Clinical trial NCT01020851: The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
Official title: The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Keywords: hypertension
stroke
cholesterol
adherence
Lead sponsor: Narrows Institute for Biomedical Research
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: cholesterol
timeFrame: 6 months
measure: dietary adherence
timeFrame: 6 months
measure: exercise adherence
timeFrame: 6 months
measure: medication adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System, NY and Brooklyn Campuses
state: New York
Study officials:
References: