Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 2:15 PM
Study NCT ID:
NCT04485468
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the economic barriers to an optimal care path', 'timeFrame': 'Day 0', 'description': 'It is the collection of the number of resources consumed and the remainder to be borne by the patient as well as the number of hours of informal help that will be valued using the replacement cost approach.'}], 'secondaryOutcomes': [{'measure': "Identify and quantify the cost of the care pathway for patients with Parkinson's disease", 'timeFrame': 'Day 0', 'description': 'it is the quantification of the number of resources consumed and identification of the unit costs for each type of resources consumed.'}, {'measure': 'identify socio-economic determinants', 'timeFrame': 'Day 0', 'description': 'identify the socio-economic and territorial determinants that could have an impact on an optimal care path.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease,', 'Socio-economic'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.\n\nIt is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.", 'detailedDescription': "According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients\n\nThe coordination of the care pathway for patients with Parkinson disease has been improved since the implementation on the national territory of 7 interregional coordination centers and 25 regional expert centers in 2012.\n\nHealth insurance reimburses 100% of direct medical and non-medical care as soon as patients are registered in Long-Term Condition n°16. However, we currently have little information about care that is not recognized for financial coverage by health insurance.\n\nIt is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's disease patients and over 18 years old", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Parkinson's disease of any stage of severity\n* Patients over 18 years of age\n* Patients living at home\n* Patient consultant at the expert center Parkinson's at Toulouse University Hospital\n\nExclusion Criteria:\n\n* Pregnant and lactating woman\n* Patient under guardianship, curatorship or safeguard of justice\n* Person who does not understand French to be able to answer the questionnaire\n* Patient who participated or participated in the iCare PD project"}, 'identificationModule': {'nctId': 'NCT04485468', 'acronym': 'ECOSO-ICAREPD', 'briefTitle': 'Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers to the Optimal Care Pathway for Parkinson Disease Patients', 'orgStudyIdInfo': {'id': 'RC31/20/0184'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease patients", 'description': "Parkinson's disease patients and over 18 years old", 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'The patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later.', 'armGroupLabels': ["Parkinson's disease patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Olivier Rascol', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}