NCT01027273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 21, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

3.7 years

First QC Date

December 4, 2009

Results QC Date

June 19, 2014

Last Update Submit

July 24, 2014

Conditions

Stroke RecurrenceTransient Ischemic Attack

Keywords

StrokeIschemic StrokeTransient Ischemic AttackStroke Recurrence PreventionCerebrovascular DisordersBrain IschemiaBrain InfractionBrain DiseasesCerebral InfractionSelf-managementPeer-ledCommunity Based

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Knowledge and Attitudes About Stroke Recurrence Risk

    6 months post enrollment into trial

  • Medication Adherence

    6 months post enrollment into trial

  • Emotional Health

    6 months post enrollment into trial

  • Access to Medical Care

    6 months post enrollment into trial

Study Arms (2)

Peer-Led Stroke Recurrence Prevention Education

EXPERIMENTAL

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

Usual Care (Delayed Intervention)

PLACEBO COMPARATOR

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

Interventions

Prevent Return of StrokeBEHAVIORAL

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.

Peer-Led Stroke Recurrence Prevention Education

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had a stroke or TIA diagnosed within 5 years
  • years of age or older
  • Able to participate in group education classes
  • English or Spanish speaking
  • Community dwelling

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (6)

  • 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.

    PMID: 22710563BACKGROUND

  • 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.

    PMID: 22618380BACKGROUND

  • 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.

    PMID: 23288379BACKGROUND

  • 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.

    PMID: 23294320BACKGROUND

  • 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.

    PMID: 34813082DERIVED

  • 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.

    PMID: 25248910DERIVED

MeSH Terms

Conditions

Ischemic Attack, TransientStrokeIschemic StrokeCerebrovascular DisordersBrain IschemiaBrain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Carol R Horowitz, MD, MPH
Organization
Icahn School of Medicine at Mount Sinai
carol.horowitz@mountsinai.org
212-659-9567

Study Officials

  • Carol R Horowitz, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 7, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 31, 2014

Results First Posted

July 21, 2014

Record last verified: 2014-07

Locations

US(1)