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

This study has been completed.
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00355147
First received: July 18, 2006
Last updated: April 6, 2015
Last verified: February 2014
  Purpose

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.


Condition Intervention
Ischemic Stroke
Transient Ischemic Attack
Behavioral: Physician stroke guideline adherence
Behavioral: Stroke Self Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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:
  • Stroke Specific Health Related Quality of Life [ Time Frame: 6 months for (SSQoL) and 3 months for Perceived Energy Subdomain ] [ Designated as safety issue: No ]
    • 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.


  • Self-Efficacy to Manage Stroke Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    • 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%

  • Medication (Statins) for Secondary Stroke Prevention Risk Factor Management [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
    • 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%.

  • Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    • 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%.


Enrollment: 174
Study Start Date: January 2009
Study Completion Date: December 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Secondary Risk Factor Management
Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence
Behavioral: Physician stroke guideline adherence
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
Behavioral: Stroke Self Management
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
Placebo Comparator: Attention Control Group
Received Phone Calls from Staff to Control for Attention

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

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 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.
  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: NCT00355147

Locations
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Teresa M. Damush, PhD Richard L. Roudebush VA Medical Center, Indianapolis, IN
  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
Results First Received: July 15, 2014
Last Updated: April 6, 2015
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:
Ischemia
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on June 30, 2015