Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-02 @ 12:57 AM
Study NCT ID:
NCT01379495
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education Program for Burn Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-22', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in perceived health status at six months', 'timeFrame': 'six months', 'description': 'The questionnaire "Burns Specific Health Scale- Revised" developed by Blalock; Bunker; De Vellis (1994), adapted by Ferreira et al. (2008) to Brasilian people, will be used to collect the data at six months between groups.'}], 'secondaryOutcomes': [{'measure': 'comparison the return to work of burn victims between groups', 'timeFrame': 'baseline and six months', 'description': 'To compare the return to work of burns victims in intervention group with the return to work of burns victims in control group at six months after hospital discharge, proportions will be calculated (returned to work: yes/no)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['burns', 'rehabilitation'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of an educative program including telephone follow-up for burn patients regarding the impact of this intervention on the health status and return to work at six months after hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult burned patients (18 years or older), male and female\n* patients burned for the first time who needed hospitalization at the Burns Unit\n* in cognitive conditions to participate (being able to tell one's address, day of the week and age or birth date)\n* in physical conditions to accomplish self-care.\n\nExclusion Criteria:\n\n* participants burned due to suicide or with previous psychiatric diagnoses or cognitive and psychological difficulties that do not allow them to answer the instrument questions and take care of themselves."}, 'identificationModule': {'nctId': 'NCT01379495', 'briefTitle': 'Education Program for Burn Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Randomized Controlled Clinical Trial on Telephone Follow-up in Rehabilitation of Burn Patients: Impact on Health Status', 'orgStudyIdInfo': {'id': 'uspqueimados2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Burns victims will receive information according to the service routine'}, {'type': 'EXPERIMENTAL', 'label': 'educational program+telephone follow up', 'description': 'Burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge', 'interventionNames': ['Behavioral: educational program+telephone follow up']}], 'interventions': [{'name': 'educational program+telephone follow up', 'type': 'BEHAVIORAL', 'description': 'burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge', 'armGroupLabels': ['educational program+telephone follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14015130', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Natália Gonçalves, PhDcandidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Lidia Ap Rossi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of São Paulo at Ribeirão Preto College of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PhD student', 'investigatorFullName': 'Natalia Gocalves', 'investigatorAffiliation': 'University of Sao Paulo'}}}}