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

Study Overview
=================
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).

Official Title
-----------------
Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda: The D²Rwanda Study

Conditions
-----------------
Diabetes Mellitus, Telemedicine, Community Health Workers

Intervention / Treatment
-----------------
* Other: HBCP programme
* Behavioral: mobile health application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for patients: 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 Exclusion Criteria for patients: 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 Inclusion criteria for HBCPs: Permanent residence in one of the cells of the study 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group 1<br>Intervention group 1 will receive access to the newly-established HBCP programme. | Other: HBCP programme<br>* 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.<br>* Other names: Intervention 1;|
| Experimental: Intervention group 2<br>Intervention group 2 will receive access to the newly-established HBCP programme, and facilitated access to a mobile health application. | Other: HBCP programme<br>* 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.<br>* Other names: Intervention 1;Behavioral: mobile health application<br>* 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.<br>* Other names: Intervention 2;|
| No Intervention: Control group<br>The control group will receive routine practice. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | Change from baseline to 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication adherence | 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. | 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 | 
| Number of referrals |  | From baseline to 12-month follow-up | 
| Change in health literacy | 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 from baseline to 12-month follow-up | 
| Change in health-related quality of life | 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 from baseline to 6- and 12-month follow-up | 
| Change in mental well-being | 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)). | Change from baseline to 6- and 12-month follow-up | 
| 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 | Recording of whether a patient is smoker or not | Change from baseline to 12-month follow-up | 
| Number of patients with recorded pack years | Pack years are calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked | Change from baseline to 12-month follow-up | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Health Care, Health Behavior, Quality of Life, Health Literacy, Global Health, Medication Adherence