NCT01254357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

2.7 years

First QC Date

November 29, 2010

Last Update Submit

October 5, 2015

Conditions

Keywords

BurnsTraumaOutcomesQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Veterans Rand 12 Item Health Survey (VR-12)

    12-24 months follow-up

Study Arms (1)

YA Burned Subjects

Any person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months.

Other: Questionnaire self report

Interventions

Burn specific outcome measurement and global health measurement

Also known as: Young Adult Burn Outcomes Questionnaire, Veterans Rand 12 Item Health Survey
YA Burned Subjects

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Persons having suffered a burn injury and treated at participating study sites that are between the ages of 19-30 years of age and speak English.

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Shriners Hospital for Children

Sacramento, California, 95817, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Shriners Hospital for Children - Boston

Boston, Massachusetts, 02114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3335, United States

Location

Shriners Hospital for Children - Galveston

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

BurnsWounds and Injuries

Study Officials

  • Colleen M Ryan, MD

    Shriners Hospitals for Children and Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
  • Jeffrey Schneider, MD

    Massachusetts General Hospital and Spaulding Rehab Hospital

    STUDY DIRECTOR
  • Tina Palmieri, MD

    Shriners Hospitals or Children,University of CA at Davis

    STUDY DIRECTOR
  • David Herndon, MD

    Shriners Hospitals forChildren, University of TX Medical Branch

    STUDY DIRECTOR
  • Lewis Kazis, ScD

    Shriners Hospitalsfor Children, Boston University School of Public Health

    STUDY CHAIR
  • Ronald G Tompkins, MD

    Shriners Hospitals for Children, Massachusetts General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 6, 2010

Study Start

December 1, 2011

Primary Completion

August 1, 2014

Study Completion

July 1, 2015

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations