Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial
Authors: Farmer Andrew , Jones Louise , Newhouse Nikki , Kenning Cassandra , Williams Nicola , Chi Yuan , Bartlett Y Kiera , Plumpton Catrin , McSharry Jenny , Cholerton Rachel , Holmes Emily , Robinson Stephanie , Allen Julie , Gudgin Bernard , Velardo Carmelo , Rutter Heather , Horne Rob , Tarassenko Lionel , Williams Veronika , Locock Louise , Rea Rustam , Yu Ly-Mee , Hughes Dyfrig , Bower Peter , French David 
Published: November 2021

Background
Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The 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 brief messages delivered through mobile phone–based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS 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 in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial.

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

Methods
The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is 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, at 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 prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention.

Results
The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024.

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

Trial Registration
ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379

International Registered Report Identifier (IRRID)
DERR1-10.2196/32918