Brief Summary

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Official Title: "Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
• Study Primary Completion Date: August 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

• Behavioral: TI
  • Tailored intervention based on the transtheoretical model
• Behavioral: AP
  • Attention placebo

Arms, Groups and Cohorts in this Clinical Trial

• Other: Arm 1
  • Tailored intervention based on the transtheoretical model
• Placebo Comparator: Arm 2
  • Attention Placebo

Outcome Measures for this Clinical Trial

Primary Measures

• Blood Pressure
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• dietary sodium
  • Time Frame: 6 months
    Safety Issue?: No
• total cholesterol/high density lipoprotein ratio
  • Time Frame: 6 months
    Safety Issue?: No
• exercise adherence
  • Time Frame: 6 months
    Safety Issue?: No
• antihypertensive/ lipid-lowering medication adherence
  • Time Frame: 6 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. Well-documented history of stroke or TIA that occurred at least 3 months prior to enrollment;

2. Age 21 years or older;

3. Continuity of care in the primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year;

4. On hypertensive and/or lipid-lowering agents;

5. A score of >16 on the Mini-Mental Status Exam;

6. ability to exercise (assessed by 6-minute walk or timed get up and go).

Exclusion Criteria

1. Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer;

2. No telephone number at which patient can be reached;

3. Plans to relocate within the next 6 months;

4. Inability to communicate over the telephone due to severe cognitive impairment or aphasia.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Department of Veterans Affairs
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Jennifer P Friedberg, PhD, Principal Investigator, New York Harbor HCS
• Overall Contact(s)
  • Eseosa Asemota, (212) 951-3395, eseosa.asemota@va.gov