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Stroke Self-Management

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01507688
First received: January 4, 2012
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
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 proposed 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.

Condition Intervention
Stroke
Behavioral: Stroke Self-Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Stroke Self-Management: Effect on Function and Stroke Quality of Life

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Stroke, Specific Quality of Life [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    This 62-item instrument assesses 12 domains relevant to stroke patients including energy, mobility, work, upper extremity function, ADLs, family roles, social roles, vision, language, thinking, mood, and personality.


Enrollment: 258
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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

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 will produce 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 are 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 will employ mixed methods. For the first aim, the investigators will conduct 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 will be assessed at baseline, 3, 6, and 12 months. The stroke self-management program will be delivered over 6 months (12 weeks biweekly sessions followed by 12 weeks of bimonthly telephone and group support sessions). Usual care participants will receive written stroke risk factor materials. The primary outcomes will be stroke specific quality of life and the secondary outcomes will be stroke self-management, self-efficacy, functioning, and post stroke depression. For the second aim, the investigators will hold focus groups with participants and their caregivers to best understand their barriers to participation and suggestions for future implementation.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 7;
  • Significant language comprehension (NIH Stroke Scale commands score > 0); or
  • Receptive language deficits (NIH Stroke Scale aphasia score > 2).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507688

Locations
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Teresa M. Damush, PhD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01507688     History of Changes
Other Study ID Numbers: SDP 10-379 
Study First Received: January 4, 2012
Last Updated: September 7, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016