Adapting Tools to Implement Stroke Risk Management to Veterans (TOOLS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00355147 |
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Recruitment Status :
Completed
First Posted : July 21, 2006
Results First Posted : February 10, 2015
Last Update Posted : October 11, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Stroke Transient Ischemic Attack | Behavioral: Physician stroke guideline adherence Behavioral: Stroke Self Management Other: Attention Control Group | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 174 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Health Services Research |
| Official Title: | Adapting Tools to Implement Stroke Risk Management to Veterans |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | June 2011 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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Placebo Comparator: Attention Control Group
Received Phone Calls from Staff to Control for Attention
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Other: Attention Control Group
Received Phone Calls from Staff to Control for Attention |
- 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.
- 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.
- 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%
- 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%.
- 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%.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355147
| 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 | |
| Principal Investigator: | Teresa M. Damush, PhD | Richard L. Roudebush VA Medical Center, Indianapolis, IN |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00355147 |
| Other Study ID Numbers: |
IAB 05-297 0608-01B ( Other Grant/Funding Number: US Veterans Health Administration ) 1009001684 ( Other Grant/Funding Number: US Veterans Health Administration ) |
| First Posted: | July 21, 2006 Key Record Dates |
| Results First Posted: | February 10, 2015 |
| Last Update Posted: | October 11, 2018 |
| Last Verified: | September 2018 |
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Ischemic stroke Preventive medicine Transient Ischemic Attack Neurology Risk management |
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Stroke Ischemic Attack, Transient Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Ischemia |