Actively Recruiting
Home Monitoring Versus Usual Care for Lung Function in Rheumatic Disease-associated Interstitial Lung Disease A 54-Week Multi-Centre Randomised Controlled Trial
Led by Oslo University Hospital · Updated on 2024-12-19
218
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
C
Carol Davila University of Medicine and Pharmacy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a home monitoring approach to improve care for adults with interstitial lung disease related to systemic rheumatic diseases. This 54-week, multi-center randomized controlled trial compares home monitoring using bi-weekly lung function and patient-reported outcome measurements against the usual care of fixed-interval hospital visits. The trial aims to see if home monitoring can detect disease progression earlier than standard hospital visits. Participants are assigned to one of two groups: one group receives usual care with scheduled hospital visits every six months, while the other group uses a home monitoring strategy that involves remote collection of lung function data, patient-reported outcomes, blood oxygen levels during a sit-to-stand test, and temperature measurements twice weekly. The home monitoring system includes an algorithm to evaluate risks of deterioration or infection, allowing for event-driven management. Throughout the study, participants complete questionnaires and perform lung function tests at home or during hospital visits. Researchers will assess outcomes such as early detection of disease progression, changes in lung function, respiratory symptoms, and events related to pulmonary fibrosis. The study includes safety monitoring and requires participants to have internet access and be able to use electronic devices. The total participation duration is 54 weeks.
CONDITIONS
Brief Title
Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with systemic rheumatic diseases such as systemic sclerosis, rheumatoid arthritis, inflammatory myopathies, mixed connective tissue disease, or Sjogren's disease
- Diagnosed interstitial lung disease confirmed by high resolution computed tomography at least 1 year before enrollment
- On stable standard treatment for at least 6 months prior to enrollment
- Ability to understand and follow study procedures including completing patient-reported outcome questionnaires
- Access to the internet and experience using smartphones or other internet-enabled devices
- Signed informed consent form
You will not qualify if you...
- Severe heart failure with ejection fraction below 30%
- Chronic kidney failure stage 4 or higher with filtration rate below 30 mL/min
- End-stage lung disease with forced vital capacity below 50% or diffusion capacity below 40%, or severe other lung diseases
- Airway obstruction with pre-bronchodilator FEV1/FVC ratio below 0.7
- Other significant pulmonary abnormalities as judged by investigators
- Significant pulmonary hypertension requiring specific therapies or showing right heart failure
- Active or non-curable cancer
- Contraindications to spirometry per guidelines
- Ongoing use of Prednisolone 20 mg/day or more at enrollment
- Inability to communicate in Norwegian, German, or Romanian
- Inability to perform good quality lung function tests on the home device after training
- Pregnancy or planned pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 54 weeks
Participants are monitored either through scheduled hospital visits every 6 months or by home monitoring with bi-weekly remote patient data collection including lung function tests and symptoms.
Hospital visits every 6 months or twice-weekly home monitoring
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0873
Actively Recruiting
Research Team
E
Emily V Langballe, MD
P
Peter M Andel, MD, Dr.med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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