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)
27. april 2026 opdateret af: Patrick-Pascal Strunz, Wuerzburg University Hospital
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
200
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Patrick-Pascal Strunz, MD
- Telefonnummer: 093120140100
- E-mail: Strunz_p@ukw.de
Undersøgelse Kontakt Backup
- Navn: Patrick-Pascal Strunz
- Telefonnummer: 093120140100
- E-mail: Strunz_p@ukw.de
Studiesteder
-
-
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Erlangen, Tyskland
- Rekruttering
- Praxisgemeinschaft Rheumatologie Nephrologie Erlangen
-
Kontakt:
- Stefan Kleinert, Prof
- Telefonnummer: 0049913189000
- E-mail: stefan.kleinert@pgrn.de
-
Erlangen, Tyskland
- Rekruttering
- University Hospital of Erlangen
-
Kontakt:
- Harriet Morf, MD
- Telefonnummer: 00499131 85-34742
- E-mail: Harriet.Morf@uk-erlangen.de
-
Hamburg, Tyskland
- Rekruttering
- MVZ Rheumatologie
-
Kontakt:
- Eva Schwaneck, MD
- Telefonnummer: 004940 333 196 10
- E-mail: info.moenckeberg@rheuma-hh.de
-
Hattingen, Tyskland
- Rekruttering
- Rheumatologische Gemeinschaftspraxis Hattingen
-
Kontakt:
- David Kiefer, MD
- Telefonnummer: 00492324 919648
- E-mail: davidkiefer@gmx.de
-
Marburg, Tyskland
- Rekruttering
- University Hospital of Marburg
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Kontakt:
- Johannes Knitza, MD
- Telefonnummer: 0049 6421 58-62651
- E-mail: johannes.knitza@staff.uni-marburg.de
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Nuremberg, Tyskland
- Rekruttering
- Klinikum Nürnberg
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Kontakt:
- Axel Hueber, Prof
- Telefonnummer: 00499113983051
- E-mail: rheumatologie@klinikum-nuernberg.de
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Underforsker:
- Vanessa Bartsch, MD
-
-
Bavaria
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Würzburg, Bavaria, Tyskland, 97080
- Rekruttering
- University Hospital of Wuerzburg
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Kontakt:
- Patrick-Pascal Strunz, MD
- Telefonnummer: 4993120140100
- E-mail: Strunz_p@ukw.de
-
Underforsker:
- Marc Schmalzing, MD
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Underforsker:
- Hannah Labinsky, MD
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Willingness to use Axia.
- Axia indication area.
- Willingness to activate via onboarding brochure.
Exclusion Criteria:
- Absence of the inclusion criteria
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Immediate app-use by a test phase
|
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. |
|
Aktiv komparator: Standard procedure
|
Axia can only be used once the activation code has been provided by the health insurance fund
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code
Tidsramme: 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.
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM)
Tidsramme: 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.
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6 and 12 weeks
|
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Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire
Tidsramme: 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.
|
6 and 12 weeks
|
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Exploratory analysis of anonymized usage data.
Tidsramme: 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.
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. april 2026
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
10. april 2027
Datoer for studieregistrering
Først indsendt
17. april 2026
Først indsendt, der opfyldte QC-kriterier
27. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-TEMP697441-ka
Plan for individuelle deltagerdata (IPD)
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