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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04428957
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Lodz
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Wojciech Piotrowski, Assoc. Prof.
Principal Investigator Affiliation	Department of Pneumology and Allergy, Medical University of Lodz
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Connective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue Diseases

Additional Details

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.

Arms & Interventions

Arms

Experimental: Telemonitoring group

3 months home-based telemonitoring

No Intervention: Control group

3 months standard care

Interventions

Other: - Telemonitoring

Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea

Contact a Trial Team

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