Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 2:33 AM
Study NCT ID:
NCT01254357
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2010-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burn Outcomes in Young Adult Burn Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2010-11-29', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form Young Adult Outcomes Questionnaire', 'timeFrame': '12-24 month follow-up', 'description': 'Once existing data are massaged we will revise the stated outcome measure to make it more contemporary.'}], 'secondaryOutcomes': [{'measure': 'Veterans Rand 12 Item Health Survey (VR-12)', 'timeFrame': '12-24 months follow-up', 'description': 'The VR-12 instrument was developed based on data from the SF-36 survey.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Burns', 'Trauma', 'Outcomes', 'Quality of Life'], 'conditions': ['Burns', 'Trauma']}, 'descriptionModule': {'briefSummary': 'As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument was developed to study the outcomes of burn survivors in the 19-30 year old age group. This workgroup has come together to re-examine the data collected during the previous study and determine next steps in understanding the recovery for this population.', 'detailedDescription': 'This study looks to understand previously collected outcomes scores. Identifying young adult burned patients at risk for poor outcomes remains an under-published field of study. We strive to identify problem areas for this population before they adversely effect their quality of life. How are these 19-30 year olds different from their non-burned counterparts and what interventions can we provide to equalize the balance?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons having suffered a burn injury and treated at participating study sites that are between the ages of 19-30 years of age and speak English.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll burn injured young adults with or without skin grafting. All burned young adults on or after their 18th birthday. Between the ages of 19-30 years. English speaking Present for inpatient or outpatient treatment. -\n\nExclusion Criteria:\n\nNon-burn skin conditions. Non-English speaking young adults. Young adults less than 19 years of age. Young adults greater than 30 years of age.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01254357', 'acronym': 'YA', 'briefTitle': 'Burn Outcomes in Young Adult Burn Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Burn Outcomes in Young Adult Burn Survivors- A Multicenter Outcomes Study', 'orgStudyIdInfo': {'id': '2010P002459'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'YA Burned Subjects', 'description': 'Any person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months.', 'interventionNames': ['Other: Questionnaire self report']}], 'interventions': [{'name': 'Questionnaire self report', 'type': 'OTHER', 'otherNames': ['Young Adult Burn Outcomes Questionnaire', 'Veterans Rand 12 Item Health Survey'], 'description': 'Burn specific outcome measurement and global health measurement', 'armGroupLabels': ['YA Burned Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Shriners Hospital for Children', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Shriners Hospital for Children - Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '68198-3335', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Shriners Hospital for Children - Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Colleen M Ryan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shriners Hospitals for Children and Massachusetts General Hospital'}, {'name': 'Jeffrey Schneider, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Massachusetts General Hospital and Spaulding Rehab Hospital'}, {'name': 'Tina Palmieri, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shriners Hospitals or Children,University of CA at Davis'}, {'name': 'David Herndon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shriners Hospitals forChildren, University of TX Medical Branch'}, {'name': 'Lewis Kazis, ScD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shriners Hospitalsfor Children, Boston University School of Public Health'}, {'name': 'Ronald G Tompkins, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shriners Hospitals for Children, Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shriners Hospitals for Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Colleen Ryan', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}