AB1284 THE PATIENT EXPERIENCE: A PROCESS EVALUATION OF A PILOT PRAGMATIC USING REMOTE MONITORING OF SYMPTOMS
Authors: Alexis Ogdie, Michael George, Kathleen Bush, Mitesh Patel, W. Benjamin Nowell, Joshua Baker
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Traditional randomized controlled trials (RCTs) are important for testing drug efficacy but this study design is burdensome for patients (pts) and clinicians. Pragmatic trials addressing real world comparative effectivness are equally important but challenging to conduct. We piloted a trial platform aspiring to optimize the patient experience and minimize patient and physician burden. The trial (NCT02912221) tests an incentive strategy informed by behavioral economics to increase physial activity in pts with rheumatoid arthritis (RA) and psoriatic arthritis (PsA). <h3>Objectives:</h3> To understand patient experiences using mobile applications (apps) and wearable activity devices (WAD) in a pilot pragmatic trial <h3>Methods:</h3> Pts had RA or PsA with active disease defined by a Routine Assessment of Patient Index Data (RAPID3) score&gt;3 (range 0-30). After screening and informed consent, pts received a WAD (FitBit™) and were assisted in setting up the device and an ArthritisPower account, a research registry where pts track patient-reported outcomes (PRO). A web-based platform, WayToHealth, was used to collect WAD data and deliver incentives. After a two-week baseline period, pts selected a daily step goal and were randomized to a financial loss-aversion incentive arm or control. Pts in both arms received weekly text messages reporting the number of days the step goal was met. In-person assessments were conducted at baseline and 14 weeks; pts completed weekly PROs (RAPID3, PROMIS Fatigue, PROMIS Sleep Disturbance and adverse event assessment) via mobile app or a web link. At 14 weeks, pts underwent a semi-structured interview to assess the patient experience in the trial. Content analysis was used to evaluate the responses <h3>Results:</h3> To date, 27 pts completed the 14-week follow-up interview. Mean age was 48 (SD 14), 85% were women, 17 (63%) had PsA and 10 (37%) had RA. Mean disease duration was 9 years, mean swollen joint count (0-66) was 6.2 (SD 5.6) and tender joint count (0-68) was 8.1 (SD 9.1). The mean RAPID3 was 10.3 (SD 4.6). Overall pts enjoyed participation in the study and provided useful feedback for improvement (Table). Weekly PRO capture was acceptable to most but PROs need to be streamlined to remove repetitive questions. Pts frequently set goals they were not able to achieve and suggested the ability to change their goal in future studies <h3>Conclusion:</h3> In this pilot pragmatic trial, only two in-office visits were conducted and all other data captured remotely. Pts enjoyed the experience and found the digital platform easy to use. Such trial designs will become increasingly important in conducting real-world comparative effectiveness and adjunct therapy trials <h3>Disclosure of Interests:</h3> Alexis Ogdie Grant/research support from: (To my university) Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly and Company, Novartis, Pfizer, and Takeda, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer Inc, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Michael George Grant/research support from: BMS, Consultant for: Abbvie, Kathleen Bush: None declared, Mitesh Patel: None declared, W. Benjamin Nowell: None declared, Joshua Baker: None declared