Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): The study protocol

Introduction: The diabetes mellitus (DM) prevalence in Rwanda is estimated at 3.5%. In 2013, there were only one medical doctor and one nurse per 15,000 and 1,200 people respectively in Rwanda. A new programme employing frontline workers (Home-Based Community Practitioners (HBCPs)) is currently piloted, aiming at following-up patients with non-communicable diseases in their communities. We hypothesise that the management of DM at community level will improve following the introduction of a HBCP programme with regular monthly assessments and disease management, coupled with integration of a mobile health (mHealth) application with patient diaries, notifications and educational material. Objective: The aim of the study is to determine the efficacy of such an integrated programme in Rwanda. Methods: The study is designed as a one-year, open-label cluster trial of two interventions (arm1: HBCP programme, arm2: HBCP programme + mHealth application) and usual care (control). The primary outcomes will be changes in glycated haemoglobin levels and health-related quality of life. Mortality, complications, health literacy, mental well-being and treatment adherence will be assessed as secondary outcomes. Measurements will be conducted at baseline, 6 and 12 months. An intention-to-treat approach will be used to evaluate outcomes. Before trial onset, ethical approval will be sought in Rwanda, Luxembourg and Denmark, and a cross-cultural adaptation of questionnaires and a pilot will be carried out. Relevance: The project will provide evidence on the efficacy of innovative approaches for integrated management of DM and may spur the development of similar solutions for other chronic diseases in low-resource settings