Clinical trial NCT00355147: Adapting Tools to Implement Stroke Risk Management to Veterans
Official title: Adapting Tools to Implement Stroke Risk Management to Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: Ischemic stroke
Preventive medicine
Transient Ischemic Attack
Neurology
Risk management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Indiana University
First posted: 2006-07-21
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stroke Specific Health Related Quality of Life
timeFrame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
measure: Self-Efficacy to Manage Stroke Symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
timeFrame: baseline, 6 months
measure: Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
timeFrame: baseline, 6 months
measure: Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Teresa M. Damush, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmid AA, Andersen J, Kent T, Williams LS, Damush TM. Using intervention mapping to develop and adapt a secondary stroke prevention program in Veterans Health Administration medical centers. Implement Sci. 2010 Dec 15;5:97. doi: 10.1186/1748-5908-5-97.
citation: Damush TM, Jackson GL, Powers BJ, Bosworth HB, Cheng E, Anderson J, Guihan M, LaVela S, Rajan S, Plue L. Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):68-71. doi: 10.1007/s11606-009-1123-5.
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Damush TM, Myers L, Anderson JA, Yu Z, Ofner S, Nicholas G, Kimmel B, Schmid AA, Kent T, Williams LS. The effect of a locally adapted, secondary stroke risk factor self-management program on medication adherence among veterans with stroke/TIA. Transl Behav Med. 2016 Sep;6(3):457-68. doi: 10.1007/s13142-015-0348-6.