UnknownNot Applicable

Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)

Poland60 participantsStarted 2020-02-11

Plain-language 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) using telemonitoring and standard care. 3. Assessment of treatment response patterns (full remission, partial remission, progression, no response) and evaluation of clinical prognostic factors (risk factors for poor response in patients with CTD-ILD. 4. Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD. 5. Evaluation of telemedicine as a tool for assessing the safety of therapy

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months

Timeframe: at baseline, after 3 months

Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months

Timeframe: at baseline, after 3 months

Trial details

NCT IDNCT04428957

SponsorMedical University of Lodz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04

Contact for this trial

Sylwia Małysiak-Szpond, MSc

+48519515038 sylwia.malysiak-szpond@stud.umed.lodz.pl