Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Sajatovic, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01807793
First received: March 6, 2013
Last updated: February 5, 2015
Last verified: February 2015

March 6, 2013
February 5, 2015
May 2012
May 2015   (final data collection date for primary outcome measure)
Medication adherence [ Time Frame: Screening/baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
The primary outcome will be change in medication treatment adherence with stroke risk reduction pharmacotherapies as measured by the Tablets Routines Questionnaire (TRQ)
Same as current
Complete list of historical versions of study NCT01807793 on ClinicalTrials.gov Archive Site
Biological and health behaviors parameters [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Targeted Management Intervention for African-American Men With TIA or Stroke
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Stroke
  • Transient Ischemic Attack (TIA)
Behavioral: Psychoeducation
  • Active Comparator: Psychoeducation
    Psychoeducation will include attending individual and group sessions.
    Intervention: Behavioral: Psychoeducation
  • No Intervention: Care as usual
    Receive care as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Male
22 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01807793
1R21NR013001-01A1, 1R21NR013001-01A1
No
Martha Sajatovic, MD, University Hospital Case Medical Center
Case Western Reserve University
National Institute of Nursing Research (NINR)
Not Provided
Case Western Reserve University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP