Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT01512992
Status:
UNKNOWN
Last Update Posted:
2013-09-05
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of hospital readmissions', 'timeFrame': '3 months period'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life of the patients as measured by the SF-36 v2 questionnaire', 'timeFrame': '3 months - at baseline and study end'}, {'measure': 'Hospital anxiety and depression scale HADS', 'timeFrame': '3 months - at baseline and study end'}, {'measure': 'Lung condition as measured by FEV1', 'timeFrame': '3 months - at baseline and study end'}, {'measure': 'Condition-related health status measured by COPD Assessment Test (CAT)', 'timeFrame': '3 months - at baseline and study end'}, {'measure': 'Mortality', 'timeFrame': '3 months period'}, {'measure': "Patients' Acceptance-Satisfaction measured by the WSD Questionnaire", 'timeFrame': 'at the 3rd month of the telehealth intervention'}, {'measure': 'Time in days to first readmission', 'timeFrame': '3 months period'}, {'measure': 'Length of stay in days for each readmission', 'timeFrame': '3 months period'}, {'measure': 'Number of emergency room visits', 'timeFrame': 'at the 3rd month (end of trial)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '16611656', 'type': 'BACKGROUND', 'citation': 'Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.'}, {'pmid': '16620167', 'type': 'BACKGROUND', 'citation': 'Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.'}, {'pmid': '20197355', 'type': 'BACKGROUND', 'citation': 'Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. In addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exacerbation of COPD\n* Age \\> 40 years\n* Capability to use the devices provided\n* Willing to participate\n\nExclusion Criteria:\n\n• Participation in a previous COPD home telehealth study'}, 'identificationModule': {'nctId': 'NCT01512992', 'briefTitle': 'Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Catalan Agency for Health Information, Assessment and Quality'}, 'officialTitle': 'Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients', 'orgStudyIdInfo': {'id': 'RH_pilotCAT'}, 'secondaryIdInfos': [{'id': 'EC Grant Agreement 250487', 'type': 'OTHER_GRANT', 'domain': 'European Comission, Information Society and Media DG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home telehealth', 'interventionNames': ['Procedure: Home telehealth']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care'}], 'interventions': [{'name': 'Home telehealth', 'type': 'PROCEDURE', 'description': 'Patients receive tailored intervention according to their clinical complexity.\n\nAll patients in the intervention group receive:\n\n* Personalised care plan\n* Education on self-management\n* Access to a personalized online health folder\n* Access to Call center\n* Access to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed).\n\nPatients with LOW complexity additionally receive:\n\n* Daily videoconferences for the 1st week after discharge\n* Remote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists.\n\nPatients with HIGH complexity additionally receive:\n\n* Videoconferences for at least 1 month after discharge, scheduled on an individual basis.\n* Remote monitoring for respiratory parameters.\n* One monthly phone call from the call centre to promote and assess patient self-management.', 'armGroupLabels': ['Home telehealth']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Capio Hospital Universitari Sagrat Cor', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Plató', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Mataró', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'city': 'Sabadell', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Terrassa', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Josep Roca Torrent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Department - Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalan Agency for Health Information, Assessment and Quality', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fundació TicSalut', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Hospital de Mataró', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}