Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
Study NCT ID:
NCT03976661
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of life quality according Nottingham Health Profile (NHP) scale', 'timeFrame': '12 months', 'description': 'Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD).'}], 'secondaryOutcomes': [{'measure': 'Assessment of the level of loss of autonomy of an elderly people according Autonomy, gerontology Iso Resources Group (AGGIR) scale', 'timeFrame': '12 months'}, {'measure': 'Assessment of functional status according Lawton Instrumental Activities of Daily Living (IADL) Scale', 'timeFrame': '12 months'}, {'measure': 'Assessment of activities of daily living, self-care, and independence according Activities of Daily Living (ADL) Scale', 'timeFrame': '12 months'}, {'measure': 'Assessment of comorbidity according Charlson scale', 'timeFrame': '12 months'}, {'measure': 'Assessment of cognitive function according Mini-Mental State Examination (MMSE) scale', 'timeFrame': '12 months'}, {'measure': 'Assessment of disorders of disruptive behaviour according (NPI-ES) scale', 'timeFrame': '12 months'}, {'measure': 'Assessment of geriatric depression according Geriatric Depression Scale (GDS) scale', 'timeFrame': '12 months'}, {'measure': 'Measuring of burden of the close caregivers according Popular Caregiver Self-report measure Burden (ZARIT)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['No severe behavioural disorders, EHPAD (retirement home), Older patients, loss of autonomy, Groupe-Iso-Ressources (GIR)'], 'conditions': ['Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare life quality of patients taking care by DIAPASON 92 with patients or residents from control group EHPAD (retirement home)', 'detailedDescription': 'This study has two components: a quantitative component(for users and caregivers) and a qualitative component (for users, caregivers and professionals)\n\nAbout population :\n\nFor quantitative component: the investigators have two arms:\n\n* Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device\n* Control arm: will be constituted by people residing at the EHPAD (retirement home)\n\nFor qualitative component: Study will cover 5 different populations since it concerns both:- - Diapason 92 professionals who work directly with users\n\n* Daipason 92 Supervisory staff\n* Diapason 92 professional partners, including referring physicians.\n* The users\n* Non-professional helpers of users\n\nConduct of study:\n\n\\- About quantitative component:\n\nAfter verification of eligibility criteria adapted to each centre and once the non-opposition has been collected and subjects have been included, the following data will be collected at M0, M3, M6 and M12:\n\n* For patients : Start date of care by Diapason 92 or EHPAD, Quality of Life score, benefit evaluation, Socio-educational level, evaluation of disruptive behaviour disorders, economic indicators, somatic comorbidities, collection of psychiatric follow-up if available, independence, nutritional status, factors(s) that motivated care, cognitive assessment, balance assessment, depression screening, ergonomic assessment (only for Diapason 92\n* Family caregiver: 3 measures will be collected: Measuring the burden by Zarit scale, self-assessment of his quality of life and psychological condition\n* About quality component:\n\nA socio-demographic heel will be collected for each participant interviewed who has given no objection to participating in the study. His agreement on the recording of his voice will also collected.\n\nFor all participants, following data will be collected: Age, sex, occupation, date and duration of the interview, relationship with the Diapason 92 user (for family caregivers) and the recovery of socio-demographic data of the case report form (for users)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For quantitative component: we have two arms:\n\n* Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device\n* Control arm: will be constituted by people residing at the EHPAD (retirement home)\n\nFor qualitative component: Study will cover 5 different populations since it concerns both:\n\n* Diapason 92 professionals who work directly with users\n* Daipason 92 Supervisory staff\n* Diapason 92 professional partners, including referring physicians.\n* The users\n* Non-professional helpers of users', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient/Resident Inclusion Criteria\n\n* Age ≥ 60 years old.\n* (Group iso-resources) GIR ≤ 4\n* Beneficiary of treatment by Diapason 92 or resident at EHPAD Aulagnier for more than 6 months.\n* Not exhibiting severe disruptive behaviour disorders (on NPI-ES all FXG 12 and resonance 4 scores).\n* Affiliate or entitled to a sickness insurance scheme\n* Patient or legal representative expressed no objection\n\nPatient/Resident Exclusion Criteria:\n\n* Age \\< 60 years old\n* GIR ˃ 4\n* Not affiliated or entitled to a sickness insurance scheme\n* Patient or legal representative did not express no objection\n\nProfessionals and caregivers Inclusion Criteria:\n\n* Exercise within Diapason 92 device or be identified as assisting a Diapason 92 user or be a professional partner of Diapason 92 device\n* Have expressed no objection to participating in the study.'}, 'identificationModule': {'nctId': 'NCT03976661', 'acronym': 'DIAPASON', 'briefTitle': 'Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes', 'orgStudyIdInfo': {'id': '2018-A03183-52'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DIAPASON 92 arm', 'description': 'Arm will be constitued by older patients with loss of autonomy, living at home benefiting from the device DIAPASON 92 (Innovative support system for elderly people in their homes)'}, {'label': 'Control arm', 'description': 'Arm will be constituted by people residing at the EHPAD (retirement home)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Agathe Raynaud-Simon', 'role': 'CONTACT', 'email': 'agathe.raynaud-simon@aphp.fr', 'phone': '140257369'}], 'facility': 'Geriatric department , Broca Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle Dufour', 'role': 'CONTACT', 'email': 'isabelle.dufour@gerondif.org', 'phone': '+33 (0) 185781010'}, {'name': 'Prisca Lucas, PhD', 'role': 'CONTACT', 'email': 'prisca.lucas@gerondif.org', 'phone': '+33 (0) 185781010'}], 'overallOfficials': [{'name': 'Olivier Phd Hanon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geriatric department, Broca hospital (Paris)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}