Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-09 @ 6:01 AM
Study NCT ID:
NCT02909205
Status:
UNKNOWN
Last Update Posted:
2016-09-21
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from knowledge score', 'timeFrame': 'Between day 0 and day 5', 'description': 'The anonymised questionnaires are identified by a number assigned to the selected case; they include items about global knowledge about gastrostomy, its day to day use, possible complications, and surveillance.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['child', 'gastrostomy', 'supportive care', 'educational program'], 'conditions': ['Gastrostomy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to improve care practice related to gastrostomy management. This a before-after study, aimed at evaluating knowledge of care givers, families and patients about gastrostomy management. The intervention includes 1) A training in a care protocol for hospital care givers, and 2) A booklet for patients, families, and outpatient care givers. The evaluation criterion is a questionnaire to assess knowledge of hospital care givers, patients, families, and outpatient care givers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parents and hospital care givers of children undergoing gastrostomy who accept to participate.\n\nExclusion Criteria:\n\n* family unable to understand French language, caregiver who has previously answered to the study questionnaire'}, 'identificationModule': {'nctId': 'NCT02909205', 'acronym': 'Gastrostomy', 'briefTitle': 'a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Development and Evaluation of a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised', 'orgStudyIdInfo': {'id': 'D21537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control', 'description': 'First phase : before training / sensitization / booklet delivery', 'interventionNames': ['Other: sensitization / educational program']}, {'type': 'OTHER', 'label': 'post intervention', 'description': 'Second phase : after training / sensitization / booklet delivery', 'interventionNames': ['Other: training / sensitization program']}], 'interventions': [{'name': 'sensitization / educational program', 'type': 'OTHER', 'description': 'the intervention program was built based on the results of the pre-intervention phase survey, about the knowledge of caregivers and parents of children with gastrostomy about gastrostomy management. It consists in booklets for caregivers and parents of children. This booklet is the support of a specific training of carers and parents of children who have recently benefitted from a gastrostomy', 'armGroupLabels': ['control']}, {'name': 'training / sensitization program', 'type': 'OTHER', 'description': 'diffusion of gastrostomy in-hospital care protocols, and booklets for families. These tools have been prepared by a pilot group of professional of the investigating centers.', 'armGroupLabels': ['post intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric VALLA', 'role': 'CONTACT'}], 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Frédéric VALLA', 'role': 'CONTACT', 'email': 'Frederic.valla@chu-lyon.fr', 'phone': '4 72 12 97 37', 'phoneExt': '+33'}, {'name': 'Behrouz Kassaï', 'role': 'CONTACT', 'email': 'behrouz.kassai-koupai@chu-lyon.fr', 'phone': '472 357 231', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Frédéric VALLA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}