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, 

References & Publications (58)

Agarwal S, Rosenblum L, Goldschmidt T, Carras M, Goal N, Labrique AB. Mobile Technology in Support of Frontline Health Workers. John Hopkins Univ Glob mHealth Initiat 2016 [Internet]. 2016;86. Available from: https://dl.dropboxusercontent.com/u/5243748/mFHW Landscape_2016 Final.pdf

Asiimwe-kateera B, Condo J, Ndagijimana A, Kumar S, Mukeshimana M, Gaju E, et al. Mobile Health Approaches to Non-Communicable Diseases in Rwanda. 2015;2(1):89-92.

Bagonza J, Rutebemberwa E, Bazeyo W. Adherence to anti diabetic medication among patients with diabetes in eastern Uganda; a cross sectional study. BMC Health Serv Res. 2015 Apr 19;15:168. doi: 10.1186/s12913-015-0820-5. — View Citation

Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. Review. — View Citation

Binagwaho A. Role of community health in strengthening Rwandan health system [Internet]. 2011 [cited 2016 Feb 6]. Available from: http://www.webcitation.org/6f5urhqiP

Bloomfield GS, Vedanthan R, Vasudevan L, Kithei A, Were M, Velazquez EJ. Mobile health for non-communicable diseases in Sub-Saharan Africa: a systematic review of the literature and strategic framework for research. Global Health. 2014 Jun 13;10:49. doi: 10.1186/1744-8603-10-49. Review. — View Citation

Boyer JG, Earp JA. The development of an instrument for assessing the quality of life of people with diabetes. Diabetes-39. Med Care. 1997 May;35(5):440-53. — View Citation

Braun R, Catalani C, Wimbush J, Israelski D. Community health workers and mobile technology: a systematic review of the literature. PLoS One. 2013 Jun 12;8(6):e65772. doi: 10.1371/journal.pone.0065772. Print 2013. Review. — View Citation

Campbell J, Buchan J, Cometto G, David B, Dussault G, Fogstad H, Fronteira I, Lozano R, Nyonator F, Pablos-Méndez A, Quain EE, Starrs A, Tangcharoensathien V. Human resources for health and universal health coverage: fostering equity and effective coverage. Bull World Health Organ. 2013 Nov 1;91(11):853-63. doi: 10.2471/BLT.13.118729. — View Citation

Condo J, Mugeni C, Naughton B, Hall K, Tuazon MA, Omwega A, Nwaigwe F, Drobac P, Hyder Z, Ngabo F, Binagwaho A. Rwanda's evolving community health worker system: a qualitative assessment of client and provider perspectives. Hum Resour Health. 2014 Dec 13;12:71. doi: 10.1186/1478-4491-12-71. — View Citation

Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004 May;27(5):1218-24. Review. — View Citation

Dodson S, Good S, Osborne R. Health literacy toolkit for low- and middle-income countries: a series of information sheets to empower communities and strengthen health systems [Internet]. National Network of Libraries of Medicine Southeastern/Atlantic Region. New Delhi: World Health Organization, Regional Office for South-East Asia; 2015. Available from: http://apps.searo.who.int/PDS_DOCS/B5148.pdf?ua=1

Farmer PE, Nutt CT, Wagner CM, Sekabaraga C, Nuthulaganti T, Weigel JL, Farmer DB, Habinshuti A, Mugeni SD, Karasi JC, Drobac PC. Reduced premature mortality in Rwanda: lessons from success. BMJ. 2013 Jan 18;346:f65. doi: 10.1136/bmj.f65. Erratum in: BMJ. 2013;346:f534. — View Citation

Fox LM, Ravishankar N, Squires J, Williamson RT, Derick B. Rwanda Health Governance Report [Internet]. Bethesda, MD; 2010. Available from: http://apps.who.int/medicinedocs/documents/s18413en/s18413en.pdf

Garratt AM, Schmidt L, Fitzpatrick R. Patient-assessed health outcome measures for diabetes: a structured review. Diabet Med. 2002 Jan;19(1):1-11. Review. — View Citation

Gill GV, Mbanya JC, Ramaiya KL, Tesfaye S. A sub-Saharan African perspective of diabetes. Diabetologia. 2009 Jan;52(1):8-16. doi: 10.1007/s00125-008-1167-9. Epub 2008 Oct 10. Review. — View Citation

GSMA. The Mobile Economy: Sub Saharan Africa 2014 [Internet]. London, United Kingdom; 2014. Available from: http://www.gsmamobileeconomyafrica.com/GSMA_ME_SubSaharanAfrica_Web_Singles.pdf

Hall V, Thomsen RW, Henriksen O, Lohse N. Diabetes in Sub Saharan Africa 1999-2011: epidemiology and public health implications. A systematic review. BMC Public Health. 2011 Jul 14;11:564. doi: 10.1186/1471-2458-11-564. Review. — View Citation

Hamine S, Gerth-Guyette E, Faulx D, Green BB, Ginsburg AS. Impact of mHealth chronic disease management on treatment adherence and patient outcomes: a systematic review. J Med Internet Res. 2015 Feb 24;17(2):e52. doi: 10.2196/jmir.3951. Review. — View Citation

Hilawe EH, Yatsuya H, Kawaguchi L, Aoyama A. Differences by sex in the prevalence of diabetes mellitus, impaired fasting glycaemia and impaired glucose tolerance in sub-Saharan Africa: a systematic review and meta-analysis. Bull World Health Organ. 2013 Sep 1;91(9):671-682D. doi: 10.2471/BLT.12.113415. Review. — View Citation

Hill Z, Dumbaugh M, Benton L, Källander K, Strachan D, ten Asbroek A, Tibenderana J, Kirkwood B, Meek S. Supervising community health workers in low-income countries--a review of impact and implementation issues. Glob Health Action. 2014 May 8;7:24085. doi: 10.3402/gha.v7.24085. eCollection 2014. Review. — View Citation

International Diabetes Federation (IDF). IDF Diabetes Atlas 7th edition [Internet]. idf.org. Brussels; 2015. Available from: http://www.diabetesatlas.org/

International Diabetes Federation. Global Diabetes Scorecard Tracking Progress for Action [Internet]. Bruxelles; 2014. Available from: http://www.idf.org/global-diabetes-scorecard/assets/downloads/Scorecard-29-07-14.pdf

Joshi R, Alim M, Kengne AP, Jan S, Maulik PK, Peiris D, Patel AA. Task shifting for non-communicable disease management in low and middle income countries--a systematic review. PLoS One. 2014 Aug 14;9(8):e103754. doi: 10.1371/journal.pone.0103754. eCollection 2014. Review. — View Citation

Kok MC, Dieleman M, Taegtmeyer M, Broerse JE, Kane SS, Ormel H, Tijm MM, de Koning KA. Which intervention design factors influence performance of community health workers in low- and middle-income countries? A systematic review. Health Policy Plan. 2015 Nov;30(9):1207-27. doi: 10.1093/heapol/czu126. Epub 2014 Dec 11. Review. — View Citation

Lam WY, Fresco P. Medication Adherence Measures: An Overview. Biomed Res Int. 2015;2015:217047. doi: 10.1155/2015/217047. Epub 2015 Oct 11. Review. — View Citation

Lavsa SM, Holzworth A, Ansani NT. Selection of a validated scale for measuring medication adherence. J Am Pharm Assoc (2003). 2011 Jan-Feb;51(1):90-4. doi: 10.1331/JAPhA.2011.09154. Review. — View Citation

Levitt NS, Bradshaw D, Zwarenstein MF, Bawa AA, Maphumolo S. Audit of public sector primary diabetes care in Cape Town, South Africa: high prevalence of complications, uncontrolled hyperglycaemia, and hypertension. Diabet Med. 1997 Dec;14(12):1073-7. — View Citation

López-Pelayo H, Wallace P, Segura L, Miquel L, Díaz E, Teixidó L, Baena B, Struzzo P, Palacio-Vieira J, Casajuana C, Colom J, Gual A. A randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain): the study protocol. BMJ Open. 2014 Dec 31;4(12):e007130. doi: 10.1136/bmjopen-2014-007130. — View Citation

Mash RJ, Rhode H, Zwarenstein M, Rollnick S, Lombard C, Steyn K, Levitt N. Effectiveness of a group diabetes education programme in under-served communities in South Africa: a pragmatic cluster randomized controlled trial. Diabet Med. 2014 Aug;31(8):987-93. doi: 10.1111/dme.12475. Epub 2014 May 20. — View Citation

Ministry of Health (MOH) [Rwanda]. Health Sector Annual Report: July 2015-June 2016 [Internet]. Kigali; 2016. Available from: http://www.moh.gov.rw/fileadmin/templates/MOH-Reports/Health_20Sector_20Annual_20Report_202015-2016_25082016.pdf

Ministry of Health (MOH) [Rwanda]. Health Sector Policy [Internet]. Kigali; 2014. Available from: http://www.moh.gov.rw/fileadmin/templates/policies/Health_Sector_Policy_2014.pdf

Ministry of Health (MOH) [Rwanda]. Non communicable diseases policy [Internet]. 2015. Available from: http://www.moh.gov.rw/fileadmin/templates/policies/NCDs_Policy.2015.pdf

Mishra SR, Neupane D, Preen D, Kallestrup P, Perry HB. Mitigation of non-communicable diseases in developing countries with community health workers. Global Health. 2015 Nov 10;11:43. doi: 10.1186/s12992-015-0129-5. — View Citation

Mrc, Clark A, Clark A. Anonymising Research Data. Sociol J Br Sociol Assoc. 2006;44:1-48

Mukeshimana MM, Nkosi ZZ. Communities' knowledge and perceptions of type two diabetes mellitus in Rwanda: a questionnaire survey. J Clin Nurs. 2014 Feb;23(3-4):541-9. doi: 10.1111/jocn.12199. Epub 2013 Jun 21. — View Citation

National Institute of Statistics of Rwanda (NISR) [Rwanda], Ministry of Health (MOH) [Rwanda], ICF International. Rwanda Demographic and Health Survey 2014-15. Rockville, Maryland, USA: NISR, MOH, and ICF International; 2015.

National Institute of Statistics of Rwanda (NISR). The Statistical Yearbook, 2014 Edition [Internet]. 2014. Available from: http://statistics.gov.rw/publications/statistical-yearbook-2014

National Institute of Statistics of Rwanda. Rwanda Integrated Household Living Conditions Survey (EICV) 2013/2014. 2014.

National Institute of Statistics of Rwanda. Statistical Yearbook 2014. 2014.

Schenker MB, Castañeda X, Rodriguez-Lainz A, editors. Migration and Health - A Research Methods Handbook. Oakland, California: University of California Press; 2014

Schillinger D, Grumbach K, Piette J, Wang F, Osmond D, Daher C, Palacios J, Sullivan GD, Bindman AB. Association of health literacy with diabetes outcomes. JAMA. 2002 Jul 24-31;288(4):475-82. — View Citation

Speight J, Reaney MD, Barnard KD. Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes. Diabet Med. 2009 Apr;26(4):315-27. doi: 10.1111/j.1464-5491.2009.02682.x. Review. — View Citation

Stephani V, Opoku D, Quentin W. A systematic review of randomized controlled trials of mHealth interventions against non-communicable diseases in developing countries. BMC Public Health. 2016 Jul 15;16:572. doi: 10.1186/s12889-016-3226-3. Review. — View Citation

Svarstad BL, Chewning BA, Sleath BL, Claesson C. The Brief Medication Questionnaire: a tool for screening patient adherence and barriers to adherence. Patient Educ Couns. 1999 Jun;37(2):113-24. — View Citation

Tapela N, Habineza H, Anoke S, Harerimana E, Mutabazi F, Hedt-Gauthier B, et al. Diabetes in Rural Rwanda: High Retention and Positive Outcomes after 24 Months of Follow-up in the Setting of Chronic Care Integration. Int J Diabetes Clin Res [Internet]. 2016 [cited 2016 Dec 5];3(2). Available from: http://clinmedjournals.org/articles/ijdcr/international-journal-of-diabetes-and-clinical-research-ijdcr-3-058.php

Torgerson DJ. Contamination in trials: is cluster randomisation the answer? BMJ. 2001 Feb 10;322(7282):355-7. Review. — View Citation

Torjesen I. Maternal deaths have nearly halved in past 25 years. BMJ. 2015 Nov 13;351:h6129. doi: 10.1136/bmj.h6129. — View Citation

United Nations Economic and Social Commission for Asia and the Pacific 2017. Bloomberg Data for Health Initiative. 201.

Utilities Rwanda Regulatory Authority. Statistics and tariff information in telecommunication, media and postal service as of the fourth quarter 2016 [Internet]. 2016. Available from: http://www.rura.rw/fileadmin/docs/statistics/Statistics_report_4th_quarter___2016_for_publication_.pdf

van Teijlingen E, Hundley V. The importance of pilot studies. Nurs Stand. 2002 Jun 19-25;16(40):33-6. Review. — View Citation

Vital Wave Consulting. mHealth for Development: The Opportunity of Mobile Technology for Healthcare in the Developing World [Internet]. Washington, D.C.; 2009. Available from: http://www.unfoundation.org/what-we-do/issues/global-health/mhealth-report.html

Watkins K, Connell CM. Measurement of health-related QOL in diabetes mellitus. Pharmacoeconomics. 2004;22(17):1109-26. Review. — View Citation

Windus DW, Ladenson JH, Merrins CK, Seyoum M, Windus D, Morin S, Tewelde B, Parvin CA, Scott MG, Goldfeder J. Impact of a multidisciplinary intervention for diabetes in Eritrea. Clin Chem. 2007 Nov;53(11):1954-9. — View Citation

World Health Organization (WHO). Adherence to long-term therapies: evidence for action. 2003;2014:1-194. Available from: http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf

World Health Organization (WHO). Global status report on noncommunicable diseases 2014. 2014;298. Available from: http://www.who.int/nmh/publications/ncd-status-report-2014/en/

World Health Organization (WHO). ITU and WHO launch mHealth initiative to combat noncommunicable diseases [Internet]. 2012 [cited 2016 Feb 6]. Available from: http://www.who.int/nmh/events/2012/mhealth/en/

World Health Organization (WHO). WHO STEPwise approach to Surveillance (STEPS). 2013.

* 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