Validation of a Digital Support App to Assess Inflammatory Disease Activity and Mental Health Patient-Reported Outcomes (PROs): A Pilot Investigation

BACKGROUND: Real-time collection of mental health and disease activity patient-reported outcomes (PROs) are essential to assist clinicians in delivering optimal holistic health care. The aim of this pilot study was to validate a digital support tool (DST) delivered via a tablet device in an outpatient setting to assess IBD activity and psychological distress. METHODS: 48 individuals (26 females; average age: 40.04) with IBD completed the DST and a paper-based survey in a hospital IBD outpatient setting. PROs for disease activity and psychological distress (Kessler K10) were compared to paper-based gold-standard measures of disease activity (Partial Mayo Index or Harvey Bradshaw Index completed by the clinician) and psychological distress (Depression Anxiety Stress Scale; completed by the patient). Patient feedback regarding usability and acceptance of the DST was also collected. RESULTS: DST patient-derived disease activity scores were significantly correlated with clinician assessment of disease activity (p < 0.01). Patient DST-derived psychological well-being scores were also significantly correlated with the gold-standard measure of psychological distress (p < 0.05). Patients found the DST to be easy to use and identified a willingness to follow through with the recommendations provided by the DST in relation to their psychological distress scores. CONCLUSIONS: The pilot study demonstrates the value in collecting disease activity and psychological distress PROs via a DST in an outpatient setting. Disease activity and psychological distress PROs were found to correlate significantly with gold standard measures. The findings provide preliminary support for the value of embedding digital technology into clinical care to promote patient engagement and optimal holistic healthcare.