Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 7:17 AM
Study NCT ID:
NCT01863992
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2013-05-23', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Quality of Life and Direct Financial Costs Associated With Home Ventilation', 'timeFrame': 'One year starting june 2013', 'description': 'The out-of-pocket expenses caused by caring for a child with home ventilation will be assessed using a validated questionnaire called the Ambulatory and Home Care Record (AHCR).'}], 'primaryOutcomes': [{'measure': 'The Quality of Life and Direct Financial Costs Associated With Home Ventilation', 'timeFrame': 'One year starting june 2013.', 'description': 'Quality of life for children on home ventilation will be assessed using the validated PedsQL score. This has been specifically designed to measure quality outcome in children with long term health problems.'}], 'secondaryOutcomes': [{'measure': 'The Quality of Life a Direct Financial Costs Associated With Home Ventilation', 'timeFrame': 'One year starting june 2013', 'description': 'The quality of life for parents caring for a child needing home ventilation will be assessed using a validated questionnaire called the Caregiving Impact Scale (CIS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['home ventilation'], 'conditions': ['Children Receiving Ventilation at Home for Chronic Illness or Disease']}, 'referencesModule': {'references': [{'pmid': '26940814', 'type': 'DERIVED', 'citation': 'Seear M, Kapur A, Wensley D, Morrison K, Behroozi A. The quality of life of home-ventilated children and their primary caregivers plus the associated social and economic burdens: a prospective study. Arch Dis Child. 2016 Jul;101(7):620-7. doi: 10.1136/archdischild-2015-309796. Epub 2016 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'The investigators wish to learn about the quality of life (QOL) of children needing long term home ventilation and also that of their regular caregivers. In addition, the investigators will monitor the extra health-related expenses these families must meet. Data will be collected using two age-specific questionnaires of QOL plus a third one validated for assessing chronic health care costs. Questionnaires will be administered at an initial face to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses, one and two months later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children receiving home ventilation for chronic illness or disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment\n\nExclusion Criteria:\n\nRefusal to join the study'}, 'identificationModule': {'nctId': 'NCT01863992', 'briefTitle': 'The Quality of Life and Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Quality of Life a Direct Financial Costs Associated With Home Ventilation of Children: A Prospective Study', 'orgStudyIdInfo': {'id': 'H13-00979'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC's Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Mike Seear, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "British Columbia's Children's Hospital"}, {'name': 'Mike Seear, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BCCH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Michael Seear', 'investigatorAffiliation': 'University of British Columbia'}}}}