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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.

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.

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

Inclusion Criteria:

  • Willingness to use Axia.
  • Axia indication area.
  • Willingness to activate via onboarding brochure.

Exclusion Criteria:

  • Absence of the inclusion criteria

Study details
    Spondylitis
    Ankylosing
    Mobile Phone Use

NCT07561255

Wuerzburg University Hospital

13 May 2026

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