Can a trial of a text message intervention to improve effective use of medication rapidly recruit people with type 2 diabetes during a global pandemic?
Problem
Type 2 diabetes affects over 400 million people worldwide. Poorly managed diabetes can lead to major complications which can be reduced with effective treatments and self-management. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. We have previously developed messages aiming to support patients’ self-management of type 2 diabetes underpinned by theory, evidence and user input. The aim of this analysis is to assess the extent to which we were able to efficiently recruit participants to an effectiveness trial during a global pandemic
Approach
A multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes. Routinely used recruitment procedures were adapted and optimised to enable remote recruitment and trial conduct. General practices from across England were ranked by deprivation score and thereby invited to participate to enable diversity of recruitment. Practices used a standard search based on the trial inclusion and exclusion criteria to invite potential participants to the trial. Invitees then registered their interest by texting the study. Following a telephone screening call, consent and questionnaires were completed online (n=894), or on paper if participants preferred (n=145). Participants were then randomised to receive short text messages three times a week or to continue to receive usual care for 12 months. Follow-up questionnaires were completed by participants at 13-, 26-, and 52-weeks using their preferred method of administration.
Findings
Recruitment began in March 2021 and concluded 16 weeks later in July 2021, with 1039 participants randomised from 42 general practices. Practices had a range of overall deprivation scores and ethnic mixes which were comparable to those of the UK as a whole.The recruitment rate was 71.8% from 1039/1447 expressions of interest and 5.1% of the cohort were from an ethnic minority group, which was lower than for practices. 95.6% (993/1039) remained in the trial for the full 12 months with a follow-up rate of 89.0% at 12 months on participant completed measures.
Consequences
Recruitment of patients with type 2 diabetes to a intervention using invitation by practices and registration via text message was well accepted with both practices and participants joining the study rapidly. Use of online systems was very effective for rapid recruitment during a global pandemic. Administration of a study using text messaging and questionnaires supplied online is also well accepted with high follow-up rates. The study successfully included practices with a range of overall deprivation scores and ethnic mixes, however, within the participant population the range of ethnicities and deprivation was less.