BurnNCT02950675
The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study
An observational study of Burn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The relationship of body function, participation and quality of life in patients with burn: A longitudinal study Read more about this study
- Who is it for?
- Ages 14 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn
- How many people
- 79 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2016to Jul 2019
- 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 14 to 74 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigators will have Normal Adult (n=30~40) and Burn Patient (n=80-90) from 14-74 years old under consent of their family.
Who may be able to join
- Clinical diagnosis of burn injuries admitted to Burn Center or followed in burn clinic
- Age >14
- No mental diseases
- Understand written Chinese or could complete the questionnaires with staff's assistance
Who cannot join
- Died during or after hospitalization
- Refused to participate in the investigation
- Concurrent medical illness that affecting the subjectivity of post burn sequelae (ex. progressive muscular or mental diseases, trauma or seizure)
- Age >74
Trial locations and contacts
1 site in 1 country.
About this study
The relationship of body function, participation and quality of life in patients with burn: A longitudinal study
Read the detailed description
Early rehabilitation to partial-thickness and full-thickness dermal injury are of vital importance for burn patient. Literature reviews have shown that burn patients experiences ADL and quality of life (QOL) difficulties. Due to varied severity, the outcome and expression of each patient also differs. The limitation of body function may consequently affect social participation and QOL thereafter.
- Conditions
- Burn
- Keywords
- Burn patient, Developmental Disabilities, Body function, Participation, Quality of Life, longitudinal study
- Medical subject headings
- Burns, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Adult | Control:Normal Adult | |
| Burn Patient | The burn patient will be identified according to the diagnoses (ICD-9-CM code: 940-949). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Vancouver Scar Scale (VSS)
Measured: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Secondary outcomes (4)
Change in muscle strength change in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
MicroFET
Measured: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in activities of daily living in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Functional Independence Measure (FIM)
Measured: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in individual independency in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Manual for the Care and Needs Scale
Measured: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in quality of life in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
The Burn-Specific Health Scale-Brief
Measured: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie P Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950675
- Sponsor's protocol ID
- 104-9848B
- Status last verified
- Jan 2019
- First submitted
- 10 Oct 2016
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT02950675
- Acronym / sponsor ID
- 104-9848B
- Conditions
- Burn
- Keywords
- Burn patient, Developmental Disabilities, Body function, Participation, Quality of Life, longitudinal study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Nov 2016 (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 relationship of body function, participation and quality of life in patients with burn: A longitudinal study
Detailed description
Early rehabilitation to partial-thickness and full-thickness dermal injury are of vital importance for burn patient. Literature reviews have shown that burn patients experiences ADL and quality of life (QOL) difficulties. Due to varied severity, the outcome and expression of each patient also differs. The limitation of body function may consequently affect social participation and QOL thereafter.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Adult | – | –Control:Normal Adult |
| Burn Patient | – | –The burn patient will be identified according to the diagnoses (ICD-9-CM code: 940-949). |
Who may qualify
- Ages
- 14 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators will have Normal Adult (n=30~40) and Burn Patient (n=80-90) from 14-74 years old under consent of their family.
Key inclusion criteria (4 listed)
- Clinical diagnosis of burn injuries admitted to Burn Center or followed in burn clinic
- Age >14
- No mental diseases
- Understand written Chinese or could complete the questionnaires with staff's assistance
Key exclusion criteria (4 listed)
- Died during or after hospitalization
- Refused to participate in the investigation
- Concurrent medical illness that affecting the subjectivity of post burn sequelae (ex. progressive muscular or mental diseases, trauma or seizure)
- Age >74
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
Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Vancouver Scar Scale (VSS)
4 secondary outcomes
Change in muscle strength change in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in activities of daily living in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in individual independency in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in quality of life in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
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 2 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Katie P Wu, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up (time frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month). 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 2 Feb 2021.