ABSTRACT
Background: Digital health applications (DHA) became indispensable patient companions accelerated by the current COVID pandemic [1]. In 2020, for the frst time worldwide, a regulatory framework to reimburse DHA was established in Germany. To get listed as a DHA, preliminary evidence needs to be generated-next to fulflling highest standards in quality and safety. The DHA ABATON RA consists of two parts;1) digital shared-decision-making (SDM) including choosing an appropriate electronic patient reported outcome (ePRO) instrument and the respective ePRO target for the next visit, 2) remote patient monitoring and ePRO tracking by the patient. Hereby, ABATON RA supports a digitally guided Treat-to-Target (T2T) approach. Objectives: The objective of this study is to evaluate a potentially benefcial effect for the patient by using ABATON RA. Methods: Three-armed, partially blinded multicenter trial (RCT) including RA patients who regularly use a smartphone. Patients attend 3 visits, 3 months apart (T0, T3, T6), with one follow-up visit (T9). Intervention group (IG): Patients use ABATON RA. Via SDM patients and rheumatologists choose a specifc ePRO and respective treatment target for the next visit in three months, e.g. RAID ≤4. Control group (CG): Standard of care treatment (no DHA). Placebo group (PG): Usage of a placebo version of ABATON RA providing only Regensburger Insomnie Skala (RIS) and Epworth Sleepiness Scale (ESS) as ePROs. No SDM is conducted and ePRO results are not presented to HCP. Results: This interim analysis evaluated the frst 38 patients that completed T3. IG: 13 patients (Av. age 55.9, 61.5% females);PG: 12 (Av. age 50.7, 66.7% females);CG: 13 (Av. age 56.1, 76.9% females). We observe a signifcant improvement in the mean over time in a pairwise comparison within the intervention group for the following: Pt-GA mean difference of 2.98 (p = 0.025, partial η2 = 0.353), pain mean difference of 1.46 (p = 0.049, partial η2 = 0.286) whereas all pairwise comparisons for the two parameters were non-signifcant in PG and CG. The patient reactions assessment (PRA) score, measuring patient perceived quality of the patient-provider relationship, increased by a mean of 4.15 points in IG, compared to a slight decrease of 1.92 for PG and 2.77 for CG. Conclusion: These preliminary fndings show benefcial differences among the groups in favor of IG: 1) for quality of life and 2) the physician-patient-relationship. A digitally enhanced therapy is non-inferior to the gold-standard of exclusive in-person treatment. Patients seem willing and able to get involved in an enhanced treat-to-target and shared decision-making approach.