The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial

Study Overview
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Brief Summary
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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.

Official Title
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The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial

Conditions
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Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Behavioral: tailored intervention
* Behavioral: attention placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tailored intervention<br>Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model. | Behavioral: tailored intervention<br>* 6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model<br>* Other names: transtheoretical model;|
| Active Comparator: attention placebo<br>Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics | Behavioral: attention placebo<br>* 6 monthly telephone-delivered sessions focusing on general health topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholesterol |  | 6 months | 
| dietary adherence |  | 6 months | 
| exercise adherence |  | 6 months | 
| medication adherence |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, stroke, cholesterol, adherence