Clinical trial NCT02950675: The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study
Official title: The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn
Keywords: Burn patient
Developmental Disabilities
Body function
Participation
Quality of Life
longitudinal study
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 79
Sex: ALL
Minimum age (years): 14
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
timeFrame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Secondary outcomes:
measure: Change in muscle strength change in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
timeFrame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
measure: Change in activities of daily living in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
timeFrame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
measure: Change in individual independency in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
timeFrame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
measure: Change in quality of life in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
timeFrame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Katie P Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: