ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burns

Condition category

Condition code

Injuries and Accidents

Burns

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group - this is an observational study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Quality of Life - measured by 8 scales (PHQ-9,PCL-C, PAS, SF-12, BSHS-B, EQ-5D, CIQ-R,
BSHS-B

Timepoint [1]

3, 6 and 12 months post date of injury

Secondary outcome [1]

Health utility (measured by Quality Adjusted Life Years - EQ-5D)

Timepoint [1]

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?

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]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Professor Stuart Pegg Adult Burn Centre, Royal Brisbane and Women's Hospital

Address [1]

Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Red Blanket Miracle (affiliated with RBWH Foundation)

Address [2]

PO Box 94
Royal Brisbane and Women's Hospital
Herston Qld 4029

Country [2]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee Metro North Hospital and Health Service

Ethics committee address [1]

Level 7 Block 7 Butterfield Street
Herston Qld 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/03/2015

Approval date [1]

03/06/2015

Ethics approval number [1]

HREC/15/QRBW/145

Ethics committee name [2]

Behavioural Social Sciences Ethics Review Committee, University of Queensland

Ethics committee address [2]

University of Queensland Research and Innovation
Cumbrae-Stewart Building (#72)
BRISBANE QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

29/06/2015

Approval date [2]

13/07/2015

Ethics approval number [2]

2015001089

Summary

Brief summary

This project is an observational prospective longitudinal cohort study with a correlational analysis to quantitatively explore the relationship between burns outcomes and domains such as injury, treatment, personal (individual) and social (environmental) factors. The objective is to identify factors that impede quality of life outcomes post-major burn in adults, in order to inform multidisciplinary clinical models of care that can target the most powerful determinants of outcome.

There has been a paucity of research specifically investigating the relationship between the social factors identified to increase risk of burns and the quality of life outcomes associated with these factors. It has been found that injury severity and burns treatment factors are less predictive of injury outcome than social factors such as level of education and income. However, the reliability of this evidence has been limited due to retrospective study designs and small sample sizes. The aim of this study is to prospectively evaluate various factors that have been previously evidenced to influence aspects of recovery such as functional or mental health outcomes. It will endeavour to determine which of the variables are significantly associated with and have the greatest explanatory power to predict long term quality of life outcomes. These will be investigated in terms of individual outcomes as well as broader societal burden of injury outcomes.

In this study, patients admitted to the Royal Brisbane and Women’s Hospital following a burn injury will be enrolled with consent. They will be invited to answer a researcher-led 15 minute questionnaire within the first two weeks of their burn injury or when they resume capacity to consent. For a proportion of participants there will be an initial period of incapacity due to sedation and intubation or delirium. This survey will be about life before their burn injury. They will then be phoned by the researcher at 3 months, 6 months and 12 months post-burn to answer further survey questions which are anticipated to take 45 minutes per time-point. Other injury and treatment related information will be sourced from the Royal Brisbane and Women’s Hospital Burns Database and the medical record, with participant consent.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Martha Druery

Address

c/- ICU Admin
Level 3 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029

Country

Australia

Phone

+61 7 3646 4096

Fax

+61 7 3646 3542

m.druery@uq.edu.au

Contact person for public queries

Name

Martha Druery

Address

c/- ICU Admin
Level 3 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029

Country

Australia

Phone

+61 7 3646 4096

Fax

+61 7 3646 3542

m.druery@uq.edu.au

Contact person for scientific queries

Name

Martha Druery

Address

c/- ICU Admin
Level 3 Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston Road
HERSTON QLD 4029

Country

Australia

Phone

+61 7 3646 4096

Fax

+61 7 3646 3542

m.druery@uq.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Factors influencing psychological, social and health outcomes after major burn injuries in adults: Cohort study protocol.	2017	https://dx.doi.org/10.1136/bmjopen-2017-017545

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically