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.

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Test-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
• Другое Standard procedure
  Axia can only be used once the activation code has been provided by the health insurance fund

Первичные конечные точки

• Percentage of participants with successful Axia app activation within 12 weeks, assessed by successful redemption of the activation code [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• Percentage of participants with a voluntarily completed application-related success measurement questionnaire (AbEM) [Срок оценки: 6 and 12 weeks]
• Mean AbEM questionnaire item scores among participants with a completed AbEM questionnaire [Срок оценки: 6 and 12 weeks]
• Exploratory analysis of anonymized usage data. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• Absence of the inclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 7 центров

• University Hospital of Wuerzburg — Würzburg
• Praxisgemeinschaft Rheumatologie Nephrologie Erlangen — Erlangen
• University Hospital of Erlangen — Erlangen
• MVZ Rheumatologie — Hamburg
• Rheumatologische Gemeinschaftspraxis Hattingen — Hattingen
• University Hospital of Marburg — Marburg
• Klinikum Nürnberg — Nuremberg

Идентификаторы

NCT: NCT07561255 · 2026-TEMP697441-ka

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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