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

Sponsor

Narrows Institute for Biomedical Research (Other)

Overall Status

Completed

CT.gov ID

NCT01020851

Collaborator

(none)

202

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Transient Ischemic Attack	Behavioral: tailored intervention Behavioral: attention placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tailored intervention Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.	Behavioral: tailored intervention 6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model Other Names: stage-matched intervention transtheoretical model
Active Comparator: attention placebo Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics	Behavioral: attention placebo 6 monthly telephone-delivered sessions focusing on general health topics

Arm

Intervention/Treatment

Experimental: tailored intervention

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

Behavioral: tailored intervention

6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model

Other Names:

stage-matched intervention

transtheoretical model

Active Comparator: attention placebo

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

Behavioral: attention placebo

6 monthly telephone-delivered sessions focusing on general health topics

Outcome Measures

Primary Outcome Measures

blood pressure [6 months]

Secondary Outcome Measures

cholesterol [6 months]
dietary adherence [6 months]
exercise adherence [6 months]
medication adherence [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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