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

VA Office of Research and Development

Status: Completed

Conditions: Ischemic Stroke; Transient Ischemic Attack

Treatments: Behavioral: Stroke Self Management; Other: Attention Control Group; Behavioral: Physician stroke guideline adherence

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00355147

0608-01B (Other Grant/Funding Number)

1009001684 (Other Grant/Funding Number)

IAB 05-297

Details and patient eligibility

About

The purpose of this study is to develop and 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 evidence based guidelines 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.

We hypothesized Veterans with stroke who receive the Veteran Stroke Prevention Program would engage in better medication compliance and stroke specific quality of life compared to those who did not receive the program.

Full description

Stroke affects at least 15,000 veterans each year, and this number will likely increase as the veteran population ages. According to the American Heart Association, the prevalence of stroke is expected to double by 2020 with the increased proportion of older adults nationwide. Our preliminary Quality Enhancement Research Initiative work indicates that stroke risk factors are often undermanaged in the Veterans Health Administration.

This proposed study of a stroke risk factor management program may benefit the Veteran Health System in several ways. First, it offers 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 Veteran Stroke Prevention Program 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/Department of Defense, American Heart Association, and the Joint Commission 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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veterans 18 years or older hospitalized with stroke or Transient Ischemic Attack at Indianapolis Veterans Administration Medical Center and Houston Veteran Administration Medical Center;
• 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 Veterans Administration 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 Veterans Administration outpatient follow-up.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups, including a placebo group

Arm 1 Secondary Risk Factor Management

Experimental group

Description:

Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence

Treatment:

Behavioral: Physician stroke guideline adherence

Behavioral: Stroke Self Management

Attention Control Group

Placebo Comparator group

Description:

Received Phone Calls from Staff to Control for Attention

Treatment:

Other: Attention Control Group