A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk Ugandans (TEAM-U)
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|ClinicalTrials.gov Identifier: NCT04685408|
Recruitment Status : Not yet recruiting
First Posted : December 28, 2020
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: TEAM Behavioral: ETAU||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||246 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||March 30, 2025|
|Estimated Study Completion Date :||March 30, 2025|
Experimental: TargEted MAnageMent Intervention (TEAM)
This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)
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.
Active Comparator: Enhanced treatment as usual (ETAU)
This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).
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.
- Change from baseline systolic blood pressure (BP) at 6 months [ Time Frame: Baseline and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685408
|Contact: Research Manageremail@example.com|
|Kiruddu Referral Hospital|
|Contact: Mark Kaddumukasa, MBChB, MMed, PhD 256 772 633 475 firstname.lastname@example.org|
|Contact: Martin Kaddumukasa, MBChB, MMed, PhD 256 772 120 965 email@example.com|
|Mbarara Regional Referral Hospital|
|Contact: Najjuma Josephine, BSC, MSC 256 779 216 724 firstname.lastname@example.org|
|Principal Investigator:||Marta Sajatovic, MD||Case Western Reserve University|