indicates poorer functioning and a higher score indicates better functioning. The minimum value was 1 and maximum value was 5. A Total Stroke Specific Quality of Life Score was calculated as the mean of the 49-items.
Change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Teresa M. Damush, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2013

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

August 29, 2019

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 6, 2012

First Posted (Estimated)

January 11, 2012

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDP 10-379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Limited deidentified dataset will be shared after publication completion from study.

IPD Sharing Time Frame

Limited de-identified dataset will be shared after publication completion beginning 2022 for 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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