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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01807793
Recruitment Status : Completed
First Posted : March 8, 2013
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Stroke Transient Ischemic Attack (TIA) Behavioral: Psychoeducation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Targeted Management Intervention for African-American Men With TIA or Stroke.
Study Start Date : May 2012
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Psychoeducation
Psychoeducation will include attending individual and group sessions.
Behavioral: Psychoeducation
No Intervention: Care as usual
Receive care as usual


Outcome Measures

Primary Outcome Measures :
  1. Medication adherence [ Time Frame: Screening/baseline, 3 months, 6 months ]
    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 :
  1. Biological and health behaviors parameters [ Time Frame: Baseline, 3 months, 6 months ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 64 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807793


Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Western Reserve University
National Institute of Nursing Research (NINR)
More Information

Responsible Party: Martha Sajatovic, MD, Professor, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01807793     History of Changes
Other Study ID Numbers: 1R21NR013001-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Martha Sajatovic, MD, University Hospitals Cleveland Medical Center:
Stroke
TIA
African American

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