Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02901535
Status:
UNKNOWN
Last Update Posted:
2017-01-18
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-spirometry in Primary Care-Randomized Clinical Trial Cluster:Telemedicine in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019114', 'term': 'Remote Consultation'}], 'ancestors': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': '20 a 22 weeks', 'description': 'Modified Medical Research Council Dyspnea Scale (difference in mMRC)'}], 'secondaryOutcomes': [{'measure': 'Spirometry - FEV1', 'timeFrame': '20 a 22 weeks', 'description': 'spirometry parameters - FEV 1 (forced expiratory volume in one second)'}, {'measure': 'Spirometry - FVC', 'timeFrame': '20 a 22 weeks', 'description': 'spirometry parameters - FVC (forced vital capacity)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['telemedicine', 'chronic obstructive pulmonary disease', 'Primary Health care', 'spirometry'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.', 'detailedDescription': 'This study is a randomized clinical trial for patients with chronic obstructive pulmonary disease from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of chronic obstructive pulmonary disease symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea \\> 0\n\nExclusion Criteria:\n\n* normal or restrictive spirometry, low quality spirometries (inadequate)'}, 'identificationModule': {'nctId': 'NCT02901535', 'acronym': 'RESPIRANET-C', 'briefTitle': 'Tele-spirometry in Primary Care-Randomized Clinical Trial Cluster:Telemedicine in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Tele-spirometry in Primary Care - Randomized Clinical Trial Cluster: the Effectiveness of Multifaceted Intervention in Symptoms Patients With Respiratory Illness', 'orgStudyIdInfo': {'id': '227190 COPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Spirometry in baseline Spirometry - 20 weeks', 'interventionNames': ['Other: Spirometry', 'Other: Spirometry - 20 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Spirometry in baseline Teleconsultation Telemonitoring Spirometry - 20 weeks', 'interventionNames': ['Other: Spirometry', 'Other: telemonitoring', 'Other: teleconsultation', 'Other: Spirometry - 20 weeks']}], 'interventions': [{'name': 'Spirometry', 'type': 'OTHER', 'description': 'Spirometry in baseline', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'telemonitoring', 'type': 'OTHER', 'description': 'telemonitoring (phone call nurse - 45 and 90 days)', 'armGroupLabels': ['Intervention']}, {'name': 'teleconsultation', 'type': 'OTHER', 'description': 'teleconsultation (general practioner received phone call to respiratory care)', 'armGroupLabels': ['Intervention']}, {'name': 'Spirometry - 20 weeks', 'type': 'OTHER', 'description': 'Spirometry (20 weeks)', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90670000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cynthia G Molina-Bastos, MD', 'role': 'CONTACT', 'email': 'cyncarol@gmail.com', 'phone': '5191322585', 'phoneExt': '+55'}, {'name': 'Marcelo R. Gonçalves, PhD', 'role': 'CONTACT', 'email': 'marcelorog@gmail.com', 'phone': '5191175156', 'phoneExt': '+55'}, {'name': 'Maria Angela F Moreira, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dimitris V Rados, Msc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'TelessaudeRS-Universidade Federal do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Marcelo R. Gonçalves, PhD', 'role': 'CONTACT', 'email': 'marcelorog@gmail.com', 'phone': '5191175156', 'phoneExt': '+55'}, {'name': 'Cynthia G Molina-Bastos, MD', 'role': 'CONTACT', 'email': 'cyncarol@gmail.com', 'phone': '5191322585', 'phoneExt': '+55'}], 'overallOfficials': [{'name': 'Erno Harzheim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}