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

Background: In Rwanda, diabetes mellitus (DM) prevalence has been estimated between 3.0 - 3.5%. Several factors, including an increase in screening and diagnosis programmes, the urbanization of the population, and changes in lifestyle are likely to contribute to a sharp increase in the prevalence of DM in the next decade, posing a daunting challenge for the fragile health care systems in low- and middle-income countries (LMICs). At the same time, the level of knowledge and perceptions of DM among patients is inadequate. Patients with low health literacy levels are often unable to recognise the signs and symptoms of DM, and may access their health provider late, hence presenting with more complications.

Although the majority of the Rwandan population seek care at the health centres, the Rwandan primary health care is facing a shortage of human resources. A community health worker programme was introduced in Rwanda in 2007 covering mainly infectious diseases, maternal and child health, and family planning.

In response to the need for better management of non-communicable diseases (NCDs) at the community level, the Ministry of Health of Rwanda and its partners adopted a new strategy and initiated a Home-Based Care Practitioner (HBCP) programme. Approximately 100 cells, belonging to the catchment area of nine selected hospitals, participate in the first phase of the HBCP programme (a "cell" is a small administrative area under the larger areas called "districts"). Every cell has two HBCPs, who completed high school and received six months of technical vocational education and training organised by the Ministry of Health in collaboration with its partners.

There is growing evidence for the efficacy of interventions using mobile devices (mHealth) in LMICs, particularly in improving treatment adherence, appointment compliance, data gathering, and developing support networks for health workers. In Rwanda, there is an urgent call to using mHealth interventions for the prevention and management of NCDs. The present research project responds to this by developing an mHealth intervention integrated in the current primary health care system, in support of both the DM patients and their healthcare providers.

Randomisation: The unit of randomisation will be the cluster, defined by the cell. In each cell two HBCPs work. Under each district hospital, the cells participating in the HBCP programme will be randomised to receive intervention 1 or 2. The patients from each group will receive the same intervention. An equal number of cells, out of those not participating in the HBCP programme, will be randomly selected and assigned to the control group.

Sample size: Lacking other data on diabetes in Rwanda, the standard deviation from a study of Levitt et al. in South Africa is used to calculate the within and between variance. A one-point difference in HbA1c is considered as clinically significant outcome based on previous studies. For the power calculation, a within variance of 4.76, a between variance of 0.53, and an intra-class correlation of 0.1 are assumed. Based on the information which will be gathered before the onset of the trial, the final sample will be estimated assuming either four or six patients per cell (in each cell two HBCPs work).

Assuming four patients per cell, the number of clusters per group needed is 27 for a total number of 108 patients per group to achieve 80% power with a 5% level of significance (total number of patients: 324, total number of cells: 81). 144 patients per group (total number of patients: 432; total number of cells: 108) will be needed to allow for a 30% attrition.

Assuming six patients per cell, the number of clusters per group needed is 21 for a total number of 126 patients per group to achieve 80% power with a 5% level of significance (total number of patients: 378, total number of cells: 63). 168 patients per group (total number of patients: 504; total number of cells: 84) will be needed to allow for a 30% attrition.

Study questionnaires: Four questionnaires will be employed for the assessment of the patients of the trial (D-39, PAID, BMQ, ISHA-Q). In preparation for their use both their translation in Kinyarwanda and their cultural adaptation will be carried out.

Qualitative study: At the end of the trial two types of focus discussion groups will be conducted: a) with patients of the two intervention groups, and; b) with HBCPs delivering the two interventions of the study. The aim of these focus discussion groups is to explore the ways the intervention will have been enacted in practice, expected and unexpected impacts, and the perceptions of relevance and contextual issues that may have impacted the intervention.

Ethical review: 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) and the Ethics Review Panel of the University of Luxembourg (ERP 17-014 D2Rwanda; amendment approved in ERP 17-048 D2Rwanda).

• HBCP programme (Other), also known as Intervention 1: 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.
• mobile health application (Behavioral), also known as Intervention 2: 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.

Primary outcomes

• Change in HbA1c [Change from baseline to 12-month follow-up]

Secondary outcomes

• Change in medication adherence [Change from baseline to 6- and 12-month follow-up]: To assess medication adherence and evaluate patients' medication-taking behaviour, reported side-effects, concerns and barriers to adherence, the Kinyarwanda version of the Brief Medication Questionnaire (BMQ) will be administered at: baseline, after six months, and on trial completion (after 12 months). Data will also be gathered from the pharmacies dispensing medications to calculate the pill count, in an attempt to triangulate the information received from the BMQ with a more objective method.
• 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]
• Number of referrals [From baseline to 12-month follow-up]
• Change in health literacy [Change from baseline to 12-month follow-up]: The Kinyarwanda version of the Information and Support for Health Actions Questionnaire (ISHA-Q) will be employed to assess the health literacy level (at baseline and after 12 months).
• Change in health-related quality of life [Change from baseline to 6- and 12-month follow-up]: The Kinyarwanda version of the Diabetes-39 (D-39) questionnaire will be used to measure health-related quality of life (at baseline, after six months, and on trial completion (after 12 months)).
• Change in mental well-being [Change from baseline to 6- and 12-month follow-up]: The Kinyarwanda version of the Problem Areas in Diabetes questionnaire (PAID) questionnaire will be administered to evaluate psychological well-being (at baseline, after six months, and on trial completion (after 12 months)).
• Percentage of patients with at least one measurement of HbA1c [Change from baseline to 12-month follow-up]
• Percentage of patients with at least one measurement of fasting blood glucose (FBG) levels [Change from baseline to 12-month follow-up]
• Percentage of patients with at least one measurement of creatinine [Change from baseline to 12-month follow-up]
• Percentage of patients with at least one measurement of urine proteins (dipstick) [Change from baseline to 12-month follow-up]
• Percentage of patients with at least one measurement of blood pressure [Change from baseline to 12-month follow-up]
• Percentage of patients with at least one recording of body mass index (BMI) [Change from baseline to 12-month follow-up]
• Fasting blood glucose (FBG) [Change from baseline to 12-month follow-up]
• Creatinine [Change from baseline to 12-month follow-up]
• Urine proteins (dipstick) [Change from baseline to 12-month follow-up]
• Blood pressure [Change from baseline to 12-month follow-up]
• Body mass index (BMI) [Change from baseline to 12-month follow-up]
• Recorded number of smokers [Change from baseline to 12-month follow-up]: Recording of whether a patient is smoker or not
• Number of patients with recorded pack years [Change from baseline to 12-month follow-up]: Pack years are calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked
• Number of patients with recorded alcohol intake per week [Change from baseline to 12-month follow-up]
• Number of smokers [Change from baseline to 12-month follow-up]
• Number of cigarettes per day [Change from baseline to 12-month follow-up]
• Alcohol intake per week [Change from baseline to 12-month follow-up]

Other outcomes

• Patients' challenges receiving care [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with patients
• Patients understanding of diabetes' natural history [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with patients
• How the patients' disease-related decision-making is influence [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with patients
• How the patients' disease-related decision-making is influenced [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with patients
• The challenges of patients in using the mobile app [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with patients
• The changes in behaviour that the intervention brought about [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with patients
• The challenges in the work of HBCPs [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with HBCPs
• The level of satisfaction of HBCPs [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with HBCPs
• The challenges in integrating the app to the usual visits [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with HBCPs
• The differences the HBCPs note from patient to patient [On trial completion (approximately after 12 months)]: The qualitative part of the study will include focus discussion groups and interviews with HBCPs

Sex: All, ages: 21 Years to 80 Years

Inclusion Criteria for patients:

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

Exclusion Criteria for patients:

1. Severe mental health conditions, including cognitive impairments, as registered in their clinical records
2. Severe hearing and visual impairments as registered in their clinical records
3. Terminal illness
4. Illiteracy
5. Pregnancy or post-partum period

Inclusion criteria for HBCPs:

1. Permanent residence in one of the cells of the study
2. Willing and able to give informed consent for enrolment in the study

Exclusion criteria for HBCPs:

1\. Not capable of accomplishing questionnaires due to reading or communication problems

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• Per Kallestrup, MD, PhD, Principal investigator, University of Aarhus
• Claus Vögele, DPsych, PhD, Principal investigator, University of Luxembourg
• Jeanine Condo Umutesi, MD, MSc, PhD, Principal investigator, Rwanda Biomedical Centre
• Conchitta D'Ambrosio, MSc, PhD, Principal investigator, University of Luxembourg