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  • 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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Diabetes and endocrinology
Protocol
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
  1. David Guwatudde1,
  2. Pilvikki Absetz2,
  3. Peter Delobelle3,4,
  4. Claes-Göran Östenson5,
  5. Josefien Olmen Van6,
  6. Helle Molsted Alvesson7,
  7. Roy William Mayega1,
  8. Elizabeth Ekirapa Kiracho8,
  9. Juliet Kiguli9,
  10. Carl Johan Sundberg10,11,
  11. David Sanders4,
  12. Göran Tomson7,12,
  13. Thandi Puoane4,
  14. Stefan Peterson7,13,
  15. Meena Daivadanam7,14
  16. for the SMART2D Consortium
    1. 1 Department of Epidemiology and Biostatistics, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda
    2. 2 Collaborative Care Systems Finland, Helsinki, Finland
    3. 3 Chronic Disease Initiative for Africa, University of Cape Town, Cape Town, South Africa
    4. 4 School of Public Health, University of the Western Cape, Cape Town, South Africa
    5. 5 Department of Molecular Medicine and Surgery, Diabetes and Endocrine Unit, Karolinska Institutet, Stockholm, Sweden
    6. 6 Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium
    7. 7 Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden
    8. 8 Department of Health Policy, Planning and Management, School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda
    9. 9 Department of Community Health and Behavioral Sciences, Makerere University School of Public Health, Kampala, Uganda
    10. 10 Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden
    11. 11 Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden
    12. 12 Swedish Institute for Global Health Transformation, SIGHT, Royal Swedish Academy of Sciences, Stockholm, Sweden
    13. 13 Department of Women’s and Children’s Health, The International Maternal and Child Health, Uppsala University, Uppsala, Sweden
    14. 14 Department of Food, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden
    1. Correspondence to Dr David Guwatudde; dguwatudde{at}musph.ac.ug

    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.

    • type 2 diabetes
    • pre-diabetes
    • adaptive implementation trial
    • cluster sampling
    • theory of change
    • chronic care model

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2017-019981

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      Footnotes

      • Contributors DG, PA, C-GO, JOV, CJS, DS, GT, TP, SP and MD conceptualised the trial. DG, PA, PD, C-GO, JOV, HMA, RWM, EEK, JK, DS, TP, MD and the SMART2D Group are implementing the trial. DG had primary responsibility for final content. All authors participated in writing, read and approved the final manuscript.

      • Funding This study is part of the SMART2D project funded by the European Commission’s Horizon2020 Health Coordination Activities (Grant agreement no 643692) under call “HCO-05-2014: Global Alliance for Chronic Diseases: prevention and treatment of type 2 diabetes”. The Uganda site is co-funded by the Sweden International Development Cooperation Agency (Sida) capacity-building grant to Makerere University 2015-2010 Project #HS 343. The contents of this article are solely the responsibility of the authors and do not reflect the views of the funders of the SMART2D Project.

      • Competing interests None declared.

      • Patient consent Not required.

      • Ethics approval Approval for conduct of this trial was obtained from the institutional review boards (IRB) at the respective trial country sites. In Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health (reference number 426), in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape (BM/17/1/36), and in Sweden from the Regional Ethical Board in Stockholm (2016/2521-31/1). In Uganda, further approval was obtained from the Uganda National Council for Science and Technology (reference number HS 2118).

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Collaborators Francis Xavier Kasujja; Barbara Kirunda; Anthony Muyingo; Gloria Naggayi; Ronald Kusolo; Edward Ikona; Mariam Hassen; Mark Spires; Kululwa Ndayi; Tshilidzi Manuga; Lungiswa Tsolekile; Juliet Aweko; Furat Al-Murani; Dell Saulnier; Linda Timm; Aravinda Berggreen-Clausen; Douglas Sematimba; Jhon Rangel Alvarez; the SMART2D Group.