Trial record 9 of 4875 for:    Stroke

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
  Purpose

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 Intervention
Stroke Recurrence
Transient Ischemic Attack
Behavioral: Prevent Return of Stroke

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Recurrence of All Inner-city Strokes Through Education

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 PHQ8 ≥ 10

  • 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


Enrollment: 600
Study Start Date: June 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027273

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
North General Hospital, New York
Stanford University
Investigators
Principal Investigator: Carol R Horowitz, MD, MPH Mount Sinai School of Medicine
  More Information

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

Keywords provided by Mount Sinai School of Medicine:
Stroke
Ischemic Stroke
Stroke Recurrence Prevention
Transient Ischemic Attack
Cerebrovascular Disorders
Brain Ischemia
Brain Infraction
Brain Diseases
Cerebral Infraction
Self-management
Peer-led
Community Based

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

ClinicalTrials.gov processed this record on July 29, 2014