The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | September 2008 |
End Date: | June 2014 |
Contact: | Jennifer P Friedberg, Ph.D. |
Email: | jennifer.friedberg@va.gov |
Phone: | 212-686-7500 |
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.
(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.
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
We found this trial at
1
site
Click here to add this to my saved trials