NCT06337786

Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical RCT Set-up in Patients With Rheumatoid Arthritis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Henning Bliddal · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Rheumatoid arthritis (RA) incurs a substantial socioeconomic burden which has been supported by the Global Burden of Disease studies. 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. Many RA patients experience a gap between the health care professionals (HCPs) and the patients regarding the understanding of living a life with a chronic disease - it is more than just blodsamples and swollen/tender joints.This trial addresses a critical, previously not well addressed, question of patient- and clinical importance about the support of using electronically patient reported outcomes (ePROs) ensuring high-quality life living with a chronic disease in patients with RA. Digital health technology, as adjunct to standard routine care, provides a big opportunity to deliver continuous relevant, timely and cost-effective support to patients including support behavioural changes, improve quality of life and optimize treatment. Many (86%) of patients with RA agree that RA self-management apps can be very helpful, but the lack of high-quality and scientifically validated apps are needed. The trial will create an evidence base covering the implications of disease- and treatment related concerns as well as non-adherence on quality of life (QoL), patient empowerment, clinical symptoms, and use of medication. Decision and policy makers need a transparent evidence base to substantiate the judgment behind any rational clinical rheumatology practice. The methodology is based on a 'bottom up' approach that hopefully will provide a state-of-the-art model for ensuring patient value in health care settings. Altogether it is very likely that the use of data collected in RB4.1 will be of significant benefit to both patients with RA and HCPs. 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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Digital app RB4.1	Standard care and the digital app RB4.1
OTHER	Control arm	Standard care alone

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-03-29
• Last updated: 2025-04-04

Locations

1 site across 1 country: Denmark