Interstitial Lung Disease Clinical Trial
Official title:
Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
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
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 disease is a common manifestation of different connective tissue diseases,
such as scleroderma, rheumatoid arthritis (RA), Sjögren's syndrome, systemic lupus,
dermatomyositis and others. Radiological and histopathological patterns are most often
nonspecific interstitial pneumonia (NSIP), organizing pneumonia (OP), usual interstitial
pneumonia (UIP) and lymphocytic interstitial pneumonia (LIP).
Current standard of care in progressive CTD associated ILD is low to medium dose of
corticosteroids, frequently combined with immunosuppressive medication, depending on disease
severity and local standards. However, based on clinical and radiological features, it is
difficult to predict what will be the response to the treatment. Effectiveness of the
treatment is assessed by functional tests and chest high resolution computed tomography
(HRCT), performed usually after 3 months of therapy.
Project objective is to assess the possible benefits of using telemonitoring of functional
and vital signs, symptoms and quality of life of patients with CTD-ILD in response to
treatment.
In the trial patients diagnosed with CTD-ILD will be randomized to intervention group
(telemonitoring) and the control group (traditional assessment). Patients from the study
after initial training will perform daily spirometry (FVC), transdermal pulse oximetry, pulse
and blood pressure measurements, activity measurement (accelerometry), and assessment of
severity of cough and dyspnea. The additional questionnaires will also be used to assess the
tolerability of treatment, quality of life and the occurrence of side effects. Telemonitoring
will start 10 to 14 days before the start of treatment and will be carried out for 3 months
of therapy. All patients (study and control group) will receive treatment in accordance with
current treatment standards. During the 3-month observation period, visits to the center will
take place at monthly intervals. In the case of treatment intolerance or deterioration of
monitored parameters, patients will be evaluated at additional time points. All patients
after the end of the 3-month follow-up will remain under the care of the Pulmonology Clinic
and will be examined during regular visits every 3 months until the end of the 12-month
follow-up period.
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