StrokeTEAM-UNCT04685408
A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk Ugandans
A study testing TEAM and ETAU in people with Stroke, run by Case Western Reserve University at 3 sites in Uganda.
Trial summary
The proposed 2-phase project will first refine the TargetEd MAnageMent (TEAM) intervention to ensure acceptability across a broad range of Ugandans at risk for stroke and then test the effects of TEAM in reducing stroke risk in a 3-site, prospective, 6-month randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- TEAM and ETAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 3 sitesUganda
- Study dates
- 13 May 2022to 3 Sep 2024
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: ≥ 18 years
- At risk for stroke defined by the following:
- High systolic BP defined as ≥ 140 mmHg assessed on at least 2 occasions at least 3 days apart and either criterion b or c as noted below:
- At least 1 other modifiable stroke risk factor including: diabetes, hyperlipidemia, obesity, smoking, problem alcohol use or sedentary lifestyle. Problem alcohol use for screening purposes will be assessed with questions on frequency, type of alcohol and quantity consumed. Participants will be classified as engaging in potential problem alcohol use if they exceed the recommended level for safe alcohol intake i.e. more than 3 drinks on average every time they drink, or if they undertook binge drinking (i.e. more than 3 drinks on one occasion in the one month preceding the evaluation).
- History of stroke or transient ischemic attack within the past 5 years
- Able to participate in group sessions
Who cannot join
- Individuals who are unable or unwilling to provide written informed consent
- Individuals who have sickle-cell disease
- Females who are pregnant or lactating
- Individuals with dementia
Trial locations and contacts
3 sites in 1 country.
Uganda3 sites
Mulago Hospital
Kampala
Nsambya Hospital
Kampala
Mbarara Regional Referral Hospital
Mbarara
About this study
Official title: A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk
The proposed 2-phase project will first refine the TargetEd MAnageMent (TEAM) intervention to ensure acceptability across a broad range of Ugandans at risk for stroke and then test the effects of TEAM in reducing stroke risk in a 3-site, prospective, 6-month randomized controlled trial (RCT).
Read the detailed description
In Phase 1 of the project, stakeholder's advisory board (SAB) will be convened across 3 Ugandan sites. The SAB will be composed of up to 15 relevant stakeholders including 3 stroke survivors, 3 individuals with multiple stroke risk factors as defined above, 3 family members, 3 clinicians and 3 administrators who practice in the proposed study enrollment sites. The purpose of the SAB is to refine the TEAM intervention content to meet the needs of patients and professional healthcare stakeholders and suggest how TEAM might best be incorporated into clinical workflow, as well as give guidance and feedback on recruitment methods and advertisements.
Phase 2 of the project will be conducted across 3 Ugandan sites that will enroll a representative sample of Ugandans at risk for stroke (Kiruddu, Nsambya and Mbarara Hospitals and their associated outpatient clinics). In the RCT portion of the study, 246 participants will be randomized at baseline on a 1:1 basis to receive either TEAM (N= 123) or enhanced treatment as usual (ETAU) (N=123) and will be followed for a total of 6 months. Since stroke is a moderately long-term health outcome (years to decades) that typically occurs in the presence of one or more stroke risk factors, the project will focus on testing whether TEAM can modify well-established short-term biomarkers that predict stroke risk, specifically BP control, serum cholesterol and blood glucose control. Secondary outcomes of interest include additional stroke risk biomarkers, (HDL, LDL, triglycerides) diet, exercise, use of alcohol and tobacco, stroke knowledge/attitudes, stress, and treatment adherence with risk-reducing medications. We will also explore associations of age, gender, urban vs. rural residential status and stroke history (prior vs. no previous stroke) on TEAM outcomes. To help inform future scale-up should RCT findings be positive, we will assess barriers and facilitators to TEAM implementation using both qualitative and quantitative methods.
- Conditions
- Stroke
- Being tested
- TEAM, ETAU
- Keywords
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAMBehavioural
TEAM is informed by principles of social cognitive theory TEAM uses nurses and peer educator dyads (PEDs) composed of patients and their care partners to co-deliver an intervention intended to help reduce future stroke risk. Team begins with one 60-minute 1:1 orientation session, in which the nurse and PED meet with the patient and his/her care partner. This is followed by 6 hour-long group sessions with 6-8 patients and their care partners held approximately weekly. The first orientation session will be done approximately 1 week post baseline, followed by group sessions were done at 2, 4, 6, 8, 10 and 12 weeks post-baseline.
ETAUBehavioural
ETAU will consist of an orientation visit with a nurse who will provide patient-education materials on stroke risk adapted from the American Heart Association materials and cover common risk factors such as hypertension, obesity, high salt/high fat diet and diabetes. Patients will also receive basic written information in their language of preference and tailored to the reading level of most patients at the clinic. Patients will be offered the opportunity to bring a family member with them to this visit who may also ask questions and who can assist them with understanding written materials for those with limited literacy. The nurse in ETAU will then follow-up with participants with a series of 9 brief phone calls spaced out over the course of 6 months (approximately every 2 weeks during months 1 and 2, then approximately monthly thereafter). Content will reinforce materials provided in the orientation visit and the nurse will be available to answer questions that may arise.
| Study group | Role | What they receive |
|---|---|---|
| TargEted MAnageMent Intervention (TEAM) | Experimental | This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM) Receives: Behavioral: TEAM |
| Enhanced treatment as usual (ETAU) | Active comparator | This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU). Receives: Behavioral: ETAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Systolic Blood Pressure (BP) at 6 Months
Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start13 May 2022
- Primary completion6 Mar 2024
- Study completion3 Sep 2024
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 (3)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Martha Sajatovic, MD, Case Western Reserve University
- Investigators
- Marta Sajatovic, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685408
- Sponsor's protocol ID
- STUDY20200882
- Other IDs
- 1R01NS118544
- Acronym
- TEAM-U
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2020
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will include self-reported demographic and behavioral data from interviews with the subjects' data. The final dataset will be stripped of identifiers prior to release for sharing; we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement (national and international are required) that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Beyond this all the information generated from the various study data sets will be made available to the global community in open access journals indexed in pub med or via the internet as described in the dissemination plan.
Publications
Sajatovic M, Kaddumukasa M, Najjuma JN, Mbalinda SN, Nakibuuka J, Birungi D, Conroy C, Yala J, Mugenyi L, Burant CJ, Moore S, Katabira ET, Kaddumukasa M. Demographics and Clinical Correlates of Blood Pressure Among Ugandans at Risk for Stroke. J Neurol Res. 2024 Dec;14(2):74-85. doi: 10.14740/jnr830. Epub 2024 Nov 15.
PubMed 41835484Kaddumukasa M, Kaddumukasa M, Mbalinda SN, Najjuma J, Nakibuuka J, Birungi D, Conroy C, Yala J, Mugenyi L, Burant CJ, Moore S, Katabira ET, Sajatovic M. A 6-month, prospective randomized controlled trial of the TargetEd MAnageMent (TEAM) intervention vs. enhanced treatment as usual among Ugandans at risk for stroke. PLoS One. 2025 Aug 22;20(8):e0330606. doi: 10.1371/journal.pone.0330606. eCollection 2025.
PubMed 40844998Kaddumukasa M, Najjuma J, Mbalinda SN, Kaddumukasa MN, Nakibuuka J, Burant C, Moore S, Blixen C, Katabira ET, Sajatovic M. Reducing stroke burden through a targeted self-management intervention for reducing stroke risk factors in high-risk Ugandans: A protocol for a randomized controlled trial. PLoS One. 2021 Jun 22;16(6):e0251662. doi: 10.1371/journal.pone.0251662. eCollection 2021.
PubMed 34157024