Participant Experience, Acceptability and Feasibility of Virtual and Digitally Supported Visits in a Phase IIa COPD Trial.

Understanding participant experience is crucial for improving participant satisfaction, retention, data quality, and clinical trial efficiency; particularly when incorporating digital patient solutions and virtual elements. CRESCENDO, an international phase-II chronic obstructive pulmonary disease (COPD) trial, incorporated daily at-home digital measurements, remote coached spirometry, and a virtual visit to evaluate feasibility and participant acceptance. This study explored participant experience in CRESCENDO through semi-structured interviews (n=21) and a Study Participant Feedback Questionnaire (SPFQ, n=81), conducted across Bulgaria, Canada, Poland, Spain, UK, and USA. Interview data were analysed thematically. Participants were generally satisfied and found digital and virtual elements user-friendly, although technical issues caused frustration. When functioning properly, participants considered remote and in-person spirometry coaching comparable. Nonetheless, participants preferred in-person visits due to positive interactions with trial staff, which increased satisfaction and feeling of appreciation. High concordance between interview and SPFQ data supported the validity of qualitative interviews for assessing participant experience. The study highlights the potential of digital elements and offers practical recommendations, like providing options for in-person and virtual visits, to enhance satisfaction and engagement. This qualitative sub-study was conducted within the CRESCENDO trial (https://clinicaltrials.gov reference: NCT05492877).