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

Not Applicable

Completed

• Conditions: Stroke; Transient Ischemic Attack (TIA)
• Interventions: Behavioral: Psychoeducation

• Registration Number: NCT01807793
• Lead Sponsor: Case Western Reserve University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation	Psychoeducation	Psychoeducation will include attending individual and group sessions.

Primary Outcome Measures

Name	Time	Method
Medication adherence	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

Name	Time	Method
Biological and health behaviors parameters	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

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States