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.

NCT07561255 | Recruiting

• 1 other identifier: 2026-TEMP697441-ka
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Spondylitis, Ankylosing; Mobile Phone Use

Keywords

axial spondyloarthritis; mobile health; digitalization; onboarding; real-world; therapeutic app

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)

  6 and 12 weeks

• Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire

  6 and 12 weeks

• Exploratory analysis of anonymized usage data.

  12 weeks

Study Arms (2)

Immediate app-use by a test phase

EXPERIMENTAL

Device: Test-phase with immediate access

Standard procedure

ACTIVE COMPARATOR

Other: Standard procedure

Interventions

Test-phase with immediate access DEVICE

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.

Immediate app-use by a test phase

Standard procedure OTHER

Axia can only be used once the activation code has been provided by the health insurance fund

Standard procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (7)

University Hospital of Wuerzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Praxisgemeinschaft Rheumatologie Nephrologie Erlangen

Erlangen, Germany

RECRUITING

University Hospital of Erlangen

Erlangen, Germany

RECRUITING

MVZ Rheumatologie

Hamburg, Germany

RECRUITING

Rheumatologische Gemeinschaftspraxis Hattingen

Hattingen, Germany

RECRUITING

University Hospital of Marburg

Marburg, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, Germany

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing; Cell Phone Use; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Communication; Behavior; Social Behavior

Central Study Contacts

Patrick-Pascal Strunz, MD

CONTACT

093120140100; Strunz_p@ukw.de

Patrick-Pascal Strunz

CONTACT

093120140100; Strunz_p@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD. Dr. med.

Model Details: Prospective, multicenter, controlled study within the framework of quality management measures on the part of the manufacturer.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 1, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 10, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)