Background/Purpose: Smartphone apps and sensors enable researchers to design novel endpoints and collect real world data directly from patients in a cost-effective, fast, and patient-focused approach. ResearchKit™, created by Apple in 2015, is an iOS-based, open-source platform for researchers to conduct App-based studies. We were the first pharmaceutical company to utilize the ResearchKit™ by conducting the Patient Rheumatoid Arthritis Data from the Real World (PARADE) Study. The objectives were to investigate the feasibility of utilizing a mobile app to recruit and enroll patients into a study and to gain insights about Rheumatoid Arthritis (RA) in a real world setting.

Methods: The PARADE study was conducted in the United States (US) using a customized Apple ResearchKit™ App. The PARADE App included study video, eligibility screen, electronic informed consent, and data collection. The enrolment period was July 12 through August 12, 2016. Recruitment was enhanced with advertisement on various targeted social media platforms. Participants could enroll if they were 21 years or older, spoke English, lived in the US, and had been diagnosed with RA by a doctor. Participants were asked to provide demographics, comorbidities, medications, and RA symptoms including pain, fatigue, mood and morning stiffness. Additionally, over the course of 12 weeks, participants were asked to complete validated questionnaires routinely used in RA clinical trials, namely HAQ, FACIT, and EQ-5D. All data were self-reported and collected via their iPhone.

Results: There were 1170 downloads of the PARADE App with 428 consents to participate in the study. Of these, 399 participants provided analyzable data, defined as those completing all demographic questions. The study population was 80% female, 81% Caucasian, mean age 47.9 years, and 77% college graduates. The duration of diagnosed RA included 122 (30.6%) participants with RA for <2 years, 91 (22.8%) for 2-5 years, 91 (22.8%) for 5-10 years and 95 (23.8%) for >10 years. Most bothersome RA symptoms included joint pain (87.5%), fatigue (73.5%), morning stiffness (57.5%), poor sleep (52.4%), walk and balance (32.8%), and mood variations (23.7%).  Mean pain score was 4.4 (SD 0.14) on a numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Mean scores for validated questionnaires were HAQ-DI, 1.1 (SD 0.04); Patient Global Assessment of Disease Activity, 5.4 (SD 0.14) (0=I don’t feel arthritis to 10=Arthritis affects me severely); EQ-5D, 0.6983 (SD 0.00822), and FACIT, 25.5 (SD 0.66). RA medications are listed in the Table.

Conclusion: The PARADE study was the first Pharma-sponsored study in which real world patients could self-recruit, consent, enroll, and report data entirely via their iPhone using a ResearchKit™ App. This study successfully demonstrated the feasibility of this novel technology to gather insights into RA from a real world perspective.