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

• Published in: Current controlled trials in cardiovascular medicine Vol. 18; no. 1; pp. 557 - 8
• Main Authors: Rorie, David A, Flynn, Robert W V, Mackenzie, Isla S, MacDonald, Thomas M, Rogers, Amy
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 23.11.2017; BioMed Central; BMC
• Subjects: Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Antihypertensives; Biobanks; Blood Pressure - drug effects; Clinical trials; Consent; Drug Administration Schedule; Electronic mail systems; Electronic records; Humans; Hypertension; Hypertension - diagnosis; Hypertension - drug therapy; Hypertension - physiopathology; Management; Medical records; Medication Adherence; Patient Dropouts; Patient Selection; Research methods; Sample Size; Technology application; Time Factors; Treatment Outcome; United Kingdom; United Kingdom > UK
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-017-2318-4

The use of information technology (IT) is now the preferred method of capturing and storing clinical research data. The Treatment In Morning versus Evening (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. The aim of this article is to assess the success of the TIME methodology compared with similar studies. To assess the TIME study, published literature on similar clinical trials was reviewed and compared against TIME recruitment, follow-up and email interaction data. The TIME website registered 31,695 individuals, 21,116 of whom were randomised. Recruitment cost per randomised participant varied by strategy: £17.40 by GP practice, £3.08 by UK Biobank and £58.82 for GoShare. Twelve-month follow-up retention rates were 96%. A total of 1089 participants have withdrawn from their assigned time of dosing, 2% of whom have declined follow-up by record linkage or further contact.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 are compared with similar study data, study recruitment is very successful. However, TIME suffers difficulties with participant follow-up and withdrawal rates similar to those of conventional studies. 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 IT.