Spondylitis, AnkylosingRAEMDNCT07561255
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.
A study testing Test-phase with immediate access and Standard procedure in people with Spondylitis, Ankylosing and Mobile Phone Use, run by Wuerzburg University Hospital at 7 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylitis, Ankylosing, Mobile Phone Use
- What is being tested?
- Test-phase with immediate access and Standard procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesGermany
- Study dates
- 10 Apr 2026to 10 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to use Axia.
- Axia indication area.
- Willingness to activate via onboarding brochure.
Who cannot join
- Absence of the inclusion criteria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen
Erlangen
Stefan Kleinert, Prof, 0049913189000, stefan.kleinert@pgrn.de
- Recruiting
University Hospital of Erlangen
Erlangen
Harriet Morf, MD, 00499131 85-34742, Harriet.Morf@uk-erlangen.de
- Recruiting
MVZ Rheumatologie
Hamburg
Eva Schwaneck, MD, 004940 333 196 10, info.moenckeberg@rheuma-hh.de
- Recruiting
Rheumatologische Gemeinschaftspraxis Hattingen
Hattingen
David Kiefer, MD, 00492324 919648, davidkiefer@gmx.de
- Recruiting
University Hospital of Marburg
Marburg
Johannes Knitza, MD, 0049 6421 58-62651, johannes.knitza@staff.uni-marburg.de
- Recruiting
Klinikum Nürnberg
Nuremberg
Axel Hueber, Prof, 00499113983051, rheumatologie@klinikum-nuernberg.de
Vanessa Bartsch, MD
- Recruiting
University Hospital of Wuerzburg
Würzburg, Bavaria, 97080
Patrick-Pascal Strunz, MD, 4993120140100, Strunz_p@ukw.de
Marc Schmalzing, MD
About this study
Official title: 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.
- Conditions
- Spondylitis, Ankylosing, Mobile Phone Use
- Being tested
- Test-phase with immediate access, Standard procedure
- Keywords
- axial spondyloarthritis, mobile health, digitalization, onboarding, real-world, therapeutic app
- Medical subject headings
- Spondylitis, Ankylosing, Cell Phone Use, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test-phase with immediate accessDevice
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 procedureOther
Axia can only be used once the activation code has been provided by the health insurance fund
| Study group | Role | What they receive |
|---|---|---|
| Immediate app-use by a test phase | Experimental | Not described Receives: Device: Test-phase with immediate access |
| Standard procedure | Active comparator | Not described Receives: Other: Standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start10 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, controlled study within the framework of quality management measures on the part of the manufacturer.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick-Pascal Strunz, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561255
- Sponsor's protocol ID
- 2026-TEMP697441-ka
- Acronym
- RAEMD
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Quality Management Study With Axia to Evaluate the Measures of the DigiG (RAEMD Study)
- ClinicalTrials.gov ID
- NCT07561255
- Acronym / sponsor ID
- RAEMD / 2026-TEMP697441-ka
- Conditions
- Spondylitis, Ankylosing, Mobile Phone Use
- Keywords
- axial spondyloarthritis, mobile health, digitalization, onboarding, real-world, therapeutic app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Prospective, multicenter, controlled study within the framework of quality management measures on the part of the manufacturer.
| Arm | Type | Receives |
|---|---|---|
| Immediate app-use by a test phase | Experimental | Device: Test-phase with immediate access |
| Standard procedure | Active comparator | Other: Standard procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to use Axia.
- Axia indication area.
- Willingness to activate via onboarding brochure.
Key exclusion criteria (1 listed)
- Absence of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test-phase with immediate accessUse 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. | Device | Immediate app-use by a test phase |
| Standard procedureAxia can only be used once the activation code has been provided by the health insurance fund | Other | Standard procedure |
Primary outcome
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.
3 secondary outcomes
Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)
Time frame: 6 and 12 weeks
Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire
Time frame: 6 and 12 weeks
Exploratory analysis of anonymized usage data.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test-phase with immediate access and Standard procedure in people with Spondylitis, Ankylosing and Mobile Phone Use, run by Wuerzburg University Hospital at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick-Pascal Strunz, MD (093120140100, Strunz_p@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.