Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden

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Date
2018Author
Guwatudde, David
Absetz, Pilvikki
Delobelle, Peter
Östenson, Claes-Göran
Olmen Van, Josefien
Molsted Alvesson, Helle
Mayega, Roy William
Ekirapa Kiracho, Elizabeth
Kiguli, Juliet
Sundberg, Carl Johan
Sanders, David
Tomson, Göran
Puoane, Thandi
Peterson, Stefan
Daivadanam, Meena
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Show full item recordAbstract
Type 2 diabetes (T2D) is increasingly
contributing to the global burden of disease. Health
systems in most parts of the world are struggling to
diagnose and manage T2D, especially in low-income
and middle-income countries, and among disadvantaged
populations in high-income countries. The aim of this
study is to determine the added benefit of community
interventions onto health facility interventions, towards
glycaemic control among persons with diabetes, and
towards reduction in plasma glucose among persons with
prediabetes.
Methods and analysis An adaptive implementation
cluster randomised trial is being implemented in two rural
districts in Uganda with three clusters per study arm, in an
urban township in South Africa with one cluster per study
arm, and in socially disadvantaged suburbs in Stockholm,
Sweden with one cluster per study arm. Clusters are
communities within the catchment areas of participating
primary healthcare facilities. There are two study arms
comprising a facility plus community interventions arm
and a facility-only interventions arm. Uganda has a third
arm comprising usual care. Intervention strategies focus
on organisation of care, linkage between health facility
and the community, and strengthening patient role in selfmanagement,
community mobilisation and a supportive
environment. Among T2D participants, the primary
outcome is controlled plasma glucose; whereas among
prediabetes participants the primary outcome is reduction
in plasma glucose.
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- Medical and Health Sciences [3670]