StrokeTEAMNCT01807793
Targeted Management Intervention for African-American Men With TIA or Stroke
A study testing Psychoeducation in people with Stroke and Transient Ischemic Attack (TIA), run by Case Western Reserve University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 64 years, men only
- Conditions the study is for
- Stroke, Transient Ischemic Attack (TIA)
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals who are unable or unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44109
About this study
Official title: 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.
- Conditions
- Stroke, Transient Ischemic Attack (TIA)
- Being tested
- Psychoeducation
- Keywords
- Stroke, TIA, African American
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Active comparator | Psychoeducation will include attending individual and group sessions. Receives: Behavioral: Psychoeducation |
| Care as usual | No intervention | Receive care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Screening/baseline, 3 months, 6 months
Secondary outcomes (1)
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
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Martha Sajatovic, MD, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807793
- Sponsor's protocol ID
- 1R21NR013001-01A1
- Other IDs
- 1R21NR013001-01A1
- Acronym
- TEAM
- Status last verified
- Jan 2017
- First submitted
- 6 Mar 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Management Intervention for African-American Men With TIA or Stroke.
- ClinicalTrials.gov ID
- NCT01807793
- Acronym / sponsor ID
- TEAM / 1R21NR013001-01A1
- Conditions
- Stroke, Transient Ischemic Attack (TIA)
- Keywords
- Stroke, TIA, African American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Active comparator | Behavioral: PsychoeducationPsychoeducation will include attending individual and group sessions. |
| Care as usual | No intervention | –Receive care as usual |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals who are unable or unwilling to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation | Behavioural | Psychoeducation |
Primary outcome
Medication adherence
Time frame: 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)
1 secondary outcome
Biological and health behaviors parameters
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Stroke and Transient Ischemic Attack (TIA), run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Screening/baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.