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

Mark Kaddumukasa, Josephine Najjuma, Scovia Nalugo Mbalinda, Martin N Kaddumukasa, Jane Nakibuuka, Christopher Burant, Shirley Moore, Carol Blixen, Elly T Katabira, Martha Sajatovic, Mark Kaddumukasa, Josephine Najjuma, Scovia Nalugo Mbalinda, Martin N Kaddumukasa, Jane Nakibuuka, Christopher Burant, Shirley Moore, Carol Blixen, Elly T Katabira, Martha Sajatovic

Abstract

Introduction: Stroke burden is rapidly increasing globally. Modifiable risk factors offer an opportunity to intervene, and targeting hypertension is a key actionable target for stroke risk reduction in sub-Saharan Africa. This 3-site planned randomized controlled trial builds on promising preliminary data.

Methods: A total of 246 Ugandan adults will be recruited randomized to experimental intervention vs. enhanced treatment control. Intervention participants will receive six weekly group-format stroke risk reduction self-management training sessions, and the controls will receive information on cardiovascular risk. The primary study outcome is systolic B.P. measured at baseline, 13-week, 24 weeks (6 months). Secondary outcomes include other biological and behavioral stroke risk factors.

Discussion: The curriculum-guided self-management TargetEd MAnageMent Intervention (TEAM) program is anticipated to reduce the stroke burden in Uganda.

Trial registration: ClinicalTrials.gov identifier: NCT04685408, registered on 28 December 2020.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Study flow diagram.
Fig 1. Study flow diagram.

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