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. (RAEMD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spondylitis, Ankylosing; Mobile Phone Use
• Intervention / Treatment: Device: Test-phase with immediate access; Other: Standard procedure

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick-Pascal Strunz, MD; Phone Number: 093120140100; Email: Strunz_p@ukw.de
• Study Contact Backup: Name: Patrick-Pascal Strunz; Phone Number: 093120140100; Email: Strunz_p@ukw.de

Study Locations

• Germany
  • Erlangen, Germany
    • Recruiting
    • Praxisgemeinschaft Rheumatologie Nephrologie Erlangen
    • Contact: Stefan Kleinert, Prof; Phone Number: 0049913189000; Email: stefan.kleinert@pgrn.de
  • Erlangen, Germany
    • Recruiting
    • University Hospital of Erlangen
    • Contact: Harriet Morf, MD; Phone Number: 00499131 85-34742; Email: Harriet.Morf@uk-erlangen.de
  • Hamburg, Germany
    • Recruiting
    • MVZ Rheumatologie
    • Contact: Eva Schwaneck, MD; Phone Number: 004940 333 196 10; Email: info.moenckeberg@rheuma-hh.de
  • Hattingen, Germany
    • Recruiting
    • Rheumatologische Gemeinschaftspraxis Hattingen
    • Contact: David Kiefer, MD; Phone Number: 00492324 919648; Email: davidkiefer@gmx.de
  • Marburg, Germany
    • Recruiting
    • University Hospital of Marburg
    • Contact: Johannes Knitza, MD; Phone Number: 0049 6421 58-62651; Email: johannes.knitza@staff.uni-marburg.de
  • Nuremberg, Germany
    • Recruiting
    • Klinikum Nürnberg
    • Contact: Axel Hueber, Prof; Phone Number: 00499113983051; Email: rheumatologie@klinikum-nuernberg.de
    • Sub-Investigator: Vanessa Bartsch, MD
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital of Wuerzburg
      • Contact: Patrick-Pascal Strunz, MD; Phone Number: 4993120140100; Email: Strunz_p@ukw.de
      • Sub-Investigator: Marc Schmalzing, MD
      • Sub-Investigator: Hannah Labinsky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate app-use by a test phase	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 and used with a 14-day trial access until the activation code from the health insurance fund arrives.
Active Comparator: Standard procedure	Other: Standard procedure; Axia can only be used once the activation code has been provided by the health insurance fund

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 and 12 weeks
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.	6 and 12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 10, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mobile health; real-world; axial spondyloarthritis; digitalization; onboarding; therapeutic app
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Behavior; Communication; Social Behavior; Axial Spondyloarthritis; Spondylitis, Ankylosing; Cell Phone Use
• Other Study ID Numbers: 2026-TEMP697441-ka

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No