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.

Abstract:

INTRODUCTION: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 self-management, 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. ETHICS AND DISSEMINATION:The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. TRIAL REGISTRATION NUMBER:ISRCTN11913581; Pre-results.

journal_name

BMJ Open

journal_title

BMJ open

authors

Guwatudde D,Absetz P,Delobelle P,Östenson CG,Olmen Van J,Alvesson HM,Mayega RW,Ekirapa Kiracho E,Kiguli J,Sundberg CJ,Sanders D,Tomson G,Puoane T,Peterson S,Daivadanam M,SMART2D Consortium.

doi

10.1136/bmjopen-2017-019981

subject

Has Abstract

pub_date

2018-03-17 00:00:00

pages

e019981

issue

3

issn

2044-6055

pii

bmjopen-2017-019981

journal_volume

8

pub_type

杂志文章,随机对照试验

相关文献

BMJ Open文献大全