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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01254357
Other study ID # 2010P002459
Secondary ID
Status Completed
Phase N/A
First received November 29, 2010
Last updated October 5, 2015
Start date December 2011
Est. completion date July 2015

Study information

Verified date October 2015
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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?


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 2015
Est. primary completion date August 2014
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 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire self report
Burn specific outcome measurement and global health measurement

Locations

Country Name City State
United States Kennedy Krieger Institute Baltimore Maryland
United States Mass General Hospital Boston Massachusetts
United States Shriners Hospital for Children - Boston Boston Massachusetts
United States Shriners Hospital 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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Short Form Young Adult Outcomes Questionnaire Once existing data are massaged we will revise the stated outcome measure to make it more contemporary. 12-24 month follow-up No
Secondary Veterans Rand 12 Item Health Survey (VR-12) The VR-12 instrument was developed based on data from the SF-36 survey. 12-24 months follow-up No
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