Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-06 @ 1:07 PM
Study NCT ID:
NCT04179695
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2019-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care
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': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'variation of the delta of G-MISS Questionnaire', 'timeFrame': 'at 7 months'}], 'secondaryOutcomes': [{'measure': 'G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)', 'timeFrame': 'at the end of each consultation (1 month and 7 months)', 'description': "Patient's satisfaction will be assessed by the G-MISS-Questionnaire. The G-MISS questionnaire is a standardized and validated tool in French. This questionnaire is taken from the American MISS-21 questionnaire, already used in neurologists to measure the satisfaction of patients with PD, after consultation It is easy to use with an average filling time of 6 minutes."}, {'measure': 'Global score of PARKINSUN', 'timeFrame': 'at the end of each consultation ((1 month and 7 months)'}, {'measure': 'Individuals scores of PARKINSUN', 'timeFrame': 'at the end of each consultation ((1 month and 7 months)'}, {'measure': 'MDS-UPDRS scores', 'timeFrame': 'at the end of each consultation ((1 month and 7 months)'}, {'measure': 'PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)', 'timeFrame': 'at the end of each consultation ((1 month and 7 months)'}, {'measure': 'Likert Scale', 'timeFrame': 'at the end of each consultation (1 month and 7 months)'}, {'measure': 'Interpersonal Reactivity Index (IRI)', 'timeFrame': 'at the end of each consultation (1 month and 7 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health pathway', 'patient centered care', 'communication aid- tool', 'primary care', 'secondary care'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': 'PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men and women with all stages of PD\n* Without severe chronic neurological or mental or psychiatric pathology\n* Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA \\> 22)\n* able to come (alone or accompanied) to consultation\n* Affiliate or beneficiary of a social security scheme\n* Subject having signed informed consent\n* Patient willing to comply with all procedures of the study and its duration\n\nExclusion Criteria:\n\n* Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.\n* Subject under tutelage or curtailer.\n* Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.'}, 'identificationModule': {'nctId': 'NCT04179695', 'acronym': 'PARKINSUN', 'briefTitle': 'Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN", 'orgStudyIdInfo': {'id': '2018_74'}, 'secondaryIdInfos': [{'id': '2019-A01008-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'consultation with Parkinsun', 'interventionNames': ['Other: Consulting with PARKINSUN as communication aid-tool']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'consultation as usual without Parkinsun', 'interventionNames': ['Other: Consulting without PARKINSUN as communication aid-tool']}], 'interventions': [{'name': 'Consulting with PARKINSUN as communication aid-tool', 'type': 'OTHER', 'description': 'Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months', 'armGroupLabels': ['consultation with Parkinsun']}, {'name': 'Consulting without PARKINSUN as communication aid-tool', 'type': 'OTHER', 'description': 'Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months', 'armGroupLabels': ['consultation as usual without Parkinsun']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'role': 'CONTACT', 'phone': '0320445962'}], 'facility': 'Hopital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'David Devos, MD,PhD', 'role': 'CONTACT', 'email': 'david.devos@chru-lille.fr', 'phone': '03 20 44 54 49', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'David Devos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': "Expert center of Parkinson's Disease (CHU Lille)", 'class': 'UNKNOWN'}, {'name': 'College of teaching general practitioners (CEMG Lille)', 'class': 'UNKNOWN'}, {'name': 'Regional Health Agency (ARS)', 'class': 'UNKNOWN'}, {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, {'name': "Orkyn'", 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}