ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001702101

Ethics application status

Approved

Date submitted

18/09/2019

Date registered

3/12/2019

Date last updated

3/12/2019

Date data sharing statement initially provided

3/12/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Improving quality of life and resilience in adults with spinal cord injury who also have cognitive impairment.

Scientific title

Improving rehabilitation outcomes in adults with spinal cord injury (SCI) who have cognitive impairment: a prospective study.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

SCI Cog Study

Linked study record

Health condition

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

Spinal Cord Injury

Cognitive impairment

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

Other injuries and accidents

Mental Health

Other mental health disorders

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is an observational and longitudinal study. A validated cognitive test standardised for SCI, known as Neuropsychiatry Unit Cognitive Assessment Tool (NUCOG) will be used to determine presence and severity of cognitive impairment. Based on the NUCOG assessment score, participants will be allocated to either those with cognitive impairment (cog-imp) group or those without cognitive impairment (ncog-imp) group.

Participants allocated to cog-imp group will be assessed over 1 year at three different timepoints. Three assessment visits are - at admission to rehabilitation; at discharge from rehabilitation; and 12-month post injury. Each assessment visit will involve the following components:
1. A 35 minutes face-to-face cognitive assessment during which participants will be evaluated for their cognitive capacity;
2. A 50 minutes online bio-psychosocial assessment collecting measures like sociodemographic factors, injury-related factors, quality of life, pain, and psychosocial variables such as social support and depressive mood (further details in outcome section).
3. A 20-minute autonomic assessment to test autonomic functioning and imbalance between sympathetic and para- sympathetic nervous system.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

This group will include participants with non-cognitive impairment. All assessments and timepoints remain the same as it is for the cog-imp group.

Control group

Active

Outcomes

Primary outcome [1]

Outcome: Extent and severity of cognitive impairments
Outcome measure: Neuropsychiatry Unit Cognitive Assessment (NUCOG) tool

Timepoint [1]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [1]

Outcome: Psychological measures
Outcome measure: Generalised Anxiety Disorder Scale

Timepoint [1]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [2]

Outcome: Psychological measures
Outcome measure: Patient Health Questionnaire-9

Timepoint [2]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [3]

Outcome: Psychological measures
Outcome measure: Post-traumatic Stress Disorder Checklist (PCL-5) - Short form

Timepoint [3]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [4]

Outcome: Psychosocial measures
Outcome measure: ISCoS Basic Pain dataset

Timepoint [4]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [5]

Outcome: Psychosocial measures
Outcome measure: Pain Catastrophizing Scale

Timepoint [5]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [6]

Outcome: Psychosocial measures
Outcome measure: Fatigue Severity Scale

Timepoint [6]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [7]

Outcome: Psychosocial measures
Outcome measure: Pittsburgh Sleep Quality Assessment

Timepoint [7]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [8]

Outcome: Psychosocial measures
Outcome measure: Berlin Questionnaire

Timepoint [8]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [9]

Outcome: Personal factors measures
Outcome measure: Coping Orientation to Problems Experienced (COPE) inventory - Brief version

Timepoint [9]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [10]

Outcome: Personal factors measures
Outcome measure: Moorong Self-efficacy Scale

Timepoint [10]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [11]

Outcome: Personal factors measures
Outcome measure: Connor-Davidson Resilience Scale - Short Form

Timepoint [11]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [12]

Outcome: Environmental factors
Outcome measure: Carer and family support questionnaire (2 items), designed especially for this study.

Timepoint [12]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [13]

Outcome: Environmental factors
Outcome measure: Compensation status questionnaire (2 items), designed especially for this study.

Timepoint [13]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [14]

Outcome: Quality of life
Outcome measure: Euro Quality of Life 5-Dimensional 5-level

Timepoint [14]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [15]

Outcome: Vital signs
Outcome measure: Heart rate from the patient's medical notes

Timepoint [15]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [16]

Outcome: Autonomic assessment
Outcome measure: ECG-derived heart rate variability using Bio-semi Active 2.

Timepoint [16]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [17]

Outcome: Participation
Outcome measure: World Health Organisation Disability Assessment Scale (WHODAS) participation domain

Timepoint [17]

12 months post-injury (in the community)

Secondary outcome [18]

Outcome: Participation
Outcome measure: Return to Work questionnaire

Timepoint [18]

12 months post-injury (in the community)

Secondary outcome [19]

Outcome: Pre-injury health care utilisation (including medications)
Outcome measure: Linkage to healthcare databases (e.g. PBS and MBS).

Timepoint [19]

Pre-injury: up to 5 years

Secondary outcome [20]

Outcome: Post-injury health care utilisation (including medications)
Outcome measure: Linkage to healthcare databases (e.g. PBS and MBS).

Timepoint [20]

Post-injury: 12 months

Secondary outcome [21]

Outcome: Psychosocial measures
Outcome measure: Social Support Questionnaire (SSQ6) - Short form

Timepoint [21]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [22]

Outcome: Secondary Health Condition
Outcome measure: Spinal Cord Injury - Secondary Condition Scale

Timepoint [22]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [23]

Outcome: Personal factors
Outcome measure: The Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST) - Short version

Timepoint [23]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [24]

Outcome: Personal factors
Outcome measure: The Appraisal of Disability: Primary and Secondary Scale (ADAPSS) - brief version

Timepoint [24]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [25]

Outcome: Psychological measure
Outcome measure: Test of Pre-morbid Functioning

Timepoint [25]

Baseline: At rehab admission

Secondary outcome [26]

Outcome: Autonomic assessment
Outcome measure: Skin Conductance using Bio-semi Active 2

Timepoint [26]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [27]

Outcome: Autonomic assessment
Outcome measure: Peripheral Blood flow using Bio-semi Active 2

Timepoint [27]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [28]

Outcome: Autonomic assessment
Outcome measure: Respiration using Bio-semi Active 2

Timepoint [28]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [29]

Outcome: Autonomic assessment
Outcome measure: Peripheral Temperature using Bio-semi Active 2

Timepoint [29]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [30]

Outcome: Vital signs
Outcome measure: Respiratory rate from the patient's medical notes

Timepoint [30]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [31]

Outcome: Vital signs
Outcome measure: Body temperature from the patient's medical notes

Timepoint [31]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [32]

Outcome: Vital signs
Outcome measure: Blood pressure from the patient's medical notes

Timepoint [32]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Secondary outcome [33]

Outcome: Vital signs
Outcome measure: Pain VAS (0 to 10), where '0' means 'no pain' and '10' means 'extreme pain'

Timepoint [33]

1. Baseline: At rehab admission
2. Follow-up #1: At discharge
3. Follow-up #2: 12 months post-injury (in the community)

Eligibility

Key inclusion criteria

A participant will be included if he/she:
a. is 17 years or older and = 80 years;
b. has an acute SCI (i.e. less than 48 hours SCI), due to any cause (traumatic or non-traumatic);
c. admitted to rehabilitation at one of the participating sites and who will complete rehabilitation and be discharged into the community;
d. has competency in English.

Minimum age

17 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

A participant will be excluded if he/she has:
a. any clinically significant medical condition that would compromise participation in the study such as severe dementia (e.g. Alzheimer’s disease) or major psychiatric disorders (e.g. psychotic disorders)
b. a severe co-morbid traumatic brain injury such that they cannot understand instructions or assessments.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Descriptive statistics will be generated for the continuous variables measured in the study. Linear mixed model repeated measures analyses will be used to determine within and between-group differences. Multivariate regression models will be employed to provide information on factors that contribute to or predict cognitive impairment in people with SCI, and arguably, such information will be critical for effective clinical decision-making.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

16/12/2019

Actual

Date of last participant enrolment

Anticipated

30/03/2021

Actual

Date of last data collection

Anticipated

31/03/2022

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Prince of Wales Hospital - Randwick

Recruitment hospital [3]

Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2031 - Randwick

Recruitment postcode(s) [3]

2112 - Ryde

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

icare NSW

Address [1]

icare NSW
321, Kent Street
Sydney NSW 2000

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital
10, Westbourne St
St Leonards NSW 2065.

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]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

NSLHD Research Office, 
Level 13 Kolling Building, 
Royal North Shore Hospital, 
St Leonards, NSW, 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/03/2019

Approval date [1]

24/06/2019

Ethics approval number [1]

2019/ETH00592

Summary

Brief summary

Spinal cord injury (SCI) is a life-changing severe injury resulting in substantial physical/psychological impairment. While significant research has investigated adjustment following SCI, very little is known about how co-morbid cognitive impairment impacts adjustment. It is believed around 50% of people with an SCI may have significant levels of cognitive impairment. 

Therefore, the major objective of this proposal is to (1) provide conclusive information about the extent and causes of cognitive impairment in adults with SCI; (2) to improve the clinical skills of rehabilitation teams to detect and manage cognitive impairment during the rehabilitation phase by developing multidisciplinary guidelines and strategies for use in the SCI rehabilitation phase, targeted at those with cognitive impairment.

Trial website

None

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

Prof Ashley Craig

Address

Professor of Rehabilitation Studies
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital
10, Westbourne St
St Leonards NSW 2065.

Country

Australia

Phone

+61 02 99264925

Fax

+61 02 99264045

[email protected]

Contact person for public queries

Name

Mohit Arora

Address

Postdoctoral Research Fellow
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine and Health, The University of Sydney
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital
10, Westbourne St
St Leonards NSW 2065.

Country

Australia

Phone

+61 02 99264772

Fax

+61 02 99264045

[email protected]

Contact person for scientific queries

Name

Ashley Craig

Address

Country

Australia

Phone

+61 02 99264925

Fax

+61 02 99264045

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Non-identifiable individual participant data of primary outcomes only.

When will data be available (start and end dates)?

At the end of the study (anticipated date: March 2022) until data retained by a journal (as per there data retention policy), where the results of the study will be published.

Available to whom?

Collaborators and independent researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.

Available for what types of analyses?

For future meta-analyses only.

How or where can data be obtained?

From the repository of journals where the results of the study will be published. Please note, part of this project also comprises part of a PhD thesis and may be obtained from The University of Sydney repository.

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	A prospective cohort study investigating contributors to mild cognitive impairment in adults with spinal cord injury: Study protocol.	2020	https://dx.doi.org/10.1186/s12883-020-01899-7

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

Trial Review

Documents added manually

Documents added automatically