Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT04816734
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2021-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Parenteral Nutrition Education of Parent Assessment Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2021-03-24', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usefulness by parent', 'timeFrame': 'Day 1', 'description': 'Perceived usefulness of the evaluation session by the learners -parents- collected via a self-report questionnaire.\n\n4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.'}], 'secondaryOutcomes': [{'measure': 'Usefulness by carer', 'timeFrame': 'Day 1', 'description': 'Perceived usefulness of the evaluation session by users -carers- collected via a self-report questionnaire.\n\n4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.'}, {'measure': 'Educational quality by parent', 'timeFrame': 'Day 1', 'description': 'Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for parents.\n\n4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.'}, {'measure': 'Educational quality by carer', 'timeFrame': 'Day 1', 'description': 'Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for carers.\n\n4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parenteral nutrition', 'Pediatric home parenteral nutrition', 'Parental therapeutic education', 'Educational evaluation'], 'conditions': ['Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'The department of gastroenterology, hepatology and pediatric nutrition at the Necker-Enfants Malades hospital has created an evaluation system for the initial therapeutic education program followed by parents of children requiring parenteral nutrition at the Necker-Enfants Malades hospital.\n\nThe aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.', 'detailedDescription': "Due to the highly technical nature of the care to be provided at home by parents of children in need of parenteral nutrition, an assessment of the acquisition of both factual knowledge provided to parents in hospital, but also of the reasoning, decision-making, technical skills and parents attitudes seem necessary and essential before the child's return to his home in order to guarantee his safety.\n\nThe department of gastroenterology, hepatology and pediatric nutrition of Necker-Enfants Malades hospital has developed an educational assessment system based on previous studies in this field. Composed of 4 tools, this plan allows a complete assessment with relevant educational decision fields of the set of skills that parents must master to cope with their child's illness on a daily basis, following their participation in the initial program of therapeutic education offered by the Necker hospital team.\n\nThe aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Holders of parental authority for children with parenteral nutrition participating in the initial education program of pediatric home parenteral nutrition of Necker hospital.\n* informed consent signed by the patient and the investigator.\n* patient affiliated to a social security scheme (beneficiary or beneficiary).\n\nExclusion Criteria:\n\n* Subject having difficulty understanding the French language.\n* Illiterate subject.'}, 'identificationModule': {'nctId': 'NCT04816734', 'acronym': 'DISEPEIN', 'briefTitle': 'Initial Parenteral Nutrition Education of Parent Assessment Plan', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition', 'orgStudyIdInfo': {'id': 'APHP200894'}, 'secondaryIdInfos': [{'id': '2020-A01159-30', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parents', 'description': 'Parents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital.', 'interventionNames': ['Other: Self-report questionnaires']}], 'interventions': [{'name': 'Self-report questionnaires', 'type': 'OTHER', 'description': 'Evaluation system of initial therapeutic education program about pediatric home parenteral nutrition.\n\nThe assessment takes place after the parents have participated in the therapeutic education program and before their child returns home.', 'armGroupLabels': ['Parents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Cécile LAMBE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Cécile GODOT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}