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Completed

NCT Number: NCT00355147

Adapting Tools to Implement Stroke Risk Management to Veterans

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Stroke Transient Ischemic Attack Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physician stroke guideline adherence

Behavioral

Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors

Stroke Self Management

Behavioral

Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA

Attention Control Group

Other

Received Phone Calls from Staff to Control for Attention

Primary outcomes

  1. Stroke Specific Health Related Quality of Life

    Time frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain

    • Stroke Specifc, Health Related Quality of Life (SSQoL)
    • Self reported survey by LS Williams Weinberger M, Clark, D, Harris L, Biller J. Development of a stroke specific quality of life scale. Stroke, 1999;30:1362-1369.
    • Contains 12 domains and 49 items Scored on a 5 pt Likert response format with lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores.

    We hypothesized the intervention group would report significantly greater stroke specific quality of life than the control group. The level of significance was set to 0.05.

  2. Self-Efficacy to Manage Stroke Symptoms

    Time frame: 6 months

    Confidence to manage symptoms and health post stroke on a 1-10 scale where 10 denotes a lot of confidence and a 1 denotes no confidence.

Secondary outcomes

  1. Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment

    Time frame: baseline, 6 months

    • Medication Possession Ratios 6 months post stroke events based upon Pharmacy Refill data
    • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of oral Diabetes drugs (range = 0 -100%)
    • Compliance is defined as Medication Possession Ratio for Diabetes drugs dichotomized as greater than and equal to 80%

  2. Medication (Statins) for Secondary Stroke Prevention Risk Factor Management

    Time frame: baseline, 6 months

    • Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
    • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of Statin drugs (range= 0-100%).
    • Compliance is defined as Medication Possession Ratio for Statin drugs dichotomized as greater than and equal to 80%.

  3. Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management

    Time frame: Baseline, 6 months

    • Medication Possession Ratios 6 months post stroke event based upon Pharmacy Refill data
    • Medication Possession Ratios are the % of days in follow up period of 6 months with possession of hypertension drugs (range = 0-100%)
    • Compliance is defined as Medication Possession Ratio for Hypertension drugs dichotomized as greater than and equal to 80%.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Indiana University

Registry information

Acronym: TOOLS

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jul 21, 2006
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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