Clinical Research Directory
Browse clinical research sites, groups, and studies.
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.
Sponsor: Wuerzburg University Hospital
Summary
This prospective, multicenter, controlled real-world quality management study explores the acceptance and utility of two measures discussed in the context of the German Digital Act (DigiG) for the digital health application (DiGA) Axia: a 14-day trial period and an application-related outcome measurement (AbEM). Patients with axial spondyloarthritis in Axia's indication area who are eligible for prescription in routine care will receive one of two onboarding brochure versions in a 1:1 allocation: either the standard access procedure or immediate 14-day trial access until the health insurance activation code arrives. The manufacturer will analyze aggregated anonymized data to compare voucher redemption and app activation frequencies between groups and to assess acceptance and return rates of a voluntary five-item AbEM questionnaire at weeks 6 and 12. Secondary analyses will descriptively evaluate AbEM results and anonymized usage data.
Official title: Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-04-10
Completion Date
2027-04-10
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
Test-phase with immediate access
Use of two versions of an onboarding brochure in A7 format containing a QR code. The brochures are provided free of charge to the study centers by the manufacturer. Each study center receives 20 cards in a 1:1 ratio. One version contains the QR code with instructions and support for the standard procedure (Axia can only be used once the activation code has been provided by the health insurance fund). The second version contains a QR code through which Axia can be downloaded from the app store and used with a 14-day trial access until the activation code from the health insurance fund arrives.
Standard procedure
Axia can only be used once the activation code has been provided by the health insurance fund
Locations (7)
University Hospital of Wuerzburg
Würzburg, Bavaria, Germany
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen
Erlangen, Germany
University Hospital of Erlangen
Erlangen, Germany
MVZ Rheumatologie
Hamburg, Germany
Rheumatologische Gemeinschaftspraxis Hattingen
Hattingen, Germany
University Hospital of Marburg
Marburg, Germany
Klinikum Nürnberg
Nuremberg, Germany