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: June 19, 2014
Last verified: June 2014
Results First Received: June 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Stroke Recurrence
Transient Ischemic Attack
Intervention: Behavioral: Prevent Return of Stroke

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from June 2009 to June 2012 recruited at community based sites as well as clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Peer-Led Stroke Recurrence Prevention Education

The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.

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.

Usual Care (Delayed Intervention)

The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.

Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial.


Participant Flow:   Overall Study
    Peer-Led Stroke Recurrence Prevention Education     Usual Care (Delayed Intervention)  
STARTED     301     299  
COMPLETED     242     266  
NOT COMPLETED     59     33  
Lost to Follow-up                 57                 31  
Death                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peer-Led Stroke Recurrence Prevention Education

The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.

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.

Usual Care (Delayed Intervention)

The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.

Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial.

Total Total of all reporting groups

Baseline Measures
    Peer-Led Stroke Recurrence Prevention Education     Usual Care (Delayed Intervention)     Total  
Number of Participants  
[units: participants]
  301     299     600  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 11     64  ± 11     63  ± 11  
Gender  
[units: participants]
     
Female     180     177     357  
Male     121     122     243  
Years since stroke  
[units: years]
Mean ± Standard Deviation
  1.8  ± 1.4     1.8  ± 1.5     1.8  ± 1.5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Blood Pressure   [ Time Frame: 6 months post enrollment into trial ]

2.  Primary:   LDL Cholesterol   [ Time Frame: 6 months post enrollment into trial ]

3.  Primary:   Use of Anti-thrombotic Medication   [ Time Frame: 6 months post enrollment into trial ]

4.  Secondary:   Medication Adherence   [ Time Frame: 6 months post enrollment into trial ]

5.  Secondary:   Emotional Health   [ Time Frame: 6 months post enrollment into trial ]

6.  Secondary:   Access to Medical Care   [ Time Frame: 6 months post enrollment into trial ]

7.  Secondary:   Knowledge and Attitudes About Stroke Recurrence Risk   [ Time Frame: 6 months post enrollment into trial ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carol R Horowitz, MD, MPH
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-659-9567
e-mail: carol.horowitz@mountsinai.org


Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01027273     History of Changes
Other Study ID Numbers: GCO 02-0515 Project 1, 5P60MD000270-08
Study First Received: December 4, 2009
Results First Received: June 19, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board