Clinical trial NCT03376607: Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda
Official title: Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda: The D²Rwanda Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Telemedicine
Community Health Workers
Keywords: Primary Health Care
Health Behavior
Quality of Life
Health Literacy
Global Health
Medication Adherence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Luxembourg
name: Karen Elise Jensens Fond
name: University of Rwanda
name: Rwanda Biomedical Centre
name: Luxembourg Institute of Socio-Economic Research (LISER)
First posted: 2017-12-18
Enrollment: 209
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Change from baseline to 12-month follow-up
Secondary outcomes:
measure: Change in medication adherence
timeFrame: Change from baseline to 6- and 12-month follow-up
measure: Number of dropouts of the NCD clinics of the district hospitals
timeFrame: From baseline to 12-month follow-up
measure: Number of lost appointments to the NCD clinics of the district hospitals
timeFrame: From baseline to 12-month follow-up
measure: Mortality
timeFrame: From baseline to 12-month follow-up
measure: Number of complications
timeFrame: From baseline to 12-month follow-up
measure: Number of referrals
timeFrame: From baseline to 12-month follow-up
measure: Change in health literacy
timeFrame: Change from baseline to 12-month follow-up
measure: Change in health-related quality of life
timeFrame: Change from baseline to 6- and 12-month follow-up
measure: Change in mental well-being
timeFrame: Change from baseline to 6- and 12-month follow-up
measure: Percentage of patients with at least one measurement of HbA1c
timeFrame: Change from baseline to 12-month follow-up
measure: Percentage of patients with at least one measurement of fasting blood glucose (FBG) levels
timeFrame: Change from baseline to 12-month follow-up
measure: Percentage of patients with at least one measurement of creatinine
timeFrame: Change from baseline to 12-month follow-up
measure: Percentage of patients with at least one measurement of urine proteins (dipstick)
timeFrame: Change from baseline to 12-month follow-up
measure: Percentage of patients with at least one measurement of blood pressure
timeFrame: Change from baseline to 12-month follow-up
measure: Percentage of patients with at least one recording of body mass index (BMI)
timeFrame: Change from baseline to 12-month follow-up
measure: Fasting blood glucose (FBG)
timeFrame: Change from baseline to 12-month follow-up
measure: Creatinine
timeFrame: Change from baseline to 12-month follow-up
measure: Urine proteins (dipstick)
timeFrame: Change from baseline to 12-month follow-up
measure: Blood pressure
timeFrame: Change from baseline to 12-month follow-up
measure: Body mass index (BMI)
timeFrame: Change from baseline to 12-month follow-up
measure: Recorded number of smokers
timeFrame: Change from baseline to 12-month follow-up
measure: Number of patients with recorded pack years
timeFrame: Change from baseline to 12-month follow-up
measure: Number of patients with recorded alcohol intake per week
timeFrame: Change from baseline to 12-month follow-up
measure: Number of smokers
timeFrame: Change from baseline to 12-month follow-up
measure: Number of cigarettes per day
timeFrame: Change from baseline to 12-month follow-up
measure: Alcohol intake per week
timeFrame: Change from baseline to 12-month follow-up
Other outcomes:
measure: Patients' challenges receiving care
timeFrame: On trial completion (approximately after 12 months)
measure: Patients understanding of diabetes' natural history
timeFrame: On trial completion (approximately after 12 months)
measure: How the patients' disease-related decision-making is influence
timeFrame: On trial completion (approximately after 12 months)
measure: How the patients' disease-related decision-making is influenced
timeFrame: On trial completion (approximately after 12 months)
measure: The challenges of patients in using the mobile app
timeFrame: On trial completion (approximately after 12 months)
measure: The changes in behaviour that the intervention brought about
timeFrame: On trial completion (approximately after 12 months)
measure: The challenges in the work of HBCPs
timeFrame: On trial completion (approximately after 12 months)
measure: The level of satisfaction of HBCPs
timeFrame: On trial completion (approximately after 12 months)
measure: The challenges in integrating the app to the usual visits
timeFrame: On trial completion (approximately after 12 months)
measure: The differences the HBCPs note from patient to patient
timeFrame: On trial completion (approximately after 12 months)
Locations:
city: Kibuye
country: Rwanda
facility: Kibuye Referral Hospital
state: Karongi
city: Ruhengeri
country: Rwanda
facility: Ruhengeri Provincial Hospital
state: Musanze
city: Kibungo
country: Rwanda
facility: Kibungo Referral Hospital
state: Ngoma
city: Bushenge
country: Rwanda
facility: Bushenge Provincial Hospital
state: Nyamasheke
city: Kigali
country: Rwanda
facility: Muhima District Hospital
state: Nyarugenge
city: Kinazi
country: Rwanda
facility: Ruhango Provincial Hospital
state: Ruhango
city: Kinihira
country: Rwanda
facility: Kinihira Provincial Hospital
state: Rulindo
city: Huye
country: Rwanda
facility: Kabutare District Hospital
city: Rwamagana
country: Rwanda
facility: Rwamagana Provincial Hospital
Study officials:
affiliation: University of Aarhus
name: Per Kallestrup, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Luxembourg
name: Claus Vögele, DPsych, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rwanda Biomedical Centre
name: Jeanine Condo Umutesi, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Luxembourg
name: Conchitta D'Ambrosio, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
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