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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Transient Ischemic Attack (TIA)
• Intervention / Treatment: Behavioral: Psychoeducation

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychoeducation; Psychoeducation will include attending individual and group sessions.	Behavioral: Psychoeducation
No Intervention: Care as usual; Receive care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; African American; TIA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: 1R21NR013001-01A1 (U.S. NIH Grant/Contract)