Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-22 @ 12:37 PM
Study NCT ID:
NCT03324750
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2017-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2017-10-25', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the difficulties encountered by patient in relation to the health and dietary advice given by physicians in the context of long term corticodteroid use', 'timeFrame': '1 day', 'description': 'To determine the difficulties encountered by patient in relation to the health and dietary advice given by physicians in the context of long term corticodteroid use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['corticotherapy', 'qualitative study', 'therapeutic education', 'lifestyle change', 'diet'], 'conditions': ['Patients Traited by Long Term Corticotherapy']}, 'descriptionModule': {'briefSummary': 'Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid therapy. When corticosteroids are introduced, patient information concerning the adverse effects and the modalities of prevention by the lifestyle changes is usually proposed. However, studies have shown an imperfect acquisition of this information about treatment and prevention of adverse effects, as well as a difficult implementation on diet and physical activity advices. In this study, the investigators aimed to evaluate the difficulties encountered by patients with dietary advice in the context of long-term corticosteroids use in order to optimize care, drug adherence and the quality of life of patients.\n\nMethods: the investigators will recruite adult patients from general medicine and rheumatology practice and treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). the investigators will perform a qualitative analysis in a semi-directed interview.', 'detailedDescription': "Prospective Qualitative Study Carried out among patients followed in rheumatology and in general medical practice.\n\nFor each voluntary patient, a semi-directed interview was carried out in a consultation room after obtaining his agreement.\n\nThe same investigator used a single guide and conducted all the interviews based on open-ended questions.\n\nAt the end of the interviews, the entire recorded audio data was converted in written form before being analysed thematically.\n\nData were analysed using a Fisher's exact test for categorical variables (presented as frequencies and percentages), and using a non-parametric Mann-Whitney test for continuous variables (presented as the median and interquartile range, IQR)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated by long-term corticotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients taking corticosteroids at an average dose ≥ 5 mg/day of equivalent prednisone over a period ≥ 3 months.\n\nExclusion Criteria:\n\n* major memory impairment or language barrier.'}, 'identificationModule': {'nctId': 'NCT03324750', 'briefTitle': 'Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients', 'orgStudyIdInfo': {'id': 'RECHMPL17_0330'}}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}