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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01807793
First Posted: March 8, 2013
Last Update Posted: February 1, 2017
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.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Martha Sajatovic, MD, University Hospitals Cleveland Medical Center
March 6, 2013
March 8, 2013
February 1, 2017
May 2012
December 2015   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01807793 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Targeted Management Intervention for African-American Men With TIA or Stroke
Targeted Management Intervention for African-American Men With TIA or Stroke.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
  • Stroke
  • Transient Ischemic Attack (TIA)
Behavioral: Psychoeducation
  • Active Comparator: Psychoeducation
    Psychoeducation will include attending individual and group sessions.
    Intervention: Behavioral: Psychoeducation
  • No Intervention: Care as usual
    Receive care as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
22 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01807793
1R21NR013001-01A1( U.S. NIH Grant/Contract )
1R21NR013001-01A1 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Martha Sajatovic, MD, University Hospitals Cleveland Medical Center
Case Western Reserve University
National Institute of Nursing Research (NINR)
Not Provided
Case Western Reserve University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP