BridgeMD
New treatment option for Rheumatoid Arthritis
Official title Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical RCT Set-up in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06337786
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Frederiksberg, Copenhagen F, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frederiksberg, Copenhagen F, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.