Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT01044927
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2010-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado
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': 'D019033', 'term': 'Delivery of Health Care, Integrated'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-03', 'studyFirstSubmitDate': '2010-01-06', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare utilization', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Quality of Life by St. Georges Respiratory Questionnaire', 'timeFrame': '3, 6 and 9 months'}, {'measure': 'Guideline-based medical therapy', 'timeFrame': '9 months'}, {'measure': 'Exercise capacity', 'timeFrame': '9 months'}, {'measure': 'Oxygen utilization and pre-and post-exercise oxygen saturations', 'timeFrame': '9 months'}, {'measure': 'Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index', 'timeFrame': '9 months'}, {'measure': 'Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)', 'timeFrame': '9 months'}, {'measure': 'Smoking status', 'timeFrame': '9 months'}, {'measure': 'Pulmonary rehabilitation', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease', 'telemedicine', 'COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United States, affects 24 million people and is responsible for up to $32 billion annually in direct and indirect health care costs. Based upon these national COPD prevalence data, we estimate that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the care of these patients costs up to $490 million annually. Therefore, to alter the impact of COPD on the State and People of Colorado, we propose to introduce a telephone-dependent, internet-supported, self-monitoring "eHealth" management system in both urban and rural Colorado settings in order to decrease healthcare utilization, improve the management of COPD based upon current national guidelines, improve quality of life, reduce health care costs decrease COPD exacerbations. We base this program on a successful clinical pilot study, performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated dramatic improvements in quality of life and decreased health care costs. We propose to enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the patients with the highest healthcare costs, the greatest disability, and the highest mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy of this proactive management strategy as it is disseminated throughout urban and rural Colorado. In this first phase we will target two Denver Metro sites, UCH and Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites because of their strong interest in enacting the eHealth Program, because of their organized systems of healthcare delivery and because of the numbers of COPD patients that they serve. We are particularly enthusiastic about the application of this technology to rural, underserved areas, because this approach has the potential to dramatically improve delivery of healthcare to a large portion of Colorado that is chronically plagued by inadequate health care networks and lack of specialty care. More broadly, we are enthusiastic about the prospect that eHealth programs may hold the potential to improve healthcare delivery for many chronic illnesses, in addition to COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD Diagnosis per GOLD Guidelines\n* Airflow obstruction on spirometry defined as an FEV1/FVC less than or equal to 70% and an FEV1 less than or equal to 50% predicted, or an FEV1 greater than 50% predicted with a history of a COPD exacerbation within the previous year.\n* Standard telephone access\n* US Citizen and Colorado resident\n\nExclusion Criteria:\n\n* Asthma\n* Co-existing conditions that are likely to cause death within two years, CXR evidence of interstitial lung disease or other pulmonary diagnoses at the time of enrollment, end-stage liver disease, end-stage renal disease, end-stage muscle disease, HIV disease or dementia.'}, 'identificationModule': {'nctId': 'NCT01044927', 'briefTitle': 'Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD', 'orgStudyIdInfo': {'id': '06-0587'}, 'secondaryIdInfos': [{'id': '07 FLA 00834', 'type': 'OTHER', 'domain': 'CDPHE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proactive Integrated Care', 'description': 'COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator', 'interventionNames': ['Other: Integrated Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Control', 'description': 'No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.', 'interventionNames': ['Other: Standard Therapy']}], 'interventions': [{'name': 'Integrated Care', 'type': 'OTHER', 'description': 'Comparison of the effect of COPD education, self-management instruction, home monitoring with a Health Buddy Telemonitor, pulse oximeter, pedometer and spirometer, and enhanced communication with a study coordinator (cell phone access)', 'armGroupLabels': ['Proactive Integrated Care']}, {'name': 'Standard Therapy', 'type': 'OTHER', 'description': 'No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.', 'armGroupLabels': ['Standard Care Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'William Vandivier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colorado Department of Public Health and Environment', 'class': 'OTHER_GOV'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}