Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06337786

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

Led by Henning Bliddal · Updated on 2025-04-04

70

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

Sponsors

H

Henning Bliddal

Lead Sponsor

E

Eurostars

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with rheumatoid arthritis according to the EULAR and American College of Rheumatology criteria
  • Patient Global Assessment (PGA) level of 40mm or higher
  • Age 18 years or older and younger than 65 years
  • Motivated to participate in the intervention
  • Willing and able to understand and take part in the study
  • Disease Activity Score 28 - C-reactive protein (DAS28-CRP) of 3.2 or lower
  • Ability to use the RheumaBuddy4.1 app
Not Eligible

You will not qualify if you...

  • Dementia or other cognitive, linguistic, or physical impairments preventing participation
  • Vision impairment preventing use of devices and computer
  • Change in disease-modifying antirheumatic drugs (DMARD) within 8 weeks prior to study
  • Chronic widespread pain (fibromyalgia) as documented in medical records
  • Acute infections as documented in medical records
  • Severe asthma as documented in medical records
  • Severe chronic obstructive pulmonary disease (COPD) as documented in medical records
  • Unstable heart disease as documented in medical records
  • Intensive physiotherapy outside standard care
  • Use of electrostimulation therapy
  • Participation in motivation training programs
  • Smoking
  • Fever
  • Pain or fatigue considered side effects by treating physician
  • Other autoimmune diseases as documented
  • Mental health disorders as documented
  • Any non-pharmacological therapies that may affect RA course
  • Any comorbid conditions interfering with study or results
  • Previous use of health apps related to rheumatoid arthritis

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Parker Institute, Bispebjerg and Frederiksberg Hospital

Frederiksberg, Copenhagen F, Denmark, 2000

Actively Recruiting

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Research Team

T

Tanja Schjødt Jørgensen

CONTACT

L

Line Rustad

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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