Results
RECRUITMENT, RECRUITMENT
Thirty-five participants were recruited and 34 were randomised over 16 months from
November 2018 to March 2020. Based on to the predicted target of 40 participants in
2 years the recruitment rate progressed ahead of time with 75% of participants being
enrolled in the first 12 months. A median of two people were recruited per month
(range 0–4). Recruitment in the latter stages of the trial was disrupted due to the
COVID-19 pandemic and further accrual was not possible during this time. As the
trial had achieved its primary aim of assessing feasibility and had surpassed the
30-participant target, with participant dropout in keeping with our predicted
attrition rate, a decision was made to close recruitment at this stage.