Trial Review

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
ACTRN12605000451606
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
21/09/2005
Date last updated
11/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Assessment Post Elective Surgery
Scientific title
Post Operative Cognitive Decline (POCD) in New Zealanders Undergoing Elective Joint-Replacement Surgery. What are the risks?
Secondary ID [1] 289926 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CAPES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
A requirement for joint replacement surgery 566 0
Condition category
Condition code
Surgery 641 641 0 0
Other surgery
Musculoskeletal 642 642 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None. A computerised test battery will be used to identify POCD.
Intervention code [1] 462 0
None
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 752 0
To determine if POCD is a significant problem for older New Zealanders having elective surgery in the short (1 and 6 weeks) and in the longer term (1 year post surgery) as measured by a validated and reliable computerised neuropsychological battery.
Timepoint [1] 752 0
one year post surgery
Secondary outcome [1] 1544 0
To establish if preoperative cognitive impairment or MCI increases the risk of POCD.
Timepoint [1] 1544 0
one year post surgery
Secondary outcome [2] 1545 0
To observe any pre- or peri-operative factors that increases the risk of POCD following surgery.
Timepoint [2] 1545 0
one year post surgery
Secondary outcome [3] 1546 0
To establish utility of a computerised battery in pre-operative screening and cognitive outcome measurement with a view to identifying people at risk in the future.
Timepoint [3] 1546 0
one year post surgery

Eligibility
Key inclusion criteria
Patients over 55 referred to a waiting list for elective joint replacement surgery; can give informed consent; able to understand sufficient English to undertake testing; no visual impairment or colour blindness.
Minimum age
55 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with serious visual difficulties or colour blindness, who will not be able to use the computerized battery; unable to follow instructions in English language; patients who cannot give informed consent to the procedure or study; acute emergency joint replacement for fracture or injury.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2006
Actual
10/04/2006
Date of last participant enrolment
Anticipated
Actual
24/06/2009
Date of last data collection
Anticipated
Actual
2/06/2009
Sample size
Target
300
Accrual to date
Final
363
Recruitment outside Australia
Country [1] 201 0
New Zealand
State/province [1] 201 0
Auckland

Funding & Sponsors
Funding source category [1] 702 0
Government body
Name [1] 702 0
Health Research Council of New Zealand
Country [1] 702 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Centre for Clinical Research and Effective Practice (CCRep)
Address
100 Hospital Rd
Papatoetoe
Auckland 2025
Country
New Zealand
Secondary sponsor category [1] 587 0
Hospital
Name [1] 587 0
Mental Health Services for Older People
Address [1] 587 0
100 Hospital Rd
Papatoetoe
Auckland 2025
Country [1] 587 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1904 0
Counties Manukau District Health Board
Ethics committee address [1] 1904 0
Ethics committee country [1] 1904 0
New Zealand
Date submitted for ethics approval [1] 1904 0
Approval date [1] 1904 0
31/08/2006
Ethics approval number [1] 1904 0
Ethics committee name [2] 295720 0
Northern X Regional Ethics Committee
Ethics committee address [2] 295720 0
Private Bag 92 522
Auckland
Ethics committee country [2] 295720 0
New Zealand
Date submitted for ethics approval [2] 295720 0
06/01/2006
Approval date [2] 295720 0
09/03/2006
Ethics approval number [2] 295720 0
AKY/03/10/252

Summary
Brief summary
People having major surgery say that it can cause temporary or long-term
changes in how they think and feel. By understanding these changes it may be
possible to improve outcomes for people having these procedures in the future.We would like to ask you some questions before and after your operation and do a thinking and memory test. As we need to have your individual baseline the first series will be once you are confirmed on the waiting list. The second series will be four months later. This is to see if your baselines change over time without surgery. This enables us to compare your post operative answers to your baseline to see what differences the surgery makes. We will also do a series just before the surgery, just after your discharge after the surgery, at the time of your 6 week follow-up and finally one year after the surgery. What we are looking for in the study is to see if there are any changes following the surgery and if so, when they reverse back to normal. That is why we need to have the tests repeated on the six different occasions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36022 0
Dr Francois Stapleburg
Address 36022 0
C/- Middlemore Hospital
100 Hospital Rd
Auckland 2025
Country 36022 0
New Zealand
Phone 36022 0
+64 9 2760000
Fax 36022 0
Email 36022 0
[email protected]
Contact person for public queries
Name 9651 0
Ms Dr Pamela Melding
Address 9651 0
Mental Health Services for Older People
Waitemata District Health Board
Private Bag 93 503
Takapuna Auckland
Country 9651 0
New Zealand
Phone 9651 0
+64 9 4861491
Fax 9651 0
Email 9651 0
[email protected]
Contact person for scientific queries
Name 579 0
Ms Post Operative Cognitive Decline (POCD) Research Fellow
Address 579 0
C/- Centre for Clinical Research and Effective Practice (CCRep)
Private Bag 93311
Otahuhu Auckland
Country 579 0
New Zealand
Phone 579 0
+64 9 2709758
Fax 579 0
Email 579 0
[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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.