Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT04991558
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Handicap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who followed the entirety of INFRA circuit', 'timeFrame': 'At discharge, assessed up to 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Type of pain evaluation scale selected by the INFRA nurse', 'timeFrame': 'enrollment'}, {'measure': 'Number of healthcare adaptations implemented during hospitalization', 'timeFrame': 'At discharge, assessed up to 4 weeks'}, {'measure': 'Satisfaction of patients and caregivers', 'timeFrame': 'At discharge, assessed up to 4 weeks', 'description': 'Satisfaction survey answered by patients and caregivers'}, {'measure': 'Satisfaction of healthcare staff', 'timeFrame': 'At discharge, assessed up to 4 weeks', 'description': 'Satisfaction survey answered by healthcare staff'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disabilities Physical', 'Disabilities Mental']}, 'descriptionModule': {'briefSummary': 'France currently has more than 10 million disabled people, including 3 millions who could be better treated. In fact, people with disabilities face many obstacles in accessing care and receiving appropriate support (physical access to certain locations, communication...). Difficulties are also encountered by the healthcare staff, leading to often heterogeneous practices in health establishments.\n\nThe INFRA health circuit has been set up at the "Groupe Hospitalier Mutualiste de Grenoble" since June 2018 according to the guidelines published by the French High Authority for Health (HAS) on improving professional practices "Reception, support and organization of care in health establishments for people in situation of handicap "of July 2017. The INFRA nurse collects and anticipates the necessary adaptations for the patient\'s stay, in conjunction with their caregivers (whether family or institutional). They are an interface with other healthcare professionals to adapt care procedures and protocols (body care, feeding methods, pain management, drug management) to the patient\'s disability. Before hospitalization and until the patient is discharged, the INFRA nurse transmits to the personnel involved all the information necessary for the proper continuation of care. In addition to legal and regulatory obligations, the INFRA nurse ensures the effective accessibility of the establishment\'s facilities and premises, and helps maintaining patient autonomy.\n\nThe INFRA study is an observational study aimed at assessing the feasibility of the INFRA health circuit and evaluating the benefit for the patients and the healthcare staff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with physical or mental disability, planned for surgical procedure and requiring an adaptation of their healthcare circuit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 13 years old or more\n* Physical or mental disability, according to french law n°2005-102 of February 11th, 2005\n* Requiring an adaptation of the healthcare circuit\n* Indication of a planned surgical procedure\n\nExclusion Criteria:\n\n* Outpatient\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT04991558', 'acronym': 'INFRA', 'briefTitle': 'Feasibility and Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Handicap', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Mutualiste de Grenoble'}, 'officialTitle': 'Prospective, Single-center Observational Study to Assess the Feasibility and Evaluate the Effectiveness of a Coordinated Healthcare Circuit Dedicated to Patients With Mental and Physical Disabilities Undergoing Planned Surgery', 'orgStudyIdInfo': {'id': '2019/09-ERA-GHMG'}}, 'contactsLocationsModule': {'locations': [{'zip': '38028', 'city': 'Grenoble', 'country': 'France', 'facility': 'Groupe Hospitalier Mutualiste de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Mutualiste de Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}