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. 2022 Feb 21;11(2):e32918.
doi: 10.2196/32918.

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

Andrew Farmer  1 , Louise Jones  1 , Nikki Newhouse  1 , Cassandra Kenning  2 , Nicola Williams  1 , Yuan Chi  3 , Y Kiera Bartlett  4 , Catrin Plumpton  5 , Jenny McSharry  6 , Rachel Cholerton  4 , Emily Holmes  5 , Stephanie Robinson  1 , Julie Allen  1 , Bernard Gudgin  7 , Carmelo Velardo  3   8 , Heather Rutter  1   9 , Rob Horne  10 , Lionel Tarassenko  3 , Veronika Williams  11 , Louise Locock  12 , Rustam Rea  13   14 , Ly-Mee Yu  1 , Dyfrig Hughes  5 , Peter Bower  2 , David French  4
Affiliations

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

Andrew Farmer et al. JMIR Res Protoc. .

Abstract

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.

Keywords: SMS text messages; cardiovascular risk prevention; diabetes; digital health; medication adherence; randomized controlled trial.

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Conflict of interest statement

Conflicts of Interest: LT reports personal fees from Sensyne Health; he also worked part-time for the company and shared options in it. CV reports salary support from Sensyne Health, and RH reports speaker engagements with honoraria from the following companies outside the submitted work: AbbVie, Abbott, Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Biogen, Gilead Sciences, GlaxoSmithKline, Janssen, Merck Sharp Dohme, Merck, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi, Shire Pharmaceuticals, Teva, and UCB. RH is a director of Spoonful of Sugar Ltd, a University College London Business company providing consultancy on treatment engagement and patient support programs to health care policy makers, providers, and industry.

Figures

Figure 1
Figure 1
Process evaluation: logic model.
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