Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 1:40 PM
Study NCT ID:
NCT01522859
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2012-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Monitoring 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-27', 'studyFirstSubmitDate': '2012-01-24', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in St Georges's Respiratory Questionnaire at six months", 'timeFrame': 'Baseline and six months', 'description': 'Self completed questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in EuroQol at six months', 'timeFrame': 'Baseline and six months', 'description': 'self completed questionnaire'}, {'measure': 'Change from baseline in Hospital Anxiety and Depression Scale at six months', 'timeFrame': 'Baseline and six months', 'description': 'self administered questionnaire'}, {'measure': 'healthcare utilisation', 'timeFrame': 'six months', 'description': 'data collected retrospectively from healthcare notes and hospital coding'}, {'measure': 'number of exacerbations', 'timeFrame': 'six months', 'description': 'data collected retrospectively from healthcare notes'}, {'measure': 'satisfaction', 'timeFrame': 'six months', 'description': 'interview administered questionnaire'}, {'measure': 'cost effectiveness', 'timeFrame': 'six months', 'description': 'QALY analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Telehealth', 'health related quality of life'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The the aim of this study is to determine the benefits of Telehealth monitoring in the management of patients with chronic obstructive pulmonary disease.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is a major burden on healthcare systems worldwide. The current management of patients with COPD includes well established interventions such as pulmonary rehabilitation and inhaled therapies which have demonstrated variable impact on reducing rates of exacerbation and improving health related quality of life.\n\nTelehealth is a home monitoring system used to record clinical observations and carry out question and answer sessions. It has been proposed that Telehealth medicine may offer an alternative strategy to the overall management of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)\n* a minimum of two: Emergency Department admissions; hospital admissions or emergency GP contacts in the 12 months previous to the study\n\nExclusion Criteria:\n\n* any respiratory disorder other than COPD\n* patients cognitively unable to learn the process of monitoring'}, 'identificationModule': {'nctId': 'NCT01522859', 'briefTitle': 'Telehealth Monitoring in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'South Eastern Health and Social Care Trust'}, 'officialTitle': 'The Efficacy of Telehealth Monitoring in the Management of Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '09/NIR01/26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'A standardised home based programme of specialist respiratory assessment and monitoring provided by the local Community Respiratory Team (CRT) and General Practitioner (GP) for a period of six months.'}, {'type': 'EXPERIMENTAL', 'label': 'Telehealth monitoring', 'description': "Daily monitoring of patient's health status using a small telecommunications device.", 'interventionNames': ['Device: Telehealth monitoring system (Honni Med)']}], 'interventions': [{'name': 'Telehealth monitoring system (Honni Med)', 'type': 'DEVICE', 'otherNames': ['Honni Med'], 'description': "The system is uploaded with personal information including: monitoring start time; clinical observations (blood pressure, heart rate, oxygen saturations); and questions relating to symptoms. The patient is instructed on use and observed monitoring. The patient is monitored daily for a period of six months. The monitoring session lasts approximately 10 minutes during which the patient attaches a finger probe and blood pressure cuff and responds 'yes' or 'no' to the set questions. Daily data is transmitted via a phone line to a secure server to be downloaded and reviewed by a Telehealth nurse.If one or more of the clinical observations is outside normal limits the appropriate healthcare intervention is utilised.", 'armGroupLabels': ['Telehealth monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT28 1JP', 'city': 'Lisburn', 'state': 'Co Antrim', 'country': 'United Kingdom', 'facility': 'South Eastern Health and Social Care Trust', 'geoPoint': {'lat': 54.52337, 'lon': -6.03527}}], 'overallOfficials': [{'name': 'Janet E McDowell, BScHons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Eastern Health and Social Care Trust'}, {'name': 'Stephen Tate, BSc,MD,FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'South Eastern Health and Social Care Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Eastern Health and Social Care Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'JE McDowell', 'investigatorAffiliation': 'South Eastern Health and Social Care Trust'}}}}