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Trial registered on ANZCTR


Registration number
ACTRN12616000828426
Ethics application status
Approved
Date submitted
7/06/2016
Date registered
23/06/2016
Date last updated
18/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychosocial outcomes post-major burn injuries in adults – a longitudinal exploratory study.
Scientific title
Psychosocial outcomes post-major burn injuries in adults – a longitudinal exploratory study.
Secondary ID [1] 289525 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns 299016 0
Condition category
Condition code
Injuries and Accidents 299075 299075 0 0
Burns
Mental Health 299241 299241 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Consenting hospitalised burns patients are contacted 3 months, 6 months and 12 months post-injury to measure Quality of Life outcomes; encompassing functional, psychological, social and life satisfaction domains, as well as health utility.
Intervention code [1] 294966 0
Not applicable
Comparator / control treatment
No control group - this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298548 0
Quality of Life - measured by 8 scales (PHQ-9,PCL-C, PAS, SF-12, BSHS-B, EQ-5D, CIQ-R,
BSHS-B



Timepoint [1] 298548 0
3, 6 and 12 months post date of injury
Secondary outcome [1] 324545 0
Health utility (measured by Quality Adjusted Life Years - EQ-5D)
Timepoint [1] 324545 0
12 months post date of injury

Eligibility
Key inclusion criteria
1. Admitted for at least 24 hours as an initial hospitalisation to the Professor Stuart Pegg Adult Burns Unit at the Royal Brisbane and Women’s Hospital.
2. Sustained a major burn injury defined as affecting greater than 10% of the Total Body Surface Area unless affecting the hands, feet, face or perineum, the presence of airway or inhalation injury, or any burn injury requiring specialist multi-disciplinary care in a burn centre.
3. Aged 18 years or over in order to legally provide consent for participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who lack the requisite medico-legal capacity to provide consent to participate — for example, those with a significant acquired brain injury, dementia, congenital intellectual disability, cognitive impairment, psychosis/incapacitating psychiatric illness. This determination will be sought from treating medical staff. The selected self-report measures have not been validated for proxy reporting, precluding the inclusion of incapacitated participants.
2. Participants who are being treated in the burns unit for skin disorders or conditions that are not related to a burn/thermal injury.
3. Burns patients who are admitted for subsequent treatment of a previously sustained injury.
4. Burns patients who are not domiciled in Australia for the 12-month period of follow-up.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Continuous data will be expressed as mean and standard deviation (SD) values. Categorical data will be expressed as frequencies and percentages. The statistical methods used will be analysis of variance (ANOVA) and Pearson correlation to explore the associated factors with QoL outcomes. Hierarchical multiple regression analyses (and possibly Structural Equation Modeling) will be used to test the predictability of injury, treatment, personal and environmental factors on QoL outcomes. All statistical analyses will be two-tailed and considered significant at p<.05.
The target sample size for this study was estimated using Epi Info online software (https://wwwn.cdc.gov/epiinfo/7/index.htm) with Quality of Life as the primary outcome. Input values for the sample size calculation were based on a of 5%, a standard power of 90%, with a large effect size, and incidence or exposure estimates as follows. The expected incidence of poor Quality of Life in the burns population with good social resources is 20%, and for those with poor social resources is 50%, based on reported figures in the OECD Better Life Index and conventional calculations from injury and disease epidemiology literature, with a ratio of exposed to unexposed participants estimated at 2.5. These input values yield a sample size calculation of 138. Allowing for 40% attrition, which is reported in the burns literature, a final sample size of 230 is required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
30/06/2018
Actual
3/04/2017
Date of last data collection
Anticipated
Actual
26/03/2018
Sample size
Target
230
Accrual to date
Final
274
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5919 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13367 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 293760 0
Hospital
Name [1] 293760 0
Professor Stuart Pegg Adult Burn Centre, Royal Brisbane and Women's Hospital
Country [1] 293760 0
Australia
Funding source category [2] 293899 0
Charities/Societies/Foundations
Name [2] 293899 0
Red Blanket Miracle (affiliated with RBWH Foundation)
Country [2] 293899 0
Australia
Primary sponsor type
Individual
Name
Martha Druery
Address
PO Box 94
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 292589 0
None
Name [1] 292589 0
None
Address [1] 292589 0
None
Country [1] 292589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295195 0
Human Research Ethics Committee Metro North Hospital and Health Service
Ethics committee address [1] 295195 0
Ethics committee country [1] 295195 0
Australia
Date submitted for ethics approval [1] 295195 0
25/03/2015
Approval date [1] 295195 0
03/06/2015
Ethics approval number [1] 295195 0
HREC/15/QRBW/145
Ethics committee name [2] 295196 0
Behavioural Social Sciences Ethics Review Committee, University of Queensland
Ethics committee address [2] 295196 0
Ethics committee country [2] 295196 0
Australia
Date submitted for ethics approval [2] 295196 0
29/06/2015
Approval date [2] 295196 0
13/07/2015
Ethics approval number [2] 295196 0
2015001089

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66466 0
Ms Martha Druery
Address 66466 0
c/- ICU Admin
Level 3 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029
Country 66466 0
Australia
Phone 66466 0
+61 7 3646 4096
Fax 66466 0
+61 7 3646 3542
Email 66466 0
[email protected]
Contact person for public queries
Name 66467 0
Martha Druery
Address 66467 0
c/- ICU Admin
Level 3 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029
Country 66467 0
Australia
Phone 66467 0
+61 7 3646 4096
Fax 66467 0
+61 7 3646 3542
Email 66467 0
[email protected]
Contact person for scientific queries
Name 66468 0
Martha Druery
Address 66468 0
c/- ICU Admin
Level 3 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029
Country 66468 0
Australia
Phone 66468 0
+61 7 3646 4096
Fax 66468 0
+61 7 3646 3542
Email 66468 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFactors influencing psychological, social and health outcomes after major burn injuries in adults: Cohort study protocol.2017https://dx.doi.org/10.1136/bmjopen-2017-017545
N.B. These documents automatically identified may not have been verified by the study sponsor.