Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care to reduce cardiovascular risk (SuMMiT-D): a protocol for an effectiveness and cost-effectiveness randomised control trial (Preprint)

Abstract

Type 2 diabetes is a common lifelong condition, affecting over 400 million people worldwide. Use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications, and face difficulties in taking their medications regularly. Support provided by using brief messages delivered through mobile phone-based text messages can be effective in some long-term conditions. We have identified promising behaviour change techniques (BCTs) to promote medication adherence in this population via systematic reviewing, and developed text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful at changing the intended determinants of medication adherence. We now plan to test this intervention at a larger scale in a clinical trial.

The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for people in reducing cardiovascular risk for people with type 2 diabetes compared to usual care.

The trial will be a 12-month, multi-centre individually randomised, controlled trial in primary care recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants will be randomised to receive short text messages intended to effect a change in medication adherence three to four times a week in addition to usual care, or to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, 13-, and 26-weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group) the trial is powered at 92.5% to detect a 4 percentage point difference in cardiovascular risk. The analysis will follow a pre-specified plan. A nested quantitative and qualitative process analysis will examine putative mechanisms of behaviour change, and wider contextual influences. A health economic analysis will assess the cost-effectiveness of the intervention.

The trial has fully recruited and is in follow up. Publication of results is anticipated in 2024.

This trial will provide evidence about the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes.

ISRCTN: ISRCTN15952379 /registered 08/09/2020. Funded National Institutue for Health Research, Programme for Applied Research