NCT06337786 Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical RCT Set-up in Patients With Rheumatoid Arthritis
| NCT ID | NCT06337786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henning Bliddal |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-03-31 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: An individual must meet all of the following criteria to be enrolled in the study: 1. Diagnosed with RA according to the EULAR \& American College of Rheumatology 2. PGA level \>= 40mm 3. Age ≥ 18 years and \< 65 years 4. Motivated for the intervention 5. Willing and able to understand and participate in the study 6. DAS28-CRP ≤ 3.2. 7. 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: 1. Dementia or other linguistic/cognitive/physical deficiency that prevents participation 2. Vision impairment that prevents the use of the devices and computer 3. Change in DMARD (within 8 weeks) 4. Chronic widespread pain (fibromyalgia) based on patient anamnesis/medical record. 5. Acute infections based on patient anamnesis/medical record. 6. Severe asthma based on patient anamnesis/medical record. 7. Severe COPD based on patient anamnesis/medical record. 8. Instable heart disease based on patient anamnesis/medical record. 9. Intensive physiotherapy outside standard care based on patient anamnesis/medical record. 10. Electrostimulation based on patient anamnesis/medical record. 11. Motivation training based on patient anamnesis/medical record. 12. Smoking based on patient anamnesis/medical record. 13. Fever based on patient anamnesis/medical record. 14. If pain/fatigue are considered a side effect judged by the treating physician. 15. Other autoimmune diseases based on patient anamnesis/medical journal. 16. Mental diseases based on patient anamnesis/medical record. 17. All other non-pharmacological therapies that may impact the course of RA judged by the treating physician. 18. 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. 19. Previous use of health apps related to the RA disease.
Contact & Investigator
Henning Bliddal
PRINCIPAL INVESTIGATOR
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Frequently Asked Questions
Who can join the NCT06337786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06337786 currently recruiting?
Yes, NCT06337786 is actively recruiting participants. Contact the research team at tanja.schjoedt.joergensen@regionh.dk for enrollment information.
Where is the NCT06337786 trial being conducted?
This trial is being conducted at Frederiksberg, Denmark.
Who is sponsoring the NCT06337786 clinical trial?
NCT06337786 is sponsored by Henning Bliddal. The principal investigator is Henning Bliddal at The Parker Institute, Bispebjerg and Frederiksberg Hospital. The trial plans to enroll 70 participants.
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