Psychometric Study of Outcomes Instruments

Terminated

• Conditions: Burns; Trauma

• Registration Number: NCT00253292
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 1997-01
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Study Completion: 2007-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-27
• Last Update Posted: 2011-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States

Shriners Hospital for Children; 🇺🇸 Sacramento, California, United States

Shriners Hospitals for Children-Galveston; 🇺🇸 Galveston, Texas, United States

Jaycee Burn Center,UNC Healthcare; 🇺🇸 Chapel Hill, North Carolina, United States

Mass General Hospital; 🇺🇸 Boston, Massachusetts, United States