Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/07/2015
Date assigned
03/08/2015
Last edited
11/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Treatment for patients with type 2 diabetes could be greatly 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, and 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. The overall aim of this study is to test if sending short message service (SMS) texts works well in improving overall diabetes control in patients and supporting them to adhere to their diabetes treatment compared to usual care.

Who can participate?
Adults (aged at least 18) with type 2 diabetes and access to a mobile phone.

What does the study involve?
First of all, a preparatory study is carried out where patients and staff are interviewed to be sure that the SMS messages are clear, informative and acceptable. We ensure that the technology is embedded in clinical care, and that the message content is appropriate for each of the planned sites. We also collect detailed information about how the systems are set up and used to guide future attempts to set up similar systems in other places and for other long-term conditions. We will extend the qualitative work during and after the main trial to see how the technology is used and how people feel about it. Participants attending each of the centres participating in the study are then randomly allocated to one of two groups. Those in group 1 are sent informative messages, telling them about the benefits of their diabetes treatment and provide reminders and encouragement to take it regularly. Those in group 2 are sent non-health related messages. Each participant is then followed-up for 12 months. Important risk factors for the development of complications in diabetes including blood glucose control and blood pressure control are assessed throughout this period so we can estimate potential health benefits, the costs of doing this, and whether it is cost effective.

What are the possible benefits and risks of participating?
The knowledge gained from carrying out this study will have wide application and provide data, not otherwise available, that will inform health policy and guide future implementation of this type of technology. Participants may find that staying in contact with the study via SMS text-message and answering questions about their experience in taking part helpful. Information from this study will be helpful to the health services and this could benefit the treatment of patients in the future. Participants will be asked to attend two study specific visits that may inconvenience them in terms of time. Participants will have their blood pressure taken that may cause some slight discomfort. We will take two blood samples that may cause some discomfort.

Where is the study run from?
The University of Cape Town (South Africa). University of the Witwatersrand (South Africa) and the The Malawi Epidemiology and Intervention Research Unit (Malawi)

When is the study starting and how long is it expected to run for?
October 2016 to April 2019

Who is funding the study?
Global Alliance for Chronic Disease in partnership with the UK Medical Research Council (UK)

Who is the main contact?
Professor Andrew Farmer

Trial website

Contact information

Type

Public

Primary contact

Prof Andrew Farmer

ORCID ID

http://orcid.org/0000-0002-6170-4402

Contact details

University of Oxford
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Type

Scientific

Additional contact

Prof Andrew Farmer

ORCID ID

http://orcid.org/0000-0002-6170-4402

Contact details

University of Oxford
Nuffield Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRC Grant Ref: MR/M016498/1

Study information

Scientific title

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

Acronym

StAR2D

Study hypothesis

The overall aim of this project is to test the effectiveness of sending short message service (SMS) texts in improving health outcomes and supporting medication adherence in patients with type 2 diabetes in the context of implementing a low-cost, mobile-health communication infrastructure in an operational setting.
The objectives of the clinical trial are to:
1. Evaluate the effectiveness of SMS messages in improving overall diabetes control and supporting adherence to diabetes medicines compared with usual care
2. Examine the incremental cost and cost-effectiveness of introducing a new SMS-text messaging programme into an existing health service setting

Ethics approval

1. Oxford Tropical Research Ethics Committee - OxTREC, 10/04/2015, ref: 22-15
2. University of Cape Town Human Research Ethics Committee, 22/05/2015, ref: 126/2015
3. University of the Witwatersrand Human Research Ethics Committee (Medical), 08/06/2015, ref:14/49
4. Malawi NHSRC, 08/09/2015, #15/7/1425

Study design

Individually randomized controlled two-arm trial stratified by clinical centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Type 2 diabetes

Intervention

The trial intervention is mobile phone short message service (SMS) texts. We will allocate patients using a randomly generated assignment plan to receive either informative messages, or non-health related messages. Trial participants allocated to the intervention group will be assigned to receive culturally appropriate text messages including motivational, educational and prompts (reminders) about medication collection with timing guided by the information collected about all participants at baseline visit, from clinic and from pharmacy attendance. Trial participants allocated to the usual care group will receive only non-informational text messages (for example messages thanking the participant for taking part in the study, and a message on their birthday) alongside usual care. Participants allocated to the usual care group, along with all clinic attendees, attendance recorded, but with no further actions relating to the randomly allocated intervention occurring. We will use a remote web-based randomisation programme for time since diagnosis, age, gender and trial site. Randomisation is carried out remotely and independently of the clinic and local research staff.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

As of 11/10/2016:
Change in HbA1c. HbA1c will be measured using International Federation of Clinical Chemistry calibrated analysers linked to a quality assurance scheme

Initial:
Change in HbA1c and the proportion of patients collecting 80% or greater of their agreed diabetes related medication derived from routine clinic data

Secondary outcome measures

As of 11/10/2016:
1. The proportion of patients collecting ≥80% of their agreed diabetes related medication derived from routine clinic data
2. Change in systolic blood pressure
3. Changes in lipids
4. A combined measure of cardiovascular risk based on HbA1c, lipids and systolic blood pressure,
4.the proportion of proportions of the participants reaching treatment goals (with HbA1c<8% and systolic BP<140mmHg.)
5. Changes in self reported measures of health status
6. Self reported medication taking, eating and physical activity
7. Satisfaction with health care

Initial:
1. Change in systolic blood pressure
2. The proportion of the participants reaching treatment goals (with HbA1c<8% and systolic BP<140mmHg.)
3. Changes in self reported measures of health status
4. Self reported medication taking, eating and physical activity
5. Satisfaction with health care

Overall trial start date

01/10/2016

Overall trial end date

01/04/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Able to communicate in one of the predominant official languages spoken in the Western Cape (Cape Town) and Gauteng (Johannesburg) provinces (e.g. English, Afrikaans, isiXhosa, isiZulu and Sesotho), in South Africa and in Malawi, English or the Chichewa language
3. Male or female, aged 18 years of above
4. A diagnosis of type 2 diabetes
5. Taking oral glucose lowering treatment
6. Has access to a mobile-phone (shared access is allowed with permission of phone owner)
7. Knows how to use SMS (it is okay if participant needs help to send or retrieve SMS)
8. Currently lives in the community served by the clinic and plans to live there for the next 18 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1065

Participant exclusion criteria

1. Within three months of a hospital admission for hyperglycaemia or hypoglycaemia
2. Pregnant or within three months post-partum by self-report or with plans to become pregnant in the next 12 months
3. A terminal medical condition
4. Another member of the household already recruited to the trial
5. Participation in the formative work for the intervention

Recruitment start date

01/10/2016

Recruitment end date

01/10/2017

Locations

Countries of recruitment

Malawi, South Africa

Trial participating centre

University of Cape Town
Rondebosch
Cape Town
7700
South Africa

Trial participating centre

University of the Witwatersrand
1 Bertha & Jorissen St
Johannesburg
2000
South Africa

Trial participating centre

The Malawi Epidemiology and Intervention Research Unit (MEIRU)
Mia Crampin P.O. Box 46
Chilumba, Karonga District
-
Malawi

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Global Alliance for Chronic Disease in partnership with the UK Medical Research Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will disseminate our findings through a wide range of routes including briefing meetings with stakeholders, conference presentations and written reports. The main findings, intervention development, trial protocol and process evaluation will be reported in peer-reviewed journals. The Main trial findings are anticipated to be published in 2020.

Intention to publish date

01/06/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/10/2016: Changed overall start date from 01/10/2015 to 01/10/2016. Made changes to primary and secondary outcome measures (date stamped in record). Corrected name of trial participating centre On 17/11/2015 the acronym was changed from STAR-D to StAR2D.