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.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07561255

Acronym

RAEMD

Enrollment

200

Registered

2026-05-01

Start date

2026-04-10

Completion date

2027-04-10

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mobile Phone Use, Spondylitis, Ankylosing

Keywords

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

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.

Interventions

DEVICETest-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.

OTHERStandard procedure

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Caregiver)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Absence of the inclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code	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

Measure	Time frame	Description
Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)	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.
Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire	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.
Exploratory analysis of anonymized usage data.	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.

Countries

Germany

Contacts

CONTACTPatrick-Pascal Strunz, MD

Strunz_p@ukw.de093120140100

CONTACTPatrick-Pascal Strunz