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

Condition(s) studied

Investigational drug(s) / intervention(s)

Digital app RB4.1: Standard care and the digital app RB4.1

Control arm: Standard care alone

Study 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

Primary outcome measure(s)

• Patient Global Assessment — Week 12, Week 24, change from baseline
  Patient Global Assessment (PGA) is scored using a visual analogue scale (VAS) range from 0-100 mm. Higher scores represent a higher level of disease activity or a worse global health. The PGA is one of the most widely reported PROs in RA. The considerable burden of RA on the individual is related to both inflammation and damage but also to broader aspects of disease, including psychological and societal impact. The way PGA is used in clinical practices covers, in fact, two very different concepts, one related to global health and the other to overall disease activity They are both usually used under the heading of PGA without further specification for which is being assessed.

Trial sites (1)

Other trials for the same condition