Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-30 @ 2:39 PM
Study NCT ID:
NCT04492761
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Impact of Polyhandicap: a Mixed Methodological Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualite of life', 'timeFrame': '5 years', 'description': 'WHOQOL-Bref'}], 'secondaryOutcomes': [{'measure': 'interview content', 'timeFrame': '2 hours', 'description': 'semi-structured interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polyhandicap']}, 'descriptionModule': {'briefSummary': 'Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- family member (parent, siblings, uncle / aunt) of a person with a severe multiple disability whose age is between 8 and 35 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35 years old\n* Patients: with severe polyhandicap defined by the combination of motor deficiency and intellectual impairment associated with everyday life dependence, restricted mobility and age at onset of cerebral lesion below 3 years old\n* Written consent signed by caregivers for participation\n\nExclusion Criteria:\n\n* caregivers refusing to participate'}, 'identificationModule': {'nctId': 'NCT04492761', 'acronym': 'PolyMiMe', 'briefTitle': 'Family Impact of Polyhandicap: a Mixed Methodological Approach', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Family Impact of Polyhandicap: Mixed Methodological Approach', 'orgStudyIdInfo': {'id': '2019-53'}}, 'armsInterventionsModule': {'interventions': [{'name': 'qualitative study', 'type': 'BEHAVIORAL', 'description': 'The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine BAUMSTARCK', 'role': 'CONTACT', 'email': 'karine.baumstarck@univ-amu.fr', 'phone': '04 91 32 44 59'}], 'facility': 'Assistance Publique Hôpiatuix de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Karine Baumstarck', 'role': 'CONTACT', 'email': 'karine.baumstarck@univ-amu.fr', 'phone': '04 91 32 44 59'}], 'overallOfficials': [{'name': 'Jean Olivier ARNAUD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitauix de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}