Reducing Risk of Recurrence (RRR)
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Purpose
Adults who have had a previous stroke or transient ischemic attack (TIA) remain at risk for having a second serious event, especially if they have uncontrolled blood pressure or cholesterol. However, many patients have difficulty following treatment recommendations for lowering blood pressure and cholesterol. The purpose of this research project is to evaluate the effect of 2 booster sessions of an educational counseling intervention on how well adults who have already participated in a 6-month clinical trial had a stroke or transient ischemic attack (TIA) are able to follow a treatment plan and control their blood pressure and cholesterol levels. We will also examine how effective this intervention is in improving adherence to diet, medication, and physical activity recommendations for adults who have had a prior stroke or TIA.
| Condition | Intervention |
|---|---|
|
Stroke TIA Hypertension Hyperlipidemia |
Behavioral: TI Behavioral: AP |
| 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: | Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009) |
- Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- dietary sodium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- total cholesterol/high density lipoprotein ratio [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- exercise adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- antihypertensive/ lipid-lowering medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 202 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1
Tailored intervention based on the transtheoretical model
|
Behavioral: TI
Tailored intervention based on the transtheoretical model
|
|
Placebo Comparator: Arm 2
Attention Placebo
|
Behavioral: AP
Attention placebo
|
Detailed Description:
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. We will determine whether a telephone-delivered behaviorally tailored intervention (TI) can lead to sustained change resulting in (a) BP and lipid control and (b) improved adherence to diet, medication, and exercise recommendations in veterans with a history of stroke or TIA compared to an attention placebo (AP) in veterans who have completed 6 months of a clinical trial. In this CDA project, we evaluate the long-term effectiveness of booster sessions in a randomized manner. One arm will receive 6 months of a tailored intervention (TI) followed by two booster TI sessions at 8 and 10 months, and one arm will receive 6 months of an attention placebo (AP) followed by two booster AP sessions at 8 and 10 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Well-documented history of stroke or TIA that occurred at least 3 months prior to enrollment;
- 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 6-minute walk or timed 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: Eseosa Asemota | (212) 951-3395 | eseosa.asemota@va.gov |
| United States, New York | |
| New York Harbor HCS | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: Eseosa Asemota 212-951-3395 eseosa.asemota@va.gov | |
| Principal Investigator: Jennifer P Friedberg, PhD | |
| Principal Investigator: | Jennifer P Friedberg, PhD | New York Harbor HCS |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01122394 History of Changes |
| Other Study ID Numbers: | CDP 09-414 |
| Study First Received: | May 10, 2010 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
stroke recurrence blood pressure prevention |
Additional relevant MeSH terms:
|
Hyperlipidemias Hypertension Recurrence Stroke Cerebral Infarction Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases |
Cardiovascular Diseases Disease Attributes Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 21, 2013