Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda

Summary

The Home Based Care Practitioners (HBCPs) programme has been established by the Rwandan Ministry of Health in response to the shortage of health professionals. Currently in its pilot first phase, it entails laypeople providing longitudinal care to chronic patients after receiving a six-month training.The diabetes mellitus (DM) prevalence in Rwanda is estimated at 3.5%. Technological mobile solutions can improve care by enabling patients to self-manage their disease.

It is hypothesised that the establishment of the HBCP programme with regular monthly assessments of DM patients and disease management by the programme's HBCPs improves the patients' HbA1c levels, medication adherence, health-related quality of life, mental well-being, and health literacy levels. It is also hypothesised that patients will show further improvement when the HBCP programme is coupled with a mobile health application for patients that includes diaries, notifications and educational material. The aim of the study is to determine the efficacy of such an integrated programme for the management of DM in primary health care in Rwanda.

Study design: The study is designed as a one-year, open-label cluster trial of two interventions (intervention 1: HBCP programme; intervention 2: HBCP programme + mobile health application) and usual care (control). In preparation for the onset of the study, a mobile application is being developed. Focus discussion groups will be carried out with selected patients and HBCPs after the end of the main trial to explore their opinions in participating in the study.

Study population: District hospitals from those running the HBCP programme will be selected according to criteria. Under each district hospital, the administrative areas ("cells") participating in the HBCP programme will be randomised to receive intervention 1 or 2. The patients from each group who meet the eligibility criteria of the study will receive the same intervention. Cells that do not participate in HBCP programme will be assigned to the control group.

Study endpoints: The primary outcomes will be changes in HbA1c levels. Medication adherence, mortality, complications, health-related quality of life, mental well-being and health literacy will be assessed as secondary outcomes.

Sponsor: The D²Rwanda project has received financial support by the Karen Elise Jensens Fond (Denmark), and the Universities of Aarhus and Luxembourg.

Conditions

• Diabetes Mellitus
• Telemedicine
• Community Health Workers

Interventions

OTHER

HBCP programme

The newly-established Home-Based Community Practitioners (HBCPs) programme will enable frontline workers to offer monthly health assessments, disease management and lifestyle advice to diabetic patients, and referral to the district hospitals when needed.

BEHAVIORAL

mobile health application

HBCPs will actively encourage the use of a mobile app by assisting patients to access it (this process is known as "facilitated access"). The app will enable: (i) the registration of measurements, such as blood glucose and weight; (ii) the registration of concerns and questions in a diary; (iii) the reception of alerts and notifications for the appointments to the health facilities, and; (iv) access to advice on lifestyle improvement and other patient educational material.

Sponsors & Collaborators

• University of Luxembourg

  collaborator OTHER

• Karen Elise Jensens Fond

  collaborator UNKNOWN

• University of Rwanda

  collaborator OTHER

• Rwanda Biomedical Centre

  collaborator OTHER

• Luxembourg Institute of Socio-Economic Research (LISER)

  collaborator UNKNOWN

• University of Aarhus

  lead OTHER

Principal Investigators

• Per Kallestrup, MD, PhD · University of Aarhus

• Claus Vögele, DPsych, PhD · University of Luxembourg

• Jeanine Condo Umutesi, MD, MSc, PhD · Rwanda Biomedical Centre

• Conchitta D'Ambrosio, MSc, PhD · University of Luxembourg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-11

Primary Completion

2020-12-18

Completion

2021-12-31

Countries

• Rwanda

Study Locations