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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Behaviorally tailored intervention Other
    Intervention Desc: provide 6 monthly counseling phone sessions about adherence to diet, medication, and exercise recommendations.
  • Attention placebo Behavioral
    Intervention Desc: 6 monthly telephone-delivered sessions focusing on general health topics
    ARM 1: Kind: Experimental
    Label: attention placebo
    Description: Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics
  • Tailored intervention Behavioral
    Other Names: stage-matched intervention; transtheoretical model
    Intervention Desc: 6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
    ARM 1: Kind: Experimental
    Label: tailored intervention
    Description: Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: 1)tailored intervention or 2)attention placebo. Participants will have a Mini Mental Status Exam prior to randomization. Participants in the tailored intervention arm will receive 6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model. Participants in attention placebo arm will receive 6 monthly telephone delivered counseling sessions about general health topics. 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Blood pressure.
Secondary Cholesterol, dietary adherence, exercise adherence, and medication adherence.
Primary blood pressure 6 months No
Secondary cholesterol 6 months No
Secondary dietary adherence 6 months No
Secondary exercise adherence 6 months No
Secondary medication adherence 6 months No

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