Prevent Return of Stroke Study
|ClinicalTrials.gov Identifier: NCT01027273|
Recruitment Status : Completed
First Posted : December 7, 2009
Results First Posted : July 21, 2014
Last Update Posted : July 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stroke Recurrence Transient Ischemic Attack||Behavioral: Prevent Return of Stroke||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Preventing Recurrence of All Inner-city Strokes Through Education|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
- 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
- Knowledge and Attitudes About Stroke Recurrence Risk [ Time Frame: 6 months post enrollment into trial ]
- Medication Adherence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months post enrollment into trial ]Number of participants who have a primary care doctor
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027273
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Carol R Horowitz, MD, MPH||Icahn School of Medicine at Mount Sinai|