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
ACTRN12618000311257
Ethics application status
Approved
Date submitted
9/02/2018
Date registered
2/03/2018
Date last updated
11/02/2020
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive impairment in people with chronic obstructive pulmonary disease (COPD)
Scientific title
Cognitive impairment in people with chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 294002 0
nil
Universal Trial Number (UTN)
U1111-1209-1827
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
COPD 306514 0
cognitive impairment 306515 0
Condition category
Condition code
Respiratory 305624 305624 0 0
Chronic obstructive pulmonary disease
Neurological 305734 305734 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
Observational, measure of cognitive impairment in people with COPD compared to age matched normal population.
The duration of each observation session depends on the time required to answer the questions by the participant but no longer than 30 minutes. The physiotherapist will ask the questions. As well measurement of height, weight and level of education will be recorded.
Intervention code [1] 300274 0
Early Detection / Screening
Comparator / control treatment
Age matched normal population
Control group
Active

Outcomes
Primary outcome [1] 304736 0
Cognitive Impairment will be assessed using the Montreal Cognitive Assessment (MoCA)
The MoCA has been used as a screening instrument for moderate cognitive impairment by assessing memory, language, executive functions, visuospatial skills, calculation, abstraction, attention, concentration and orientation. participants will be asked to answer the questions on the MoCa which will be asked by the physiotherapist.
Timepoint [1] 304736 0
One time point only at baseline (T1)
Secondary outcome [1] 342965 0
No other outcomes
Timepoint [1] 342965 0
No secondary time points

Eligibility
Key inclusion criteria
1. Participants will be aged > 40 years and have a diagnosis of COPD [FEV1/FVC: <70%; FEV1% predicted <80% (GOLD Criteria)]
2. Other group will be age matched normal population
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For COPD population: excluded if they have respiratory diseases other than COPD, diagnosis of dementia or unable to read and understand English.
For Age-matched normals: excluded if they have COPD or other respiratory disease, diagnosis of dementia or unable to read and understand English.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
100 participants were calculated using computerised sample size calculation based on other studies of cognitive impairment (Wong et al, 2017)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/03/2018
Actual
5/03/2018
Date of last participant enrolment
Anticipated
5/03/2021
Actual
Date of last data collection
Anticipated
5/09/2021
Actual
Sample size
Target
100
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9992 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 18832 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 298628 0
Hospital
Name [1] 298628 0
Royal Prince Alfred Hospital
Country [1] 298628 0
Australia
Primary sponsor type
Individual
Name
Dr Lissa Spencer
Address
Dr Lissa Spencer
Physiotherapy Dept
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 297793 0
University
Name [1] 297793 0
University of Sydney
Address [1] 297793 0
University of Sydney
75 East St
Lidcombe NSW 2141
Country [1] 297793 0
Australia
Secondary sponsor category [2] 297794 0
Hospital
Name [2] 297794 0
Royal Prince Alfred Hospital
Address [2] 297794 0
Royal Prince Alfred Hospital
50 Missenden rd.
Camperdown 2050
NSW
Country [2] 297794 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299588 0
Research Ethics and Governance Office
Ethics committee address [1] 299588 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 299588 0
Australia
Date submitted for ethics approval [1] 299588 0
28/11/2017
Approval date [1] 299588 0
05/12/2017
Ethics approval number [1] 299588 0
X17-0395

Summary
Brief summary
Participants are invited to take part in a research study into ‘difficulties with thinking and memory’ in people with COPD. The objective is to investigate the incidence of cognitive impairment (difficulties with thinking and memory) in people with COPD who attend a pulmonary rehabilitation program compared to an age-matched normal population.

Participants (those with COPD and the age matched normal population) will be asked to complete a questionnaire designed to assess cognitive function. the questionnaire is the MoCa (described earlier in the application)
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2419 2419 0 0
/AnzctrAttachments/374470-Cognitive impairment in COPD ethics proposal version 1.docx
Attachments [2] 2420 2420 0 0
/AnzctrAttachments/374470-ethics approval.pdf
Attachments [3] 2421 2421 0 0
/AnzctrAttachments/374470-Information for Participants CI in COPD Version 2 final.doc
Attachments [4] 2422 2422 0 0
/AnzctrAttachments/374470-Consent form CI in COPD Version 1. 25.10.2017.doc

Contacts
Principal investigator
Name 80938 0
A/Prof Lissa Spencer
Address 80938 0
Physiotherapy Dept
Royal Prince Alfred Hospital
Missenden rd Camperdown
NSW 2050
Country 80938 0
Australia
Phone 80938 0
+61 2 95159857
Fax 80938 0
+61 2 95159751
Email 80938 0
[email protected]
Contact person for public queries
Name 80939 0
A/Prof Lissa Spencer
Address 80939 0
Physiotherapy Dept
Royal Prince Alfred Hospital
Missenden rd Camperdown
NSW 2050
Country 80939 0
Australia
Phone 80939 0
+61 2 95159857
Fax 80939 0
+61 2 95159751
Email 80939 0
[email protected]
Contact person for scientific queries
Name 80940 0
A/Prof Lissa Spencer
Address 80940 0
Physiotherapy Dept
Royal Prince Alfred Hospital
Missenden rd Camperdown
NSW 2050
Country 80940 0
Australia
Phone 80940 0
+61 2 95159857
Fax 80940 0
+61 2 95159751
Email 80940 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?
all outcome measures will be available: MoCa results, 6MWTs and HRQoL measures
When will data be available (start and end dates)?
after the completion of the trial estimated to be 2020
Available to whom?
Only researchers named in the study who may wish to combine data for fuller analysis
Available for what types of analyses?
Only to achieve the aims of the original study in a wider group of participants
How or where can data be obtained?
Will be required to sign an access agreement


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.