Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000322932
Ethics application status
Approved
Date submitted
24/03/2011
Date registered
28/03/2011
Date last updated
20/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of a pharmacist supporting beliefs about medications in people who have experienced a heart attack
Scientific title
Community pharmacists supporting beliefs towards medicines in patients who have experienced an episode of acute coronary syndrome compared to routine pharmacy care improves adherence to medicines; a randomised controlled trial
Secondary ID [1] 259852 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 265429 0
Condition category
Condition code
Cardiovascular 265589 265589 0 0
Coronary heart disease
Public Health 265602 265602 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be interviewed at one, three and six months post discharge from hospital using the repertory grid technique to identify their opinions towards their medicines.
In the intervention group, the community pharmacist will provide usual care (information on how to take their medication, the potential side effects to look out for and what to do if they arise) and also establish how participants are coping with their medicines. The usual care should take place at approximately monthly intervals when the patient collects their prescription medicines for ACS and should last for five minutes. At one, three, six and twelve months after discharge from hospital, the pharmacist will have a longer discussion (maximum 10 minutes) with the participant about the medicines they are taking, and will also support the patients’ beliefs about their medicines for acute coronary syndrome. This will be done by enforcing positive health beliefs about medications for acute coronary syndrome and discussing the patient's own health beliefs generated from the interview with the student researcher using the repertory grid technique. The community pharmacist will also review the participants ACS medications for appropriateness and monitor adherence.
The researcher utilised the repertory grid technique at one, three and six months to explore participant’s opinions towards their ACS medicines. The repertory grid component of the interview asks participants to compare and contrast between their ACS medicines to generate statements that reflect their individual opinions. Participants were presented their ACS medicines in groups of three and asked; “which two medicines are similar in some way” and “how is the third one different to the others.” This generated two opposing poles of the individual’s opinions towards their medicines. The process was repeated for different combinations of their ACS medicines, creating a list of statements reflecting their individual opinion of their medicines. The process was repeated until all combinations of their ACS medicines were exhausted or no new statements were generated. A likert scale was placed between the two poles of the generated statements and the participant rated each of their medicines against each statement. The information generated for each individual patient formed a grid of data, with their statements of opinions as the rows and their medicines as the columns.
Intervention code [1] 264271 0
Behaviour
Comparator / control treatment
In the control group, when a patient presents a prescription for their ACS medicines to a community pharmacist, they will provide usual care (information on how to take their medication, the potential side effects to look out for and what to do if they arise).
Control group
Active

Outcomes
Primary outcome [1] 262386 0
Improved adherence measured by Medication Adherence Reporting Scale and Medication Possession ratio.
Timepoint [1] 262386 0
12 months
Secondary outcome [1] 273669 0
Beliefs towards medicines and the relationship to adherence, measured by the Beliefs About Medicines Questionnaire and the Repertory Grid Technique.
Timepoint [1] 273669 0
6 months and 12 months
Secondary outcome [2] 273670 0
Optimised medications as assessed from dispensing history
Timepoint [2] 273670 0
12 months

Eligibility
Key inclusion criteria
Admitted to hospital with an episode of acute coronary syndrome with a diagnosis of STEMI or non-STEMI
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People whose primary language is other than English (LOTE)
Children and/or young people (ie. <18 years)
People with an intellectual or mental impairment
Aboriginal and/or Torres Strait Islander peoples
Women who are pregnant

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be approached in hospital by the cardiac rehabilitation nurse and asked if they
would be willing to take part in the study. If the patient is willing to take part, they will be introduced to the
student researcher who will provide them with written information about the study for them to read. After the
patient has read the information sheet, the student researcher will explain the process of the study to them
to ensure that they have understood what is required.
The researcher will have a predetermined randmoisation sequence with which to allocate the participant.
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Will use an Excel data base to generate a permuted block randomisation sequence to ensure equal numbers of participants in both groups.
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
1/10/2009
Actual
2/10/2009
Date of last participant enrolment
Anticipated
Actual
9/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264727 0
Other
Name [1] 264727 0
Pharmacy Board of Queensland
Country [1] 264727 0
Australia
Primary sponsor type
Individual
Name
Neil Cottrell
Address
The School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country
Australia
Secondary sponsor category [1] 263854 0
Individual
Name [1] 263854 0
Lisa Nissen
Address [1] 263854 0
The School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country [1] 263854 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266716 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 266716 0
Ethics committee country [1] 266716 0
Australia
Date submitted for ethics approval [1] 266716 0
26/06/2009
Approval date [1] 266716 0
24/08/2009
Ethics approval number [1] 266716 0
HREC/09/QPAH/175

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

Contacts
Principal investigator
Name 32383 0
A/Prof Neil Cottrell
Address 32383 0
The University of Queensland Pharmacy Australia Centre of Excellence Level 4, 20 Cornwall Street Woolloongabba, QLD, 4102
Country 32383 0
Australia
Phone 32383 0
61 7 3346 1977
Fax 32383 0
Email 32383 0
[email protected]
Contact person for public queries
Name 15630 0
Gina Gujral
Address 15630 0
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country 15630 0
Australia
Phone 15630 0
61 7 3346 1743
Fax 15630 0
61 7 3346 1999
Email 15630 0
[email protected]
Contact person for scientific queries
Name 6558 0
Gina Gujral
Address 6558 0
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country 6558 0
Australia
Phone 6558 0
61 7 3346 0610
Fax 6558 0
61 7 3346 1999
Email 6558 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
EmbaseInterventions to improve adherence to lipid-lowering medication.2016https://dx.doi.org/10.1002/14651858.CD004371.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.