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.

Study Overview

• Status: Completed
• Conditions: Transient Ischemic Attack; Stroke Recurrence
• Intervention / Treatment: Behavioral: Prevent Return of Stroke; 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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg	6 months post enrollment into trial
LDL Cholesterol	Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL	6 months post enrollment into trial
Use of Anti-thrombotic Medication	Number of participants taking anti-thrombotic medication	6 months post enrollment into trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and Attitudes About Stroke Recurrence Risk		6 months post enrollment into trial
Medication Adherence	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.	6 months post enrollment into trial
Emotional Health	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.	6 months post enrollment into trial
Access to Medical Care	Number of participants who have a primary care doctor	6 months post enrollment into trial

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Stanford University; North General Hospital, New York

Publications and helpful links

General Publications

• Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
• Goldfinger JZ, Kronish IM, Fei K, Graciani A, Rosenfeld P, Lorig K, Horowitz CR. Peer education for secondary stroke prevention in inner-city minorities: design and methods of the prevent recurrence of all inner-city strokes through education randomized controlled trial. Contemp Clin Trials. 2012 Sep;33(5):1065-73. doi: 10.1016/j.cct.2012.06.003. Epub 2012 Jun 15.
• Kronish IM, Edmondson D, Goldfinger JZ, Fei K, Horowitz CR. Posttraumatic stress disorder and adherence to medications in survivors of strokes and transient ischemic attacks. Stroke. 2012 Aug;43(8):2192-7. doi: 10.1161/STROKEAHA.112.655209. Epub 2012 May 22.
• Kronish IM, Diefenbach MA, Edmondson DE, Phillips LA, Fei K, Horowitz CR. Key barriers to medication adherence in survivors of strokes and transient ischemic attacks. J Gen Intern Med. 2013 May;28(5):675-82. doi: 10.1007/s11606-012-2308-x. Epub 2013 Jan 4.
• Edmondson D, Horowitz CR, Goldfinger JZ, Fei K, Kronish IM. Concerns about medications mediate the association of posttraumatic stress disorder with adherence to medication in stroke survivors. Br J Health Psychol. 2013 Nov;18(4):799-813. doi: 10.1111/bjhp.12022. Epub 2013 Jan 7.
• Kronish IM, Goldfinger JZ, Negron R, Fei K, Tuhrim S, Arniella G, Horowitz CR. Effect of peer education on stroke prevention: the prevent recurrence of all inner-city strokes through education randomized controlled trial. Stroke. 2014 Nov;45(11):3330-6. doi: 10.1161/STROKEAHA.114.006623. Epub 2014 Sep 23.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: December 4, 2009
• First Submitted That Met QC Criteria: December 4, 2009
• First Posted (ESTIMATE): December 7, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Stroke; Ischemic Stroke; Community Based; Self-management; Brain Diseases; Cerebrovascular Disorders; Transient Ischemic Attack; Brain Ischemia; Brain Infraction; Peer-led; Stroke Recurrence Prevention; Cerebral Infraction
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Brain Ischemia; Stroke; Ischemic Attack, Transient; Recurrence
• Other Study ID Numbers: GCO 02-0515 Project 1; 5P60MD000270-08 (NIH)