JMIR Publications

ABSTRACT

Background:

Digital health technology enables collection of continuous physiological and behavioural data from participants in clinical trials. This supports hybrid trial designs, potentially reducing clinic visits and participant burden for patient monitoring. Interstitial lung disease (ILD)is characterised by an unpredictable clinical course, creating a need for new treatments and more sensitive approaches to assessing treatment effectiveness, disease progression and clinically meaningful trial endpoints.

Objective:

To explore the experiences of individuals with ILD using digital tools in a clinical study to inform digital health-enabled clinical research.

Methods:

This qualitative study was conducted within the PRODIGY-ILD (Predicting outcomes using digital technology) cohort, a prospective observational study using wearable devices and electronic patient reported outcome measures for longitudinal monitoring. Participants were recruited from a specialist outpatient ILD clinic. A topic guide was developed iteratively and individual semi-structured interviews were conducted remotely via Zoom and or telephone, audio-recorded and transcribed. Data were analysed using reflexive thematic analysis with NVivo software.

Results:

Fifteen of the final twenty participants recruited to the PRODIGY-ILD study consented and completed interviews. Four key themes were identified, highlighting how trust, digital literacy, participant-initiated engagement with data, and illness burden, shape sustained participation in digital health–enabled clinical research; (1) Trust and altruism override data concerns: Confidence in researchers data handling and a desire to contribute enabled data sharing. (2) Navigating digital tools: friction and flexibility: Digital literacy, usability, and device compatibility varied but participants were able to use workarounds to maintain engagement. (3) Participant-initiated engagement with wearable data: Participants moved from passive to active engagement, in many cases integrating devices into daily routines. (4) Life-limiting illness as a constraint on digital trial participation: Managing symptoms and severe comorbidities reduce motivation, and engagement with study technology.

Conclusions:

Despite participants motivations to contribute data to research, engagement was shaped by usability, participant-initiated engagement and the constraints of living with chronic illness. There is a need for patient-centred design, tailored support, and flexible trial procedures to optimise adherence in digital health enabled clinical research. Clinical Trial: Not Applicable