SUpport through Mobile Messaging and digital health Technology for Diabetes (SuMMiT-D): feasibility study protocol.
Self-management support is a key component of care for people with type 2 diabetes with evidence for improved outcomes. The increasing availability of digital communication and monitoring tools offers the possibility of increasing the relevance of health messages by delivering them by mobile phone and tailoring them for individuals. Evidence suggests that text-messages may be an effective means of providing support, although studies in the UK are few, and the role of messages developed using health psychology is unclear.
SuMMiT-D is a trial aimed at testing the feasibility for using SMS text-messages to support self-management of type 2 diabetes focused on use of medication. The aim of this feasibility trial is to test recruitment of patients to, and collection of planned primary and secondary outcome data. SuMMiT-D is a primary-care based, individual randomised two arm parallel group trial comparing brief, tailored behaviour change messages with usual care. Participants are adults >35 years taking oral glucose lowering treatment and with access to a mobile phone. The intervention consists of brief, health related messages delivered via SMS text-message over 6 months. Content of messages is based on participant feedback received during formative work for this trial and there is tailoring of messages based on participant feedback. A range of different types of messages have been developed that use different behaviour change techniques to target health-related behaviour change. Usual care includes infrequent non-health related messages. With 200 participants (100 in each group) the feasibility trial is powered to detect 80% follow up within 95% confidence intervals of 73.8% to 85.3%.
The primary outcome of this feasibility study is the rate of recruitment and randomisation of participants to the trial. Secondary outcomes focus on the feasibility of collection of clinical measurement data for the proposed main trial including the feasibility of obtaining HbA1c, systolic blood pressure and cholesterol from the medical records of trial participants. We will use qualitative methods to assess the feasibility and acceptability of the intervention for patients and also among health care workers (including general practitioners, nurses, receptionists and pharmacists).
The findings from this study will inform the design of a trial to test brief messaging support that would estimate the extent of benefit and costs, and identify difficulties that might be encountered in practice. The brief messaging system used in this study offers a unique range of messages targeting different ways of supporting behaviour change. This research could offer a model for technology-based self-management support that could be extended more widely in the NHS.