Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000705280
Ethics application status
Approved
Date submitted
10/08/2009
Date registered
14/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increasing Community Pharmacy Involvement in the Prevention of Cardiovascular Disease Project
Scientific title
Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives
Universal Trial Number (UTN)
Trial acronym
HAPPY trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication compliance and persistence 243481 0
Condition category
Condition code
Cardiovascular 239780 239780 0 0
Hypertension
Public Health 239816 239816 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A package of strategies (e.g. Home blood pressure monitoring, motivation interviewing, medication use review, home medicines review (where necessary), patient reminders (SMS, telephone, mail), and general practitioner referral (when needed). This intervention program is for 6 months and will be offered by the pharmacist at baseline, 3 months and 6 months. Each patient is provided with a blood pressure (BP) monitor and advised to carry out home montoring of their blood pressure every 2-3 days.
Intervention code [1] 237098 0
Other interventions
Comparator / control treatment
standard care. The patients in the control group will receive the usual care during the 6 months duration. At the end of the study period each control patient will receive a blood pressure monitor.
Control group
Active

Outcomes
Primary outcome [1] 240547 0
Persistence and compliance with antihypertensive medicines using Morisky Score and Tool for Adherence Behaviour Screening.
Timepoint [1] 240547 0
6 months after randomisation
Secondary outcome [1] 257127 0
Improvement in blood pressure control. Each patient is given a blood pressure monitor (Omron HEM-790it) with the capacity to store 200 measurements and is advised to carry out home montioring every 2-3 days. At 3 and 6 months the pharmacist will download patients' home BP recordings, review and discuss compliance issues.
Timepoint [1] 257127 0
6 months after randomisation

Eligibility
Key inclusion criteria
Using or have used one or more antihypertensive medications (angiotensin converting enzyme inhibitors, angiotensin-II receptor antagonists, calcium channel blockers, beta blockers and thiazide diuretics) in the last 6 months, primary hypertension confirmed by the GP, and
available for follow-up at 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participation in other compliance promotion or medication profiling programs or receipt of a recent home medicines review, unavailable for follow-up, unable to
communicate in English, and does not self-
administer anti-hypertensive medicines.

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 was done at the pharmacy level through a central randomisation using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation through Pharmacy Access/ Remoteness Index of Australia (PhARIA).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237470 0
Other
Name [1] 237470 0
Australian Government Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement through the Fourth Community Pharmacy Agreement Grants Program managed by the Pharmacy Guild of Australia
Country [1] 237470 0
Australia
Primary sponsor type
University
Name
Monash
Address
Department of Pharmacy Practice,
Faculty of Pharmacy and Pharmaceutical Sciences,
Monash University (Parkville Campus),
381 Royal Parade,
Parkville,
Victoria 3052.
Country
Australia
Secondary sponsor category [1] 236957 0
University
Name [1] 236957 0
Curtin University of Technology
Address [1] 236957 0
Bentley Campus,
Kent Street,
Bentley,
Western Australia 6102.
Country [1] 236957 0
Australia
Other collaborator category [1] 812 0
University
Name [1] 812 0
University of Tasmania
Address [1] 812 0
Sandy Bay Campus,
Churchill Avenue,
Sandy Bay,
Tasmania 7005.
Country [1] 812 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239604 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 239604 0
Monash Research Office
Building 3e
Monash University
Clayton campus
Victoria 3800
Ethics committee country [1] 239604 0
Australia
Date submitted for ethics approval [1] 239604 0
Approval date [1] 239604 0
22/12/2008
Ethics approval number [1] 239604 0
CF08/3281 - 2008001602

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

Contacts
Principal investigator
Name 30022 0
Address 30022 0
Country 30022 0
Phone 30022 0
Fax 30022 0
Email 30022 0
Contact person for public queries
Name 13269 0
A/Prof Kay Stewart
Address 13269 0
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
Parkville Campus
381 Royal Parade
Parkville
Victoria 3052
Country 13269 0
Australia
Phone 13269 0
+61 (03) 9903 9618
Fax 13269 0
+61 (03) 9903 9629
Email 13269 0
[email protected]
Contact person for scientific queries
Name 4197 0
A/Prof Kay Stewart
Address 4197 0
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences
Monash University
Parkville Campus
381 Royal Parade
Parkville
Victoria 3052
Country 4197 0
Australia
Phone 4197 0
+61 (03) 9903 9618
Fax 4197 0
+61 (03) 9903 9629
Email 4197 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
SourceTitleYear of PublicationDOI
Dimensions AIEvaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial2010https://doi.org/10.1186/1472-6963-10-34
N.B. These documents automatically identified may not have been verified by the study sponsor.