Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000405112
Ethics application status
Approved
Date submitted
28/02/2019
Date registered
13/03/2019
Date last updated
26/02/2020
Date data sharing statement initially provided
13/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Community screening of participants across community pharmacies detecting asymptomatic clinical markers or risk factors associated with cardiovascular disease and chronic disease.
Scientific title
Early detection and management of cardiovascular risk factors and chronic disease markers in community pharmacy trial
Secondary ID [1] 297576 0
Nil known
Universal Trial Number (UTN)
U1111-1229-3974
Trial acronym
PTP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 311828 0
diabetes 311880 0
High Cholestrol 311982 0
Condition category
Condition code
Cardiovascular 310429 310429 0 0
Coronary heart disease
Metabolic and Endocrine 310430 310430 0 0
Diabetes
Cardiovascular 310551 310551 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Comprehensive risk assessment will be performed by a trained pharmacist in the community pharmacy setting. Collection of your age, gender, smoking status, blood pressure measurement and heart rate and questions from the Australian type 2 diabetes risk assessment tool (AUSDRISK) be taken. A waist measurement and a finger prick blood test that measures blood sugar and cholesterol. The Complete time of this test would be 20-30 minutes..

Blood pressure measurement and heart rate will be measured using an omron BP machine and the finger prick blood sample will be analysed through the cobas machine with an immediate result printed.
There will be the requirement to complete some validate questionnaires as part of this visit, (Ausrisk, 36 item health survey questionnaire, Health care utilisation questionnaire).

Face to face contact at the pharmacy site (with a trained pharmacist performing the assessment/visit) will be required at baseline, 6 month visit and 12 month vist. A total of 3 visits for the duration of 12 month long trial will be required for consented participants.
On site monitoring and source verification checks will be performed on case report forms during the 12 month trial. SMS reminders will be sent to consented participants to advise when their 6 month or 12 month visit is due. A internal database will monitor participant visit schedules to check for adherence to the protocol and documentation of any minor deviations from this for example on holiday or missed visits.
Intervention code [1] 313805 0
Early detection / Screening
Comparator / control treatment
Comparison of a low intensity CVD risk assessment of demographic information, subjective health measures via questionnaire, waist measurement collected by validated risk assessment tool of AUSDRISK. Blood pressure measurements with screening for irregular heart beat. The control group do not have the point of care testing of finger prick blood sample to assess Hba1c and lipid levels. Everything else remains the same, the time to complete this test will be 10-15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 319296 0
Composite Outcome measure of proportion of screened individuals, identified with disease risk factors.
Validated tools and equipment will be used to estimate CVD risk or detect existing or related disease.
Ausdrisk score, SF 36 validated quality of life questionnaire. (POC) testing for lipid and HbA1c. Equipment used will be COBAs (POC) machine, BP Omron machine.
Timepoint [1] 319296 0
Baseline, 6 Month 12 months
Secondary outcome [1] 367617 0
Percentage of screened participants referred on to primary care services through data linkage of MBS/PBS data consent form and referral medical records.
Timepoint [1] 367617 0
6 month and 12 month assessment after randomisation/baseline visit.
Secondary outcome [2] 367829 0
Quality of life SF 36 validated health survey questionnaire
Timepoint [2] 367829 0
Baseline, 6 month and 12 month visits.

Eligibility
Key inclusion criteria
individuals 45-74 years
individuals 35-74 years if Aboriginal or Torres strait Islander
Who are able to make independent decisions regarding their health care
Both Males and Females
Healthy volunteers
Minimum age
35 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed cardiovascular disease or diabetes
Currently being treated for hypertension or lipid disorders
Currently engaged in any lifestyle modification program

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation based on centre site/location of pharmacy
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed suing 2x3 repeated measures (group x time) analysis, SPSS and STATA software will be used. The program will involve 20 pharmacies, recruitment potential is based on Krass et al (Kras I, Hourihan F, Chen T. Health promotion and screening for cardiovascular risk factors in NSW: a Community pharmacy model. Health Prom J Aust 2003;14("2):101-7). Recruitment target of around 2500 , 40 per month.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
20/09/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2200
Accrual to date
200
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302124 0
Government body
Name [1] 302124 0
Commonwealth of Australia represented by The Dept of Health
Country [1] 302124 0
Australia
Primary sponsor type
Other
Name
Blackswan Health
Address
Suite 4, 137 Main street Osborne park. Perth , Western Australia 6017
Country
Australia
Secondary sponsor category [1] 301961 0
None
Name [1] 301961 0
Address [1] 301961 0
Country [1] 301961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302804 0
Curtin University Human Research Ethics committee
Ethics committee address [1] 302804 0
Ethics committee country [1] 302804 0
Australia
Date submitted for ethics approval [1] 302804 0
14/12/2018
Approval date [1] 302804 0
02/04/2019
Ethics approval number [1] 302804 0
HRE2019-0215

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

Contacts
Principal investigator
Name 91458 0
Ms Sarah Tadier
Address 91458 0
Black Swan Health
137 Main street, Osborne Park 6017 Perth
Western Australia
Country 91458 0
Australia
Phone 91458 0
+61 08 9208 9596
Fax 91458 0
Email 91458 0
sarah.tadier@blackswanhealth.com.au
Contact person for public queries
Name 91459 0
Ayesha Shoukat
Address 91459 0
Black Swan Health
137 Main street, Osborne Park 6017 Perth
Western Australia
Country 91459 0
Australia
Phone 91459 0
+61 08 6559 1542
Fax 91459 0
Email 91459 0
ayesha.shoukat@blackswanhealth.com.au
Contact person for scientific queries
Name 91460 0
Sarah Tadier
Address 91460 0
BlackSwan Health
137 Main street, Osborne Park 6017 Perth
Western Australia
Country 91460 0
Australia
Phone 91460 0
+61 08 9208 9596
Fax 91460 0
Email 91460 0
sarah.tadier@blackswanhealth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data collection at baseline, 6 month and 12 month includes:
Demographic and anthropomorphic measures, subjective screening tools, blood pressure, point of care testing to screen for HbA1c and lipids. Further data of attendance of referral health services, patient reported outcomes on behaviours and attitudinal change and quality of life.
When will data be available (start and end dates)?
Starting from baseline capture planned July 2019 to end Oct 2020
Available to whom?
Data rights owned by Blackswan health
Requests for data sharing that come before the end of embargo period will be considered on a case to case basis
Available for what types of analyses?
Report to Dept of Health
Research outcomes will be prepared for publication in high impact peer reviewed jorunals
Identified journals include Health Promotion Journal of Australia, Journal of Cardiovascular Disease Research
How or where can data be obtained?
Dissemiation at local and international conferences, embargo from open sharing until final publication of all journal articles. Requests for data sharing that come before the end of embargo period will be considered on a case to case basis.


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.