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Prevent Return of Stroke Study

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ClinicalTrials.gov Identifier: NCT01027273
Recruitment Status : Completed
First Posted : December 7, 2009
Results First Posted : July 21, 2014
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Stroke Recurrence Transient Ischemic Attack Behavioral: Prevent Return of Stroke

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Recurrence of All Inner-city Strokes Through Education
Study Start Date : June 2009
Primary Completion Date : February 2013
Study Completion Date : February 2013
Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 6 months post enrollment into trial ]
    Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg

  2. 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

  3. Use of Anti-thrombotic Medication [ Time Frame: 6 months post enrollment into trial ]
    Number of participants taking anti-thrombotic medication

Secondary Outcome Measures :
  1. Knowledge and Attitudes About Stroke Recurrence Risk [ Time Frame: 6 months post enrollment into trial ]
  2. 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.

  3. 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.

  4. Access to Medical Care [ Time Frame: 6 months post enrollment into trial ]
    Number of participants who have a primary care doctor

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Minority Health and Health Disparities (NIMHD)
North General Hospital, New York
Stanford University
Principal Investigator: Carol R Horowitz, MD, MPH Icahn School of Medicine at Mount Sinai
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01027273     History of Changes
Other Study ID Numbers: GCO 02-0515 Project 1
5P60MD000270-08 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2009    Key Record Dates
Results First Posted: July 21, 2014
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Icahn School of Medicine at Mount Sinai:
Ischemic Stroke
Stroke Recurrence Prevention
Transient Ischemic Attack
Cerebrovascular Disorders
Brain Ischemia
Brain Infraction
Brain Diseases
Cerebral Infraction
Community Based

Additional relevant MeSH terms:
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Brain Ischemia