Prevent Return of Stroke Study

Completed

Phase N/A Results

Trial Description

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:
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.

Conditions

Interventions

  • Peer-Led Stroke Recurrence Prevention Education Other
    Intervention Desc: 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.
  • Prevent Return of Stroke Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Peer-Led Stroke Recurrence Prevention Education
    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.
    ARM 2: Kind: Experimental
    Label: Usual Care (Delayed Intervention)
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Participants will be randomized to one of two arms: 1) Peer-Led Stroke Recurrence Prevention Education or Usual Care Group. 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. 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Blood Pressure; LDL Cholesterol; Use of anti-thrombotic medication.
Secondary Knowledge and attitudes about stroke recurrence risk; Medication Adherence; Emotional health; Access to Medical Care.
Primary Blood Pressure 6 and 12 months post enrollment into trial No
Primary LDL Cholesterol 6 and 12 months post enrollment into trial No
Primary Use of anti-thrombotic medication 6 and 12 months post enrollment into trial No
Secondary Knowledge and attitudes about stroke recurrence risk 6 and 12 months No
Secondary Medication Adherence 6 and 12 months No
Secondary Emotional health 6 and 12 months No
Secondary Access to Medical Care 6 and 12 months No

Sponsors