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Randomized Controlled Trial
. 2021 Jun 22;16(6):e0251662.
doi: 10.1371/journal.pone.0251662. eCollection 2021.

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  1 , Josephine Najjuma  2 , Scovia Nalugo Mbalinda  3 , Martin N Kaddumukasa  4 , Jane Nakibuuka  4 , Christopher Burant  5 , Shirley Moore  6 , Carol Blixen  7 , Elly T Katabira  1 , Martha Sajatovic  7
Affiliations
Randomized Controlled Trial

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 et al. PLoS One. .

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

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Fig 1. Study flow diagram.
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