Clinical trial NCT04428957: Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Official title: Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Connective Tissue Disease-associated Interstitial Lung Disease
Interstitial Lung Disease
Connective Tissue Diseases
Keywords: Telemonitoring
Telemedicine
Interstitial lung disease
Connective Tissue Diseases
Treatment
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months
timeFrame: at baseline, after 3 months
measure: Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months
timeFrame: at baseline, after 3 months
Secondary outcomes:
measure: Costs of health service utilization in Polish zloty
timeFrame: after 3 months, after 6 months
measure: Assessment of Dyspnea using Modified Medical Research Council (mMRC)
timeFrame: at baseline, after 3 months
measure: Assessment of fatigue using Fatigue Assessment Scale (FAS)
timeFrame: at baseline, after 3 months
measure: Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)
timeFrame: at baseline, after 3 months
measure: Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)
timeFrame: at baseline, after 3 months
measure: Change from baseline depression as measured by PHQ-9
timeFrame: at baseline, after 3 months
measure: For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, forced vital capacity (FVC) expressed in percent
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, forced expiratory volume in 1st second (FEV1) expressed in percent
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.
timeFrame: after 3 months
measure: For the telemonitoring arm, cough severity measured using 5-point Likert scale (range 0-4)
timeFrame: twice a day day from baseline for 3 months
measure: For the telemonitoring arm, dyspnea severity measured using a 5-point Likert scale (range 0-4)
timeFrame: twice a day day from baseline for 3 months
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Department of Pneumology and Allergy, Medical University of Lodz
state: Lodz Province
Study officials:
affiliation: Department of Pneumology and Allergy, Medical University of Lodz
name: Wojciech Piotrowski, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: