Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001483145
Ethics application status
Approved
Date submitted
13/10/2019
Date registered
28/10/2019
Date last updated
14/02/2020
Date data sharing statement initially provided
28/10/2019
Date results information initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The ARISE trial: Arthroplasty Rehabilitation Initial Screening Evaluation tool used to determine prognostic patient factors for discharge destination following primary total knee replacement surgery.
Scientific title
The ARISE trial: Arthroplasty Rehabilitation Initial Screening Evaluation tool used to determine prognostic patient factors for discharge destination following primary total knee replacement surgery.
Secondary ID [1] 299538 0
None
Universal Trial Number (UTN)
Trial acronym
ARISE (Arthroplasty Rehabilitation Initial Screening Evaluation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing total knee replacement for Osteoarthritis 314796 0
Condition category
Condition code
Musculoskeletal 313131 313131 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 313132 313132 0 0
Physiotherapy
Surgery 313231 313231 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients undergoing Total Knee Replacement for Osteoarthritis will be asked to complete a pre-operative survey (ARISE rehabilitation screening tool). Patients will be observed from admission for their total knee replacement surgery until their discharge from the hospital.
The ARISE (Arthroplasty Rehabilitation Initial Screening Evaluation) tool will be used for the first time in this study, question responses will undergo statistical analysis to determine level of predictability for discharge destination. The ARISE tool consists of 13 questions across 4 health domains and should take approximately 5 minutes or less to complete. The ARISE tool will also be assessed with regards to it's correlation to the well-validated EQ5D tool which participants will be asked to complete at the same time.
Intervention code [1] 315792 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321664 0
Discharge destination (Home vs rehabilitation in an inpatient hospital facility) will be recorded by the physiotherapist on day of discharge, there is also a record of discharge destination in the patient's hospital notes that may be used.
Timepoint [1] 321664 0
Day of discharge from the acute hospital inpatient setting
Secondary outcome [1] 375809 0
EQ5D-5L
The EQ5D 5L questionnare comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.
Timepoint [1] 375809 0
1) 1-week pre total knee replacement surgery
2) Day of discharge from the acute hospital inpatient setting
Secondary outcome [2] 375810 0
EQ5D VAS
The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale, where the endpoints are labelled ‘The best health you can imagine’ and ‘The worst health you can imagine’.
Timepoint [2] 375810 0
1) 1-week pre total knee replacement surgery
2) Day of discharge from the acute hospital inpatient setting
Secondary outcome [3] 375811 0
ARISE questionnaire
The ARISE (Arthroplasty Rehabilitation Initial Screening Evaluation) questionnaire is comprised of 4 themed sections: living situation, physical function, psychosocial, and attitude towards exercise interventions. Within each section, there are 3-6 individual questions with responses to be answered on a Likert style scale. The ARISE questionnaire will be used for the first time in this study and will be assessed for it's correlation to the well-validated EQ5D tool, which is also a listed secondary outcome.
Timepoint [3] 375811 0
1-week pre total knee replacement surgery

Eligibility
Key inclusion criteria
Patients scheduled to undergo primary total knee replacement surgery at Pindara Private Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contralateral total knee replacement surgery within the last 12 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size of 100 participants will be based on existing literature which developed a prediction model for patient satisfaction following total knee replacement surgery (Van Onsem, S., Van Der Straeten, C., Arnout, N., Deprez, P., Van Damme, G., & Victor, J. (2016). A New Prediction Model for Patient Satisfaction After Total Knee Arthroplasty. J Arthroplasty, 31(12), 2660-2667.e2661. doi:10.1016/j.arth.2016.06.004)
Data analysis will be performed using IBM-SPSS Statistics 26 (SPSS,
an IBM Company, Chicago, IL). Level of statistical significance will be set to
0.05. The model will be built under the supervision of a biostatistician with the aim to evaluate the predictive effect of the ARISE score. Each ARISE question will undergo both univariable and multivariable analyses to report it's predictiveness of inpatient rehabilitation as a discharge destination. Demographics will be analyzed and compared between the
home and rehabilitation groups using an independent samples t test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/11/2019
Actual
4/11/2019
Date of last participant enrolment
Anticipated
Actual
9/01/2020
Date of last data collection
Anticipated
Actual
12/01/2020
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14948 0
Pindara Private Hospital - Benowa
Recruitment postcode(s) [1] 28234 0
4217 - Benowa

Funding & Sponsors
Funding source category [1] 304028 0
University
Name [1] 304028 0
Bond University
Country [1] 304028 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Larissa Sattler
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country
Australia
Secondary sponsor category [1] 304276 0
None
Name [1] 304276 0
Address [1] 304276 0
Country [1] 304276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304519 0
Bond University Human Research Ethics Comittee
Ethics committee address [1] 304519 0
14 University Dr, Robina QLD 4226
Ethics committee country [1] 304519 0
Australia
Date submitted for ethics approval [1] 304519 0
05/02/2019
Approval date [1] 304519 0
12/02/2019
Ethics approval number [1] 304519 0
15631

Summary
Brief summary
The primary aim of this study will be to determine if a pre-operative questionnaire, the ARISE tool, can predict discharge destination to home or inpatient rehabilitation following primary total knee replacement surgery. Existing tools have been criticised for not being predictive of "moderate" scorers, only predictive of those scoring in the high or low range categories. The ARISE tool is designed to capture additional information around a patient's beliefs rather than demographic features such as age and gender etc alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97238 0
Ms Larissa Sattler
Address 97238 0
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country 97238 0
Australia
Phone 97238 0
+61406537395
Fax 97238 0
Email 97238 0
[email protected]
Contact person for public queries
Name 97239 0
Ms Larissa Sattler
Address 97239 0
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country 97239 0
Australia
Phone 97239 0
+61406537395
Fax 97239 0
Email 97239 0
[email protected]
Contact person for scientific queries
Name 97240 0
Ms Larissa Sattler
Address 97240 0
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia
Country 97240 0
Australia
Phone 97240 0
+61406537395
Fax 97240 0
Email 97240 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?
De-identified participant demographics and outcome measure results
When will data be available (start and end dates)?
From publication to 5 years
Available to whom?
Only researchers who provide a methodologically sound proposal, each request will be granted by a case-by-case basis at the discretion of the Primary Investigator.
Available for what types of analyses?
To achieve aims in an approved proposal, for example, IPD meta-analysis.
How or where can data be obtained?
Data-Sharing web link access will be provided subject to approvals by Principal Investigator.
The principal investigator, Larissa Sattler, can be contacted via email: [email protected] or mail:
Larissa Sattler
Health Sciences and Medicine
2 Promethean Way
Bond Institute of Health and Sport
Robina Queensland 4226
Australia


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378545-(Uploaded-08-02-2020-10-18-06)-Basic results summary.docx
Plain language summaryNo After multivariable regression, the domain which c... [More Details]

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
2518Basic resultsNo 378545-(Uploaded-08-02-2020-10-18-06)-Basic results summary.docx
3378Plain language summaryNo After multivariable regression, the domain which c... [More Details]
4780Study results articleYes Sattler, L. N., Hing, W. A., Rathbone, E. N., & Ve... [More Details]

Documents added automatically
No additional documents have been identified.