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

Diabetes Mellitus Clinical Trial

— D²Rwanda  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03376607
• Other study ID #: D²Rwanda
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 209
• Est. completion date: December 31, 2021
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Community Health Workers
• Diabetes Mellitus
• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Bushenge Provincial Hospital	Bushenge	Nyamasheke
Rwanda	Kabutare District Hospital	Huye
Rwanda	Kibungo Referral Hospital	Kibungo	Ngoma
Rwanda	Kibuye Referral Hospital	Kibuye	Karongi
Rwanda	Muhima District Hospital	Kigali	Nyarugenge
Rwanda	Ruhango Provincial Hospital	Kinazi	Ruhango
Rwanda	Kinihira Provincial Hospital	Kinihira	Rulindo
Rwanda	Ruhengeri Provincial Hospital	Ruhengeri	Musanze
Rwanda	Rwamagana Provincial Hospital	Rwamagana

Sponsors (6)

Lead Sponsor	Collaborator
University of Aarhus	Karen Elise Jensens Fond, Luxembourg Institute of Socio-Economic Research (LISER), Rwanda Biomedical Center (RBC), University of Luxembourg, University of Rwanda

Country where clinical trial is conducted

Rwanda, 

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' challenges receiving care	The qualitative part of the study will include focus discussion groups and interviews with patients	On trial completion (approximately after 12 months)
Other	Patients understanding of diabetes' natural history	The qualitative part of the study will include focus discussion groups and interviews with patients	On trial completion (approximately after 12 months)
Other	How the patients' disease-related decision-making is influence	The qualitative part of the study will include focus discussion groups and interviews with patients	On trial completion (approximately after 12 months)
Other	How the patients' disease-related decision-making is influenced	The qualitative part of the study will include focus discussion groups and interviews with patients	On trial completion (approximately after 12 months)
Other	The challenges of patients in using the mobile app	The qualitative part of the study will include focus discussion groups and interviews with patients	On trial completion (approximately after 12 months)
Other	The changes in behaviour that the intervention brought about	The qualitative part of the study will include focus discussion groups and interviews with patients	On trial completion (approximately after 12 months)
Other	The challenges in the work of HBCPs	The qualitative part of the study will include focus discussion groups and interviews with HBCPs	On trial completion (approximately after 12 months)
Other	The level of satisfaction of HBCPs	The qualitative part of the study will include focus discussion groups and interviews with HBCPs	On trial completion (approximately after 12 months)
Other	The challenges in integrating the app to the usual visits	The qualitative part of the study will include focus discussion groups and interviews with HBCPs	On trial completion (approximately after 12 months)
Other	The differences the HBCPs note from patient to patient	The qualitative part of the study will include focus discussion groups and interviews with HBCPs	On trial completion (approximately after 12 months)
Primary	Change in HbA1c		Change from baseline to 12-month follow-up
Secondary	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
Secondary	Number of dropouts of the NCD clinics of the district hospitals		From baseline to 12-month follow-up
Secondary	Number of lost appointments to the NCD clinics of the district hospitals		From baseline to 12-month follow-up
Secondary	Mortality		From baseline to 12-month follow-up
Secondary	Number of complications		From baseline to 12-month follow-up
Secondary	Number of referrals		From baseline to 12-month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients with at least one measurement of HbA1c		Change from baseline to 12-month follow-up
Secondary	Percentage of patients with at least one measurement of fasting blood glucose (FBG) levels		Change from baseline to 12-month follow-up
Secondary	Percentage of patients with at least one measurement of creatinine		Change from baseline to 12-month follow-up
Secondary	Percentage of patients with at least one measurement of urine proteins (dipstick)		Change from baseline to 12-month follow-up
Secondary	Percentage of patients with at least one measurement of blood pressure		Change from baseline to 12-month follow-up
Secondary	Percentage of patients with at least one recording of body mass index (BMI)		Change from baseline to 12-month follow-up
Secondary	Fasting blood glucose (FBG)		Change from baseline to 12-month follow-up
Secondary	Creatinine		Change from baseline to 12-month follow-up
Secondary	Urine proteins (dipstick)		Change from baseline to 12-month follow-up
Secondary	Blood pressure		Change from baseline to 12-month follow-up
Secondary	Body mass index (BMI)		Change from baseline to 12-month follow-up
Secondary	Recorded number of smokers	Recording of whether a patient is smoker or not	Change from baseline to 12-month follow-up
Secondary	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
Secondary	Number of patients with recorded alcohol intake per week		Change from baseline to 12-month follow-up
Secondary	Number of smokers		Change from baseline to 12-month follow-up
Secondary	Number of cigarettes per day		Change from baseline to 12-month follow-up
Secondary	Alcohol intake per week		Change from baseline to 12-month follow-up

External Links

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