NCT01807793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.6 years

First QC Date

March 6, 2013

Last Update Submit

January 31, 2017

Conditions

StrokeTransient Ischemic Attack (TIA)

Keywords

StrokeTIAAfrican American

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Biological and health behaviors parameters

    Baseline, 3 months, 6 months

Study Arms (2)

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation will include attending individual and group sessions.

Behavioral: Psychoeducation

Care as usual

NO INTERVENTION

Receive care as usual

Interventions

PsychoeducationBEHAVIORAL
Psychoeducation

Eligibility Criteria

Age22 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals who are unable or unwilling to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 8, 2013

Study Start

May 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)