Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-31 @ 4:00 AM
Study NCT ID:
NCT06580756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Problematic Use and Addiction in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who received information about the addictive disorders from the primary care professional', 'timeFrame': '24 months', 'description': 'The main aim of the study was to measure the effect of brief training in the identification of addictive disorders on the rate of patients who actually received the information from the primary care professional.'}, {'measure': 'number of patients identified with an addictive disorder from the primary care professional', 'timeFrame': '24 months', 'description': 'The main aim of the study was to measure the effect of brief training in the identification of addictive disorders on the rate of patients who actually received the information from the primary care professional.'}], 'secondaryOutcomes': [{'measure': 'prevalence of addictive disorders in primary care', 'timeFrame': '24 months', 'description': 'Measure the prevalence'}, {'measure': 'types of addictive disorders', 'timeFrame': '24 months', 'description': 'List of addictive disorders identified in patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['short training program'], 'conditions': ['Addiction Disorders', 'Primary Care']}, 'descriptionModule': {'briefSummary': 'The morbi-mortality and social cost of addictive disorders led the French authorities to set up a government plan in 2018 to combat drugs and addictive behavior (Interministerial mission to combat drugs and addictive behaviour - (MILDECA)). In particular, it encourages early detection, which is the first stage in a validated global approach to the management of addictive disorders. Improving early identification of addictive disorders in primary care would reduce morbidity and mortality and improve quality of life for patients with addictive disorders. The identification of use disorders should be systematic in primary care and was the subject of a recommendation in 2015. Numerous tests are cited in these recommendations, but few have actually been validated in primary care, and none has been shown to be feasible. For example, only 23% of GPs claim to systematically identify alcohol consumption.\n\nOther primary care professionals (physiotherapists, nurses, midwives, dentists, pharmacists) also have a role to play in identifying addictive disorders. The evolution of their respective professions (delegation of tasks, creation of the profession of advanced practice nurse, medical assistants) and the recent reorganization of the practice framework, both in terms of practice structures and professional community organizations, involve them in a global multidisciplinary collaboration on patient care, particularly in the early identification of addictive disorders.\n\nThe hypothesis is that the difficulties in implementing tests to identify addictive disorders in primary care are linked to the lack of specific consideration of the needs of primary care patients and caregivers.\n\nThe overall aim of the study is to improve the early detection of addictive disorders through brief training for primary care healthcare professionals.', 'detailedDescription': 'The project comprises three successive stages:\n\n1. Design a training program with content tailored to primary care professionals;\n2. Evaluate the feasibility and acceptability of the training;\n3. Evaluate the implementation of this training program by comparing the incidence of addiction disorder detection by primary care professionals between a trained and an untrained group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care ambulatory professional', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be a primary care professional (physiotherapists, nurses, midwives, dentists, pharmacists, General practitioner)\n* in ambulatory practice. Recruitment will be carried out with the help of territorial professional health communities, to include practitioners practicing in conditions representative of the diversity of primary care practice.\n\nGPs agreeing to take part will be divided into a control group and an intervention group, by drawing lots.\n\nExclusion Criteria:\n\n* Refusal to participate.\n* The same participant may not be included in more than one stage.'}, 'identificationModule': {'nctId': 'NCT06580756', 'acronym': 'PAPRICA', 'briefTitle': 'Problematic Use and Addiction in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Development and Validation of a Short Training Course to Help Primary Care Healthcare Professionals Identify Addictive Disorders', 'orgStudyIdInfo': {'id': 'DR230127-PAPRICA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group intervention', 'description': 'Group with a brief training', 'interventionNames': ['Other: Short training program']}, {'label': 'group control', 'description': 'Group without a brief training'}], 'interventions': [{'name': 'Short training program', 'type': 'OTHER', 'description': 'Training in the early identification of addictive disorders in primary care', 'armGroupLabels': ['group intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29620', 'city': 'Lanmeur', 'country': 'France', 'contacts': [{'name': 'Jean Yves LE RESTE', 'role': 'CONTACT', 'email': 'lereste@univ-brest.fr'}], 'facility': 'CPTS Lanmeur', 'geoPoint': {'lat': 48.64711, 'lon': -3.71638}}, {'zip': '37240', 'city': 'Ligueil', 'country': 'France', 'contacts': [{'name': 'Maxime PAUTRAT', 'role': 'CONTACT', 'email': 'maxime.pautrat@univ-tours.fr'}], 'facility': 'CPTS Sud Lochois', 'geoPoint': {'lat': 47.0421, 'lon': 0.81893}}, {'zip': '41100', 'city': 'Vendôme', 'country': 'France', 'contacts': [{'name': 'Alain AUMARECHAL', 'role': 'CONTACT', 'email': 'alain.aumarechal@univ-tours.fr'}], 'facility': 'CPTS du Vendomois', 'geoPoint': {'lat': 47.79292, 'lon': 1.06556}}], 'centralContacts': [{'name': 'Maxime PAUTRAT', 'role': 'CONTACT', 'email': 'maxime.pautrat@univ-tours.fr', 'phone': '02 47 59 61 52', 'phoneExt': '+33'}, {'name': 'Agathe EDELINE', 'role': 'CONTACT', 'email': 'agathe.edeline@univ-tours.fr', 'phone': '02 47 82 89 77', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Maxime PAUTRAT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tours university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}