Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
Study NCT ID:
NCT04428957
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2020-04-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Sponsor:
Medical University of Lodz
Organization:
Study Overview
Official Title:
Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEL-CTD-ILD
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) 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
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
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 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 0047/DW/2018 | OTHER_GRANT | Polish Ministry of Science and Higher Education | View |