Mobile phone text-messaging to support treatment for people with type 2 diabetes in sub-Saharan Africa: a pragmatic individually randomised trial

Lead Research Organisation: University of Oxford
Department Name: Primary Care Health Sciences

Abstract

Treatment for patients with type 2 diabetes could be substantially improved in sub-Saharan Africa. Amongst the problems identified, failure to take medicines to treat diabetes regularly, is a major problem. Resources to identify and support patients who are not making best use of medicine in low and middle-income settings are scarce. Mobile phones are widely available in these settings including among people with diabetes and linked technologies such as SMS-text messaging, have shown promise in delivering low cost interventions efficiently.. However, evidence that these interventions will work when carried out at a larger scale, and of the extent to which they will improve health outcomes when added to usual care is limited. Despite wide policy encouragement for using this type of technology to improve outcomes for non-communicable diseases such as diabetes, there are only a small number of studies evaluating this type of system. There are none, as far as we are aware evaluating systems sending SMS text-messages to individual patients with diabetes that have embedded their system within existing community based diabetes care. In addition, we are also not aware of studies that are measuring the costs and benefits of such systems.
We plan to carry out a study (a clinical trial) that will provide information about the overall benefits and harms of using carefully developed SMS text-messages to inform people about the benefits of their diabetes treatment and, motivate and prompt them to take it regularly. We also plan to collect detailed information about how the systems were set up and used in three different health care settings to guide future attempts to implement similar systems more widely in other settings and for other long-term conditions, and to carry out a detailed study of the costs of wider implementation and the potential value for money of such a system.
The knowledge gained from carrying out this study will have wide application. The technology being evaluated has been developed in-line with the direction of health, and information and communications technology policy in the countries where the research is based. We will use open source software that will intercommunicate with government systems to register and send individualised messages to patients. The same system also allows us to allocate patients to receive either informative messages, or non-health related messages. We will allocate patients in this way using a randomly generated assignment plan so that the benefits of the system can be tested in a carefully controlled trial. We will follow-up people for twelve months and measure important risk factors for the development of complications in diabetes including blood glucose control, blood pressure control and the levels of cholesterol so we can estimate potential health benefits. Before starting the trial, we will work with our clinical collaborators and patients with diabetes to ensure that the technology is embedded in clinical care, and that the message content is appropriate for each of the planned sites. We will extend this qualitative work during and after the main study to see how the technology was used and how people felt about it.
This study will provide data, not otherwise available, that will inform health policy and guide future implementation of this type of technology. We will work with a wide network that includes patients, clinicians, academics, industry and policy makers to help us identify opportunities for informing people about the work and raise awareness of what is being developed and studied.

Technical Summary

Non-communicable long-term conditions and associated failure to use effective medicines place a major burden on the health of patients and health care systems. Current strategies to address problems of motivation and volition in taking medicines as intended are costly and of limited effectiveness. Mobile phones and other forms of digital health technology offer promise in delivering more effective support to patients around medicines adherence, but studies have not generally explored broader implementation within health care, comparative effectiveness and costs in low-resource settings. We have carried out a study using a novel system to send individualised text messages linked to available health care data for people with hypertension. We now plan to extend this work to people with diabetes, in different health-care settings and include formal qualitative methods and evaluation of costs.
We propose to (i) test the impact of educational and motivational messages, and prompts delivered through a system of SMS text-messaging on diabetes risk biomarkers, health status and satisfaction with care in a randomized trial; (ii) determine the factors associated with successful implementation of the system using a mixed-methods approach; (iii) study the costs of implementing the system and of its cost-effectiveness. The primary trial outcome is HbA1c with secondary measure including blood pressure and the ratio of total-cholesterol to HDL-cholesterol. The SMS text-message system has already been used with hypertensive patients in a low-income setting with 87% follow up of patients over one year. We are an international collaboration with expertise in diabetes research in sub-Sarahan Africa. We have statistical support from a UK registered primary care clinical trials unit, engineering support from a world-leading biomedical engineering based mHealth group, able to provide support for clinical measurement at the proposed research sites.

Planned Impact

We anticipate that the health impacts from this work will come from setting up the infrastructure based around mobile phones, from the knowledge gained about effectively communicating through text messages, and from the lessons learned about the contextual factors that need to be addressed in wider implementation of technology.

In the first instance, setting up the technology will offer direct benefits to patients and health care staff. In our previous work at a single site, we have noted that patients see the text messages as a sign of more personal care, and thus improved satisfaction with the health care offered. Looking more closely at processes within the clinic, and the way that information is stored also has immediate application. Even at its most basic, the ability to store a small amount of data, linked to the identifier of a mobile phone number, will allow information about patients (for example the use of specific health facilities) to be stored and made accessible to health workers. The ability to track use of medications also has immediate application in identifying the possible impact when medications are unavailable, or identifying specific individuals who may be affected by "stock-outs". The wider integration of data would enable vulnerable groups of patients to be identified and better managed.

The specific knowledge that we might gain about effectively communicating through text messages, and how best to address contextual factors has potential to inform the content of text messages to support medication adherence widely. Many of the messages used in our previous work are likely to require little adaptation, and we will test whether this is an accurate perception in the different settings. Some messages are likely to be facility or process specific, and by observing the development of the new messages at the different sites, we will be able to learn how to facilitate the efficient processes of implementation and local ownership at different levels. The evidence this work will provide about the clinical effectiveness of the specific approach to delivering text messages and their content will ensure that the work has wide application and directly engages policy makers. For example, proven impact on health care outcomes, quality of life, satisfaction with health care, and careful recording of costs (health care and technology) will add to the case for wider use of the technology and may also encourage individual facilities to implement the technology.

We also aim to demonstrate the potential for open data and open source software to deliver greater integration of data to support delivery of healthcare. With our group's continuing involvement in developing and evaluating Internet linked mobile devices for long-term conditions in high as well as low-income setting, we are well placed to link to international work to establish information technology standards for health data.

In addition to impact for the early career investigators supported through this initiative, we intend to develop local capacity through the work. We will encourage appropriate staff to undertake educational courses alongside their work, and also encourage secondment of PhD and MSc students.

We will establish and be guided by an advisory board and also review recommendations for leveraging health innovations (e.g. the WHO ExpandNet programme) with the aim of ensuring that clear benefits are realised within three to five years of the end of a successful programme. The basic infrastructure (mobile phones) is already in place and we anticipate that within this time-frame, many health workers, will be using smart-phones for themselves with potential for leveraging our work through the wider availability of compatible technology.
 
Description Commonwealth Distance Learning Scholarship
Amount £13,000 (GBP)
Organisation Government of the UK 
Department Commonwealth Scholarship Commission
Sector Public
Country United Kingdom
Start 09/2015 
End 08/2018
 
Description Global Brain Health Initiative Atlantic Fellowship
Amount $300,000 (USD)
Organisation Global Brain Health Institute 
Start 08/2018 
End 07/2019
 
Description John Fell OUP Research Fund
Amount £175,000 (GBP)
Organisation Oxford University Press 
Sector Private
Country United Kingdom
Start 04/2017 
End 03/2019
 
Description Knowledge Exchange Seed Fund
Amount £2,380 (GBP)
Organisation University of Oxford 
Sector Academic/University
Country United Kingdom
Start 04/2018 
End 10/2018
 
Description MRC Confidence in Global Nutrition and Health Research Initiative
Amount £999 (GBP)
Organisation Medical Research Council (MRC) 
Sector Academic/University
Country United Kingdom
Start 10/2017 
End 09/2018
 
Description Newton RCUK PhD Partnership: Biomedical Sciences Exchange PhD studentships
Amount £152,443 (GBP)
Organisation Newton Fund 
Sector Public
Country United Kingdom
Start 12/2015 
End 12/2018
 
Description Programme Grant
Amount £1,980,000 (GBP)
Organisation National Institute for Health Research 
Department Programme Grants for Applied Research (PGfAR)
Sector Charity/Non Profit
Country United Kingdom
Start 04/2017 
End 12/2022
 
Description University of Cape Town URC Postdoctoral Fellowship
Amount R 220,000 (ZAR)
Funding ID Grant no: 1251981 
Organisation University of Cape Town 
Sector Academic/University
Country South Africa
Start 01/2016 
End 12/2017
 
Description Establishing a cross departmental Global Health Systems Group at Oxford 
Organisation Oxford Health Alliance
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution I am a co-applicant in this grant awarded by the Wellcome Institutional Support Fund at Oxford. We have committed to invite members of our international research groups to attend conferences in Oxford at which we invite a wide range of Global health stakeholders and students so that we explore partnerships and ways in which we might work together and also gain greater visibility for our work.
Collaborator Contribution We presented our work at this meetings and set up a series of meetings between our team and other researchers based in Oxford and working with other Oxford collaborators. Our contribution is based on our work in South Africa (townships) and Malawi and contributes to improving health in these settings, as well as implementing novel technology to support the goal of better health. This has included inviting partners from these settings and reporting our work.
Impact Presentations (see engagement)
Start Year 2017
 
Description Establishing a cross departmental Global Health Systems Group at Oxford 
Organisation University of Oxford
Department Social Sciences Division
Country United Kingdom 
Sector Academic/University 
PI Contribution I am a co-applicant in this grant awarded by the Wellcome Institutional Support Fund at Oxford. We have committed to invite members of our international research groups to attend conferences in Oxford at which we invite a wide range of Global health stakeholders and students so that we explore partnerships and ways in which we might work together and also gain greater visibility for our work.
Collaborator Contribution We presented our work at this meetings and set up a series of meetings between our team and other researchers based in Oxford and working with other Oxford collaborators. Our contribution is based on our work in South Africa (townships) and Malawi and contributes to improving health in these settings, as well as implementing novel technology to support the goal of better health. This has included inviting partners from these settings and reporting our work.
Impact Presentations (see engagement)
Start Year 2017
 
Description Global Alliance for Chronic Disease working groups on data harmonisation in diabetes and understanding context in research 
Organisation Global Alliance for Chronic Diseases
PI Contribution Dr Bobrow has represented our team, liaising with working groups drawing on projects funded through the GACD umbrella.
Collaborator Contribution We have contributed data on measurements used in our study and design of our process development work. This data is being synthesised and evaluated by members of the group with the aim of publication and dissemination. This is based on our work in South Africa (townships) and Malawi and contributes to improving health in these settings, as well as implementing novel technology to support the goal of better health.
Impact No publications as yet
Start Year 2017
 
Description Text 2 Stop - Collaboration of trialists for an individual patient data meta-analysis 
Organisation George Institute for Global Health
Country Australia 
Sector Academic/University 
PI Contribution Collaborative work to share data from previous research. This will inform the current MRC study funded through GACD, and facilitate seeking further funding for new international work
Collaborator Contribution We have contributed data from our previous studies, time in teleconferences, work around grant applications. Our contribution to this collaboration is based on our work in South Africa (townships) and Malawi and contributes to improving health in these settings, as well as implementing novel technology to support the goal of better health. And also on our UK based work on text-messaging.
Impact None as yet
Start Year 2015
 
Title SMS text message content for intervention for people with type 2 diabetes in sub-Saharan Africa 
Description As part of the programme of research funded through the MRC UK/GACD grant the team undertook a process of interviews with patients and clinic staff in Cape Town and Lilongwe to develop content of messages. Message content was developed in English, Afrikaans, Xhosa and Chichewa. This package of brief messages, focussed on people with type 2 diabetes and their use of medicines, although covering other aspects of diabetes care, is now being tested in a clinical trial. We are actively seeking additional support to test and implement these messages more widely. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2016
Development Status Actively seeking support
Impact We are currently in discussion with our collaborators (TXT2PREVENT Collaboration) to compare and contrast the library of messages with others developed, and apply existing taxonomies to understand differences between libraries of messages and how they might differ in effectiveness in different contexts. 
 
Description A formative approach to developing and pre-testing a set of SMS text-messages for diabetes adherence support in Sub-Saharan Africa. Poster at Public Health Association of South Africa 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Poster
Year(s) Of Engagement Activity 2016
 
Description BRC3 D&M 5th PPI meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Chief Investigator, Professor Andrew Farmer, spoke at the Diabetes Reference Panel BRC3 D&M 5th PPI Meeting on 29th January 2019. The talk was titled, "Supporting people with diabetes through digital technologies: research and opportunities". This included work carried out more widely as an NIHR Senior Investigator and details of current trials, including SuMMiT-D and StAR2D
Year(s) Of Engagement Activity 2019
 
Description Crossing Boundaries - Interdisciplinary Global health Conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Third sector organisations
Results and Impact Three members of our team (Leon, Farmer and Bobrow) made formal presentations at this meeting in Oxford bringing a wide range of people involved in Global Health work together to discuss initiatives involving Oxford Collaborations (Dec 5-7 2017). We presented the technology used in our study, the way we have developed brief health messages and recent work in which we have been looking at cognition in our participants using tablet computer based approaches. The audience, over 200 people, asked questions and followed up with requests for further information and discussion.
Year(s) Of Engagement Activity 2017
 
Description Developing & pre-testing brief messages for diabetes treatment adherence support: role of formative and process evaluations in mHealth 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact Presentation to the Public Health Faculty Seminar, Karolinska University, Sweden, June 2017
Year(s) Of Engagement Activity 2017
 
Description Development & pre-testing brief text-messaging for Type 2 diabetes adherence support in sSA: Using the MRC Framework for Development of Complex Interventions 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact 9 Jan 2018, UVA J-term Global Health Course Seminar, University of Virginia, Charlottesville, Virginia, USA
Year(s) Of Engagement Activity 2018
 
Description Digital Health presentation at a seminar between British Heart Foundation and Primary Care, University of Oxford 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Supporters
Results and Impact Farmer gave a presentation to the medical director and other senior leaders of the British Heart Foundation in a seminar also attended by other senior University researchers and postgraduate students about his group's digital health work. This included details of StAR2D (MRC), SuMMiT-D (NIHR) and other digital health studies relevant to the NIHR Senior Investigator Award.
Year(s) Of Engagement Activity 2019
 
Description GACD Scientific meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 1. Enitha Phiri (Malawi) and Naomi Levitt, Natalie Leon (SA) participated in Sao Paulo meeting presenting and discussing the research
2. Enita Piri attended the week-long Implementation Science course
3. Natalie Leon attended the 3 day Implementation Science course
4. All provided written update for publication in GACD book of proceedings
5. All contribted to presentations of the research within working group meetings
Year(s) Of Engagement Activity 2018
 
Description NIHR Oxford BRC Public Engagement Talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact This was a review of the work that my group, working with colleagues from BioMedial Engineering, have been doing - highlighting the potential for changes in the way health care is delivered and some of the challenges that need to be faced, particularly around better use of electronic health records in delivering direct patient care.
Year(s) Of Engagement Activity 2016
URL https://oxfordbrc.nihr.ac.uk/event/free-public-talk-digital-health-devices-how-mobile-computing-and-...
 
Description Poster presented at Global Alliance for Chronic Diseases Annual Scientific Meeting October 2016. 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Poster presentation: Developing and pre-Testing brief messages for Diabetes Treatment Adherence Support: A formative study
Year(s) Of Engagement Activity 2016
 
Description Presentation at a Public Health Conference, East London, South Africa 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Policymakers/politicians
Results and Impact Leon N, Namadingo H, Cooper S, Bobrow K, Crampin M, Norris S, Levitt N, Farmer A. A formative approach to developing and pre-testing a set of SMS text-messages for diabetes adherence support in Sub-Saharan Africa. PHASA 2016 (Public Health Association of South Africa), Sept 19-22 East London, SA.

This was a talk at a conference
Year(s) Of Engagement Activity 2016
 
Description Presentation at the Annual Meeting of the Global Alliance for Chronic Disease 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact N Leon, H Namadingo, S Cooper, K Bobrow, M Crampin, S Norris, N Levitt, A Farmer. Developing and pre-testing brief messages for diabetes treatment adherence support: A formative study. Poster Presentation. Global Alliance for Chronic Diseases Research Network 5 th Annual Scientific Meeting (17 - 21 October 2016 Sydney, Australia).

The presentation was awarded first prize in the "People's Choice" category. As a result of the presentation there have been requests for additional information about the project.
Year(s) Of Engagement Activity 2016
 
Description Presentations and feedback of findings to participants in focus group work at the BME Centre for Health , Leicester 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact 25 participants - mainly from the local South Asian community gathered for an afternoon to discuss the problems of living with type 2 diabetes. Presentations included findings from previous focus groups with them, and personal stories of the impact of diabetes.
Year(s) Of Engagement Activity 2018
 
Description University of Virginia (UVA) Seminar (1) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Undergraduate students
Results and Impact 4th-year Capstone class (35 students); Topic: Digital health and Health systems
Year(s) Of Engagement Activity 2018
 
Description University of Virginia (UVA) Seminar (2) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Feb 2019: Lecture to Medical registrars from across UVA, 30 doctors in various specialty training. On Implementation Science, using StAR2D study as a case study
Year(s) Of Engagement Activity 2019
 
Description Visits to policy makers, academics and health care facilities in Cape Town, Soweto and Lilongwe, Malawi 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Policymakers/politicians
Results and Impact A series of meetings in November 2015 and March 2016 to meet those taking part in the research and to begin to plan implementation and dissemination of future findings
Year(s) Of Engagement Activity 2015,2016
 
Description Western Cape Dept of Health Provincial Health Research Day, 18 Nov 2019 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Policymakers/politicians
Results and Impact 2 presentations; 1 one Developing the StAR2 D interventions and 2nd on Patient perspective of the StAR2D intervention in Cape Town; preliminary findings of process evaluation.
Year(s) Of Engagement Activity 2018
 
Description What do we need to know and for upscaling mhealth: "Ask not what mhealth can do for you." 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Briefing to SDAIA (Swedish Funding Agency at a conference in Stockholm 16 June 2017
Year(s) Of Engagement Activity 2017