RecruitingNot ApplicableNCT07561255

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.

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


Sponsor

Wuerzburg University Hospital

Enrollment

200 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Willingness to use Axia.
  • Axia indication area.
  • Willingness to activate via onboarding brochure.

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Interventions

DEVICETest-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.

OTHERStandard 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

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NCT07561255


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