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

Stroke Clinical Trial

— PREVENTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020851
• Other study ID #: AHA0835195N
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: April 14, 2015
• Start date: September 2008
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Narrows Institute for Biomedical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Behavioral:
• tailored intervention
6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
• attention placebo
6 monthly telephone-delivered sessions focusing on general health topics

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System, NY and Brooklyn Campuses	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Narrows Institute for Biomedical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		6 months	No
Secondary	cholesterol		6 months	No
Secondary	dietary adherence		6 months	No
Secondary	exercise adherence		6 months	No
Secondary	medication adherence		6 months	No