An interventional study of HBCP programme and mobile health application in Diabetes Mellitus, Telemedicine and Community Health Workers, sponsored by University of Aarhus. Status unknown at 9 sites in Rwanda. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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).
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 209 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for patients:
Exclusion Criteria for patients:
Inclusion criteria for HBCPs:
Exclusion criteria for HBCPs:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention group 1 will receive access to the newly-established HBCP programme.
Other: HBCP programme
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
The control group will receive routine practice.
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
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
Change in HbA1c
Time frame: Change from baseline to 12-month follow-up
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.
Time frame: Change from baseline to 6- and 12-month follow-up
Number of dropouts of the NCD clinics of the district hospitals
Time frame: From baseline to 12-month follow-up
Number of lost appointments to the NCD clinics of the district hospitals
Time frame: From baseline to 12-month follow-up
Mortality
Time frame: From baseline to 12-month follow-up
Number of complications
Time frame: From baseline to 12-month follow-up
Number of referrals
Time frame: 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).
Time frame: 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)).
Time frame: 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)).
Time frame: Change from baseline to 6- and 12-month follow-up
Percentage of patients with at least one measurement of HbA1c
Time frame: Change from baseline to 12-month follow-up
Percentage of patients with at least one measurement of fasting blood glucose (FBG) levels
Time frame: Change from baseline to 12-month follow-up
Percentage of patients with at least one measurement of creatinine
Time frame: Change from baseline to 12-month follow-up
Percentage of patients with at least one measurement of urine proteins (dipstick)
Time frame: Change from baseline to 12-month follow-up
Percentage of patients with at least one measurement of blood pressure
Time frame: Change from baseline to 12-month follow-up
Percentage of patients with at least one recording of body mass index (BMI)
Time frame: Change from baseline to 12-month follow-up
Fasting blood glucose (FBG)
Time frame: Change from baseline to 12-month follow-up
Creatinine
Time frame: Change from baseline to 12-month follow-up
Urine proteins (dipstick)
Time frame: Change from baseline to 12-month follow-up
Blood pressure
Time frame: Change from baseline to 12-month follow-up
Body mass index (BMI)
Time frame: Change from baseline to 12-month follow-up
Recorded number of smokers
Recording of whether a patient is smoker or not
Time frame: 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
Time frame: Change from baseline to 12-month follow-up
Number of patients with recorded alcohol intake per week
Time frame: Change from baseline to 12-month follow-up
Number of smokers
Time frame: Change from baseline to 12-month follow-up
Number of cigarettes per day
Time frame: Change from baseline to 12-month follow-up
Alcohol intake per week
Time frame: Change from baseline to 12-month follow-up
Patients' challenges receiving care
The qualitative part of the study will include focus discussion groups and interviews with patients
Time frame: On trial completion (approximately after 12 months)
Patients understanding of diabetes' natural history
The qualitative part of the study will include focus discussion groups and interviews with patients
Time frame: On trial completion (approximately after 12 months)
How the patients' disease-related decision-making is influence
The qualitative part of the study will include focus discussion groups and interviews with patients
Time frame: On trial completion (approximately after 12 months)
How the patients' disease-related decision-making is influenced
The qualitative part of the study will include focus discussion groups and interviews with patients
Time frame: On trial completion (approximately after 12 months)
The challenges of patients in using the mobile app
The qualitative part of the study will include focus discussion groups and interviews with patients
Time frame: On trial completion (approximately after 12 months)
The changes in behaviour that the intervention brought about
The qualitative part of the study will include focus discussion groups and interviews with patients
Time frame: On trial completion (approximately after 12 months)
The challenges in the work of HBCPs
The qualitative part of the study will include focus discussion groups and interviews with HBCPs
Time frame: On trial completion (approximately after 12 months)
The level of satisfaction of HBCPs
The qualitative part of the study will include focus discussion groups and interviews with HBCPs
Time frame: On trial completion (approximately after 12 months)
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
Time frame: On trial completion (approximately after 12 months)
The differences the HBCPs note from patient to patient
The qualitative part of the study will include focus discussion groups and interviews with HBCPs
Time frame: On trial completion (approximately after 12 months)
Plan to share: Undecided
Ran from Jan 2019 to primary completion in Dec 2020, 23 months.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 23 months is close to that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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