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Trial registered on ANZCTR


Registration number
ACTRN12609000235202
Ethics application status
Approved
Date submitted
21/10/2008
Date registered
11/05/2009
Date last updated
12/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fremantle Primary Prevention study in general practice – a pilot study of risk factor modification for cardiovascular disease
Scientific title
Are cardiovascular risk factors modified in the 40-80 year old age group with frequent General Practitioner contact?
Secondary ID [1] 283455 0
None
Universal Trial Number (UTN)
Trial acronym
Fremantle Primary Prevention Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk factor modification 3850 0
Condition category
Condition code
Cardiovascular 4044 4044 0 0
Hypertension
Cardiovascular 4046 4046 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Increased General Practitioner contact. Patients were seen at the clinic. No home visits were made. Patients were seen at baseline and then at 3,6,9 and 12 months. Patients were advised at initial consultation that they would need to be seen at 3 monthly intervals and encouraged to make their own appointment at the due date. Patients who attended opportunistically (ie for reasons other than the study) close to the follow-up date were seen at that time as part of study follow-up. In some instances telephone or letter reminders were given. At baseline information booklets from the Heart Foundation on healthy living were made available to all participants as were "quit packs" for smokers. Baseline and three month follow-up involved: review of current smoking status, blood pressure, weight, body mass index (BMI), waist circumference, exercise in minutes per week for 5 days, fasting bloods for lipids and glucose, if patients were known diabetics blood tests were done for HbA1c and creatinine and urine for albumin-creatinine ratio (ACR). Cardiac, diabetic, anti-smoking and weight reduction medications were reviewed as appropriate. Advice on the importance of giving up smoking, healthy diet and exercise was also given. Referral information to allied health or other specialists were also recorded.
Intervention code [1] 3576 0
Early detection / Screening
Intervention code [2] 3577 0
Prevention
Comparator / control treatment
Control group-was seen by the General practitioner at baseline and again at 12 months with no scheduled follow-up in between. Patients were seen at the clinic. No home visits were made. Patients were advised at initial consultation that they would need to be seen at 12 months encouraged to make their own appointment at the due date. Patients who attended opportunistically (ie for reasons other than the study) close to the 12 month date were seen at that time as part of study follow-up. In some instances telephone or letter reminders were given. At baseline information booklets from the Heart Foundation on healthy living were made available to all participants as were "quit packs" for smokers. Baseline and 12 month follow-up involved: review of current smoking status, blood pressure, weight, BMI, waist circumference, exercise in minutes oer week for 5 days, fasting bloods for lipids and glucose, if patients were known diabetics blood tests were done for HbA1c and creatinine and urine for ACR. Cardiac, diabetic, anti-smoking and weight reduction medications were reviewed as appropriate. Advice on the importance of giving up smoking, healthy diet and exercise was also given. Referral information to allied health or other specialists were also recorded.
Control group
Active

Outcomes
Primary outcome [1] 4945 0
Improvement in cardiovascular risk factors using the New Zealand Risk calculator
Timepoint [1] 4945 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [1] 8332 0
Blood pressure using medical equipment
Timepoint [1] 8332 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group
Secondary outcome [2] 8333 0
Smoking history through patient questions
Timepoint [2] 8333 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [3] 8334 0
Body Mass Index
Timepoint [3] 8334 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [4] 8335 0
Waist Circumference
Timepoint [4] 8335 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [5] 8336 0
Fasting blood sugar through pathology tests
Timepoint [5] 8336 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [6] 8337 0
Cholesterol profile through pathology testing
Timepoint [6] 8337 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [7] 8338 0
Physical activity through asking patient questions
Timepoint [7] 8338 0
Baseline and at 3 monthly intervals to 12 months (intervention group), Baseline and 12 months (non-intervention group)
Secondary outcome [8] 8339 0
General Health Questionnaire (GHQ28)
Timepoint [8] 8339 0
Baseline and 12 months

Eligibility
Key inclusion criteria
Patients presenting to a General Practitioner
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not within age range for study
Prior cardiovascular event
Incapable of giving informed consent
Tansient visitor
Physical inability

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)
Following screening and provision of study information and the answering of relevant questions, potential subjects gave their written informed consent on an approved consent form. Once this was completed subjects were allocated to one of the two groups by a practice nurse. The practice nurse assigned patients to the next available group on a randomly generated allocation schedule. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2006
Actual
2/11/2006
Date of last participant enrolment
Anticipated
18/10/2007
Actual
18/10/2007
Date of last data collection
Anticipated
Actual
31/07/2008
Sample size
Target
1200
Accrual to date
Final
1200
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4030 0
Commercial sector/Industry
Name [1] 4030 0
Pfizer Australia Pty Ltd
Country [1] 4030 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country
Australia
Secondary sponsor category [1] 3623 0
None
Name [1] 3623 0
Address [1] 3623 0
Country [1] 3623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6111 0
University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 6111 0
Ethics committee country [1] 6111 0
Australia
Date submitted for ethics approval [1] 6111 0
Approval date [1] 6111 0
31/05/2006
Ethics approval number [1] 6111 0
None

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

Contacts
Principal investigator
Name 29054 0
Prof Tom Brett
Address 29054 0
General Practice and Primary Health Care Reserach
School of Medicine
University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle
WA 6959
Australia
Country 29054 0
Australia
Phone 29054 0
+61 89433 0571
Fax 29054 0
Email 29054 0
tom.brett @nd.edu.au
Contact person for public queries
Name 12211 0
Tom Brett
Address 12211 0
General Practice and Primary Health Care Research, School of Medicine, University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 12211 0
Australia
Phone 12211 0
+61 89433 0571
Fax 12211 0
+61 8 9433 0250
Email 12211 0
tom.brett@nd.edu.au
Contact person for scientific queries
Name 3139 0
Professor Tom Brett
Address 3139 0
General Practice and Primary Health Care Research, School of Medicine, University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia 6959
Country 3139 0
Australia
Phone 3139 0
+61 89433 0571
Fax 3139 0
+61 8 9433 0250
Email 3139 0
tom.brett@nd.edu.au

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.