Improving rates of remission by using a digital health app for triaging patients with axial spondyloarthritis and high disease activity to subsequently adapt medication (DATAX)

Not Applicable

Recruiting

• Conditions: M45; Ankylosing spondylitis

• Registration Number: DRKS00032408
• Lead Sponsor: St. Elisabeth Gruppe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

•Diagnosis of axSpA according to their rheumatologist
•High disease activity defined as BASDAI = 4
•Treatment initiation with continuous NSAIDs (nonsteroidal anti-inflammatory drug) medication is planned
•bDMARD-naïve
•Willingness to adhere to the study intervention, especially willigness to document disease activity measures frequently
•Willingness of the patient to use their own smartphone to install (to download the app from the app stores: Apple’s App Store or Google’s Play Store on their mobile device) the RheCORD app and for documentation of disease activity

Exclusion Criteria

•Patient received two full courses of NSAIDs at a daily full dose for at least 2 weeks each
•have contraindications to NSAIDs
•taking high potency opioid analgesics (e.g. methadone)
•comorbidities which cause back pain or might confound initiation and evaluation of the treatment response, such as fibromyalgia
•concurrent liver disease (ALT >2 times upper limit of normal)
•renal disease (creatinine clearance <30 ml/minute)
•Any medical condition that would preclude the participant from adhering to the protocol
•Insufficient knowledge of the German language

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission defined as ASDAS (Ankylosing Spondylitis Disease Activity Score) <1.3 in week 24

Secondary Outcome Measures

Name	Time	Method
• Time to reach ASDAS (Ankylosing Spondylitis Disease Activity Score) <1.3,<br>• ASDAS <1.3 in week 12,<br>• BASDAI50 response,<br>• changes of medication based on BASDAI levels,<br>• patient switching to bDMARD (biologic disease-modifying antirheumatic drugs) treatment,<br>• changes of pain level, physical function and health-related quality of life