Effects of the Rheumabuddy4.1 app on patients with rheumatoid arthritis

A Randomized Controlled Clinical Trial Investigating the Effects of the Digital App Rheumabuddy4.1 in Patients With Rheumatoid Arthritis

This study tests if the Rheumabuddy4.1 app can help people with rheumatoid arthritis better understand their condition and stick to their treatment plans to improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Frederiksberg University Hospital (Academic / other)
• Locations: 1 site (Frederiksberg, Copenhagen F)
• Trial ID: NCT06337786 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of the digital app Rheumabuddy4.1 on patients diagnosed with rheumatoid arthritis (RA). The study aims to empower patients by enhancing their understanding of the disease and improving treatment adherence through the use of electronically reported outcomes. By integrating this digital health technology into standard care, the trial seeks to provide timely support that can lead to better quality of life for RA patients. The trial will assess the app's effectiveness in bridging the gap between healthcare professionals and patients regarding disease management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with rheumatoid arthritis and are motivated to use the Rheumabuddy4.1 app.

Not a fit: Patients with cognitive impairments, severe respiratory or heart conditions, or those unable to use the app due to physical limitations may not benefit from this study.

Why it matters

Potential benefit: If successful, this app could significantly improve the quality of life for patients with rheumatoid arthritis by enhancing their self-management and treatment adherence.

How similar studies have performed: Other studies have shown promise in using digital health technologies for chronic disease management, indicating potential success for this approach.

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.

Where this trial is running

Frederiksberg, Copenhagen F

• The Parker Institute, Bispebjerg and Frederiksberg Hospital — Frederiksberg, Copenhagen F, Denmark (Recruiting)

Study contacts

• Principal investigator: Henning Bliddal — The Parker Institute, Bispebjerg and Frederiksberg Hospital
• Study coordinator: Tanja Schjødt Jørgensen

Conditions Rheumatoid Arthritis; Patient Perspectives; Digital app; Quality of life; Empowerment; Socioeconomic burden