BurnsYANCT01254357
Burn Outcomes in Young Adult Burn Survivors
An observational study of Burns and Trauma, run by Massachusetts General Hospital at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Questionnaire self report
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2011to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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. -
Who cannot join
- 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.
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Mass General Hospital
Boston, Massachusetts, 02114
Shriners Hospital for Children - Boston
Boston, Massachusetts, 02114
Shriners Hospital for Children - Galveston
Galveston, Texas, 77550
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3335
Shriners Hospital for Children
Sacramento, California, 95817
About this study
Official title: Burn Outcomes in Young Adult Burn Survivors- A Multicenter Outcomes Study
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.
Read the detailed 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?
- Being tested
- Questionnaire self report
- Keywords
- Burns, Trauma, Outcomes, Quality of Life
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire self reportOther
Also called Young Adult Burn Outcomes Questionnaire, Veterans Rand 12 Item Health Survey
Burn specific outcome measurement and global health measurement
| Study group | Role | What they receive |
|---|---|---|
| YA Burned Subjects | Any person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months. Receives: Other: Questionnaire self report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Young Adult Outcomes Questionnaire
Once existing data are massaged we will revise the stated outcome measure to make it more contemporary.
Measured: 12-24 month follow-up
Secondary outcomes (1)
Veterans Rand 12 Item Health Survey (VR-12)
The VR-12 instrument was developed based on data from the SF-36 survey.
Measured: 12-24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startDec 2011
- Primary completionAug 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Responsible party
- Principal investigator, Colleen Ryan, Massachusetts General Hospital
- Investigators
- Colleen M Ryan, MD, Principal investigator, Shriners Hospitals for Children and Massachusetts General HospitalJeffrey Schneider, MD, Study director, Massachusetts General Hospital and Spaulding Rehab HospitalTina Palmieri, MD, Study director, Shriners Hospitals or Children,University of CA at DavisDavid Herndon, MD, Study director, Shriners Hospitals forChildren, University of TX Medical BranchLewis Kazis, ScD, Study chair, Shriners Hospitalsfor Children, Boston University School of Public HealthRonald G Tompkins, MD, Study director, Shriners Hospitals for Children, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254357
- Sponsor's protocol ID
- 2010P002459
- Acronym
- YA
- Status last verified
- Oct 2015
- First submitted
- 29 Nov 2010
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Outcomes in Young Adult Burn Survivors- A Multicenter Outcomes Study
- ClinicalTrials.gov ID
- NCT01254357
- Acronym / sponsor ID
- YA / 2010P002459
- Keywords
- Burns, Trauma, Outcomes, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YA Burned Subjects | – | Other: Questionnaire self reportAny person between the years of 19-30 years old treated for a burn injury, having incurred within past 12 months. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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. -
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire self reportAlso: Young Adult Burn Outcomes Questionnaire, Veterans Rand 12 Item Health SurveyBurn specific outcome measurement and global health measurement | Other | YA Burned Subjects |
Primary outcome
Short Form Young Adult Outcomes Questionnaire
Time frame: 12-24 month follow-up
Once existing data are massaged we will revise the stated outcome measure to make it more contemporary.
1 secondary outcome
Veterans Rand 12 Item Health Survey (VR-12)
Time frame: 12-24 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen M Ryan, MD principal investigator
Shriners Hospitals for Children and Massachusetts General Hospital
Jeffrey Schneider, MD study director
Massachusetts General Hospital and Spaulding Rehab Hospital
Tina Palmieri, MD study director
Shriners Hospitals or Children,University of CA at Davis
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Trauma, run by Massachusetts General Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Young Adult Outcomes Questionnaire (time frame: 12-24 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.