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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Test-phase with immediate access, Standard procedure.
- Who it may be relevant to
- Registry conditions: Spondylitis, Ankylosing, Mobile Phone Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
Overview
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.
Interventions
- Device Test-phase with immediate access
Use of two versions of an onboarding brochure in A7 format containing a QR code. The brochures are provided free of charge to the study centers by the manufacturer. Each study center receives 20 cards in a 1:1 ratio. One version contains the QR code with instructions and support for the standard procedure (Axia can only be used once the activation code has been provided by the health insurance fund). The second version contains a QR code through which Axia can be downloaded from the app store - Other Standard procedure
Axia can only be used once the activation code has been provided by the health insurance fund
Primary outcome measures
- Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code [Time frame: 12 weeks]
Secondary outcome measures (3)
- Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM) [Time frame: 6 and 12 weeks]
- Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire [Time frame: 6 and 12 weeks]
- Exploratory analysis of anonymized usage data. [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Willingness to use Axia.
- Axia indication area.
- Willingness to activate via onboarding brochure.
Exclusion criteria
- Absence of the inclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Germany · 7 centers
- University Hospital of Wuerzburg — Würzburg
- Praxisgemeinschaft Rheumatologie Nephrologie Erlangen — Erlangen
- University Hospital of Erlangen — Erlangen
- MVZ Rheumatologie — Hamburg
- Rheumatologische Gemeinschaftspraxis Hattingen — Hattingen
- University Hospital of Marburg — Marburg
- Klinikum Nürnberg — Nuremberg
Identifiers
NCT: NCT07561255 · 2026-TEMP697441-ka