ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000231246

Ethics application status

Approved

Date submitted

29/11/2017

Date registered

12/02/2018

Date last updated

12/02/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Australia - Canada (AusCAN) Risk Scale for Pressure Injuries

Scientific title

AusCAN Risk Scale for sitting acquired pressure injuries for individuals with spinal cord injury: a multi site prospective study

Secondary ID [1]

NHMRC Project Grant 634388

Universal Trial Number (UTN)

U1111-1202-8492

Trial acronym

AusCAN Risk

Linked study record

Health condition

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

pressure injuries

spinal cord injury

deep tissue injury

Condition category

Condition code

Skin

Other skin conditions

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a prospective study of individuals who have acquired spinal cord injury who are followed and regularly assessed for 3 years or until they develop a sitting-acquired pressure injury (SAPI). At the time they develop a pressure injury, they are followed for 12 months or until their pressure injury is healed.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The development of a pressure injuries on the pelvis using the NPUAP Pressure Ulcer Classification System (2009)

Timepoint [1]

Both acute and chronic participants were contacted every 2 weeks by telephone to screen for the standardised signs of the primary outcome (pressure injury).

If these specific sign(s) were identified by the participant, an unscheduled visit was conducted to determine if a primary outcome was reached (NPUAP Pressure Ulcer Classification System, 2009).

Secondary outcome [1]

Spinal Cord Injury Severity - the American Spinal Injury Association Impairment Scale (ASI) will be determined. In the acute cohort, the ASI score will be completed at baseline, 3 months and 12 months. In the chronic cohort, a previous ASI score is valid if it has been completed within the past 5 years, otherwise, it will be completed at baseline.

Timepoint [1]

Acute group - assessed at Baseline, 3 months, 12 months.
Chronic group - assessed at Baseline.

Secondary outcome [2]

Genetic markers - A saliva sample will be taken for extraction of DNA. Initial sample screening will be done using pooled DNA (pools of 40 patient samples) on 2 genome wide association platforms. Candidate genes will be identified; these will be assessed on each individual sample using TaqMan SNP genotyping.

This is an exploratory outcome.

Timepoint [2]

Saliva collected at Baseline.
Genotyping within 3 months of the completion of data collection.

Secondary outcome [3]

Score on the Braden and SCIPUS Risk Assessments for the development of pressure ulcers.

Timepoint [3]

Acute participants: Baseline, 3, 6, 12, 18, 24, 30.
Chronic participants: Baseline, 12 months, 24 months.

Secondary outcome [4]

Level of function using Functional Independence Measure (FIM).

Timepoint [4]

Acute participants: Baseline, 6, 12, 24 months.
Chronic participants: Baseline, 12, 24 months.

Secondary outcome [5]

Degree of spasticity of the muscles of the hip/buttocks and lower limb – using modified Penn Spasm Frequency Scale and a Visual Analog Scale for spasticity intensity.

Timepoint [5]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [6]

Thickness of soft tissue under the ischial tuberosities of the pelvis - will be assessed by standard high frequency ultrasound by making similar measurements as have been made with the open MRI. Measures will be taken in a simulated sitting position.

Timepoint [6]

Acute participants: Baseline, 3, 6, 12, 18, 24, 30, 36 months.
Chronic participants: Baseline, 12, 24, 36 months.

Secondary outcome [7]

Body Mass Index and Waist Circumference will be measured and recorded.

Timepoint [7]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [8]

Wheelchair seating system – wheelchair, cushion and backrest will be documented and recorded, and the seat to back angle and the seat to floor angle will be measured.

Timepoint [8]

Acute Participants: Baseline, 3,6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [9]

Wheelchair posture – wheelchair posture will be documented using a standardised posture assessment that will include assessment of pelvic obliquity.

Timepoint [9]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [10]

Interface pressure mapping between the seating surface and the bony prominences using an FSA™ pressure mapping system. A standardised protocol will be used to calibrate the pressure mapping system and to record parameters from a map that is averaged from 1000 frames.

Timepoint [10]

Acute Participants: Baseline, 3,6,12,18,24,30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [11]

Cumulative sitting time will be estimated using a self report questionnaire from the participant for the week prior to each study visit. A questionnaire was designed for this study.

Timepoint [11]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [12]

Activity, support surface and transfer questionnaire – will be completed at each visit.

Timepoint [12]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [13]

Frequency of bladder incontinence - individuals will be asked the frequency of urinary incontinence during the previous month.

Timepoint [13]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [14]

Faecal incontinence - individuals will be asked the frequency of faecal incontinence during the previous month.

Timepoint [14]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [15]

Number of hours of paid and unpaid carer support per week using a questionnaire designed for this study.

Timepoint [15]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [16]

Quality of life measure – Two quality of life instruments, the WHOQOL-BREF and EQ-5D will be used to examine health-related quality of life.

Responses to the items in the WHOQOL-BREF and EQ-5D will be used to provide profile scores of health-related quality of life on the different dimensions of the instruments and to compute utility-based health-related quality of life scores.

Profile and utility scores will be used to establish the impact of spinal cord injury on the quality of life of individuals and to track changes over the follow-up period.
3. For individuals who develop SAPUs or suspected deep tissue injury, profile and utility scores will be used to assess the loss in health-related quality of life from SAPUs and suspected deep tissue injury. Modelling, based on changes in health-related quality of life for individuals who do not develop SAPUs and suspected deep tissue injury, will be used to account for the adjustment over time in quality of life following the sudden onset of spinal cord injury.

Timepoint [16]

Part A: Acute Participants: Baseline, 6, 12, 24 months.
Part A: Chronic Participants: Baseline, 12, 24 months.

Part B: for Acute and Chronic Participants with pressure injuries on the pelvis, they will be have the WHOQOL-BREF and EQ-5D at the following timepoints if they are enrolled in the study as per the protocol at: Time 0, Time 1 month, Time 3 months, Time 6 months, Time 12 months.

Secondary outcome [17]

Blood tests – Haemoglobin will be collected and recorded.

Timepoint [17]

Acute Participants: Baseline, 6, 12, 24 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [18]

Co-morbidities – Heart disease, diabetes, respiratory diseases, renal failure, liver failure, and any other diseases, will be recorded using a standardised measure: the Charlson Comorbidity Index is a composite tool being used.

Timepoint [18]

Acute Participants: Baseline, 6, 12, 24 months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [19]

Part B: Telephone contacts will be made until the pressure injury heals or there is resolution of the pressure ulcer or the suspected deep tissue injury using the NPUAP Pressure Ulcer Classification System (2009). At these contacts, the individual will be asked to report the treatments, investigations and costs that have occurred for the pressure ulcer or the suspected deep tissue injury. A checklist cost diary of treatments, investigations and costs will be used for data collection.

Timepoint [19]

Part B: All activities related to treating the pressure are collected from the Every 2 weeks until the pressure injury heals or 12 months is reached.

Secondary outcome [20]

Risk factors for abnormal tissue overlying the ischial tuberosity following spinal cord injury. A nested case-control design will be used within the AusCAN Risk Assessment for Sitting Acquired Pressure Ulcer prospective study. This study will identify the individuals who have confirmed abnormal soft tissue overlying their ischial tuberosity but without clinical evidence of a suspected deep tissue injury or a SAPU.

Timepoint [20]

Acute Participants: Baseline, 3, 6, 12, 18, 24, 30, 36 months.
Chronic Participants: Baseline, 12, 24, 36 months.

Secondary outcome [21]

SCI - date of injury

Timepoint [21]

Acute group - assessed at Baseline.
Chronic group - assessed at Baseline.

Secondary outcome [22]

Blood work - Haematocrit levels will be recorded

Timepoint [22]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [23]

Blood work: Creatinine will be recorded.

Timepoint [23]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [24]

Blood work: Random blood glucose will be recorded.

Timepoint [24]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [25]

Blood work: Albumin will be recorded.

Timepoint [25]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [26]

Blood work: total protein will be recorded.

Timepoint [26]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [27]

Blood work: C-reactive protein will be recorded.

Timepoint [27]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [28]

Blood work: Creatine kinase will be recorded.

Timepoint [28]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [29]

Blood work: Haemoglobin A1c levels will be recorded.

Timepoint [29]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [30]

The CAGE questionnaire to assess substance abuse and will be self-administered.

Timepoint [30]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [31]

Hospital Anxiety and Depression Scale will be self-administered.

Timepoint [31]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [32]

The Moorong Self Efficacy Scale will be self-administered.

Timepoint [32]

Acute Participants: Baseline, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [33]

Question on type of living environment using a questionnaire designed for this study.

Timepoint [33]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Secondary outcome [34]

Income source and level using a questionnaire designed for this study.

Timepoint [34]

Acute Participants: Baseline, 6, 12, 24, months.
Chronic Participants: Baseline, 12, 24 months.

Eligibility

Key inclusion criteria

Inclusion Criteria for Acute SCI Cohort
1. Individuals with acute spinal cord injury (either traumatic or secondary to medical conditions) resulting in permanent injury that requires them to use a wheelchair for mobility.
2. Individuals 18 years of age and older.
Inclusion Criteria for Chronic SCI Cohort
1. Individuals with a spinal cord injury (either traumatic or secondary to medical conditions) resulting in permanent injury of more than fifteen years that requires them to use a wheelchair for mobility.
2. No history of a stage III or IV sitting-acquired pressure ulcer.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria for Both Acute SCI and Chronic SCI Cohort
1. Individuals with spinal cord injury due to malignancy.
2. Individuals with myelomeningocoele.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Convenience sample

Timing

Statistical methods / analysis

Part A: Observational Study
The patients will be categorised into those who developed a SAPU, and those who did not. The data will be analysed as follows:
1. Demographic data will be compared between the two groups using direct comparisons by Chi-squared tests and Student’s T tests.
2. Measured risk factors will initially be compared between the two groups using univariate analyses. A Logistic regression analysis will be used to identify if any of the demographic or clinical variables (last measurements taken prior to first ulcer development or measurement at 30 months for those who never develop an ulcer) are associated with development of pressure ulcer at any time within the 3 year follow-up period. In order to account for any variation between Australia and Canada, the country of recruitment will be included as an additional independent variable. In the case that some variables are highly correlated (and therefore measure some similar underlying characteristic), standard Factor Analysis techniques will be used to identify a reduced set of factors which will take the place of these correlated variables in the regression models.
The Risk Factor Groups that will be considered for the analyses are:
a. Degree of impairment/activity limitation – ASIA motor score/impairment grade, FIM™, 5-AML, degree of spasticity
b. Nutritional status – BMI, waist circumference, prealbumin, serum albumin level
c. Local tissue status – curvature of the ischial tuberosities; thickness of muscle, fat and skin overlying the ischial tuberosities; and strain levels within soft tissues as computed using the Finite Element Method
d. Seating environment – seating system, seating posture, interface pressure mapping, cumulative sitting time, preventative strategies, bladder incontinence, bowel incontinence
e. Psychological factors – level of support from carers and family, substance abuse, educational level, depression/anxiety, locus of control, problem-solving abilities.
f. Co-morbidities – based on history (including traumatic brain injury), blood test results and genetic polymorphisms, Charlson Co-morbidity Index.
g. Injury Duration – acute SCI (within first 3 years) or chronic SCI (more than fifteen years post SCI)
h. Country – Australia or Canada
3. A Cox Proportional Hazards model with time-dependent covariates will be used to identify if any of the risk factors which may change during the course of the study may change the chance of an individual developing a pressure ulcer.
4. A risk assessment score will be calculated from the Logistic regression analysis, which is most closely associated with those patients who develop a SAPU. The sensitivity and specificity will be calculated using a range of different cut-off scores to predict ulcer development, and these will be used to construct a Receiver Operator Characteristic (ROC) curve. This curve will demonstrate the relationship between these quantities at different score cut-off points. The sensitivity and specificity for the Braden, Norton and Salzberg risk assessments will be compared with the figures obtained from this study.
5. Individuals who leave the study will be contacted and interviewed to determine if a SAPU occurred. Data acquired for this subgroup will be compared with that for patients who remained in the study, to determine if those who leave the study influence the study sample.

Part B: Health Economics
Health-Related Quality of Life
1. Responses to the items in the AQoL will be used to provide profile scores of health-related quality of life on the four dimensions of the instrument (independent living, social relationships, physical senses and psychological wellbeing) and to compute utility-based health-related quality of life scores. The latter will be calculated using the SPSS computer scoring algorithm that is available to users.
2. Profile and utility scores will be used to establish the impact of spinal cord injury on the quality of life of individuals and to track changes over the follow-up period. Australian population norms for the AQoL are available.
3. For individuals who develop SAPUs, profile and utility scores will be used to assess the loss in health-related quality of life from SAPUs. Modelling, based on changes in health-related quality of life for individuals who do not develop SAPUs, will be used to account for the adjustment over time in quality of life following the sudden onset of spinal cord injury.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

1/06/2011

Date of last participant enrolment

Anticipated

Actual

1/11/2016

Date of last data collection

Anticipated

1/11/2019

Actual

Sample size

Target

480

Accrual to date

Final

109

Recruitment in Australia

Recruitment state(s)

NSW,SA,WA

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [3]

Royal North Shore Hospital - St Leonards

Recruitment hospital [4]

Fremantle Hospital and Health Service - Fremantle

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment postcode(s) [3]

2065 - St Leonards

Recruitment postcode(s) [4]

6160 - Fremantle

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Ontario and Quebec

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Research Administration Section
National Health and Medical Research Council
GPO Box 1421
Canberra City,
ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Rick Hansen Institute

Address [2]

6400-818 West 10th Avenue
Vancouver BC V5Z 1M9

Country [2]

Canada

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Ontario Neurotrauma Foundation

Address [3]

90 Eglinton Avenue East, Suite 601
Toronto, Ontario, Canada
M4P 2Y3

Country [3]

Canada

Primary sponsor type

University

Name

University of Western Australia

Address

Mailbox M460,
Perth, Western Australia 6009

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Rick Hansen Institute

Address [1]

6400-818 West 10th Avenue
Vancouver BC V5Z 1M9

Country [1]

Canada

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Ontario Neurotrauma Foundation

Address [2]

90 Eglinton Avenue East, Suite 601
Toronto, Ontario, Canada
M4P 2Y3

Country [2]

Canada

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service - Human Research Ethics Committee

Ethics committee address [1]

Level 3, Harry Perkins building, Fiona Stanley Hospital Campus, 11 Robin Warren Drive
MURDOCH WA 6150
Locked Bag 100, PALMYRA DC WA 6961

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/04/2010

Approval date [1]

10/05/2010

Ethics approval number [1]

10/101

Summary

Brief summary

This is a prospective study of individuals who have acquired spinal cord injury. Part 1 is a prospective study that will identify risk factors associated with the development of a sitting acquired pressure injuries (SAPi) in acute and chronic cohorts with SCI. Part 2 will assess individuals who develop a SAPU to measure the loss of health related quality of life and to quantify the costs of treating their SAPi. Subjects will be recruited from 6 sites – 3 state spinal cord injury units in Australia and 3 in Canada and it is intended that 480 subjects will complete the study. 240 will be acute (first 3 years post SCI) and 240 will be chronic (more than 15 years post SCI). Both cohorts will be followed and 9 Risk Factor Groups will be measured – degree of impairment/activity limitation, nutritional status, local tissue status including cutting edge ultrasound and Finite Element Modelling, wheelchair seating environment, psychological factors, co-morbidities, injury duration and country. Those factors that are significantly associated with the development of a pressure injury will be identified through Logistic regression modelling and a risk assessment tool will be derived.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Jillian M Swaine

Address

Institute for Health Research
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle WA 6959

Country

Australia

Phone

+61 8 6151 1226

Fax

+61 8 9433 0210

[email protected]

Contact person for public queries

Name

A/Prof Jillian M Swaine

Address

Institute for Health Research
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle WA 6959

Country

Australia

Phone

+61 8 6151 1226

Fax

+61 8 9433 0210

[email protected]

Contact person for scientific queries

Name

A/Prof Jillian M Swaine

Address

Institute for Health Research
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle WA 6959

Country

Australia

Phone

+61 8 6151 1226

Fax

+61 8 9433 0210

[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

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Ultrasound imaging of tissue overlying the ischial tuberosity: Does patient position matter?.	2019	https://dx.doi.org/10.1016/j.jtv.2019.07.001

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

Trial Review

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