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Table 1 Problems experienced during the pilot study of REMIND

From: The trials and tribulations of conducting an m-health pilot randomized controlled trial to improve oral cancer therapy adherence: recommendations for future multisite, non-drug clinical trials

  Problem Suggested solution
Recruitment Overestimation of the prevalence of patients diagnosed with CML within the past 2 years Expand patient eligibility criteria to other conditions where medication adherence is critical for long-term survival; Add more recruitment sites
Infrastructure Limited computer availability on site to train participants as per protocol Use versatile and portable devices such as tablet computers for research purposes. Where necessary, allocate appropriate devices to each site for the duration of the study period
Staff expertise Inadequate knowledge and understanding of supportive care research Provide specific training in the purpose and conduct of supportive care studies for clinical trial staff; collaborate with other hospital departments more familiar with supportive care methodologies (e.g. psychology and psychiatry)
Site visit Site initiation and monitoring conducted over the phone or by email Adopt a combination of central and on-site visits; ideally, funding should support site initiation visits, then monitoring can be conducted centrally
Objective measurement of medication adherence Monitoring drug response
Difficulty in coordinating routine blood testing with study commencement and baseline assessment
Pill count
Unused meditation packs and prescription refills not returned
Hospital was not the only place for meditation refills
Use of electronic pill monitoring device
Conduct secondary database analysis
Data collection Use of two separate online platforms for data collection Use of a single software application to capture and manage clinical data (e.g. REDCap)