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

Medical University of Lodz

Status: Unknown

Conditions: Connective Tissue Diseases; Interstitial Lung Disease; Connective Tissue Disease-associated Interstitial Lung Disease

Treatments: Other: Telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04428957

RNN/50/20/KE

0047/DW/2018 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Telemonitoring group

Experimental group

Description:

3 months home-based telemonitoring

Treatment:

Other: Telemonitoring

Control group

No Intervention group

Description:

3 months standard care