NCT06337786Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 14 Mar 2024
- Start date
- 31 Mar 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Henning Bliddal
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06337786
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 31 Mar 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- All other non-pharmacological therapies that may impact the course of RA judged by the treating physician.
- Previous use of health apps related to the RA disease.
Other illness
- Dementia or other linguistic/cognitive/physical deficiency that prevents participation
- Vision impairment that prevents the use of the devices and computer
- Acute infections based on patient anamnesis/medical record.
- Instable heart disease based on patient anamnesis/medical record.
- Other autoimmune diseases based on patient anamnesis/medical journal.
- Mental diseases based on patient anamnesis/medical record.
- 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.
Other
- An individual will be excluded from the study if she meets any of the following criteria:
- Change in DMARD (within 8 weeks)
- Chronic widespread pain (fibromyalgia) based on patient anamnesis/medical record.
- Severe asthma based on patient anamnesis/medical record.
- Severe COPD 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Parker Institute, Bispebjerg and Frederiksberg Hospital Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.