Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 5:17 AM
Study NCT ID:
NCT04390633
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '20 semi-structured interviews', 'timeFrame': '12 months', 'description': 'Qualitative data analysis - Theorical saturation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Intestinal Failure', 'Small Intestine Disease']}, 'descriptionModule': {'briefSummary': 'The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners\n\nChronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF.\n\nSemi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included.\n\nAfter analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women aged 18 and over, fulfilling the conditions of major Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 and over\n* With Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"\n* medical follow-up in one of the two nutrition departments of the study\n* Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.\n\nExclusion Criteria:\n\n* Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews\n* Person who does not speak French easily\n* Generally, any person unlikely to cooperate in the study\n* Adults under guardianship'}, 'identificationModule': {'nctId': 'NCT04390633', 'acronym': 'SBS-NEEDS', 'briefTitle': 'Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Qualitative Assessment of the Needs and Knowledge of Patients With Chronic Intestinal Failure of Their Disease as Well as Those of Their Practitioners', 'orgStudyIdInfo': {'id': 'EI/2019/616'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société Francophone Nutrition Clinique et Métabolisme', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}