Table 2

WHO trial registration dataset

Data categoryInformation
1. Primary registry and trial identifying numberClinicalTrials.gov NCT03376607
2. Date of registration in primary registry18 December 2017
3. Secondary identifying numbers–
4. Source(s) of monetary or material supportKaren Elise Jensens Fond, Aarhus University, University of Luxembourg
5. Primary sponsorAarhus University
6. Secondary sponsor(s)Karen Elise Jensens Fond, University of Luxembourg
7. Contact for public queriesJean Paul Uwizihiwe, MD, MSc, Aarhus University, Aarhus, Denmark; email: jpaul.uwizihiwe@ph.au.dk
Charilaos Lygidakis, MD, PgD, University of Luxembourg, Esch-sur-Alzette, Luxembourg; email: charilaos.lygidakis@uni.lu
8. Contact for scientific queriesPer Kallestrup, MD, PhD, Aarhus University, Aarhus, Denmark; email: kallestrup@dadlnet.dk
Claus Vögele, Dipl.-Psych., PhD, University of Luxembourg, Esch-sur-Alzette, Luxembourg; email: claus.voegele@uni.lu
Jeanine Condo Umutesi, MD, MSc, PhD, Rwanda Biomedical Center, Kigali, Rwanda; email: jeanine.condo@rbc.gov.rw
Conchitta D’Ambrosio, MSc, PhD, University of Luxembourg, Esch-sur-Alzette, Luxembourg; email: conchita.dambrosio@uni.lu
9. Public titleCommunity- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda
10. Scientific titleCommunity- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda: The D²Rwanda Study
11. Countries of recruitmentRwanda
12. Health condition(s) or problem(s) studiedDiabetes Mellitus, Telemedicine, Community Health Workers
13. Intervention(s) Intervention 1: HBCP programme
The newly established Home-Based Community Practitioners (HBCPs) programme will provide monthly health assessments, disease management and lifestyle advice by the HBCPs, and referral to the district hospitals when needed.
Intervention 2: behavioural: 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: (1) the registration of measurements, such as blood glucose and weight; (2) the registration of concerns and questions in a diary; (3) the reception of alerts and notifications for the appointments to the health facilities, and; (4) access to advice on lifestyle improvement and other patient educational material.
14. Key inclusion and exclusion 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 six 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 two-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 postpartum 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.

15. Study typeType: interventional
Study design:

  • Allocation: randomised.

  • Intervention model: parallel assignment.

  • Masking: none (open label).

  • Primary purpose: treatment.

16. Date of first enrolment11 January 2019
17. Sample size432
18. Recruitment statusEnrolling by invitation
19. Primary outcome(s)Change in glycated haemoglobin (HbA1c) (time frame: change from baseline to 12-month follow-up)
20. Key secondary outcomes

  • Medication adherence (time frame: change from baseline to six-month and 12-month follow-up). 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 (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).

  • Health literacy (time frame: 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).

  • Health-related quality of life (time frame: change from baseline to six-month and 12-month follow-up). The Kinyarwanda version of the Diabetes-39 questionnaire will be used to measure health-related quality of life (at baseline, after six months and on trial completion (after 12 months)).

  • Diabetes-related distress (time frame: change from baseline to six-month and 12-month follow-up). The Kinyarwanda version of the Problem Areas in Diabetes 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 (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) levels (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 (time frame: change from baseline to 12-month follow-up). Recording of whether a patient is smoker or not.

  • Number of patients with recorded pack years (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).

21. Ethics reviewEthical approval has been obtained from the Rwanda National Ethics Committee (100/RNEC/2017; amendment approved in 463/RNEC/2017; renewed in 113/RNEC/2018; renewed in 192/RNEC/2019) and the Ethics Review Panel of the University of Luxembourg (ERP 17–014 D2Rwanda; amendment approved in ERP 17–048 D2Rwanda).
22. Completion date31 May 2020 (anticipated)
23. Summary resultsn/a
24. IPD sharing statementUndecided