Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000677202
Ethics application status
Approved
Date submitted
11/06/2008
Date registered
10/08/2009
Date last updated
16/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Primary prevention of cardiovascular disease through community pharmacist management of multiple risk factors
Scientific title
Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease
Secondary ID [1] 946 0
Healthy Hearts in Pharmacy
Universal Trial Number (UTN)
Trial acronym
PAART CVD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 3245 0
Condition category
Condition code
Cardiovascular 3409 3409 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacists will provide counselling to patients at monthly intervals for five months and liaise with general practitioners to improve medications management, medication adherence and lifestyle management. General practitioners (GPs) will be informed of patient's involvement in research, provided with a written copy of the the pharmacy treatment plan, and asked for comment. They will also be informed verbally or in writing of any recommended chages to patient medication.
Intervention code [1] 2986 0
Prevention
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4307 0
Change to risk of cardiovascular disease (as per New Zealand risk calculations)
Timepoint [1] 4307 0
At six months from the baseline timepoint for each individual patient
Secondary outcome [1] 7254 0
Change to individual cardiovascular risk factors. Blood pressure, lipid profile, random blood glucose, waist, hip and body mass index (BMI) will be measured using point of care testing equipment. Depression will be self-reported by administration of the Center for Epidemiologic Studies Depression (CES D ) 10 item survey scale.
Timepoint [1] 7254 0
At six months from the baseline timepoint for each individual patient
Secondary outcome [2] 7255 0
Change to patient health behaviour. Issues around medication adherence, physical activity, smoking, nutrition, weight management, quality of life and alcohol consumption will be measured using survey instruments administered by researchers.
Timepoint [2] 7255 0
At six months from the baseline timepoint for each individual patient

Eligibility
Key inclusion criteria
Patients aged 50-74 years, taking one or more medicines for cholesterol or hypertension, and without established cardiovascular disease or a cardiovascular event
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients with a complex debilitating coexisting medical condition (e.g. mental illness, end-stage cancer)
2. Previously-identified diabetes
3. Target organ damage
4. Any cognitive impairment
5. Dependent patients relying on a carer or living in a residential aged care facility
6. Recent hospital inpatients who were medical admissions and discharged less than four weeks prior to recruitment
7. Non-English speaking
8. Living more than 40 km from a participating pharmacy
9. Patients who have received a Home Medication Review (HMR) in the past 12 months
10. Patients whose GP has deemed them inappropriate for this intervention
Patients of GPs who express a desire not to have any involvement with this project

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A convenience sample of patients will be approached by their community pharmacist. Interested patients will be contacted by the researchers if they give consent to their community pharmacy to provide contact details. The research team will screen the patient for eligibiilty and also seek confirmation from the patient's GP that the patient is suitable for inclusion.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 886 0
3030
Recruitment postcode(s) [2] 887 0
3264
Recruitment postcode(s) [3] 888 0
3260
Recruitment postcode(s) [4] 889 0
3025
Recruitment postcode(s) [5] 931 0
7050
Recruitment postcode(s) [6] 932 0
7140
Recruitment postcode(s) [7] 933 0
7190
Recruitment postcode(s) [8] 934 0
7000
Recruitment postcode(s) [9] 935 0
7173

Funding & Sponsors
Funding source category [1] 3470 0
Government body
Name [1] 3470 0
Pharmacy Guild of Australia
Country [1] 3470 0
Australia
Primary sponsor type
University
Name
Monash University
Address
381 Royal Parade
Parkville 3052
Victoria
Country
Australia
Secondary sponsor category [1] 3118 0
None
Name [1] 3118 0
Address [1] 3118 0
Country [1] 3118 0
Other collaborator category [1] 305 0
University
Name [1] 305 0
University of Tasmania
Address [1] 305 0
Unit for Medication Outcomes Research and Education (UMORE)
Tasmania School of Pharmacy
University of Tasmania
Private Bag 83
Hobart Tas 7001
Country [1] 305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5501 0
Standing Committee for Ethics in Research involving Human
Ethics committee address [1] 5501 0
Human Ethics Office
Building 3E, Room 111
Monash University, Clayton 3800
Ethics committee country [1] 5501 0
Australia
Date submitted for ethics approval [1] 5501 0
22/01/2008
Approval date [1] 5501 0
10/04/2008
Ethics approval number [1] 5501 0
CF08/0305 - 2008000110

Summary
Brief summary
The primary purpose of this study is to develop an intervention in community pharmacy which gives community pharmacies a role in the primary prevention of cardiovascular disease within a multidisciplinary context.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28656 0
Address 28656 0
Country 28656 0
Phone 28656 0
Fax 28656 0
Email 28656 0
Contact person for public queries
Name 11813 0
Kevin Mc Namara
Address 11813 0
Dept of Pharmacy Practice
Monash University
381 Royal Parade
Parkville 3052
Victoria
Country 11813 0
Australia
Phone 11813 0
+61399039030
Fax 11813 0
+61399039629
Email 11813 0
[email protected]
Contact person for scientific queries
Name 2741 0
Kevin Mc Namara
Address 2741 0
381 Royal Parade
Parkville 3052
Victoria
Country 2741 0
Australia
Phone 2741 0
+61399039030
Fax 2741 0
+61399039629
Email 2741 0
[email protected]

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.