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Global health
Protocol
Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial
  1. Charilaos Lygidakis1,2,
  2. Jean Paul Uwizihiwe2,3,
  3. Per Kallestrup3,
  4. Michela Bia4,
  5. Jeanine Condo2,5,
  6. Claus Vögele1
  1. 1 Institute for Health and Behaviour – Research Unit INSIDE, Universite du Luxembourg, Esch-sur-Alzette, Luxembourg
  2. 2 College of Medicine and Health Sciences, University of Rwanda, Butare, Rwanda
  3. 3 Centre for Global Health, Department of Public Health, Aarhus Universitet, Aarhus, Denmark
  4. 4 Labor Market, Luxembourg Institute of Socio-Economic Research, Esch-sur-Alzette, Luxembourg
  5. 5 Rwanda Biomedical Center, Kigali, Rwanda
  1. Correspondence to Dr Charilaos Lygidakis; charilaos.lygidakis{at}uni.lu

Abstract

Introduction In Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction.

Methods and analysis This is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.

Ethics and dissemination Ethics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number NCT03376607; Pre-results.

  • information technology
  • telemedicine
  • primary care
  • public health

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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-028427

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    Footnotes

    • Contributors CL, JPU, CV and PK conceived of the study and developed the design and protocol. MB made substantial contributions to sample calculation and the statistical analysis plan. JC contributed to the development of the protocol. CL wrote the first draft of the manuscript and all authors contributed to revising it critically.

    • Funding The D²Rwanda study is supported by the Karen Elise Jensens Fond, and the Universities of Luxembourg and Aarhus.

    • Competing interests None declared.

    • Ethics approval Ethical approval has been obtained from the Rwanda National Ethics Committee (100/RNEC/2017; amendment approved in 463/RNEC/2017; renewed in 113/RNEC/2018; renewed in 192/RNEC/2019) and the Ethics Review Panel of the University of Luxembourg (ERP 17–014 D2Rwanda; amendment approved in ERP 17–048 D2Rwanda).

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

    • Patient consent for publication Not required.