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Psychometric Study of Outcomes Instruments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253292
Recruitment Status : Terminated (Unable to recruit necessary sample size)
First Posted : November 15, 2005
Last Update Posted : July 28, 2011
Shriners Hospitals for Children
Information provided by:
Massachusetts General Hospital

Brief Summary:
The purpose of this study is to develop a standardized, practical self-administered questionnaire to monitor young adult burn patients and to evaluate the effectiveness of burn management treatments with regard to improved function, physical appearance and other relevant outcomes.

Condition or disease
Burns Trauma

Detailed Description:
Identifying young adult burned patients at risk for poor outcomes remains an underpublished field of study. The first step to identifying these patients is to review their responses to this burn specific young adult measure, that attempts to quantify aspects of quality of life. We are validating this questionnaire by now collecting information from non burned community based subjects and by having burned patients complete the questionnaire at 4 timepoints. Once we have recruited sufficient subjects we will finalize our testing of this questionnaire and publish the validity and reliability of the instrument. Our questionnaires will help us answer the question of how burn people differ from non burned person's reported quality of life. This will complete our array of burn specific outcomes questionnaires from infancy through young adulthood.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychometric Study of Outcomes Instruments
Study Start Date : January 1997
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the MGH burn unit for a burn injury between the ages of 19-30 years.

Inclusion Criteria:

  • All burn injured young adults with or without grafting
  • All burned on or after their 17th birthday
  • Between the ages of 19-30
  • English speaking
  • Present for inpatient or outpatient treatment

Exclusion Criteria:

Non-burned skin conditions

  • Non-English speaking
  • Patients less than 19 years of age
  • Patients over 30 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253292

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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
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3335
United States, North Carolina
Jaycee Burn Center,UNC Healthcare
Chapel Hill, North Carolina, United States, 27599-7050
United States, Texas
Shriners Hospitals for Children-Galveston
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
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Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston

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Responsible Party: Ronald Tompkins, MD, Sc.D.-PI, Shriners Hospitals for Children Identifier: NCT00253292     History of Changes
Other Study ID Numbers: 1999-P-008281/15
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Massachusetts General Hospital:
Quality of Life