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

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tailored intervention
attention placebo
Sponsored by
Narrows Institute for Biomedical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring hypertension, stroke, cholesterol, adherence

Eligibility Criteria

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

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

Sites / Locations

  • VA New York Harbor Healthcare System, NY and Brooklyn Campuses

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tailored intervention

attention placebo

Arm Description

Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.

Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics

Outcomes

Primary Outcome Measures

blood pressure

Secondary Outcome Measures

cholesterol
dietary adherence
exercise adherence
medication adherence

Full Information

First Posted
November 25, 2009
Last Updated
April 14, 2015
Sponsor
Narrows Institute for Biomedical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01020851
Brief Title
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
Acronym
PREVENTS
Official Title
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Narrows Institute for Biomedical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
hypertension, stroke, cholesterol, adherence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tailored intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.
Arm Title
attention placebo
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics
Intervention Type
Behavioral
Intervention Name(s)
tailored intervention
Other Intervention Name(s)
stage-matched intervention, transtheoretical model
Intervention Description
6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
Intervention Type
Behavioral
Intervention Name(s)
attention placebo
Intervention Description
6 monthly telephone-delivered sessions focusing on general health topics
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cholesterol
Time Frame
6 months
Title
dietary adherence
Time Frame
6 months
Title
exercise adherence
Time Frame
6 months
Title
medication adherence
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
VA New York Harbor Healthcare System, NY and Brooklyn Campuses
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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