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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:
Secondary aims are to
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tailored intervention | Experimental | Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model. |
|
| attention placebo | Active Comparator | Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tailored intervention | Behavioral | 6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| cholesterol | 6 months | |
| dietary adherence | 6 months | |
| exercise adherence |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA New York Harbor Healthcare System, NY and Brooklyn Campuses | New York | New York | 10010 | United States |
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|
| attention placebo | Behavioral | 6 monthly telephone-delivered sessions focusing on general health topics |
|
| 6 months |
| medication adherence | 6 months |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| D000083362 | Transtheoretical Model |
| ID | Term |
|---|---|
| D000083342 | Health Belief Model |
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |
| D008960 | Models, Psychological |
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