Prevent Return of Stroke Study

Mount Sinai Health System

Status: Completed

Conditions: Stroke Recurrence; Transient Ischemic Attack

Treatments: Behavioral: Prevent Return of Stroke

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01027273

GCO 02-0515 Project 1

5P60MD000270-08 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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:

1. 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;
2. 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
3. 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.

Enrollment: 600 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups, including a placebo group

Peer-Led Stroke Recurrence Prevention Education

Experimental group

Description:

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.

Treatment:

Behavioral: Prevent Return of Stroke

Behavioral: Prevent Return of Stroke

Usual Care (Delayed Intervention)

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Prevent Return of Stroke

Behavioral: Prevent Return of Stroke