Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00355147
First received: July 18, 2006
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the local adaptation of existing stroke prevention tools into practice. A stroke prevention program is a collection of materials including written materials like pamphlets and brochures, videotapes and training guides for stroke survivors and for the doctors that provide care for them. Other tools that may be used in a stroke prevention program include devices that help patients monitor medical symptoms at home like home blood pressure machines or blood sugar monitors and messaging devices that allow reporting symptoms from home to a health care provider.


Condition Intervention
Ischemic Stroke
Transient Ischemic Attack
Behavioral: Physician stroke guideline adherence
Behavioral: Evaluation of stroke self management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Adapting Tools to Implement Stroke Risk Management to Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Provider based outcomes: guideline adherent treatment, medication management at stroke discharge, 3 and 6 mos. Risk factor screening, examination of CPRS records during hospitalization or following 6 mos. Lifestyle counseling, examination of CPRS records [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient demographics, BL; depression symptoms at BL, 3 & 6 mos; other co morbidities at 6 mos. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: January 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
None
Behavioral: Physician stroke guideline adherence
Interviewing Providers, conducting Focus Groups
Behavioral: Evaluation of stroke self management
Implementing a Peer/Mentoring Program for Stroke Survivors

Detailed Description:

Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the AHA, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary QUERI work indicates that stroke risk factors are often undermanaged in VHS.

This proposed study of a stroke risk factor management program may benefit the VHS in several ways. First, it offers VHS a systematic program for reduction in stroke risk factors leading to better health for our veterans and a reduction in inpatient and outpatient rehabilitation and home health services for these events. Second, the VSPP takes into account the varied resources and services offered in VAMCs across the nation, allowing the program to be tailored both to a given facility and to the individual veteran's needs and readiness to change. Importantly, the program could allow all VA facilities to offer guideline-concurrent stroke risk reduction programs and therefore increase compliance with VA/DoD, AHA, and JCAHO stroke care guidelines and improve their quality of stroke care.

Comparison(s): We will compare two regionally matched facilities on rates of secondary stroke prevention guideline care during the course of the study at the intervention sites.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans 18 years or older hospitalized with stroke or TIA at Indianapolis VAMC and Houston VAMC;
  • willing to participate;
  • access to telephone;
  • speaks and understands English;
  • no severe cognitive impairments;
  • life expectancy of at least 6 mos;
  • willingness to follow-up in VA outpatient care.

Exclusion Criteria:

  • Severe aphasia or cognitive impairment;
  • active alcohol or substance abuse;
  • cannot or unwilling to participate;
  • does not speak or understand English;
  • life expectancy less than 6 mos;
  • no access to telephone;
  • no VA outpatient follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355147

Locations
United States, Indiana
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Teresa M. Damush, PhD Roudebush VA Medical Center Indianapolis
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00355147     History of Changes
Other Study ID Numbers: IAB 05-297, 0608-01B, 1009001684
Study First Received: July 18, 2006
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Ischemic stroke
Preventive medicine
Transient Ischemic Attack
Neurology
Risk management

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on April 17, 2014