Prevent Return of Stroke Study

Not Applicable

Completed

Conditions: Transient Ischemic Attack
Stroke Recurrence

Interventions: Behavioral: Prevent Return of Stroke

Registration Number: NCT01027273

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 600

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer-Led Stroke Recurrence Prevention Education	Prevent Return of Stroke	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.
Usual Care (Delayed Intervention)	Prevent Return of Stroke	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure	6 months post enrollment into trial	Percentage of Participants with Blood Pressure controlled at \<140/90 mm Hg
LDL Cholesterol	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	6 months post enrollment into trial	Number of participants taking anti-thrombotic medication

Secondary Outcome Measures

Name	Time	Method
Knowledge and Attitudes About Stroke Recurrence Risk	6 months post enrollment into trial
Medication Adherence	6 months post enrollment into trial	Number of participants adherent to medications as determined with Morisky score ≥ 6 Adherence to medications was measured using the 8-item Morisky Medication Adherence Questionnaire (Morisky). The questionnaire has been validated against an objective measure of adherence and has been used in racially diverse and elderly patient samples. Scores on the questionnaire can be used to classify patients into low and high adherence groups. Consistent with standard cut points, participants who scored less than 6 points on the Morisky were categorized as nonadherent to medications and participants who scored 6 to 8 points were categorized as adherent.
Emotional Health	6 months post enrollment into trial	Number of participants diagnosed as depressed utilizing depression scale. Participant is determined to be depressed if Patient Health Questionnaire (PHQ8) ≥ 10. Scale has a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.
Access to Medical Care	6 months post enrollment into trial	Number of participants who have a primary care doctor