Psychometric Study of Outcomes Instruments

This study has been terminated.
(Unable to recruit necessary sample size)
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00253292
First received: November 11, 2005
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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
Burns
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychometric Study of Outcomes Instruments

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Enrollment: 40
Study Start Date: January 1997
Study Completion Date: December 2007
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.

  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

Patients admitted to the MGH burn unit for a burn injury between the ages of 19-30 years.

Criteria

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
  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: NCT00253292

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
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
Investigators
Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital - Boston
  More Information

No publications provided

Responsible Party: Ronald Tompkins, MD, Sc.D.-PI, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00253292     History of Changes
Other Study ID Numbers: 1999-P-008281/15
Study First Received: November 11, 2005
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on October 30, 2014