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Taking people in GermanyNo phase

Testing a 14-day trial period for the Axia app in ankylosing spondylitis

Tests a 14-day trial of the Axia app in adults with axial spondyloarthritis.

Plain-language title generated from the registry record
Registry title: 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.

Key facts

Where
Erlangen, Hamburg, Hattingen, Marburg, Nuremberg, and Würzburg, GermanySee the 7 sites

Where in Germany

  • Praxisgemeinschaft Rheumatologie Nephrologie ErlangenErlangen, GermanyTaking people
  • University Hospital of ErlangenErlangen, GermanyTaking people
  • MVZ RheumatologieHamburg, GermanyTaking people
  • Rheumatologische Gemeinschaftspraxis HattingenHattingen, GermanyTaking people
  • University Hospital of MarburgMarburg, GermanyTaking people
  • Klinikum NürnbergNuremberg, GermanyTaking people
  • University Hospital of WuerzburgWürzburg, GermanyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Wuerzburg University Hospital
Trial code
NCT07561255
Record updated
1 May 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: Willingness to use Axia; Axia indication area; Willingness to activate via onboarding brochure.

Exclusion: Absence of the inclusion criteria.

ClinicalTrials.gov NCT07561255