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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01020851
Acronym
PREVENTS
Enrollment
202
Registered
2009-11-26
Start date
2008-09-30
Completion date
2014-09-30
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Transient Ischemic Attack

Keywords

hypertension, stroke, cholesterol, adherence

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.

Interventions

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

6 monthly telephone-delivered sessions focusing on general health topics

Sponsors

Narrows Institute for Biomedical Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood pressure6 months

Secondary

MeasureTime frame
cholesterol6 months
dietary adherence6 months
exercise adherence6 months
medication adherence6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026