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.
Recruiting now · Not applicable
Conditions studied: Spondylitis, Ankylosing, Mobile Phone Use
In brief
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.
Key facts
- Study ID
- NCT07561255
- Run by
- Wuerzburg University Hospital
- People needed
- 200
- Starts
- 2026-04-10
- Expected to finish
- 2027-04-10
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willingness to use Axia.
- Axia indication area.
- Willingness to activate via onboarding brochure.
You may not qualify if…
- Absence of the inclusion criteria
Where it is running
- University Hospital of Wuerzburg — Würzburg, Bavaria, Germany (enrolling)
- Praxisgemeinschaft Rheumatologie Nephrologie Erlangen — Erlangen, Germany (enrolling)
- University Hospital of Erlangen — Erlangen, Germany (enrolling)
- MVZ Rheumatologie — Hamburg, Germany (enrolling)
- Rheumatologische Gemeinschaftspraxis Hattingen — Hattingen, Germany (enrolling)
- University Hospital of Marburg — Marburg, Germany (enrolling)
- Klinikum Nürnberg — Nuremberg, Germany (enrolling)
Full record on ClinicalTrials.gov
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