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

Stroke Clinical Trial

— TEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807793
• Other study ID #: 1R21NR013001-01A1
• Secondary ID: 1R21NR013001-01A
• Status: Completed
• Phase: N/A
• First received: March 6, 2013
• Last updated: January 31, 2017
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack (TIA)

Intervention

Behavioral:
• Psychoeducation

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	The primary outcome will be change in medication treatment adherence with stroke risk reduction pharmacotherapies as measured by the Tablets Routines Questionnaire (TRQ)	Screening/baseline, 3 months, 6 months
Secondary	Biological and health behaviors parameters	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	Baseline, 3 months, 6 months