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

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician stroke guideline adherence
Stroke Self Management
Attention Control Group
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Ischemic Stroke focused on measuring Ischemic stroke, Preventive medicine, Transient Ischemic Attack, Neurology, Risk management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1 Secondary Risk Factor Management

Attention Control Group

Arm Description

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

Received Phone Calls from Staff to Control for Attention

Outcomes

Primary Outcome Measures

Stroke Specific Health Related Quality of Life
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
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
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
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
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%.

Full Information

First Posted
July 18, 2006
Last Updated
September 10, 2018
Sponsor
VA Office of Research and Development
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT00355147
Brief Title
Adapting Tools to Implement Stroke Risk Management to Veterans
Acronym
TOOLS
Official Title
Adapting Tools to Implement Stroke Risk Management to Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack
Keywords
Ischemic stroke, Preventive medicine, Transient Ischemic Attack, Neurology, Risk management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Secondary Risk Factor Management
Arm Type
Experimental
Arm Description
Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence
Arm Title
Attention Control Group
Arm Type
Placebo Comparator
Arm Description
Received Phone Calls from Staff to Control for Attention
Intervention Type
Behavioral
Intervention Name(s)
Physician stroke guideline adherence
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Stroke Self Management
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Attention Control Group
Intervention Description
Received Phone Calls from Staff to Control for Attention
Primary Outcome Measure Information:
Title
Stroke Specific Health Related Quality of Life
Description
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.
Time Frame
6 months for (SSQoL) and 3 months for Perceived Energy Subdomain
Title
Self-Efficacy to Manage Stroke Symptoms
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication (Diabetes) Compliance for Secondary Stroke Prevention Risk Factor Managment
Description
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%
Time Frame
baseline, 6 months
Title
Medication (Statins) for Secondary Stroke Prevention Risk Factor Management
Description
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%.
Time Frame
baseline, 6 months
Title
Medication (Hypertension) Compliance for Secondary Stroke Prevention Risk Factor Management
Description
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%.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa M. Damush, PhD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21159171
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.
Results Reference
result
PubMed Identifier
20077155
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.
Results Reference
result
PubMed Identifier
34813082
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.
Results Reference
derived
PubMed Identifier
27349906
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. Erratum In: Transl Behav Med. 2016 Sep;6(3):469.
Results Reference
derived

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Adapting Tools to Implement Stroke Risk Management to Veterans

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