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NCT00253292 Clinical Trial

Psychometric Study of Outcomes Instruments

Trauma Clinical Trial

Official title:
Psychometric Study of Outcomes Instruments

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00253292
Other study ID # 1999-P-008281/15
Secondary ID
Status Terminated
Phase N/A
First received November 11, 2005
Last updated July 27, 2011
Start date January 1997
Est. completion date December 2007

Study information
Verified date July 2011
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 30 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Kennedy Krieger Institute Baltimore Maryland
United States Mass General Hospital Boston Massachusetts
United States Jaycee Burn Center,UNC Healthcare Chapel Hill North Carolina
United States Shriners Hospitals for Children-Galveston Galveston Texas
United States University of Nebraska Medical Center Omaha Nebraska
United States Shriners Hospital for Children Sacramento California

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

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