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

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ClinicalTrials.gov Identifier: NCT01020851
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Jennifer Friedberg, Narrows Institute for Biomedical Research

November 25, 2009
November 26, 2009
April 15, 2015
September 2008
September 2014   (Final data collection date for primary outcome measure)
blood pressure [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01020851 on ClinicalTrials.gov Archive Site
  • cholesterol [ Time Frame: 6 months ]
  • dietary adherence [ Time Frame: 6 months ]
  • exercise adherence [ Time Frame: 6 months ]
  • medication adherence [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Transient Ischemic Attack
  • 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
  • Behavioral: attention placebo
    6 monthly telephone-delivered sessions focusing on general health topics
  • Experimental: tailored intervention
    Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.
    Intervention: Behavioral: tailored intervention
  • Active Comparator: attention placebo
    Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics
    Intervention: Behavioral: attention placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
190
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01020851
AHA0835195N
No
Not Provided
Not Provided
Jennifer Friedberg, Narrows Institute for Biomedical Research
Narrows Institute for Biomedical Research
Not Provided
Not Provided
Narrows Institute for Biomedical Research
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP