SuMMiT-D: Feasibility
Research type
Research Study
Full title
Supporting people with type 2 diabetes in effective use of their medicine through a system comprising mobile health technology integrated with clinical care compared with usual care: a randomised feasibility trial
IRAS ID
246057
Contact name
Andrew Farmer
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Summary of Research
SuMMiT-D: SUpport through Mobile Messaging and dIgital health Technology for Diabetes (Feasibility Trial)
Type 2 diabetes is a lifelong condition that causes a person’s blood sugar to become too high. In the UK, it affects more than 3.4 million people. It can cause serious long-term health problems. Medicines to lower blood glucose, blood pressure and cholesterol, can stop complications developing, if taken as intended. However, people are often concerned about starting new medicines and face difficulties in taking them regularly.
SuMMiT-D has drawn on patients’ experiences and suggestions and previous research which has shown that mobile text messages can be effective for some conditions. Based on these we have developed messages that aim to encourage and support people with type 2 diabetes in taking their medication and managing their condition. The messages were put together by health psychologists and have been reviewed by patients.
The aim of this feasibility trial is to test recruitment methods, feasibility of data collection and the processes of a clinical trial to follow.
Cohort 1: 200 People with type 2 diabetes >/=35 years of age that have started or had a change in their diabetes-related oral medication recently, will be invited or approached by their healthcare team or may see trial promotional material. They will be asked to contact the trial team to register their interest in taking part. Participants will be randomised to either tailored condition specific text messages or non-health related messages for 6 months following randomisation. They will be asked to complete questionnaires at baseline and the end of the six-month period.
Notes reviews will be conducted at Baseline, 6- and 24-months.
30 participants will also take part in qualitative interviews.Cohort 2: 12 to 30 healthcare professionals will be invited to a qualitative study to share their experiences of taking part in this trial.
Summary of Results
Brief messages sent by mobile phones (SMS text-messages) may be a way to help people with type 2 diabetes receive regular hints and tips about looking after themselves. Research studies carried out don’t give a clear answer about whether this approach helps, so we planned to carry out a large -scale trial to test how they work. Before we did this, we wanted to carry out a small study to test whether: we could find people to join the trial, that the messaging system worked, and that we could follow people up.
We carried out a study in which individual people with type 2 diabetes who had agreed to take part were assigned at random to receive messages for six months, or not to receive messages. People who took part in the study continued to receive treatment for diabetes in United Kingdom primary care. The texts included messages aimed at helping people change the way they used their medication and to take up healthier lifestyles.
In total, 209 people took part in the trial, they were evenly split between those receiving and those not receiving regular text messages. Participants were recruited at the rate of 60-80 per month. The failure rate of sending messages was 47 out of 12,734. We were able to find (with permission from patients) information from routine electronic health records for HbA1c in over 90% of participants at the beginning of the trial and in 67% of participants after 6 months. In a larger trial this information would allow us to check the impact of receiving the text messages.
This study showed that a larger trial, carried out for a longer period appears to be possible. This study shows us that people can join a study like this quickly and efficiently, that the messaging system works, and that we can using routine electronic health record data to collect important information.REC name
West of Scotland REC 5
REC reference
18/WS/0173
Date of REC Opinion
27 Sep 2018
REC opinion
Favourable Opinion