Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 8:22 AM
Study NCT ID:
NCT04094259
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2019-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative Care in Patients With Auto-Immune Diseases
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': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients using alternative medicine.', 'timeFrame': 'At day 1', 'description': 'Counting the number of patients using alternative medicine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Auto-Immune Diseases']}, 'descriptionModule': {'briefSummary': 'Patients followed in Internal Medicine bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with in the department of Internal Medicine A', 'detailedDescription': "Patients followed in Internal Medicine department bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with autoimmune diseases in the department of Internal Medicine .\n\nAt all times alternative medicine has existed. Internal Medicine deals with rare autoimmune diseases, of which there is not always a cure. Even when the treatment is optimal, there are often subjective complaints.Patients followed in Internal Medicine therefore have favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. This information will make it possible to target the patient's needs, and to be able to offer alternative medicines that are better focused, without calling into question their conventional treatment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)\n* Patient with signed consent\n\nExclusion criteria:\n\n* Patients deprived of their liberty\n* Minors and adults subject to legal protection measures\n* Patients subject to a justice safeguard measure\n* Patient unable to understand or adhere to the protocol"}, 'identificationModule': {'nctId': 'NCT04094259', 'acronym': 'Alter-MAI', 'briefTitle': 'Alternative Care in Patients With Auto-Immune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Proportion of the Use of Medicines and Alternative Care in Patients With Auto-Immune Diseases Alter-MAI', 'orgStudyIdInfo': {'id': '87RI19-0020 (ALTER-MAI)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire.', 'type': 'BEHAVIORAL', 'description': 'patients will respond to a specific questionnaire regarding the use of alternative medicine'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limoges', 'country': 'France', 'facility': 'Médecin Interne A', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}