A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial

Abstract

Background Inflammatory bowel diseases (IBDs) are chronic inflammatory conditions of the gastrointestinal tract. Although adherence to IBD therapies is associated with improved clinical outcomes, overall adherence is poor. Consequently, there is a critical need to develop interventions that monitor adherence in real time and identify reasons for nonadherence to support clinical teams in initiating effective interventions. Recently, electronic- and web-based platforms have been developed to monitor adherence and guide interventions. A novel remote therapy monitoring (RTM) technology, the Tappt digital health system, has been developed to monitor real-time medication adherence patterns through smart label technologies, capture patient-reported outcomes and barriers to care, and process patient data through algorithms that trigger personalized digital and human touch points between clinical visits. Such a digital health solution enables care teams to proactively identify and mitigate nonadherence and worsening clinical outcomes. Objective We propose a 12-month multicenter randomized controlled trial to assess the effectiveness of the Tappt digital health system on adherence, clinical outcomes, and health care use among patients diagnosed with IBD starting a new oral or subcutaneous therapy. Methods The digital health system intervention will provide automatic measurement of medication adherence via smart labels for pill bottles or injectors as well as a monitoring platform for providers. The system will prompt patients to complete a two-item assessment of symptoms monthly using the PRO-2 scales for UC and Crohn disease, from which increased symptoms will be alerted to providers. Participants will be randomized 2:1 to the intervention group or the control group, which will receive standard of care. All participants are required to complete questionnaires at baseline as well as at 12, 26, and 52 weeks. Assuming an adherence rate of 0.65 and 0.9 among control and intervention participants, respectively, we will need to enroll 123 participants: 82 (66.7%) in the intervention group and 41 (33.3%) controls. We will compare adherence as measured by the medication possession ratio, defined as the number of days of supply of medication obtained during the observation period out of the total number of days in the observation period, in participants using the RTM versus those receiving standard of care. We will also compare clinical outcomes and health care use in participants using the RTM versus those receiving standard of care. Results We anticipate starting recruitment in December 2022. Conclusions Effective medication adherence monitoring and intervention programs need to be cost-efficient, pose little or no burden to the patient, record reliable data in real time, and provide actionable insights to the health care team. We anticipate the Tappt digital health system to improve the medication possession ratio, clinical outcomes, and health care use compared with standard of care. Trial Registration ClinicalTrials.gov NCT05316584; https://clinicaltrials.gov/ct2/show/NCT05316584 International Registered Report Identifier (IRRID) PRR1-10.2196/40382

Growth of Remote Therapeutic Monitoring Lands New Opportunities for Case Management

“…An example of a novel RTM application has been reported in the ASSIST study, a randomized controlled trial in five large U.S. health systems evaluating an RTM system called Tappt™ among patients in outpatient care (Axelrad et al, 2022). This RTM technology monitors real-time medication adherence patterns using smart battery-free labels affixed to medication packages.…”

“…This RTM technology monitors real-time medication adherence patterns using smart battery-free labels affixed to medication packages. It processes validated patient-reported outcomes through algorithms that trigger personalized digital and human touch points, allowing the patient's care team to proactively identify and mitigate worsening clinical outcomes in between visits (Axelrad et al, 2022). Through this technology, patients tap their smartphone against the medication label to record their intake at each oral, subcutaneous, or intravenous dosage.…”