14-day trial access and brief in-app outcome checks for Axia in axial spondyloarthritis
Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuerzburg University Hospital Academic / other |
| Locations | 7 sites (Würzburg, Bavaria and 6 other locations) |
| Trial ID | NCT07561255 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Würzburg, Bavaria and 6 other locations
- 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)
- Klinikum Nürnberg — Nuremberg, Germany (Recruiting)
Study contacts
- Study coordinator: Patrick-Pascal Strunz, MD
- Email: Strunz_p@ukw.de
- Phone: 093120140100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.