Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)

What this Trial Is About

Researchers are exploring the acceptance and usefulness of two specific measures related to the digital health application (DiGA) Axia for patients with axial spondyloarthritis. This real-world quality management study examines a 14-day trial period and an application-related outcome measurement (AbEM) as part of the German Digital Act (DigiG). The study focuses on patients eligible for prescription in routine care and seeks to understand how these measures impact app activation and patient engagement. Participants will be randomly assigned to receive one of two versions of an onboarding brochure: one follows the standard access procedure where Axia can only be used after receiving an activation code from the health insurance fund, and the other offers immediate 14-day trial access to Axia until the activation code arrives. The brochures contain QR codes to guide app download and activation, with each study center receiving an equal number of both versions to distribute. During the 12-week study period, researchers will track the percentage of participants who successfully activate the Axia app, along with the completion and results of a voluntary five-item AbEM questionnaire at weeks 6 and 12. Anonymized app usage data will also be analyzed to assess engagement. This study aims to provide insights into the practicality of these measures within routine prescription and digital health app use.

Exploratory Investigation of the Acceptance and Utility of 14-day Trial Periods and Application-related Outcome Measurement (AbEM) Within the Routine Prescription of the DiGA Axia.