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.
Willingness to use Axia.
Axia indication area.
Willingness to activate via onboarding brochure.
Absence of the inclusion criteria
Parallel
Test-phase with immediate access
DeviceUse 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 and used with a 14-day trial access until the activation code from the health insurance fund arrives.
Standard procedure
Other interventionAxia can only be used once the activation code has been provided by the health insurance fund
Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code
Successful app activation is defined as successful redemption of the activation code by the participant. The outcome measure is the percentage of participants with successful app activation from baseline through week 12.
Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)
Voluntary completion of the AbEM questionnaire is defined as submission of a completed application-related success measurement questionnaire by the participant.
Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire
The AbEM questionnaire consists of 6 items assessing application-related success. One item assesses improvement in health status using a 7-point Likert scale. Five items assess the quality of the DiGA using numerical rating scales ranging from 0 to 10, with higher scores indicating better perceived quality. Item scores will be summarized descriptively among participants with a completed AbEM questionnaire.
Exploratory analysis of anonymized usage data.
App usage days are defined as calendar days on which at least one app usage event is recorded for a participant. The total number of app usage days per participant from baseline through week 12 will be assessed using app usage log data and summarized descriptively.
Click on the lead sponsor to view all of their trials.
