Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-01 @ 5:38 PM
Study NCT ID:
NCT04150302
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scale calibration of the new developped questionnaire', 'timeFrame': 'about 30 minutes', 'description': 'Calibration measure'}, {'measure': 'Structure of the new developped questionnaire', 'timeFrame': 'about 30 minutes', 'description': 'Structure identification'}, {'measure': 'Convergence proprieties of the new developped questionnaire', 'timeFrame': 'about 30 minutes', 'description': 'Convergence evaluation'}, {'measure': 'Reproducibility of the new developped questionnaire', 'timeFrame': 'Up to 8 days', 'description': 'Test of reproducibility'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SBS - Short Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up. It is therefore essential to better understand the needs, expectations and values of patients with SBS in order to better understand the impact of the disease on their lives, and thus improve the conditions for medical, social, psychological and technical care. The clinical expertise of health professionals and meetings with patient associations demonstrate the major gap between the parameters taken into account by physician to evaluate the evolution of the SBS and the day-to-day experience of the disease perceived by the patient.\n\nThe objective of the ARTEMIS-GC study is to develop and validate an instrument to measure the impact of SBS and its treatments on daily life from the perspective of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years with SBS for more than 6 months and returned home for at least 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with SBS defined by a hail length remaining in post-duodenal \\< 2 meters\n* Patients with intestinal insufficiency, i.e. chronic malabsorption requiring energetic and/or hydro-electrolytic intravenous support for more than 6 months\n* Patients with a period of at least 6 months after the establishment of the SBS\n* Patients who has already had a return home after the establishment of the SBS for a period of at least 3 months\n\nExclusion Criteria:\n\n* Patients with intestinal insufficiency but with a cause other than SBS\n* Lack of understanding of the study\n* Not speaking French'}, 'identificationModule': {'nctId': 'NCT04150302', 'acronym': 'ARTEMIS_GC', 'briefTitle': "Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives", 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "Development and Validation of a Questionnaire to Measure the Impact of Short Bowel Syndrome (SBS) and Its Treatments on Patients' Lives", 'orgStudyIdInfo': {'id': '2019-A02034-53'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Exploratory interviews', 'type': 'OTHER', 'description': 'Exploratory interviews to generate an interview guide'}, {'name': 'Semi-directive interviews', 'type': 'OTHER', 'description': 'Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation'}, {'name': 'Delphi Process', 'type': 'OTHER', 'description': 'Cotation of newly developed items pertinence on a 4 points likert scale.'}, {'name': 'Think aloud interviews', 'type': 'OTHER', 'description': 'Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.'}, {'name': 'Psychometric validation', 'type': 'OTHER', 'description': 'Psychometric properties study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Francisca Joly, MD Pr', 'role': 'CONTACT', 'email': 'francisca.joly@bjn.aphp.fr'}], 'facility': 'Beaujon Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Laetitia Ricci, PhD', 'role': 'CONTACT', 'email': 'l.ricci@chru-nancy.fr', 'phone': '0033383852092'}, {'name': 'Francisca Joly, MD, PhD', 'role': 'CONTACT', 'email': 'francisca.joly@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beaujon Hospital', 'class': 'OTHER'}, {'name': 'Société Francophone Nutrition Clinique et Métabolisme', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}