Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda (D²Rwanda)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03376607
Recruitment Status : Enrolling by invitation
First Posted : December 18, 2017
Last Update Posted : July 8, 2019
Sponsor:
Collaborators:
University of Luxembourg
Karen Elise Jensen Foundation
University of Rwanda
Rwanda Biomedical Center (RBC)
Luxembourg Institute of Socio-Economic Research (LISER)
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Telemedicine Community Health Workers Other: HBCP programme Behavioral: mobile health application Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community- and mHealth-Based Integrated Management of Diabetes in Primary Healthcare in Rwanda: The D²Rwanda Study
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: Intervention group 1
Intervention group 1 will receive access to the newly-established HBCP programme.
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.
Other Name: Intervention 1

Experimental: Intervention group 2
Intervention group 2 will receive access to the newly-established HBCP programme, and facilitated access to a mobile health application.
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.
Other Name: Intervention 1

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.
Other Name: Intervention 2

No Intervention: Control group
The control group will receive routine practice.



Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Change from baseline to 12-month follow-up ]

Secondary Outcome Measures :
  1. Change in medication adherence [ Time Frame: Change from baseline to 6- and 12-month follow-up ]
    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.

  2. Number of dropouts of the NCD clinics of the district hospitals [ Time Frame: From baseline to 12-month follow-up ]
  3. Number of lost appointments to the NCD clinics of the district hospitals [ Time Frame: From baseline to 12-month follow-up ]
  4. Mortality [ Time Frame: From baseline to 12-month follow-up ]
  5. Number of complications [ Time Frame: From baseline to 12-month follow-up ]
  6. Number of referrals [ Time Frame: From baseline to 12-month follow-up ]
  7. Change in 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).

  8. Change in health-related quality of life [ Time Frame: Change from baseline to 6- and 12-month follow-up ]
    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)).

  9. Change in mental well-being [ Time Frame: Change from baseline to 6- and 12-month follow-up ]
    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)).

  10. Percentage of patients with at least one measurement of HbA1c [ Time Frame: Change from baseline to 12-month follow-up ]
  11. Percentage of patients with at least one measurement of fasting blood glucose (FBG) levels [ Time Frame: Change from baseline to 12-month follow-up ]
  12. Percentage of patients with at least one measurement of creatinine [ Time Frame: Change from baseline to 12-month follow-up ]
  13. Percentage of patients with at least one measurement of urine proteins (dipstick) [ Time Frame: Change from baseline to 12-month follow-up ]
  14. Percentage of patients with at least one measurement of blood pressure [ Time Frame: Change from baseline to 12-month follow-up ]
  15. Percentage of patients with at least one recording of body mass index (BMI) [ Time Frame: Change from baseline to 12-month follow-up ]
  16. Fasting blood glucose (FBG) [ Time Frame: Change from baseline to 12-month follow-up ]
  17. Creatinine [ Time Frame: Change from baseline to 12-month follow-up ]
  18. Urine proteins (dipstick) [ Time Frame: Change from baseline to 12-month follow-up ]
  19. Blood pressure [ Time Frame: Change from baseline to 12-month follow-up ]
  20. Body mass index (BMI) [ Time Frame: Change from baseline to 12-month follow-up ]
  21. Recorded number of smokers [ Time Frame: Change from baseline to 12-month follow-up ]
    Recording of whether a patient is smoker or not

  22. Number of patients with recorded pack years [ Time Frame: Change from baseline to 12-month follow-up ]
    Pack years are calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked

  23. Number of patients with recorded alcohol intake per week [ Time Frame: Change from baseline to 12-month follow-up ]
  24. Number of smokers [ Time Frame: Change from baseline to 12-month follow-up ]
  25. Number of cigarettes per day [ Time Frame: Change from baseline to 12-month follow-up ]
  26. Alcohol intake per week [ Time Frame: Change from baseline to 12-month follow-up ]

Other Outcome Measures:
  1. Patients' challenges receiving care [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with patients

  2. Patients understanding of diabetes' natural history [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with patients

  3. How the patients' disease-related decision-making is influence [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with patients

  4. How the patients' disease-related decision-making is influenced [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with patients

  5. The challenges of patients in using the mobile app [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with patients

  6. The changes in behaviour that the intervention brought about [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with patients

  7. The challenges in the work of HBCPs [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with HBCPs

  8. The level of satisfaction of HBCPs [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with HBCPs

  9. The challenges in integrating the app to the usual visits [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with HBCPs

  10. The differences the HBCPs note from patient to patient [ Time Frame: On trial completion (approximately after 12 months) ]
    The qualitative part of the study will include focus discussion groups and interviews with HBCPs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376607


Locations
Layout table for location information
Rwanda
Kibuye Referral Hospital
Kibuye, Karongi, Rwanda
Ruhengeri Provincial Hospital
Ruhengeri, Musanze, Rwanda
Kibungo Referral Hospital
Kibungo, Ngoma, Rwanda
Bushenge Provincial Hospital
Bushenge, Nyamasheke, Rwanda
Muhima District Hospital
Kigali, Nyarugenge, Rwanda
Ruhango Provincial Hospital
Kinazi, Ruhango, Rwanda
Kinihira Provincial Hospital
Kinihira, Rulindo, Rwanda
Kabutare District Hospital
Huye, Rwanda
Rwamagana Provincial Hospital
Rwamagana, Rwanda
Sponsors and Collaborators
University of Aarhus
University of Luxembourg
Karen Elise Jensen Foundation
University of Rwanda
Rwanda Biomedical Center (RBC)
Luxembourg Institute of Socio-Economic Research (LISER)
Investigators
Layout table for investigator information
Principal Investigator: Per Kallestrup, MD, PhD University of Aarhus
Principal Investigator: Claus Vögele, DPsych, PhD University of Luxembourg
Principal Investigator: Jeanine Condo Umutesi, MD, MSc, PhD Rwanda Biomedical Center
Principal Investigator: Conchitta D'Ambrosio, MSc, PhD University of Luxembourg

Additional Information:
Publications:
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/
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
World Health Organization (WHO). WHO STEPwise approach to Surveillance (STEPS). 2013.
International Diabetes Federation (IDF). IDF Diabetes Atlas 7th edition [Internet]. idf.org. Brussels; 2015. Available from: http://www.diabetesatlas.org/
National Institute of Statistics of Rwanda. Rwanda Integrated Household Living Conditions Survey (EICV) 2013/2014. 2014.
National Institute of Statistics of Rwanda (NISR). The Statistical Yearbook, 2014 Edition [Internet]. 2014. Available from: http://statistics.gov.rw/publications/statistical-yearbook-2014
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
National Institute of Statistics of Rwanda. Statistical Yearbook 2014. 2014.
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
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
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
Binagwaho A. Role of community health in strengthening Rwandan health system [Internet]. 2011 [cited 2016 Feb 6]. Available from: http://www.webcitation.org/6f5urhqiP
United Nations Economic and Social Commission for Asia and the Pacific 2017. Bloomberg Data for Health Initiative. 201.
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
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
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
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.
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
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/
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.
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
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
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
Schenker MB, Castañeda X, Rodriguez-Lainz A, editors. Migration and Health - A Research Methods Handbook. Oakland, California: University of California Press; 2014
Mrc, Clark A, Clark A. Anonymising Research Data. Sociol J Br Sociol Assoc. 2006;44:1-48

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03376607     History of Changes
Other Study ID Numbers: D²Rwanda
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Primary Health Care
Health Behavior
Quality of Life
Health Literacy
Global Health
Medication Adherence

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases