Prevent Return of Stroke Study

This study has been completed.
Sponsor:
Collaborators:
North General Hospital, New York
Stanford University
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01027273
First received: December 4, 2009
Last updated: July 24, 2014
Last verified: July 2014

December 4, 2009
July 24, 2014
June 2009
February 2013   (final data collection date for primary outcome measure)
  • Blood Pressure [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
    Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg
  • LDL Cholesterol [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of participants taking anti-thrombotic medication
  • Blood Pressure [ Time Frame: 6 and 12 months post enrollment into trial ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: 6 and 12 months post enrollment into trial ] [ Designated as safety issue: No ]
  • Use of anti-thrombotic medication [ Time Frame: 6 and 12 months post enrollment into trial ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01027273 on ClinicalTrials.gov Archive Site
  • Knowledge and Attitudes About Stroke Recurrence Risk [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]
  • Medication Adherence [ Time Frame: 6 months post enrollment into trial ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of participants who have a primary care doctor
  • Knowledge and attitudes about stroke recurrence risk [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Medication Adherence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Emotional health [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Access to Medical Care [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prevent Return of Stroke Study
Preventing Recurrence of All Inner-city Strokes Through Education

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke Recurrence
  • Transient Ischemic Attack
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Prevent Return of Stroke
  • 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.
    Intervention: Behavioral: Prevent Return of Stroke

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01027273
GCO 02-0515 Project 1, 5P60MD000270-08
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
  • National Center on Minority Health and Health Disparities (NCMHD)
  • North General Hospital, New York
  • Stanford University
Principal Investigator: Carol R Horowitz, MD, MPH Mount Sinai School of Medicine
Mount Sinai School of Medicine
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP