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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Martha Sajatovic, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT01807793
First received: March 6, 2013
Last updated: January 31, 2017
Last verified: January 2017
  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: Outcomes Assessor
Primary Purpose: Other
Official Title: Targeted Management Intervention for African-American Men With TIA or Stroke.

Resource links provided by NLM:


Further study details as provided by Martha Sajatovic, MD, University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 43
Study Start Date: May 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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   (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
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
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 )
Study First Received: March 6, 2013
Last Updated: January 31, 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

ClinicalTrials.gov processed this record on July 25, 2017