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
ACTRN12618000555257
Ethics application status
Approved
Date submitted
15/03/2018
Date registered
13/04/2018
Date last updated
10/06/2021
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Ryman Cardiac Health And Monitoring Protocol In Older New Zealanders Study
Scientific title
An observational study to identify the prevalence of cardiovascular disease (CVD) and risk of new onset CVD within Ryman Healthcare NZ facilities
Secondary ID [1] 294515 0
nil known
Universal Trial Number (UTN)
U1111-1210-9840
Trial acronym
The CHAMPIONZ Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 307066 0
Condition category
Condition code
Cardiovascular 306175 306175 0 0
Coronary heart disease
Cardiovascular 306176 306176 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This 2-3 year project performed by the Christchurch Heart Institute (CHI) and will include a focus on identifying the prevalence of cardiovascular disease (CVD) and risk of new onset CVD within Ryman Healthcare New Zealand facilities and also assist healthcare staff current practices in CVD. This project will include lectures and information sessions to
the Ryman medical and care staff as well as residents themselves.CHI research staff will partner with Ryman Healthcare staff to collect relevant clinical data from residents. Residents at all or selected Ryman Healthcare facilities will be invited to participate and consent will be obtained to collect clinical, medication, laboratory and mortality data from records. Among a representative sub group of approximately 1000 residents, consent would be obtained to collect blood samples to allow measurement of biomarkers as well
as perform measurements of body height, weight and composition, heart rate and rhythm, blood pressure and other relevant indices.
Intervention code [1] 300649 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305461 0
Cardiovascular disease will be present in a significant proportion of Ryman Healthcare residents
Timepoint [1] 305461 0
A self reported medical history questionnaire at baseline
Secondary outcome [1] 345309 0
The prevalence of certain Cardiovascular diseases (such as atrial fibrillation) will be higher than current Ministry of Health estimates in the retirement residential community
Timepoint [1] 345309 0
As assessed by electrocardiography at a single research clinic attendance from a randomly selected representative sub-set of participants who completed the baseline questionnaire within the previous 12 month period.
Secondary outcome [2] 345310 0
Measurement of circulating biomarkers in the blood such as NT-proBNP and cardiac troponin will allow better risk stratification and monitoring of residents by their healthcare providers.
Timepoint [2] 345310 0
As assessed from a blood sample collected at a single research clinic attendance from a randomly selected representative sub-set of participants who completed the baseline questionnaire within the previous 12 month period.

Eligibility
Key inclusion criteria
Male or female
Resident of a Ryman Healthcare facility

Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling or unable to provide signed informed consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2019
Actual
22/03/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
10000
Accrual to date
236
Final
Recruitment outside Australia
Country [1] 9685 0
New Zealand
State/province [1] 9685 0

Funding & Sponsors
Funding source category [1] 298989 0
Charities/Societies/Foundations
Name [1] 298989 0
Ryman Healthcare
Country [1] 298989 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Heart Foundation
Address
National Office
9 Kalmia Street
Ellerslie
Auckland, 1051
Country
New Zealand
Secondary sponsor category [1] 298214 0
None
Name [1] 298214 0
Address [1] 298214 0
Country [1] 298214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299919 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 299919 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299919 0
New Zealand
Date submitted for ethics approval [1] 299919 0
20/02/2018
Approval date [1] 299919 0
06/04/2018
Ethics approval number [1] 299919 0
18/NTB/5

Summary
Brief summary
This 2-3 year project will support clinical research performed by the Christchurch Heart Institute (CHI) and will include a focus on identifying the prevalence of cardiovascular disease (CVD) and risk of new onset CVD within Ryman Healthcare NZ facilities and also assist healthcare staff current practices in CVD. This project will include lectures and information sessions to the Ryman medical and care staff as well as residents themselves.
CHI research staff will partner with Ryman Healthcare staff to collect relevant clinical data from residents. Residents at selected Ryman Healthcare facilities will be invited to participate and consent will be obtained to collect clinical and medication data from a questionnaire and clinical and administrative records held by their general practitioner and the Ministry of Health. Among a representative sub group of approximately 1000 residents, consent would be obtained to attend a research clinic to perform measurements of body height, weight and composition, heart rate and rhythm, blood pressure and other relevant indices as well as collect blood samples to allow measurement of biomarkers. At the time of data collection, CHI staff will provide heart health education in partnership with the Heart Foundation.
Trial website
none
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 43850 0
Prof Richard Troughton
Address 43850 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Central 8041
Country 43850 0
New Zealand
Phone 43850 0
+6433640640
Fax 43850 0
+6433641115
Email 43850 0
[email protected]
Contact person for public queries
Name 43851 0
Ms Lorraine Skelton
Address 43851 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Central 8041
Country 43851 0
New Zealand
Phone 43851 0
+6433641063
Fax 43851 0
+6433641115
Email 43851 0
[email protected]
Contact person for scientific queries
Name 43852 0
A/Prof Chris Pemberton
Address 43852 0
Christchurch Heart Institute
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch Central 8041
Country 43852 0
New Zealand
Phone 43852 0
+6433640887
Fax 43852 0
+6433641115
Email 43852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participant confidentiality


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.