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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.

Study acronym: RAEMD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07561255
Lead Sponsor Wuerzburg University Hospital
Conditions
(from sponsor)		 Spondylitis, Ankylosing, Mobile Phone Use
Related terms Axial Spondyloarthritis, Cell Phone Use, Spondylitis, Ankylosing
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov