The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
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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 |
- blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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: | 190 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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:
|
|
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 |
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| Contact: Jennifer P Friedberg, Ph.D. | 212-686-7500 ext 4521 | jennifer.friedberg@va.gov |
| Contact: Eseosa Asemota | 212-951-3395 | eseosa.asemota@va.gov |
| United States, New York | |
| VA New York Harbor Healthcare System, NY and Brooklyn Campuses | Recruiting |
| New York, New York, United States, 10010 | |
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: | December 6, 2012 |
| 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:
|
Ischemic Attack, Transient Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction |
ClinicalTrials.gov processed this record on June 13, 2013