AORTA - ABATON for RheumaToid Arthritis

Not Applicable

Recruiting

• Conditions: M05; M06; Seropositive rheumatoid arthritis; Other rheumatoid arthritis

• Registration Number: DRKS00024205
• Lead Sponsor: ABATON GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Legally valid consent of the patient has been given
- Age = 18 years
- Medical diagnosis of RA according to EULAR / ACR criteria.
- Access to an internet-enabled device, e.g. smartphones, tablet PC or laptop or computer with a modern browser
- Possession of a mobile phone number
- The ability to speak and understand German

Exclusion Criteria

- Patients whose informed consent has not been obtained
- Patients participating in other interventional studies
- Persons who are in a dependent / employment relationship with the sponsor or investigator.
- Persons in institutionalisation due to a court or administrative order.
- Patients with any of the following concomitant therapies that have taken place or are ongoing: ABATON as a digital health application

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to demonstrate that the care of patients with rheumatoid arthritis is improved by the structured digital recording of PROs via ABATON, by facilitating, digitally-assisted patient-centered care based on the T2T principle improves the experienced health status based on the RAID.

Secondary Outcome Measures

Name	Time	Method
- Reduction of experienced disease activity<br>- Improvement of quality of life<br>- Reduction of rheumatism-associated symptoms (pain, morning stiffness)<br>- Reduction of disease activity according to DAS28, CDAI, SDAI<br>- Increase in patient conversion rate from non-remission to remission<br>- Increase of physical functions in daily life<br>- Improvement of doctor-patient relationship<br>- Increase in adherence to drug therapy<br>- Increase in patient sovereignty<br>- Increase in subjective work ability<br>- Increase in adherence to guidelines through increased adherence to the T2T principle<br>- Increase in cost-effectiveness