Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: January 23, 2015
Last verified: January 2015

July 18, 2006
January 23, 2015
January 2009
June 2011   (final data collection date for primary outcome measure)
  • 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.
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 record
Complete list of historical versions of study NCT00355147 on ClinicalTrials.gov Archive Site
Not Provided
Patient demographics, BL; depression symptoms at BL, 3 & 6 mos; other co morbidities at 6 mos.
Not Provided
Not Provided
 
Adapting Tools to Implement Stroke Risk Management to Veterans
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Ischemic Stroke
  • Transient Ischemic Attack
  • 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
  • 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
    Interventions:
    • Behavioral: Physician stroke guideline adherence
    • Behavioral: Stroke Self Management
  • Placebo Comparator: Attention Control Group
    Received Phone Calls from Staff to Control for Attention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
December 2013
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00355147
IAB 05-297, 0608-01B, 1009001684
No
Department of Veterans Affairs
Department of Veterans Affairs
Indiana University
Principal Investigator: Teresa M. Damush, PhD Roudebush VA Medical Center Indianapolis
Department of Veterans Affairs
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP