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. 2022 Dec;42(12):2177-2190.
doi: 10.1007/s00296-022-05175-4. Epub 2022 Sep 16.

Efficacy and safety of a mobile app intervention in patients with inflammatory arthritis: a prospective pilot study

Dmytro Fedkov  1 , Andrea Berghofen  2 , Christel Weiss  3 , Christine Peine  4 , Felix Lang  4 , Johannes Knitza  5   6   7 , Sebastian Kuhn  8   9 , Bernhard K Krämer  10 , Jan Leipe  2
Affiliations

Efficacy and safety of a mobile app intervention in patients with inflammatory arthritis: a prospective pilot study

Dmytro Fedkov et al. Rheumatol Int. 2022 Dec.

Abstract

EULAR highlighted the essential role of digital health in increasing self-management and improving clinical outcomes in patients with arthritis. The objective of this study was to evaluate the efficacy and safety of the digital health application (DHA) in patients with inflammatory arthritis. We assessed demographic parameters, treatment regimen, disease activity, and other patient-reported outcomes at baseline and after 4 weeks of DHA use added to standard care treatment. Of 17 patients, who completed the study, 7 (41.2%) patients were male, ranging from 19 to 63 (40.5 ± 12.2) years. No significant change in antirheumatic treatment was observed during the study. Statistically significant improvements (p < 0.05) were noted for health-related quality of life (increase in Physical Component Summary of Short Form-36 (SF-36) by 23.6%) and disease activity (decrease of Clinical Disease Activity Index and Simple Disease Activity Index by 38.4% and 39.9%, respectively). Clinically significant improvement was demonstrated for SF-36 Total Score (+ 14.4%), disease activity (Rheumatoid Arthritis Disease Activity Index- 5 to 15.9%), and depression (Patient Health Questionnaire- 9 to 13.5%). None of the efficacy parameters showed negative trends. No adverse events were reported throughout the study. The usability level was high i.e., the mean mHealth Application Usability Questionnaire Score of 5.96 (max.: 7.0) demonstrated a high level of application usability. This suggests that using a personalized disease management program based on DHA significantly improves several measures of patient-reported outcomes and disease activity in patients with inflammatory arthritis in a timely manner. These findings highlight the potential of complementary digital therapy in patients with inflammatory arthritis.

Keywords: Health-related quality of life; Healthy lifestyle; Mobile applications; Rheumatoid arthritis; Spondyloarthritis; mHealth.

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Conflict of interest statement

DF, FL, and CP are employees and have an equity interest in Midaia GmbH and have no other disclosures to make. Midaia GmbH developed a mobile application that was used in this study but did not finance this study. JK received financial support from ABATON GmbH, developer of software for rheumatic diseases. SK is founder and managing partner of MED.digital GmbH. He is member of the “Digitalization of health care “ and “Medical Education and University Medicine” committees of the German Medical Association. JL, AB, CW, BK declare that they have no conflict of interest. The investigator (JL) and his respective research team collected all the data. Statistical analyses were conducted by a biostatistician (CW) at Heidelberg University following a prespecified statistical analysis plan.

Figures

Fig. 1
Fig. 1
Midaia Software components
Fig. 2
Fig. 2
Mida Rheuma App
Fig. 3
Fig. 3
DocBoard Web-App
Fig. 4
Fig. 4
Schematic flow chart of protocol
See this image and copyright information in PMC

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