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

NCT03376607 | Unknown DMC

• 1 other identifier: D²Rwanda
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Primary Health Care; Health Behavior; Quality of Life; Health Literacy; Global Health; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline to 12-month follow-up

Secondary Outcomes (26)

• Change in medication adherence

  Change from baseline to 6- and 12-month follow-up

• Number of dropouts of the NCD clinics of the district hospitals

  From baseline to 12-month follow-up

• Number of lost appointments to the NCD clinics of the district hospitals

  From baseline to 12-month follow-up

• Mortality

  From baseline to 12-month follow-up

• Number of complications

  From baseline to 12-month follow-up

Other Outcomes (10)

• Patients' challenges receiving care

  On trial completion (approximately after 12 months)

• Patients understanding of diabetes' natural history

  On trial completion (approximately after 12 months)

• How the patients' disease-related decision-making is influence

  On trial completion (approximately after 12 months)

Study Arms (3)

Intervention group 1

EXPERIMENTAL

Intervention group 1 will receive access to the newly-established HBCP programme.

Other: HBCP programme

Intervention group 2

EXPERIMENTAL

Intervention group 2 will receive access to the newly-established HBCP programme, and facilitated access to a mobile health application.

Other: HBCP programme; Behavioral: mobile health application

Control group

NO INTERVENTION

The control group will receive routine practice.

Interventions

HBCP programme OTHER

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.

Also known as: Intervention 1

Intervention group 1; Intervention group 2

mobile health application BEHAVIORAL

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.

Also known as: Intervention 2

Intervention group 2

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (male and female) aged between 21 and 80 years
• Diagnosed and confirmed as diabetic patient at least 6 months prior to study start
• Living in the administrative areas (called "cells") of the district hospitals participating in the first phase of the HBCP programme
• Residing, and planning to reside within a 2-hour travel distance on foot from the study site for the duration of follow-up
• Willing and able to adhere to the study protocol
• Willing and able to give informed consent for enrolment in the study

You may not qualify if:

• Severe mental health conditions, including cognitive impairments, as registered in their clinical records
• Severe hearing and visual impairments as registered in their clinical records
• Terminal illness
• Illiteracy
• Pregnancy or post-partum period
• Permanent residence in one of the cells of the study
• Willing and able to give informed consent for enrolment in the study
• \. Not capable of accomplishing questionnaires due to reading or communication problems

Sponsors & Collaborators

• University of Aarhus: lead
• University of Luxembourg: collaborator
• Karen Elise Jensens Fond: collaborator
• University of Rwanda: collaborator
• Rwanda Biomedical Centre: collaborator
• Luxembourg Institute of Socio-Economic Research (LISER): collaborator

Study Sites (9)

Kibuye Referral Hospital

Kibuye, Karongi, Rwanda

Location

Ruhengeri Provincial Hospital

Ruhengeri, Musanze, Rwanda

Location

Kibungo Referral Hospital

Kibungo, Ngoma, Rwanda

Location

Bushenge Provincial Hospital

Bushenge, Nyamasheke, Rwanda

Location

Muhima District Hospital

Kigali, Nyarugenge, Rwanda

Location

Ruhango Provincial Hospital

Kinazi, Ruhango, Rwanda

Location

Kinihira Provincial Hospital

Kinihira, Rulindo, Rwanda

Location

Kabutare District Hospital

Huye, Rwanda

Location

Rwamagana Provincial Hospital

Rwamagana, Rwanda

Location

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Related Links

• Karen Elise Jensens Fond is the main sponsor of the study

MeSH Terms

Conditions

Diabetes Mellitus; Health Behavior; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Per Kallestrup, MD, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Claus Vögele, DPsych, PhD

  University of Luxembourg

  PRINCIPAL INVESTIGATOR

• Jeanine Condo Umutesi, MD, MSc, PhD

  Rwanda Biomedical Centre

  PRINCIPAL INVESTIGATOR

• Conchitta D'Ambrosio, MSc, PhD

  University of Luxembourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 18, 2017
• Study Start: January 11, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 31, 2021
• Last Updated: February 21, 2021

Record last verified: 2020-06

Locations

RW (9)