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

Primary Purpose

Stroke, Transient Ischemic Attack (TIA)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, TIA, African American

Eligibility Criteria

22 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Psychoeducation

Care as usual

Arm Description

Psychoeducation will include attending individual and group sessions.

Receive care as usual

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2013
Last Updated
January 31, 2017
Sponsor
Case Western Reserve University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01807793
Brief Title
Targeted Management Intervention for African-American Men With TIA or Stroke
Acronym
TEAM
Official Title
Targeted Management Intervention for African-American Men With TIA or Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack (TIA)
Keywords
Stroke, TIA, African American

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Psychoeducation will include attending individual and group sessions.
Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Receive care as usual
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
Medication adherence
Description
The primary outcome will be change in medication treatment adherence with stroke risk reduction pharmacotherapies as measured by the Tablets Routines Questionnaire (TRQ)
Time Frame
Screening/baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Biological and health behaviors parameters
Description
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
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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

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