Background: Clear characterization of how different types of patient-generated data reflect patient experience is needed to guide integration of electronic patient-reported outcome (ePRO) measures and biometrics in generating real-word evidence (RWE) related to rheumatoid arthritis (RA).

Objectives: To characterize the level of participant (pt) engagement/adherence and data completeness in an ongoing study of 250 RA pts enrolled in the Digital Tracking of Arthritis Longitudinally (DIGITAL) study ¹ of the ArthritisPower real-world registry.

Methods: ArthritisPower pts with RA were invited to join a digital RWE study with 14-day lead-in and 12-week main study period. In the lead-in, pts were required to electronically complete: a) two daily single-item Pain and Fatigue numeric rating scales and b) longer weekly sets of ePROs. Successful completers of the lead-in were mailed a smartwatch (Fitbit Versa) and study materials. The smartwatch collected activity, heart rate, and sleep duration/quality biosensor data; a study-specific customization of the ArthritisPower mobile application collected ePROs. The main study period included automated and manual reminders/prompts about completing ePROs, wearing the smartwatch and regularly syncing it. Study coordinators monitored pt data and contacted pts via email, text and/or phone to resolve adherence issues during the conduct of the study based on pre-determined rules triggering pt contact. Rules were based chiefly on consecutive spans of missing data. Pts were considered adherent in giving complete data for each week if providing (1) daily ePROs for ≥5 of 7 days/week, (2) weekly ePROs and (3) ≥80% of synced activity data for ≥5 of 7 days/week. Composite adherence for the first month of the main study period required meeting >70% weekly adherence parameters during the first 30 days, ie completing daily ePROs for ≥5 of 7 days/week, weekly ePROs ≥3 of 4 weeks and ≥80% of synced activity data for ≥5 of 7 days/week.

Results: As of December 2019, 170 ArthritisPower members enrolled and completed at least 30 days of the main study period; 92.9% female with mean (SD) age 52.5 (10.7) and 10.5 (10.4) years since diagnosis. The overall conversion rate from initial interest to successful completion of the lead-in period was 49.0%. Pts who advanced to the main study were significantly more likely than those who did not to be currently employed (52.9% vs. 41.8%, p=0.038) and be on biologic DMARD monotherapy (64.7% vs. 47.5%, p=0.001). Overall, daily ePRO data had the lowest adherence with 70.0% of pts providing >70% of the requested data consistently across the first 30 days of the main study period ( Figure 1 ). Composite adherence was met by 66.5% of pts. The most common time of day to provide ePRO data was morning, in the hours around scheduled app and email notifications at 10 a.m. in pt’s local time zone. Activity data had the highest adherence and persistence, with 92.9% of pts providing 80% or more of activity data for each 24-hour period in the first 30 days ( Figures 1 & 2). Observed weekly adherence did not decline over time. Of 5100 possible person days in the study at day 30, we observed 643 days (91.0% of actual to maximum possible total patient days) where activity data was provided for at least 80% of the 24-hour period.

Conclusion: RWE studies involving passive data collection in RA require pt-centric implementation and design to minimize pt burden, promote longitudinal engagement and maximize adherence. Passive data capture via activity trackers such as smartwatches, along with regular contact such as automated reminders, may facilitate greater pt adherence in providing longitudinal data for clinical trials.

REFERENCES:

[1]Nowell WB, et al. JMIR Res Protoc. 2019;8(9):e14665.

Disclosure of Interests: W. Benjamin Nowell: None declared, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Fenglong Xie: None declared, Hong Zhao: None declared, David Curtis: None declared, Kelly Gavigan: None declared, Shilpa Venkatachalam: None declared, Laura Stradford: None declared, Jessica Boles: None declared, Justin Owensby: None declared, Cassie Clinton: None declared, Ilya Lipkovich Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Amy Calvin Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Virginia S. Haynes Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company