Cure8 trial brief
The trial could show whether a smart-label app plus clinician alerts improves medication adherence and downstream clinical outcomes for people with Crohn's disease or ulcerative colitis starting oral or subcutaneous therapy.
Adults with IBD initiating oral or subcutaneous treatments; clinicians and care teams managing IBD medications; researchers and digital health developers focused on adherence interventions.
The study is a 12-month, multicenter, randomized controlled trial (2:1 randomization) comparing the TapptTM remote monitoring intervention to standard care in adults with Crohn's disease or ulcerative colitis who are initiating oral or subcutaneous IBD medication.
The system uses scannable smart labels, a patient-facing app for PROs and adherence visibility, and a provider dashboard with algorithms that trigger alerts to clinicians when adherence or symptoms cross preset thresholds. Alert-triggered outreach (nurse, pharmacist, social worker) is planned to identify and address barriers to adherence.
The main planned outcome is difference in mean medication possession ratio over 12 months; secondary outcomes include self-reported adherence, clinical response/remission (HBI, partial Mayo), steroid-free remission, PROMIS domains (fatigue, sleep, pain interference, anxiety, depression), IBD self-efficacy, new steroid use, and healthcare utilization.
Planned enrollment is 123 participants (82 intervention, 41 control), analysis by intention-to-treat.
This is a registered interventional trial (active, not recruiting) describing planned methods and outcomes; it does not report results. The TapptTM system is a proprietary remote monitoring product and uses algorithmic alerts to prompt human outreach when adherence or PRO thresholds are crossed.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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