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Study protocol for ...
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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- Guwatudde, D (author)
- Makerere Univ, Sch Publ Hlth, Dept Epidemiol & Biostat, Coll Hlth Sci, Kampala, Uganda
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- Absetz, P (author)
- Collaborat Care Syst Finland, Helsinki, Finland
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- Delobelle, P (author)
- Univ Cape Town, Chron Dis Initiat Africa, Cape Town, South Africa;Univ Western Cape, Sch Publ Hlth, Cape Town, South Africa
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- Ostenson, CG (author)
- Karolinska Institutet,Karolinska Inst, Dept Mol Med & Surg, Diabet & Endocrine Unit, Stockholm, Sweden
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- Van, JO (author)
- Inst Trop Med, Dept Publ Hlth, Antwerp, Belgium
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- Alvesson, HM (author)
- Karolinska Institutet,Karolinska Inst, Dept Publ Hlth Sci, Stockholm, Sweden
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- Mayega, RW (author)
- Makerere Univ, Sch Publ Hlth, Dept Epidemiol & Biostat, Coll Hlth Sci, Kampala, Uganda
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- Kiracho, EE (author)
- Makerere Univ, Sch Publ Hlth, Coll Hlth Sci, Dept Hlth Policy Planning & Management, Kampala, Uganda
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- Kiguli, J (author)
- Makerere Univ, Dept Community Hlth & Behav Sci, Sch Publ Hlth, Kampala, Uganda
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- Sundberg, CJ (author)
- Karolinska Institutet,Karolinska Inst, Dept Physiol & Pharmacol, Stockholm, Sweden;Karolinska Inst, Dept Learning Informat Management & Eth, Stockholm, Sweden
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- Sanders, D (author)
- Univ Western Cape, Sch Publ Hlth, Cape Town, South Africa
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- Tomson, G (author)
- Karolinska Institutet,Karolinska Inst, Dept Publ Hlth Sci, Stockholm, Sweden;Royal Acad Sci, SIGHT, Stockholm, Sweden
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- Puoane, T (author)
- Univ Western Cape, Sch Publ Hlth, Cape Town, South Africa
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- Peterson, Stefan, 1962- (author)
- Uppsala universitet,Karolinska Institutet,Internationell barnhälsa och nutrition,Karolinska Inst, Dept Publ Hlth Sci, Stockholm, Sweden
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- Daivadanam, Meena (author)
- Uppsala universitet,Karolinska Institutet,Institutionen för kostvetenskap,Internationell barnhälsa och nutrition,Karolinska Inst, Dept Publ Hlth Sci, Stockholm, Sweden
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(creator_code:org_t)
- 2018-03-17
- 2018
- English.
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In: BMJ open. - : BMJ. - 2044-6055. ; 8:3, s. e019981-
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https://doi.org/10.1...
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http://kipublication...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
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- 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 analysisAn 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 disseminationThe 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 numberISRCTN11913581; Pre-results.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
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- ref (subject category)
- art (subject category)
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BMJ open
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- By the author/editor
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Guwatudde, D
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Absetz, P
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Delobelle, P
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Ostenson, CG
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Van, JO
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Alvesson, HM
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Mayega, RW
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Kiracho, EE
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Kiguli, J
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Sundberg, CJ
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Sanders, D
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Tomson, G
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Puoane, T
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Peterson, Stefan ...
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Daivadanam, Meen ...
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- MEDICAL AND HEALTH SCIENCES
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BMJ open
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Karolinska Institutet
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Uppsala University