The Treatment In Morning versus Evening (TIME) study:Analysis of recruitment, follow-up and retention rates post-recruitment

Abstract

Purpose: The use of Information Technology (IT) is now the preferred method of capturing and storing clinical research data. The TIME study predominantly uses electronic data capture and IT to compare morning dosing of hypertensive medication against evening dosing. Registration, consent, participant demographics, and follow-up data are all captured via the study website. This article aims to assess the success of the TIME methodology in comparison to similar studies.Methods: To assess the TIME study, published literature on similar clinical trials was reviewed and compared against TIME recruitment, follow-up and email interaction data.Results: The TIME website registered 31,695 individuals, 21,116 of which were randomised. Recruitment cost per randomised participant varied by strategy; £17.40 by GP practice, £3.08 by UK Biobank, £58.82 for GoShare. Twelve month follow-up retention rates are 96%. 1,089 participants have withdrawn from their assigned time of dosing, 2% of whom have declined follow up by record-linkage or further contact. When the TIME data is compared with similar study data, study recruitment is very successful. However, TIME suffers similar difficulties with participant follow-up and withdrawal rates as conventional studies.Conclusion: The TIME study has been successful in recruitment. Follow-up, retention rates and withdrawal rates are all acceptable, but ongoing work is required to ensure participants remain engaged with the study. Various recruitment strategies are necessary, and all viable options should be encouraged to maintain participant engagement throughout the life of studies using information technology