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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months', 'timeFrame': 'at baseline, after 3 months', 'description': 'The EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L) questionnaire will be used for the assessment of quality of life. The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L is especially suited to cost effectiveness analyses.'}, {'measure': "Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months", 'timeFrame': 'at baseline, after 3 months', 'description': "St. George's Respiratory Questionnaire (SGRQ) will be used to assess health related quality-of-life. The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. SGRQ is survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life."}], 'secondaryOutcomes': [{'measure': 'Costs of health service utilization in Polish zloty', 'timeFrame': 'after 3 months, after 6 months', 'description': 'Mean costs in telemonitoring and control group will be estimated. Healthcare utilization will be assessed through the number of emergency department, hospital or outpatient clinic visits, medications and adverse events treatments. Resource use categories will be monetarily valued using unit cost and multiplied with the collected amount of resource use. Mean costs in Polish zloty per group will be calculated.'}, {'measure': 'Assessment of Dyspnea using Modified Medical Research Council (mMRC)', 'timeFrame': 'at baseline, after 3 months', 'description': "The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine functional impairment due to dyspnea. It is a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance."}, {'measure': 'Assessment of fatigue using Fatigue Assessment Scale (FAS)', 'timeFrame': 'at baseline, after 3 months', 'description': 'Fatigue Assessment Scale (FAS) will be used for assessment of fatigue status. The total score ranges from 10 to 50. A total FAS score \\< 22 indicates no fatigue, a score ≥ 22 indicates fatigue.'}, {'measure': "Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)", 'timeFrame': 'at baseline, after 3 months', 'description': 'The Adherence Scale in Chronic Diseases is a self-reported questionnaire with 8 items and with proposed 5 sets of answers. The total score in the Adherence Scale in Chronic Diseases ranges from 0 to 32 points. Three levels of adherence were considered (low: scores of 0 to 20; medium 21 to 25; high \\> 26).'}, {'measure': 'Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)', 'timeFrame': 'at baseline, after 3 months', 'description': 'The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.'}, {'measure': 'Change from baseline depression as measured by PHQ-9', 'timeFrame': 'at baseline, after 3 months', 'description': 'The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.'}, {'measure': 'For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent', 'timeFrame': 'twice a day day from baseline for 3 months', 'description': 'Oxygen saturation level (SpO2) will be measured by transdermal Pulse Oximeter.'}, {'measure': 'For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)', 'timeFrame': 'twice a day day from baseline for 3 months', 'description': 'Heart rate home telemonitoring consisted of twice-daily patient self-measurement of heart rate with automated device.'}, {'measure': 'For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg', 'timeFrame': 'twice a day day from baseline for 3 months', 'description': 'Systolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer'}, {'measure': 'For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg', 'timeFrame': 'twice a day day from baseline for 3 months', 'description': 'Diastolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer'}, {'measure': 'For the telemonitoring arm, forced vital capacity (FVC) expressed in percent', 'timeFrame': 'twice a day day from baseline for 3 months', 'description': 'Lung function like forced vital capacity (FVC, %FVC) will be assessed using home spirometry.'}, {'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', 'description': 'Lung function like forced expiratory volume in 1 second (FEV1, ％FEV1) will be assessed using home spirometry.'}, {'measure': "For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.", 'timeFrame': 'after 3 months', 'description': "Developed telemonitoring satisfaction survey will be used for the assessment of patient's satisfaction in 10 areas assessed using the 5-point Likert scale."}, {'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', 'description': 'A 5-point Likert scale will be used to measure cough severity'}, {'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', 'description': 'A 5-point Likert scale will be used to measure dyspnea severity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemonitoring', 'Telemedicine', 'Interstitial lung disease', 'Connective Tissue Diseases', 'Treatment'], 'conditions': ['Connective Tissue Disease-associated Interstitial Lung Disease', 'Interstitial Lung Disease', 'Connective Tissue Diseases']}, 'referencesModule': {'references': [{'pmid': '36574413', 'type': 'DERIVED', 'citation': 'Malysiak-Szpond S, Mozga M, Miadlikowska E, Milkowska-Dymanowska J, Bialas AJ, Piotrowski WJ. Study protocol for connective tissue disease-associated interstitial lung disease trial (TEL-CTD-ILD): A randomized controlled trial of a home-based telemonitoring of treatment effects. PLoS One. 2022 Dec 27;17(12):e0278601. doi: 10.1371/journal.pone.0278601. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': '1. Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD\n2. Evaluation of health status of patients with connective tissue disease-associated interstitial lung disease (CTD-ILD) using telemonitoring and standard care.\n3. 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.\n4. Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.\n5. Evaluation of telemedicine as a tool for assessing the safety of therapy', 'detailedDescription': "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).\n\nCurrent 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.\n\nProject 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed interstitial lung disease with a small component of fibrous changes;\n* Indications for systemic glucocorticoid therapy +/- immunosuppressant;\n* 18 years and older\n* Informed consent to participate in the study;\n* Effective contraception;\n* Result of the Mini Mental test ensuring the possibility of efficient operation of monitoring devices;\n* Completed training in the operation of telemedicine equipment.\n\nExclusion Criteria:\n\n* Evidence of irreversible interstitial fibrotic changes in lung HRCT;\n* Pattern of definite or probable usual interstitial pneumonia (UIP) in the HRCT examination;\n* Contraindications to glucocorticoid and immunosuppressive therapy (azathioprine or mycophenolate mofetil or cyclophosphamide or cyclosporine);\n* Pregnancy and breast-feeding.'}, 'identificationModule': {'nctId': 'NCT04428957', 'acronym': 'TEL-CTD-ILD', 'briefTitle': 'Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)', 'orgStudyIdInfo': {'id': 'RNN/50/20/KE'}, 'secondaryIdInfos': [{'id': '0047/DW/2018', 'type': 'OTHER_GRANT', 'domain': 'Polish Ministry of Science and Higher Education'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemonitoring group', 'description': '3 months home-based telemonitoring', 'interventionNames': ['Other: Telemonitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '3 months standard care'}], 'interventions': [{'name': 'Telemonitoring', 'type': 'OTHER', 'description': 'Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea', 'armGroupLabels': ['Telemonitoring group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90-153', 'city': 'Lodz', 'state': 'Lodz Province', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maria Mozga, MD', 'role': 'CONTACT', 'email': 'maria.mozga@umed.lodz.pl'}, {'name': 'Wojciech Piotrowski, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joanna Miłkowska-Dymanowska, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Pneumology and Allergy, Medical University of Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'centralContacts': [{'name': 'Sylwia Małysiak-Szpond, MSc', 'role': 'CONTACT', 'email': 'sylwia.malysiak-szpond@stud.umed.lodz.pl', 'phone': '+48519515038'}], 'overallOfficials': [{'name': 'Wojciech Piotrowski, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pneumology and Allergy, Medical University of Lodz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}