- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020851
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial (PREVENTS)
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
National recommendations state that patients with a history of transient ischemic attack (TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120 mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of secondary stroke prevention, there is a gap between evidence and implementation in clinical practice. By a randomized controlled trial, the investigators will test whether a tailored, telephone-delivered transtheoretical model-based behavioral intervention will improve adherence to treatment in veterans with a history of TIA or stroke, thereby leading to better control of BP and cholesterol levels, as compared to an attention placebo.
The primary specific aims of this project are to:
- determine whether a behaviorally tailored intervention (TI) can effectively lower BP after 6 months of counseling as compared to an attention placebo (AP) in veterans with a history of stroke or TIA
- assess whether the TI is effective in improving adherence to diet after 6 months of counseling in veterans with a history of stroke or TIA.
Secondary aims are to
- assess whether the TI is effective in improving cholesterol levels in post-stroke veterans after 6 months
- evaluate whether the TI is effective in improving adherence to antihypertensive and lipid-lowering medications after 6 months of counseling in veterans with a history of stroke or TIA
- determine whether the TI is effective in improving adherence to exercise recommendations after 6 months.
To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally to the TI, which will use the transtheoretical framework to provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations, and the AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will be provided. Participants will make in-person visits at baseline and 6 months. BP (3 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10010
- VA New York Harbor Healthcare System, NY and Brooklyn Campuses
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Well-documented history of stroke or TIA
- Age 21 years or older
- Continuity of care in the primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year
- On hypertensive and/or lipid-lowering agents
- A score of >16 on the Mini-Mental Status Exam-
- Ability to exercise (assessed by time to get up and go).
Exclusion Criteria
- Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer
- No telephone number at which patient can be reached
- Plans to relocate within the next 6 months
- Inability to communicate over the telephone due to severe cognitive impairment or aphasia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tailored intervention
Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.
|
6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
Other Names:
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Active Comparator: attention placebo
Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics
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6 monthly telephone-delivered sessions focusing on general health topics
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
medication adherence
Time Frame: 6 months
|
6 months
|
exercise adherence
Time Frame: 6 months
|
6 months
|
cholesterol
Time Frame: 6 months
|
6 months
|
dietary adherence
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHA0835195N
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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