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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
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Fogarty International Center of the National Institute of Health
Information provided by (Responsible Party):
Martha Sajatovic, MD, Case Western Reserve University

Brief 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).

Condition or disease Intervention/treatment Phase
Stroke Behavioral: TEAM Behavioral: ETAU Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: TargEted MAnageMent Intervention (TEAM)
This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)
Behavioral: 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).
Behavioral: 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.




Primary Outcome Measures :
  1. Change from baseline systolic blood pressure (BP) at 6 months [ Time Frame: Baseline and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range: ≥ 18 years
  • At risk for stroke defined by the following:

    1. 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:
    2. 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).
    3. History of stroke or transient ischemic attack within the past 5 years
  • Able to participate in group sessions

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Research Manager 888-819-0004 carla.conroy@uhhospitals.org

Locations
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Uganda
Kiruddu Referral Hospital
Kampala, Uganda
Contact: Mark Kaddumukasa, MBChB, MMed, PhD    256 772 633 475    kaddumark@yahoo.co.uk   
Nsambya Hospital
Kampala, Uganda
Contact: Martin Kaddumukasa, MBChB, MMed, PhD    256 772 120 965    kaddumart@yahoo.com   
Mbarara Regional Referral Hospital
Mbarara, Uganda
Contact: Najjuma Josephine, BSC, MSC    256 779 216 724    najjumajosephine@yahoo.co.uk   
Sponsors and Collaborators
Case Western Reserve University
National Institute of Neurological Disorders and Stroke (NINDS)
Fogarty International Center of the National Institute of Health
Investigators
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Principal Investigator: Marta Sajatovic, MD Case Western Reserve University
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Responsible Party: Martha Sajatovic, MD, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT04685408    
Other Study ID Numbers: STUDY20200882
1R01NS118544 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martha Sajatovic, MD, Case Western Reserve University:
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases