StrokeTEAM2NCT04402125
Reducing Stroke Risk in African-American Men
A study testing TargEted MAnageMent Intervention (TEAM) in people with Stroke and Transient Ischemic Attack, run by Case Western Reserve University at 1 site in United States.
Trial summary
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- TargEted MAnageMent Intervention (TEAM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2020to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 18 to 90
- Self-identified African American male
- Have had a stroke or TIA in the past 10 years based on date of hospital discharge from an acute stroke program or Emergency Room/physician visit for TIA
- Barthel Index (BI) score of >= 40
- Able to participate in group sessions
- Age range from 18 to 90
Show all 14Show fewer
- Able to participate in group sessions
- Age range: from 18 to 90
- Self-identified African American male
- Have had a stroke or TIA
- Able to participate in group sessions
- Age range: from 18 to 90
- Able to participate in group sessions
- Is either a family member, friend or other individual who is important in an enrolled peer educator's stroke recovery OR the family member, friend or other individual of someone who has had a stroke or TIA and is/was important in their stroke recovery
Who cannot join
- Individuals who are unable or unwilling to provide written informed consent
- Individuals who have had stroke due to sickle-cell disease
- Exclusion Criteria for Care Partner participant 1. Individuals who are unable or unwilling to provide written informed consent
- Individuals who are unable or unwilling to provide written informed consent
- Individuals who have had stroke due to sickle-cell disease
- 1. 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, 44106
About this study
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years.
Read the detailed description
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. TEAM features a nurse-led, person-centered, holistic intervention that takes advantage of existing strengths in AA families/communities. TEAM uses peer educator dyads (PEDs) to provide support and model behaviors. The PED consists of an AA man peer educator (PE) with experience in managing his own stroke risk and a care partner. A care partner is someone who is the family member, friend or other individual of someone who has had a stroke or TIA. A care partner can be associated with a PE but they do not have to be. PEs and care partners will be matched depending on schedules and availability and may not always be members of the same household. The nurse and PED co-deliver TEAM to an AA male patient who has experienced stroke or TIA. Patients are also encouraged to include a family, friend, or other individual important his stroke recovery in the TEAM programming. The intervention is a practical approach suitable for implementation in specialty, primary care or community settings, and has the potential to reverse the unacceptably high morbidity seen in AA men due to stroke-related disorders.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- TargEted MAnageMent Intervention (TEAM)
- 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.
TargEted MAnageMent Intervention (TEAM)Behavioural
TEAM targets acquisition of self-management expertise and use of healthy behaviors that are intended to reduce stroke risk and burden. TEAM participants will continue in their regular medical care, supplemented by the TEAM intervention. Components are as follows:
- A 60 minute initial session in which the nurse and the PED meet with the patient who has experienced stroke or TIA. The initial session will cover introductions, orientation, and logistic planning.
- Five 60-minute group sessions with 6-10 stroke survivors (and their care partners as applicable) held approximately 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 week after enrollment. Sessions are co-lead by a nurse and a PED.
- Six brief telephone sessions implemented after the conclusion of the 5 TEAM group sessions. Calls will be conducted every 2 weeks for 12 weeks. Calls will reinforce group session content, provide social support and facilitate linkage with other care providers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up Receives: Behavioral: TargEted MAnageMent Intervention (TEAM) |
| Waitlist | Other | Participants randomized to waitlist for 6 months, then offered the intervention for 6 months Receives: Behavioral: TargEted MAnageMent Intervention (TEAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAM vs WL Systolic BP
BP was assessed using an Omron 3 Model BP7100 (Omron Healthcare, 2018). As RCT enrollment began shortly before the onset of the COVID-19 pandemic, BP assessments were primarily done remotely, using home-based BP evaluation methods. In situations where individuals were unable to capture BP readings using multiple home-based measurements, the baseline BP data could be obtained using either homebased reading, an in-person BP reading conducted by the study team or clinical research unit nursing staff or extracted from the electronic health record up to 8 weeks prior to or 6 weeks after the baseline time-point and up to 6 weeks before or after follow-up time points. The team prioritized home-based or in-person BP measurement capture and only used electronic health record extraction if other methods of BP evaluation were not available.
Measured: Baseline, Month 3, Month 6
Secondary outcomes (7)
TEAM vs WL Diastolic BP
BP was assessed using an Omron 3 Model BP7100 (Omron Healthcare, 2018). As RCT enrollment began shortly before the onset of the COVID-19 pandemic, BP assessments were primarily done remotely, using home-based BP evaluation methods. In situations where individuals were unable to capture BP readings using multiple home-based measurements, the baseline BP data could be obtained using either homebased reading, an in-person BP reading conducted by the study team or clinical research unit nursing staff or extracted from the electronic health record up to 8 weeks prior to or 6 weeks after the baseline time-point and up to 6 weeks before or after follow-up time points. The team prioritized home-based or in-person BP measurement capture and only used electronic health record extraction if other methods of BP evaluation were not available.
Measured: Baseline, Month 3, Month 6
TEAM vs WL Cholesterol
Laboratory testing for serum total cholesterol, HDL, LDL, triglycerides, and HbA1c was conducted at baseline and at 6-month follow-up timepoints. Laboratory testing was conducted using an academic medical center clinical services or national laboratory services for participants who resided outside of the regional reach of the medical center. If individuals were unable to travel to laboratory testing locations due to the COVID-19 pandemic restrictions, results were extracted from the electronic health record using similar timeframes as the BP health record data extraction.
Measured: Baseline, Month 6
TEAM vs WL HDL
Laboratory testing for serum total cholesterol, HDL, LDL, triglycerides, and HbA1c was conducted at baseline and at 6-month follow-up timepoints. Laboratory testing was conducted using an academic medical center clinical services or national laboratory services for participants who resided outside of the regional reach of the medical center. If individuals were unable to travel to laboratory testing locations due to the COVID-19 pandemic restrictions, results were extracted from the electronic health record using similar timeframes as the BP health record data extraction.
Measured: Baseline, Month 6
TEAM vs WL LDL
Laboratory testing for serum total cholesterol, HDL, LDL, triglycerides, and HbA1c was conducted at baseline and at 6-month follow-up timepoints. Laboratory testing was conducted using an academic medical center clinical services or national laboratory services for participants who resided outside of the regional reach of the medical center. If individuals were unable to travel to laboratory testing locations due to the COVID-19 pandemic restrictions, results were extracted from the electronic health record using similar timeframes as the BP health record data extraction.
Measured: Baseline, Month 6
TEAM vs WL Triglycerides
Laboratory testing for serum total cholesterol, HDL, LDL, triglycerides, and HbA1c was conducted at baseline and at 6-month follow-up timepoints. Laboratory testing was conducted using an academic medical center clinical services or national laboratory services for participants who resided outside of the regional reach of the medical center. If individuals were unable to travel to laboratory testing locations due to the COVID-19 pandemic restrictions, results were extracted from the electronic health record using similar timeframes as the BP health record data extraction.
Measured: Baseline, Month 6
TEAM vs WL BMI
Height was measured at baseline and weight was measured at baseline and at 6-month follow-up timepoints. If individuals were unable to provide accurate height and weight measurements, results were extracted from the electronic health record using similar timeframes as the BP health record data extraction.
Measured: Baseline, Month 6
TEAM vs WL HbA1c
Laboratory testing for serum total cholesterol, HDL, LDL, triglycerides, and HbA1c was conducted at baseline and at 6-month follow-up timepoints. Laboratory testing was conducted using an academic medical center clinical services or national laboratory services for participants who resided outside of the regional reach of the medical center. If individuals were unable to travel to laboratory testing locations due to the COVID-19 pandemic restrictions, results were extracted from the electronic health record using similar timeframes as the BP health record data extraction.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start5 May 2020
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
- Masking
- None (open label)
- Enrolment
- 171 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, Case Western Reserve University
- Investigators
- Martha Sajatovic, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402125
- Sponsor's protocol ID
- R01NR018023
- Other IDs
- R01NR018023
- Acronym
- TEAM2
- Status last verified
- Oct 2026
- First submitted
- 15 May 2020
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Still CH, Burant C, Moore S, Einstadter D, Killion C, Modlin C, Sundararajan S, Thornton JD, Wright JT Jr, Sajatovic M. The Targeted Management (TEAM) Intervention for Reducing Stroke Risk in African American Men: Rationale and Study Design of a Prospective Randomized Controlled Trial. J Multidiscip Healthc. 2021 Feb 23;14:513-522. doi: 10.2147/JMDH.S288753. eCollection 2021.
PubMed 33654407
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stroke Risk in African-American Men
- ClinicalTrials.gov ID
- NCT04402125
- Acronym / sponsor ID
- TEAM2 / R01NR018023
- Conditions
- Stroke, Transient Ischemic Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 5 May 2020 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years.
Detailed description
The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years. TEAM features a nurse-led, person-centered, holistic intervention that takes advantage of existing strengths in AA families/communities. TEAM uses peer educator dyads (PEDs) to provide support and model behaviors. The PED consists of an AA man peer educator (PE) with experience in managing his own stroke risk and a care partner. A care partner is someone who is the family member, friend or other individual of someone who has had a stroke or TIA. A care partner can be associated with a PE but they do not have to be. PEs and care partners will be matched depending on schedules and availability and may not always be members of the same household. The nurse and PED co-deliver TEAM to an AA male patient who has experienced stroke or TIA. Patients are also encouraged to include a family, friend, or other individual important his stroke recovery in the TEAM programming. The intervention is a practical approach suitable for implementation in specialty, primary care or community settings, and has the potential to reverse the unacceptably high morbidity seen in AA men due to stroke-related disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 80 participants are assigned to receive TEAM, and 80 participants are assigned to wait list
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: TargEted MAnageMent Intervention (TEAM)Participants randomized to TEAM intervention for 6 months, then observed for 6 month follow up |
| Waitlist | Other | Behavioral: TargEted MAnageMent Intervention (TEAM)Participants randomized to waitlist for 6 months, then offered the intervention for 6 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age range 18 to 90
- Self-identified African American male
- Have had a stroke or TIA in the past 10 years based on date of hospital discharge from an acute stroke program or Emergency Room/physician visit for TIA
- Barthel Index (BI) score of >= 40
- Able to participate in group sessions
Key exclusion criteria (6 listed)
- Individuals who are unable or unwilling to provide written informed consent
- Individuals who have had stroke due to sickle-cell disease
- Exclusion Criteria for Care Partner participant 1. Individuals who are unable or unwilling to provide written informed consent
- Individuals who are unable or unwilling to provide written informed consent
- Individuals who have had stroke due to sickle-cell disease
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 |
|---|---|---|
| TargEted MAnageMent Intervention (TEAM)TEAM targets acquisition of self-management expertise and use of healthy behaviors that are intended to reduce stroke risk and burden. TEAM participants will continue in their regular medical care, supplemented by the TEAM intervention. Components are as follows: 1. A 60 minute initial session in which the nurse and the PED meet with the patient who has experienced stroke or TIA. The initial session will cover introductions, orientation, and logistic planning. 2. Five 60-minute group sessions with 6-10 stroke survivors (and their care partners as applicable) held approximately 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 week after enrollment. Sessions are co-lead by a nurse and a PED. 3. Six brief telephone sessions implemented after the conclusion of the 5 TEAM group sessions. Calls will be conducted every 2 weeks for 12 weeks. Calls will reinforce group session content, provide social support and facilitate linkage with other care providers. | Behavioural | Intervention, Waitlist |
Primary outcome
TEAM vs WL Systolic BP
Time frame: Baseline, Month 3, Month 6
BP was assessed using an Omron 3 Model BP7100 (Omron Healthcare, 2018). As RCT enrollment began shortly before the onset of the COVID-19 pandemic, BP assessments were primarily done remotely, using home-based BP evaluation methods. In situations where individuals were unable to capture BP readings using multiple home-based measurements, the baseline BP data could be obtained using either homebased reading, an in-person BP reading conducted by the study team or clinical research unit nursing staff or extracted from the electronic health record up to 8 weeks prior to or 6 weeks after the baseline time-point and up to 6 weeks before or after follow-up time points. The team prioritized home-based or in-person BP measurement capture and only used electronic health record extraction if other methods of BP evaluation were not available.
7 secondary outcomes
TEAM vs WL Diastolic BP
Time frame: Baseline, Month 3, Month 6
TEAM vs WL Cholesterol
Time frame: Baseline, Month 6
TEAM vs WL HDL
Time frame: Baseline, Month 6
TEAM vs WL LDL
Time frame: Baseline, Month 6
TEAM vs WL Triglycerides
Time frame: Baseline, Month 6
TEAM vs WL BMI
Time frame: Baseline, Month 6
TEAM vs WL HbA1c
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33654407Still CH, Burant C, Moore S, Einstadter D, Killion C, Modlin C, Sundararajan S, Thornton JD, Wright JT Jr, Sajatovic M. The Targeted Management (TEAM) Intervention for Reducing Stroke Risk in African American Men: Rationale and Study Design of a Prospective Randomized Controlled Trial. J Multidiscip Healthc. 2021 Feb 23;14:513-522. doi: 10.2147/JMDH.S288753. eCollection 2021.
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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.
Martha Sajatovic, MD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TargEted MAnageMent Intervention (TEAM) in people with Stroke and Transient Ischemic Attack, 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 14 inclusion and 6 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 28 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
TEAM vs WL Systolic BP (time frame: Baseline, Month 3, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402125, which also lists 1 linked publication.
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 28 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.