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

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 t...

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Main Authors: Per Kallestrup, Charilaos Lygidakis, Claus Vögele, Jean Paul Uwizihiwe, Michela Bia, Jeanine Condo
Format: Article
Language:English
Published: BMJ Publishing Group 2019-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/7/e028427.full
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author Per Kallestrup
Charilaos Lygidakis
Claus Vögele
Jean Paul Uwizihiwe
Michela Bia
Jeanine Condo
author_facet Per Kallestrup
Charilaos Lygidakis
Claus Vögele
Jean Paul Uwizihiwe
Michela Bia
Jeanine Condo
author_sort Per Kallestrup
collection DOAJ
description 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.
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spelling doaj-art-8bfc2d3d6ec44bfc814a7ce0508ed5c52024-11-28T22:35:11ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-028427Community- 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 trialPer Kallestrup0Charilaos Lygidakis1Claus Vögele2Jean Paul Uwizihiwe3Michela Bia4Jeanine Condo53 Centre for Global Health, Department of Public Health, Aarhus Universitet, Aarhus, Denmark2 College of Medicine and Health Sciences, University of Rwanda, Butare, RwandaDepartment of Behavioral and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, LuxembourgDepartment of Public Health, Center for Global Health, Aarhus University, Aarhus University, Aarhus, Denmark4 Labor Market, Luxembourg Institute of Socio-Economic Research, Esch-sur-Alzette, LuxembourgSchool of Public Health, University of Rwanda, Kigali, RwandaIntroduction 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.https://bmjopen.bmj.com/content/9/7/e028427.full
spellingShingle Per Kallestrup
Charilaos Lygidakis
Claus Vögele
Jean Paul Uwizihiwe
Michela Bia
Jeanine Condo
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/9/7/e028427.full
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