Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04020120
Status:
UNKNOWN
Last Update Posted:
2019-11-13
First Post:
2019-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Professional Difficulties of Adult With Attention Deficit / Hyperactivity Disorder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Work Limitations Questionnaire (WLQ-25)', 'timeFrame': '1 year', 'description': 'It is a questionnaire with 25 items exploring 4 distinct dimensions: time management, physical demands, mental interpersonal demands and output demands.'}], 'secondaryOutcomes': [{'measure': 'Maslach Burnout Inventory', 'timeFrame': '1 year', 'description': 'It is a questionnaire with 22 items exploring 3 distinct dimensions: emotional exhaustion, deshumanization and personal achievement at work'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prospective', 'Descriptive', 'Non-interventional', 'Monocentric'], 'conditions': ['Attention Deficit Hyperactivity Disorder in Adults']}, 'descriptionModule': {'briefSummary': 'Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired.\n\nThe investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels.\n\nThe main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview.\n\nThe secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who consulted at the psychiatric clinic of Strasbourg, aged 18 to 62, with a diagnosis of attention deficit disorder with or without hyperactivity assessed by a psychiatrist, and who have been in a working situation in the last 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients aged 18 to 62 years\n* Diagnosis of attention deficit disorder with or without hyperactivity by a psychiatrist\n* No treatment for ADHD in childhood or adolescence\n* Patient who has been in a professional situation during the last 3 months\n\nExclusion criteria:\n\n* Patient on sick leave or unemployed for more than 3 months\n* Depressive episode in acute phase\n* Subject with a mobility project that prevents follow-up for 1 year (planned move)\n* Impossibility of providing the subject with informed information (subject in an emergency situation, difficulties in understanding the subject, mental retardation, illiteracy or insufficient command of the French language...)\n* Subject under the protection of justice\n* Subject under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT04020120', 'acronym': 'WORKTDA', 'briefTitle': 'Assessment of the Professional Difficulties of Adult With Attention Deficit / Hyperactivity Disorder Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Impact of Adult With Attention Deficit / Hyperactivity Disorder on Professional Activity, a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '7482'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ADHD in professional activity', 'description': 'Adult ADHD patients in active employment at the time of inclusion or who were in employment within 3 months prior to inclusion', 'interventionNames': ['Other: questionnaires']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': 'answer questionnaires', 'armGroupLabels': ['ADHD in professional activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Sébastien WEIBEL', 'role': 'CONTACT', 'email': 'sebastien.weibel@chru-strasbourg.fr', 'phone': '+33 3 88 11 51 57'}, {'name': 'Sébastien WEIBEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}