Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT01285895
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2011-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung and heart transplantations', 'Mucoviscidosis', 'Educational needs'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.\n\nSpecific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation\n\nSecondary objectives :\n\n* Assess the state of health\n* Assess the knowledge\n* Assess gestural know-how\n* Assess the cognitive know-how\n* Assess the behaviour adopted in reality by the patient\n* Assess motivation psychosocial factors of :\n\n * self-efficacy and inefficiency\n * representation of obstacles, disadvantages of treatment\n * sense of control over their health\n * feeling of being supported by health professionals, by his close\n * representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received a lung transplantation or a simultaeous heart-lung transplantation for mucoviscidosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis\n\nExclusion Criteria:\n\n* Patient with a psychiatric disorder\n* Patient in intensive care\n* Palliative patient\n* Patient aged under 18 years old\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT01285895', 'briefTitle': 'Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis', 'orgStudyIdInfo': {'id': 'PROG/10/90'}}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Valérie DAVID, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Romain GUILLEMAIN, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Européen Georges-Pompidou'}, {'name': 'Jean-François MORNEX, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Marc STERN, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Foch'}, {'name': 'Martine REYNAUD-GAUBERT, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de Marseille'}, {'name': 'Marlène MURRIS-ESPIN, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'Romain KESSLER, Profesor', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}