Burn Outcomes in Young Adult Burn Survivors (YA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Colleen Ryan, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01254357
First received: November 29, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Burns
Trauma
Other: Questionnaire self report

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Burn Outcomes in Young Adult Burn Survivors- A Multicenter Outcomes Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Short Form Young Adult Outcomes Questionnaire [ Time Frame: 12-24 month follow-up ] [ Designated as safety issue: No ]
    Once existing data are massaged we will revise the stated outcome measure to make it more contemporary.


Secondary Outcome Measures:
  • Veterans Rand 12 Item Health Survey (VR-12) [ Time Frame: 12-24 months follow-up ] [ Designated as safety issue: No ]
    The VR-12 instrument was developed based on data from the SF-36 survey.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
YA Burned Subjects
Any person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months.
Other: Questionnaire self report
Burn specific outcome measurement and global health measurement
Other Names:
  • Young Adult Burn Outcomes Questionnaire
  • Veterans Rand 12 Item Health Survey

Detailed Description:

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?

  Eligibility

Ages Eligible for Study:   19 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

All 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. -

Exclusion Criteria:

Non-burn skin conditions. Non-English speaking young adults. Young adults less than 19 years of age. Young adults greater than 30 years of age.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01254357

Locations
United States, California
Shriners Hospital for Children
Sacramento, California, United States, 95817
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Shriners Hospital for Children - Boston
Boston, Massachusetts, United States, 02114
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3335
United States, Texas
Shriners Hospital for Children - Galveston
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
Investigators
Principal Investigator: Colleen M Ryan, MD Shriners Hospitals for Children and Massachusetts General Hospital
Study Director: Jeffrey Schneider, MD Massachusetts General Hospital and Spaulding Rehab Hospital
Study Director: Tina Palmieri, MD Shriners Hospitals or Children,University of CA at Davis
Study Director: David Herndon, MD Shriners Hospitals forChildren, University of TX Medical Branch
Study Chair: Lewis Kazis, ScD Shriners Hospitalsfor Children, Boston University School of Public Health
Study Director: Ronald G Tompkins, MD Shriners Hospitals for Children, Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Colleen Ryan, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01254357     History of Changes
Other Study ID Numbers: 2010P002459
Study First Received: November 29, 2010
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Burns
Trauma
Outcomes
Quality of Life

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2014