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

Abstract

OBJECTIVE: Integrating mobile phone-based health (m-health) interventions into healthcare systems is one solution to improve access to services for the growing number of patients with chronic illness. Practical challenges such as poor recruitment and inadequate resource allocation can hamper the assessment of such interventions with clinical trial methodology. This paper highlights the challenges encountered during a pilot randomized controlled trial of an m-health medication adherence intervention and offers recommendations for future multi-site, non-drug clinical trials. RESULTS: Eighteen patients were recruited to the study; eight were randomly allocated to the intervention arm. Intervent..