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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Friedberg, Narrows Institute for Biomedical Research
ClinicalTrials.gov Identifier:
NCT01020851
First received: November 25, 2009
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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 Intervention
Stroke
Transient Ischemic Attack
Behavioral: tailored intervention
Behavioral: attention placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial

Resource links provided by NLM:


Further study details as provided by Narrows Institute for Biomedical Research:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • dietary adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • exercise adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 202
Study Start Date: September 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020851

Locations
United States, New York
VA New York Harbor Healthcare System, NY and Brooklyn Campuses
New York, New York, United States, 10010
Sponsors and Collaborators
Narrows Institute for Biomedical Research
  More Information

No publications provided

Responsible Party: Jennifer Friedberg, Clinical Psychologist, Narrows Institute for Biomedical Research
ClinicalTrials.gov Identifier: NCT01020851     History of Changes
Other Study ID Numbers: AHA0835195N
Study First Received: November 25, 2009
Last Updated: March 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Narrows Institute for Biomedical Research:
hypertension
stroke
cholesterol
adherence

Additional relevant MeSH terms:
Ischemia
Ischemic Attack, Transient
Brain Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on September 16, 2014