Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 7:47 AM
Study NCT ID:
NCT05076669
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, randomised, comparative, controlled, national and multi-centre study with minimal risks and constraints to routine care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '3 months', 'description': 'score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean'}], 'secondaryOutcomes': [{'measure': 'Satisfaction of patient', 'timeFrame': '3 and 6 months', 'description': 'scale 0-100'}, {'measure': 'Quality of life', 'timeFrame': '1, 2, 3 and 6 months', 'description': 'Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean'}, {'measure': 'Quality of life', 'timeFrame': '1, 2, 3 and 6 months', 'description': 'EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean'}, {'measure': 'Cost', 'timeFrame': '3 and 6 months', 'description': '• Calculation of resource use at 3 and 6 months per expenditure item (use of services, drug use, medical device and home healthcare service use, MCO (Médecine chirurgie obstétrique \\[Obstetric surgery\\]) hospitalisations and SSR (Soins de suite et de réadaptation \\[Follow-up care and rehabilitation\\]) hospitalisations) for each group.'}, {'measure': 'Morbidity', 'timeFrame': '3 and 6 months', 'description': 'readmission rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stoma Ileostomy', 'Stoma Colostomy', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '10390579', 'type': 'BACKGROUND', 'citation': 'Becker A, Schulten-Oberborsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3. doi: 10.1007/pl00012361.'}, {'pmid': '19519689', 'type': 'RESULT', 'citation': 'Persson E, Berndtsson I, Carlsson E, Hallen AM, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis. 2010 Oct;12(10):971-6. doi: 10.1111/j.1463-1318.2009.01941.x.'}, {'pmid': '26633166', 'type': 'RESULT', 'citation': 'Neil N, Inglese G, Manson A, Townshend A. A Cost-Utility Model of Care for Peristomal Skin Complications. J Wound Ostomy Continence Nurs. 2016 Jan-Feb;43(1):62-8. doi: 10.1097/WON.0000000000000194.'}, {'pmid': '12598701', 'type': 'RESULT', 'citation': 'Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.'}, {'pmid': '24609004', 'type': 'RESULT', 'citation': 'Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://fsk.fr', 'label': 'Website of FSK'}]}, 'descriptionModule': {'briefSummary': 'In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.\n\nThe interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.\n\nThe control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.', 'detailedDescription': "France currently has about 80,000 ostomy patients. Stoma placement exposes patients to many surgical or peristomal skin complications which could impair the quality of life of the ostomy patient.\n\nThe management of ostomy patients varies from institution to institution and according to how the patient's medical equipment is supplied as well as whether or not specialised personnel are available.\n\nIn the last decade, the market for stoma therapy in France has evolved, with a significant increase in the delivery of equipment by HHNs, meeting a need for patient follow-up and accompaniment.\n\nThis increased preference of HHNs to use specialist nurses seems to be explained by the added benefits. Early international studies have demonstrated the impact of an enterostomal therapy nurse follow-up on the improvement of ostomy patient's quality of life (QoL) relative to their health.\n\nHowever, none of the studies available today on follow-ups performed by an enterostomal therapist included the French population. Furthermore, the studies show methodological gaps, a limited time span and are based on strong hypotheses.\n\nIn this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.\n\nThe interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.\n\nThe control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 18 years\n* Patients with a stoma placed less than 10 days ago\n* Patients who had a stoma during their current hospitalisation\n* Patients informed verbally and in writing via the information sheet and who signed the informed consent form.\n\nExclusion Criteria:\n\n* Patients in palliative care\n* Patients participating in another clinical study interested in the management of ostomy patients\n* Patients not enrolled in a social security system or with the CMU (Couverture maladie universelle \\[Universal Health Coverage\\])\n* Patients under judicial protection or under guardianship\n* Patients deprived of freedom (in prison and psychiatric patients being treated without consent)\n* Patients with difficulties understanding or reading French'}, 'identificationModule': {'nctId': 'NCT05076669', 'acronym': 'StomaCare', 'briefTitle': 'Quality of Life Impact After Enhanced Follow-up of Ostomy Patients', 'nctIdAliases': ['NCT05061927'], 'organization': {'class': 'INDUSTRY', 'fullName': 'FSK'}, 'officialTitle': 'Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care', 'orgStudyIdInfo': {'id': 'FSK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.', 'interventionNames': ['Other: standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'interventional group', 'description': 'The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.', 'interventionNames': ['Other: stoma follow-up']}], 'interventions': [{'name': 'stoma follow-up', 'type': 'OTHER', 'description': 'delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites', 'armGroupLabels': ['interventional group']}, {'name': 'standard of care', 'type': 'OTHER', 'description': 'routine management of stoma', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93043', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hopital Bicètre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Eddy Cotte, MD, PhD', 'role': 'CONTACT'}, {'name': 'Eddy Cotte, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Lyon-Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75009', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Alexandra Masson-Lecomte, MD', 'role': 'CONTACT'}, {'name': 'Alexandra Masson-Lecomte', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital SAint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75009', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Jeremie Lefevre', 'role': 'CONTACT'}, {'name': 'Jeremie H Lefevre, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital de la Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'ESPIC FOCH - Digestige Unit', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Suresnes', 'country': 'France', 'contacts': [{'name': 'Yann Neuzillet, MD,PhD', 'role': 'CONTACT'}, {'name': 'Yann Neuzillet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ESPIC Foch - Urology Unit', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Mathieu Roumiguié, MD', 'role': 'CONTACT'}, {'name': 'Mathieu Roumiguié, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Ingrid Kuhn', 'role': 'CONTACT', 'email': 'i.kuhn@fsk.fr', 'phone': '+33 7 61 47 98 25'}], 'overallOfficials': [{'name': 'Jeremie H Lefevre, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sorbonne University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FSK', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}