Prevent Return of Stroke Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke Recurrence Transient Ischemic Attack |
Behavioral: Prevent Return of Stroke |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Preventing Recurrence of All Inner-city Strokes Through Education |
- Blood Pressure [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- LDL Cholesterol [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- Use of anti-thrombotic medication [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- Blood Pressure [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
- LDL Cholesterol [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
- Use of anti-thrombotic medication [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
- Knowledge and attitudes about stroke recurrence risk [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- Medication Adherence [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- Emotional health [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- Access to Medical Care [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
- Knowledge and attitudes about stroke recurrence risk [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
- Medication Adherence [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
- Emotional health [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
- Access to Medical Care [ Time Frame: 12 months post enrollment into trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peer-Led Stroke Recurrence Prevention Education
The intervention group will participate in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aims to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.
|
Behavioral: Prevent Return of Stroke
Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial.
|
|
Placebo Comparator: Usual Care (Delayed Intervention)
The control group will be offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.
|
Behavioral: Prevent Return of Stroke
The intervention arm will participate in the intervention shortly after enrolling in the trial. The usual care arm will be offered the intervention after 12 months from enrolling in the trial.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| 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
- Pregnant
- Nursing home resident
- Prisoner
Contacts and Locations| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Carol R Horowitz, MD, MPH | Mount Sinai School of Medicine |
More Information
No publications provided
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01027273 History of Changes |
| Other Study ID Numbers: | GCO 02-0515 Project 1, 5P60MD000270-08 |
| Study First Received: | December 4, 2009 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Stroke Ischemic Stroke Stroke Recurrence Prevention Transient Ischemic Attack Cerebrovascular Disorders Brain Ischemia |
Brain Infraction Brain Diseases Cerebral Infraction Self-management Peer-led Community Based |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Ischemic Attack, Transient Ischemia Recurrence Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Disease Attributes Brain Infarction |
ClinicalTrials.gov processed this record on May 23, 2013