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.

ClinicalTrials.gov ID

NCT07561255

Lead Sponsor

Wuerzburg University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

May 1, 2026Actual

Start Date

Apr 10, 2026Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Apr 10, 2027Estimated

Official Title

Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)

Brief Summary

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.

• Spondylitis, Ankylosing
• Mobile Phone Use

• Test-phase with immediate access
• Standard procedure

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of the inclusion criteria

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Wuerzburg University HospitalOTHER

Harriet.Morf@uk-erlangen.de00499131 85-34742

info.moenckeberg@rheuma-hh.de004940 333 196 10

johannes.knitza@staff.uni-marburg.de0049 6421 58-62651

rheumatologie@klinikum-nuernberg.de00499113983051

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