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Trial registered on ANZCTR


Registration number
ACTRN12615000153516
Ethics application status
Approved
Date submitted
30/01/2015
Date registered
17/02/2015
Date last updated
13/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A proof of concept study to identify familial hypercholesterolaemia in primary care
Scientific title
A proof of concept study to identify familial hypercholesterolaemia (FH) among 18 - 40 year old patients presenting in a primary care setting
Secondary ID [1] 286076 0
NIL
Universal Trial Number (UTN)
Trial acronym
POCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
familial hypercholesterolaemia 294071 0
Condition category
Condition code
Cardiovascular 294375 294375 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 294487 294487 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a proof of concept study:

Recruitment of patients will take place over 5 months.

Patients presenting to general practitioner (GP) will be invited to participate. Upon consent GP or practice nurse (PN) will undertake a non-fasting finger prick test using the Cardiocheck PA analyser to measure patient's LDL-c level. If level is above 4.9mmol/L, a fasting lipid blood test will be carried out to confirm the results. If a level above 4.9mmol/L is maintained, patient will be recalled and assessed using the Dutch Lipid Clinic Network Score (DLCNS) for FH. Patients with a score under or equal to 5 will be classed as low complexity FH and managed at the discretion of the GP. Patients with a score above 5 will be referred for FH in a shared care model between GP and specialist. As part of clinical care, first degree relatives will also be offered further investigations for FH.
Intervention code [1] 291066 0
Early detection / Screening
Intervention code [2] 291072 0
Diagnosis / Prognosis
Comparator / control treatment
uncontrolled. This is a proof of concept study of protocol feasibility.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294166 0
Frequencies of unlikely, possible, probable, definite familial hypercholesterolaemia patients will be determined. The study will use the Dutch Lipid Clinic Network Scoring system to class patients into the mentioned (unlikely, possible, probable and definite) FH categories
Timepoint [1] 294166 0
over 5 months
Secondary outcome [1] 312663 0
The suitability of the protocol for integration into general practice will be determined using semi structured interviews and focus groups
Timepoint [1] 312663 0
within 5 months of the end of recruitment phase
Secondary outcome [2] 312681 0
The post-study awareness of FH among participants and practice staff will be assessed using semi structured interviews and focus groups.

Timepoint [2] 312681 0
within 5 months of the end of recruitment phase
Secondary outcome [3] 312682 0
The sustainability of the protocol will be determined using both results from the qualitative assessments and the cost analysis of the trial
Timepoint [3] 312682 0
Within 5 months of the end of recruitment phase

Eligibility
Key inclusion criteria
patients, 18 - 40 years of age, who are presenting to their GP for any consultation.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 18 or more than 40 years of age

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients, of 18 to 40 years of age, presenting to their GP for any consultation will be invited to participate. Patient will undergo finger prick LDL-c test if they consent to participating. LDL-c levels >4.9mmol/L will be rechecked using a fasting blood samples. Patients with confirmatory high levels of LDL-c will be investigated for FH using the Dutch Lipid network scoring system. Treatment options will be presented to those in the probable and definite FH category as part of GP's clinical care
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable. convenience sampling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Convenience sampling of patients, aged 18-40years, presenting to their GP for any consultation. All consented patients will have their LDL-c tested using a finger-prick test. Only those with levels > 4.9mmol/L will require a confirmatory fasting blood test. Patients with confirmed LDL-c levels >4.9mmol/L will have their risks of FH assessed using the Dutch Lipid Clinic Network scoring system. Patients classed as probable or definite FH will be given treatment options as part of GP's clinical care
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a proof of concept study of protocol feasibility and therefore sample sizes do not require statistical power. Sample size is based on convenience sampling.

Percentage for possible, unlikely, probable, definite Familial hypercholesterolaemia using the number screened as the denominator. Interpretive Phenomenological Analysis (IPA) for interviews and Thematic Analysis for focus groups. Descriptive cost analysis will be used.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/04/2015
Actual
4/05/2015
Date of last participant enrolment
Anticipated
2/09/2015
Actual
27/10/2015
Date of last data collection
Anticipated
Actual
12/11/2015
Sample size
Target
500
Accrual to date
Final
199
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290666 0
Government body
Name [1] 290666 0
Australian Primary Health Care Research Institute (APHCRI)
Country [1] 290666 0
Australia
Primary sponsor type
Individual
Name
Prof Tom Brett
Address
The University of Notre Dame Australia
19 Mouat Street, Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 289359 0
Individual
Name [1] 289359 0
A/Prof Diane Arnold-Reed
Address [1] 289359 0
The University of Notre Dame Australia
19 Mouat Street, Fremantle, WA 6959
Country [1] 289359 0
Australia
Other collaborator category [1] 278309 0
Individual
Name [1] 278309 0
Winthrop Prof Gerald Watts
Address [1] 278309 0
University of Western Australia
Level 4, MRF Building
Rear 50 Murray Street,
Perth, WA 6000
Country [1] 278309 0
Australia
Other collaborator category [2] 278310 0
Individual
Name [2] 278310 0
A/Prof Caroline Bulsara
Address [2] 278310 0
The University of Notre Dame Australia
19 Mouat Street, Fremantle, WA 6959
Country [2] 278310 0
Australia
Other collaborator category [3] 278311 0
Individual
Name [3] 278311 0
Prof Alistair Vickery
Address [3] 278311 0
University of Western Australia
M706, 35 Stirling Highway
Crawley, WA 6009
Country [3] 278311 0
Australia
Other collaborator category [4] 278312 0
Individual
Name [4] 278312 0
Prof Max Bulsara
Address [4] 278312 0
The University of Notre Dame Australia
19 Mouat Street, Fremantle, WA 6959
Country [4] 278312 0
Australia
Other collaborator category [5] 278313 0
Individual
Name [5] 278313 0
Dr Lakhina Troeung
Address [5] 278313 0
The University of Notre Dame Australia
19 Mouat Street, Fremantle, WA 6959
Country [5] 278313 0
Australia
Other collaborator category [6] 278314 0
Individual
Name [6] 278314 0
Dr Jing Pang
Address [6] 278314 0
University of Western Australia
Level 3, MRF building
Rear 50 Murray Street,
Perth WA 6000
Country [6] 278314 0
Australia
Other collaborator category [7] 278315 0
Individual
Name [7] 278315 0
Dr Wendy Chan She Ping-Delfos
Address [7] 278315 0
The University of Notre Dame Australia
19 Mouat Street, Fremantle, WA 6959
Country [7] 278315 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292295 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 292295 0
19 Mouat Street,
Fremantle, WA 6959
Ethics committee country [1] 292295 0
Australia
Date submitted for ethics approval [1] 292295 0
03/03/2015
Approval date [1] 292295 0
02/04/2015
Ethics approval number [1] 292295 0
015024F

Summary
Brief summary
Familial Hypercholesterolaemia (FH) is an inherited condition which results in excessively high levels of cholesterol in the bloodstream from birth, with increased risk of heart problems by age 40 or earlier if not treated. Early diagnosis and treatment are very effective and reduces long-term disease costs. This study examines the feasibility of employing a new method of detecting FH through GP clinics using a finger prick cholesterol blood test. If FH is diagnosed, close relatives will also be checked so early treatment can be offered. This proposed innovative approach will alleviate hospital load and allow FH to be managed by the patient’s GP and lipid specialist in shared care approach
Trial website
Trial related presentations / publications
Chan She Ping-Delfos W, Brett T, Arnold-Reed D, Watts G, Bulsara C, Vickery A. (2015). A proof of concept study to identify familial hypercholesterolaemia (FH) in primary care. In: 2015 Primary Health Care Research Conference: Program & Abstracts. Primary Health Care Research and Information Service, Australia. phcris.org.au/conference/abstract/8049

Wendy Chan She Ping-Delfos, Tom Brett, Diane Arnold-Reed (2016). A proof of concept study to identify Familial Hypercholesterolaemia in primary care. http://aphcri.anu.edu.au/files/Brett%20Key%20Messages%20%20FINAL.pdf

Wendy Chan She Ping-Delfos, Tom Brett, Diane Arnold-Reed (2016). A proof of concept study to identify Familial Hypercholesterolaemia in primary care. http://aphcri.anu.edu.au/files/Brett%20Policy%20Options%20%20FINAL%20doc.pdf

Wendy Chan She Ping-Delfos, Tom Brett, Diane Arnold-Reed (2016). A proof of concept study to identify Familial Hypercholesterolaemia in primary care. http://aphcri.anu.edu.au/files/Brett%20Full%20report%20FINAL.pdf
Public notes

Contacts
Principal investigator
Name 54506 0
Prof Tom Brett
Address 54506 0
The University of Notre Dame Australia
19 Mouat Street
Fremantle, WA 6959
Country 54506 0
Australia
Phone 54506 0
+61 8 9433 0571
Fax 54506 0
Email 54506 0
[email protected]
Contact person for public queries
Name 54507 0
Tom Brett
Address 54507 0
The University of Notre Dame Australia
19 Mouat Street,
Fremantle, WA 6959
Country 54507 0
Australia
Phone 54507 0
+61 8 9433 0571
Fax 54507 0
Email 54507 0
[email protected]
Contact person for scientific queries
Name 54508 0
Tom Brett
Address 54508 0
The University of Notre Dame Australia
19 Mouat Street,
Fremantle, WA 6959
Country 54508 0
Australia
Phone 54508 0
+61 8 9433 0571
Fax 54508 0
Email 54508 0
[email protected]

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