Targeted Management Intervention for African-American Men With TIA or Stroke (TEAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Case Western Reserve University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Sajatovic, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01807793
First received: March 6, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

Stroke is the leading cause of disability, third leading cause of death, and one of the most resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly double that of Euro-Americans (EA), and AA who experience a first-ever stroke are younger, have greater stroke disability, more post-stroke complications, and slower recovery compared to EA.


Condition Intervention
Stroke
Transient Ischemic Attack (TIA)
Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Targeted Management Intervention for African-American Men With TIA or Stroke.

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: Screening/baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    The primary outcome will be change in medication treatment adherence with stroke risk reduction pharmacotherapies as measured by the Tablets Routines Questionnaire (TRQ)


Secondary Outcome Measures:
  • Biological and health behaviors parameters [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    Secondary outcomes are changes in biologic parameters of stroke risk (blood pressure, HbA1c, BMI, cholesterol and triglycerides) and in health behaviors (diet, exercise, smoking, substance use) using standardized instruments


Estimated Enrollment: 76
Study Start Date: May 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psychoeducation
Psychoeducation will include attending individual and group sessions.
Behavioral: Psychoeducation
No Intervention: Care as usual
Receive care as usual

  Eligibility

Ages Eligible for Study:   22 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identified AA male
  • Between 22 and 64 years of age (> age 21 and < age 65).
  • Within 6 months of discharge for Stroke /TIA
  • Planned or recent home discharge
  • Barthel Index (BI) score of > 60
  • Available care partner willing to participate
  • Be able to speak and understand English

Exclusion Criteria:

  • Individuals who are unable or unwilling to provide written informed consent
  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: NCT01807793

Locations
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44109
Contact: John Harvis-Bey, LISW    216-368-5723      
Principal Investigator: Martha Sajatovic, MD         
Sponsors and Collaborators
Case Western Reserve University
  More Information

No publications provided

Responsible Party: Martha Sajatovic, MD, Professor, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01807793     History of Changes
Other Study ID Numbers: 1R21NR013001-01A1, 1R21NR013001-01A1
Study First Received: March 6, 2013
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Stroke
TIA
African American

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

ClinicalTrials.gov processed this record on August 26, 2014