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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] 298644 0
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 313533 0
Cognitive impairment 313534 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311965 311965 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 312999 312999 0 0
Other injuries and accidents
Mental Health 313000 313000 0 0
Other mental health disorders
Neurological 313001 313001 0 0
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] 314910 0
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] 320619 0
Outcome: Extent and severity of cognitive impairments
Outcome measure: Neuropsychiatry Unit Cognitive Assessment (NUCOG) tool
Timepoint [1] 320619 0
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] 372219 0
Outcome: Psychological measures
Outcome measure: Generalised Anxiety Disorder Scale
Timepoint [1] 372219 0
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] 372220 0
Outcome: Psychological measures
Outcome measure: Patient Health Questionnaire-9
Timepoint [2] 372220 0
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] 374938 0
Outcome: Psychological measures
Outcome measure: Post-traumatic Stress Disorder Checklist (PCL-5) - Short form
Timepoint [3] 374938 0
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] 375454 0
Outcome: Psychosocial measures
Outcome measure: ISCoS Basic Pain dataset
Timepoint [4] 375454 0
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] 375455 0
Outcome: Psychosocial measures
Outcome measure: Pain Catastrophizing Scale
Timepoint [5] 375455 0
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] 375457 0
Outcome: Psychosocial measures
Outcome measure: Fatigue Severity Scale
Timepoint [6] 375457 0
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] 375458 0
Outcome: Psychosocial measures
Outcome measure: Pittsburgh Sleep Quality Assessment
Timepoint [7] 375458 0
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] 375459 0
Outcome: Psychosocial measures
Outcome measure: Berlin Questionnaire
Timepoint [8] 375459 0
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] 375460 0
Outcome: Personal factors measures
Outcome measure: Coping Orientation to Problems Experienced (COPE) inventory - Brief version
Timepoint [9] 375460 0
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] 375462 0
Outcome: Personal factors measures
Outcome measure: Moorong Self-efficacy Scale
Timepoint [10] 375462 0
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] 375463 0
Outcome: Personal factors measures
Outcome measure: Connor-Davidson Resilience Scale - Short Form
Timepoint [11] 375463 0
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] 375464 0
Outcome: Environmental factors
Outcome measure: Carer and family support questionnaire (2 items), designed especially for this study.
Timepoint [12] 375464 0
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] 375465 0
Outcome: Environmental factors
Outcome measure: Compensation status questionnaire (2 items), designed especially for this study.
Timepoint [13] 375465 0
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] 375466 0
Outcome: Quality of life
Outcome measure: Euro Quality of Life 5-Dimensional 5-level
Timepoint [14] 375466 0
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] 375469 0
Outcome: Vital signs
Outcome measure: Heart rate from the patient's medical notes
Timepoint [15] 375469 0
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] 375470 0
Outcome: Autonomic assessment
Outcome measure: ECG-derived heart rate variability using Bio-semi Active 2.
Timepoint [16] 375470 0
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] 375471 0
Outcome: Participation
Outcome measure: World Health Organisation Disability Assessment Scale (WHODAS) participation domain
Timepoint [17] 375471 0
12 months post-injury (in the community)
Secondary outcome [18] 375472 0
Outcome: Participation
Outcome measure: Return to Work questionnaire
Timepoint [18] 375472 0
12 months post-injury (in the community)
Secondary outcome [19] 375473 0
Outcome: Pre-injury health care utilisation (including medications)
Outcome measure: Linkage to healthcare databases (e.g. PBS and MBS).
Timepoint [19] 375473 0
Pre-injury: up to 5 years
Secondary outcome [20] 375474 0
Outcome: Post-injury health care utilisation (including medications)
Outcome measure: Linkage to healthcare databases (e.g. PBS and MBS).
Timepoint [20] 375474 0
Post-injury: 12 months
Secondary outcome [21] 376959 0
Outcome: Psychosocial measures
Outcome measure: Social Support Questionnaire (SSQ6) - Short form
Timepoint [21] 376959 0
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] 376960 0
Outcome: Secondary Health Condition
Outcome measure: Spinal Cord Injury - Secondary Condition Scale
Timepoint [22] 376960 0
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] 376961 0
Outcome: Personal factors
Outcome measure: The Alcohol, Smoking and Substance Involvement Screening Test (WHO ASSIST) - Short version
Timepoint [23] 376961 0
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] 376962 0
Outcome: Personal factors
Outcome measure: The Appraisal of Disability: Primary and Secondary Scale (ADAPSS) - brief version
Timepoint [24] 376962 0
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] 377285 0
Outcome: Psychological measure
Outcome measure: Test of Pre-morbid Functioning
Timepoint [25] 377285 0
Baseline: At rehab admission
Secondary outcome [26] 377478 0
Outcome: Autonomic assessment
Outcome measure: Skin Conductance using Bio-semi Active 2
Timepoint [26] 377478 0
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] 377479 0
Outcome: Autonomic assessment
Outcome measure: Peripheral Blood flow using Bio-semi Active 2
Timepoint [27] 377479 0
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] 377480 0
Outcome: Autonomic assessment
Outcome measure: Respiration using Bio-semi Active 2
Timepoint [28] 377480 0
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] 377481 0
Outcome: Autonomic assessment
Outcome measure: Peripheral Temperature using Bio-semi Active 2
Timepoint [29] 377481 0
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] 377482 0
Outcome: Vital signs
Outcome measure: Respiratory rate from the patient's medical notes
Timepoint [30] 377482 0
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] 377483 0
Outcome: Vital signs
Outcome measure: Body temperature from the patient's medical notes
Timepoint [31] 377483 0
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] 377484 0
Outcome: Vital signs
Outcome measure: Blood pressure from the patient's medical notes
Timepoint [32] 377484 0
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] 377485 0
Outcome: Vital signs
Outcome measure: Pain VAS (0 to 10), where '0' means 'no pain' and '10' means 'extreme pain'
Timepoint [33] 377485 0
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?
No
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] 14136 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 14137 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 14809 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 26948 0
2065 - St Leonards
Recruitment postcode(s) [2] 26949 0
2031 - Randwick
Recruitment postcode(s) [3] 28059 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 303184 0
Government body
Name [1] 303184 0
icare NSW
Country [1] 303184 0
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] 304122 0
None
Name [1] 304122 0
None
Address [1] 304122 0
None
Country [1] 304122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303746 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 303746 0
Ethics committee country [1] 303746 0
Australia
Date submitted for ethics approval [1] 303746 0
23/03/2019
Approval date [1] 303746 0
24/06/2019
Ethics approval number [1] 303746 0
2019/ETH00592

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

Contacts
Principal investigator
Name 94654 0
Prof Ashley Craig
Address 94654 0
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 94654 0
Australia
Phone 94654 0
+61 02 99264925
Fax 94654 0
+61 02 99264045
Email 94654 0
[email protected]
Contact person for public queries
Name 94655 0
Mohit Arora
Address 94655 0
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 94655 0
Australia
Phone 94655 0
+61 02 99264772
Fax 94655 0
+61 02 99264045
Email 94655 0
[email protected]
Contact person for scientific queries
Name 94656 0
Ashley Craig
Address 94656 0
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 94656 0
Australia
Phone 94656 0
+61 02 99264925
Fax 94656 0
+61 02 99264045
Email 94656 0
[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
SourceTitleYear of PublicationDOI
EmbaseA prospective cohort study investigating contributors to mild cognitive impairment in adults with spinal cord injury: Study protocol.2020https://dx.doi.org/10.1186/s12883-020-01899-7
N.B. These documents automatically identified may not have been verified by the study sponsor.