Preventing Recurrence of All Inner-city Strokes Through Education
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Blood Pressure
Study Overview
Brief Summary
The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.
Detailed Description
Twenty nine percent of the 700,000 strokes that occur yearly nationwide are among stroke survivors. Blacks, both nationally and among Harlem residents, have a twofold increase in recurrent strokes. Harlem Latinos have a threefold increase in risk relative to Whites.
Primary risk factors for recurrent stroke include hypertension, hyperlipidemia, and under use of anti-thrombotic agents. Controlling risk factors can be particularly challenging for low-income, minority populations who lack the resources needed to adhere to necessary therapies. In Harlem, 72% of adults studied six months post stroke did not have these three risk factors treated adequately.
We propose to determine if participation in a recurrent stroke prevention educational intervention, versus usual care, can activated stroke survivors to at reduce primary risk factors for recurrent strokes while providing an effective, low-cost, sustainable recurrent stroke prevention program in neighborhoods like Harlem, whose residents bear a disproportionate burden of suffering from strokes. Specifically, we propose:
- Recruit 600 adults who sustained a stroke or transient ischemic attack (TIA) within the past five years by working with Harlem community leaders, local clinical sites including the Mount Sinai Medical Center and the Institute for Family Health, and the Visiting Nurse Service of New York;
- To conduct a randomized, controlled trial to determine if participation in a peer-led stroke prevention program activates stroke and TIA survivors to improve their knowledge and self-management strategies and treatments related to stroke prevention; and
- To rigorously compare the impact of the intervention with usual care (delayed intervention), on increasing the proportion of individuals with strokes and TIAs who are appropriately treated to reduce the risk of recurrent events, specifically through control of hypertension (blood pressure ≤ 140/90mmHg), hyperlipidemia (LDL cholesterol≤100 mg/dl) and use of anti-thrombotic medicines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Had a stroke or TIA diagnosed within 5 years
- •40 years of age or older
- •Able to participate in group education classes
- •English or Spanish speaking
- •Community dwelling
Exclusion Criteria
- •No incidence of stroke or TIA
- •Stroke or TIA occurred more than 5 years ago
- •less than 40 years of age
- •Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak, aphasia)
- •Self-reported terminal illness with life expectancy of less than 1 year
- •Plans to relocate from New York City within one year of enrollment
- •Nursing home resident
Outcomes
Primary Outcomes
Blood Pressure
Time Frame: 6 months post enrollment into trial
Percentage of Participants with Blood Pressure controlled at \<140/90 mm Hg
LDL Cholesterol
Time Frame: 6 months post enrollment into trial
Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL
Use of Anti-thrombotic Medication
Time Frame: 6 months post enrollment into trial
Number of participants taking anti-thrombotic medication
Secondary Outcomes
- Knowledge and Attitudes About Stroke Recurrence Risk(6 months post enrollment into trial)
- Medication Adherence(6 months post enrollment into trial)
- Emotional Health(6 months post enrollment into trial)
- Access to Medical Care(6 months post enrollment into trial)