BurnsNCT00253292
Psychometric Study of Outcomes Instruments
An observational study of Burns and Trauma, run by Massachusetts General Hospital at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 1997to Dec 2007
- 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: Patients admitted to the MGH burn unit for a burn injury between the ages of 19-30 years.
Who may be able to join
- 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
Who cannot join
- Non-burned skin conditions
- Non-English speaking
- Patients less than 19 years of age
- Patients over 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
Jaycee Burn Center,UNC Healthcare
Chapel Hill, North Carolina, 27599-7050
Shriners Hospitals 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
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.
Read the 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.
- Keywords
- Burns, Trauma, Outcomes, Quality of Life
- Medical subject headings
- Burns, Wounds and Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJan 1997
- Study completionDec 2007
Why it stopped: Unable to recruit necessary sample size
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Investigators
- Ronald G. Tompkins, MD, ScD, Principal investigator, MGH, Shriners Burn Hospital - Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253292
- Sponsor's protocol ID
- 1999-P-008281/15
- Status last verified
- Jul 2011
- First submitted
- 11 Nov 2005
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Study of Outcomes Instruments
- ClinicalTrials.gov ID
- NCT00253292
- Acronym / sponsor ID
- 1999-P-008281/15
- Keywords
- Burns, Trauma, Outcomes, Quality of Life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit necessary sample size
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Shriners Hospitals for Children
- Study start
- Jan 1997
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Nov 2005 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients admitted to the MGH burn unit for a burn injury between the ages of 19-30 years.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Non-burned skin conditions
- Non-English speaking
- Patients less than 19 years of age
- Patients over 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.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Unable to recruit necessary sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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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.
Ronald G. Tompkins, MD, ScD principal investigator
MGH, Shriners Burn Hospital - Boston
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Jul 2011. 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 was stopped early (reason given: Unable to recruit necessary sample size). Results are not available in the source record.
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.
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 28 Jul 2011.