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OpenTrials
Completed

NCT Number: NCT01807793

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Transient Ischemic Attack (TIA) Vascular Diseases

Age range

22 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Targeted Management Intervention for African-American Men With TIA or Stroke.

Acronym: TEAM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 8, 2013
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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