A Randomized Controlled Clinical Trial Investigating the Effects of the Digital App Rheumabuddy4.1 in Patients With Rheumatoid Arthritis

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population. RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability. The substantial socioeconomic burden and the challenge of RA patients adhering to treatment is an important factor of this disease and its impact on both patients and society. An innovative approach is needed in order to find new ways to assist and truly empower patients to understand their disease, increase compliance and thereby increase quality of life. There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease. The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual. The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ An individual must meet all of the following criteria to be enrolled in the study:

• Diagnosed with RA according to the EULAR \& American College of Rheumatology

• PGA level \>= 40mm

• Age ≥ 18 years and \< 65 years

• Motivated for the intervention

• Willing and able to understand and participate in the study

• DAS28-CRP ≤ 3.2.

• Ability to use the RB4.1 app

Locations
Other Locations
Denmark
The Parker Institute, Bispebjerg and Frederiksberg Hospital
RECRUITING
Frederiksberg
Contact Information
Primary
Tanja Schjødt Jørgensen
tanja.schjoedt.joergensen@regionh.dk
+4538164173
Backup
Line Rustad
line.rustad@regionh.dk
+4538164158
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2026-06
Participants
Target number of participants: 70
Treatments
Experimental: Intervention arm
Patients diagnosed with rheumatoid arthritis receiving standard care and the digital app RB4.1
Active_comparator: Control arm
Patients diagnosed with rheumatoid arthritis receiving standard care alone.
Related Therapeutic Areas
Sponsors
Collaborators: Medical University of Vienna, DAMAN, Eurostars
Leads: Henning Bliddal

This content was sourced from clinicaltrials.gov