NCT07561255 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.
| NCT ID | NCT07561255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wuerzburg University Hospital |
| Condition | Spondylitis, Ankylosing |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-04-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Willingness to use Axia. * Axia indication area. * Willingness to activate via onboarding brochure. Exclusion Criteria: * Absence of the inclusion criteria
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07561255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spondylitis, Ankylosing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07561255 currently recruiting?
Yes, NCT07561255 is actively recruiting participants. Contact the research team at Strunz_p@ukw.de for enrollment information.
Where is the NCT07561255 trial being conducted?
This trial is being conducted at Würzburg, Germany, Erlangen, Germany, Erlangen, Germany, Hamburg, Germany and 3 additional locations.
Who is sponsoring the NCT07561255 clinical trial?
NCT07561255 is sponsored by Wuerzburg University Hospital. The trial plans to enroll 200 participants.