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NCT Number: NCT07561255

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.

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.

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Key information

Conditions

Spondylitis, Ankylosing Ankylosis Arthritis Axial Spondyloarthritis Behavior Bone Diseases Cell Phone Use Communication Joint Diseases Mobile Phone Use Musculoskeletal Diseases Social Behavior Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Wuerzburg, Würzburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Absence of the inclusion criteria

Treatment and study plan

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.

Standard procedure

Other

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

Primary outcomes

  1. Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 6 and 12 weeks

    Voluntary completion of the AbEM questionnaire is defined as submission of a completed application-related success measurement questionnaire by the participant.

  2. Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire

    Time frame: 6 and 12 weeks

    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.

  3. Exploratory analysis of anonymized usage data.

    Time frame: 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick-Pascal Strunz

CONTACT

[email protected]

093120140100

Patrick-Pascal Strunz, MD

CONTACT

[email protected]

093120140100

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: RAEMD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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