Developing theory-based SMS messages to support retention in clinical trials: a mixed methods approach

Samuel Smith* (Corresponding Author), S.M.C. Green, Erin Brierley, Louise H. Hall, M. Collinson, E. Mason, Katie Gillies, David French, Kiera Bartlett, S. Hartley, R Foy, A. J. Farrin

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Background: Returning a trial questionnaire is a behaviour affected by a range of psychological and contextual factors.
Previously tested Short Message Service (SMS) messages to prompt questionnaire return have not addressed these factors, and have not been characterised by established taxonomies of behaviour change techniques (BCTs).
Purpose: We aimed to develop acceptable theory-based SMS messages, with fidelity to four BCTs, to support participant
understanding of the consequences of not returning trial questionnaires.
Methods and Results: We initially developed 32 messages. Ten behaviour change experts assessed message fidelity to the intended BCT (Study 1a). All messages had appropriate fidelity to the intended BCT (mean ratings = 6.8/10 [SD = 0.6) to 7.5/10
[SD = 0.3]). Study 1b, a focus group with five patient representatives, recommended removing the BCT ‘comparative imagining of future outcomes’ (4 messages), two further messages be removed, and amendments to five messages. In Study 1c, 60 breast cancer
survivors rated all remaining 26 messages as acceptable (mean = 3.8/5 [SD = 1.2] to 4.3/5 [SD = 0.8]). Twelve behaviour change
experts rated the fidelity of the 26 messages to intended BCTs (Study 1d); all messages had appropriate fidelity (mean ratings = 6.1/
10 [SD = 2.4] to 6.9/10 [SD = 1.4]).
Conclusions: In these studies, we developed 26 SMS messages that were acceptable to the intended recipients and had sufficient
fidelity to the intended BCTs. This approach could be taken to design interventions supporting behaviours needed for the successful delivery of clinical trials. The messages are available to research teams who can evaluate them in Studies within Trials.
Original languageEnglish
Pages (from-to)22-31
Number of pages10
JournalResearch Methods in Medicine & Health Sciences
Issue number1
Early online date31 Jan 2022
Publication statusPublished - 31 Jan 2022

Bibliographical note

The author(s) disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This report is independent research supported by the National Institute for Health Research NIHR Advanced Fellowship, Dr Samuel Smith NIHR300588. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design of the study, data collection, analysis, interpretation of data and in the writing of this manuscript. Dr Smith also acknowledges the support of a Yorkshire Cancer Research Fellowship. Prof French is supported by the NIHR Manchester Biomedical Research Centre (IS-BRC1215-20007).


  • clinical trial retention
  • behaviour change technique
  • SMS text messages
  • studies within trials
  • questionnaire return


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