Burn Outcomes in Young Adult Burn Survivors (YA)

October 5, 2015 updated by: Colleen Ryan, Massachusetts General Hospital

Burn Outcomes in Young Adult Burn Survivors- A Multicenter Outcomes Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • Shriners Hospital for Children
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Kennedy Krieger Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital
      • Boston, Massachusetts, United States, 02114
        • Shriners Hospital for Children - Boston
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3335
        • University of Nebraska Medical Center
    • Texas
      • Galveston, Texas, United States, 77550
        • Shriners Hospital for Children - Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
YA Burned Subjects
Any person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months.
Burn specific outcome measurement and global health measurement
Other Names:
  • Young Adult Burn Outcomes Questionnaire
  • Veterans Rand 12 Item Health Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form Young Adult Outcomes Questionnaire
Time Frame: 12-24 month follow-up
Once existing data are massaged we will revise the stated outcome measure to make it more contemporary.
12-24 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Veterans Rand 12 Item Health Survey (VR-12)
Time Frame: 12-24 months follow-up
The VR-12 instrument was developed based on data from the SF-36 survey.
12-24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P002459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burns

Clinical Trials on Questionnaire self report

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