Status:
UNKNOWN
Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Lead Sponsor:
Medical University of Lodz
Conditions:
Connective Tissue Disease-associated Interstitial Lung Disease
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
1. Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD 2. Evaluation of health status of patients with connective tissue disease-associated interstitial lung disease (CTD-ILD) u...
Detailed Description
Interstitial lung disease (ILD) is one of the most serious pulmonary complications related to connective tissue diseases (CTDs), resulting in substantial morbidity and mortality. Interstitial lung dis...
Eligibility Criteria
Inclusion
- Newly diagnosed interstitial lung disease with a small component of fibrous changes;
- Indications for systemic glucocorticoid therapy +/- immunosuppressant;
- 18 years and older
- Informed consent to participate in the study;
- Effective contraception;
- Result of the Mini Mental test ensuring the possibility of efficient operation of monitoring devices;
- Completed training in the operation of telemedicine equipment.
Exclusion
- Evidence of irreversible interstitial fibrotic changes in lung HRCT;
- Pattern of definite or probable usual interstitial pneumonia (UIP) in the HRCT examination;
- Contraindications to glucocorticoid and immunosuppressive therapy (azathioprine or mycophenolate mofetil or cyclophosphamide or cyclosporine);
- Pregnancy and breast-feeding.
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04428957
Start Date
February 11 2020
End Date
April 1 2022
Last Update
June 11 2020
Active Locations (1)
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1
Department of Pneumology and Allergy, Medical University of Lodz
Lodz, Lodz Province, Poland, 90-153