14-day trial access and brief in-app outcome checks for Axia in axial spondyloarthritis
Official title: Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
Run by Wuerzburg University Hospital · NCT07561255 · Data updated 2026-11-12
This project will try whether giving patients immediate 14-day trial access to the Axia app and asking a short five-item questionnaire improves app activation and engagement for people with axial spondyloarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 7 sites (Würzburg, Bavaria and 6 other locations) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | April 10, 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07561255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with axial spondyloarthritis who are eligible for an Axia prescription and willing to follow the onboarding brochure and use the app are ideal candidates.
✕Probably not a fit
Patients who are unwilling to use a smartphone app, who lack smartphone/internet access, or who are outside Axia's indication area are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, controlled real-world quality management project comparing two onboarding approaches for the DiGA Axia in routine care. Patients eligible for an Axia prescription are randomized 1:1 to receive either the standard access procedure or an onboarding version that grants immediate 14-day trial access until the insurer activation code arrives. The manufacturer will analyze aggregated anonymized data to compare voucher redemption and app activation rates between groups and to measure acceptance and return rates of a voluntary five-item application-related outcome measurement (AbEM) at weeks 6 and 12. Secondary analyses will descriptively report AbEM responses and anonymized usage patterns from the app.
Why it matters
Potential benefit: If successful, this could increase early app activation and engagement and provide a simple way to collect short patient-reported outcomes for Axia users.
How similar studies have gone: Similar strategies of offering trial access and short in-app outcome questionnaires have been used in digital health, but controlled evidence specifically in axial spondyloarthritis is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willingness to use Axia. * Axia indication area. * Willingness to activate via onboarding brochure. Exclusion Criteria: * Absence of the inclusion criteria
Where it's running
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University Hospital of Wuerzburg
Würzburg, Bavaria, Germany Recruiting -
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen
Erlangen, Germany Recruiting -
University Hospital of Erlangen
Erlangen, Germany Recruiting -
MVZ Rheumatologie
Hamburg, Germany Recruiting -
Rheumatologische Gemeinschaftspraxis Hattingen
Hattingen, Germany Recruiting -
University Hospital of Marburg
Marburg, Germany Recruiting
Show 1 more location
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Klinikum Nürnberg
Nuremberg, Germany Recruiting
Study contacts
- Study coordinator: Patrick-Pascal Strunz, MD
- Email: Strunz_p@ukw.de
- Phone: 093120140100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.