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
About this trial
This is an interventional prevention trial for Stroke focused on measuring hypertension, stroke, cholesterol, adherence
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
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
NCT ID
NCT01020851
First Posted
November 25, 2009
Last Updated
April 14, 2015
Sponsor
Narrows Institute for Biomedical Research
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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