Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical RCT Set-up in Patients With Rheumatoid Arthritis
Recruiting · NCT06337786 · Interventional (participants receive a specific treatment) · Lead sponsor: Henning Bliddal
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- An individual will be excluded from the study if she meets any of the following criteria:
- Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer
- Change in DMARD (within 8 weeks)
- Chronic widespread pain (fibromyalgia) based on patient anamnesis/medical record.
- Acute infections based on patient anamnesis/medical record.
- Severe asthma based on patient anamnesis/medical record.
- Severe COPD based on patient anamnesis/medical record.
- Instable heart disease based on patient anamnesis/medical record.
- Intensive physiotherapy outside standard care based on patient anamnesis/medical record.
- Electrostimulation based on patient anamnesis/medical record.
- Motivation training based on patient anamnesis/medical record.
- Smoking based on patient anamnesis/medical record.
- Fever based on patient anamnesis/medical record.
- If pain/fatigue are considered a side effect judged by the treating physician.
- Other autoimmune diseases based on patient anamnesis/medical journal.
- Mental diseases based on patient anamnesis/medical record.
- All other non-pharmacological therapies that may impact the course of RA judged by the treating physician.
- Any comorbid condition, that in the opinion of the investigator would interfere with the conduction of the trial or the interpretation of the study outcome.
- Previous use of health apps related to the RA disease.
Where it is running
1 location listed.
- The Parker Institute, Bispebjerg and Frederiksberg Hospital - Frederiksberg, Copenhagen F, Denmark