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Trial registered on ANZCTR


Registration number
ACTRN12613000162718
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
11/02/2013
Date last updated
12/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving medication adherence in patients with chronic diseases
Scientific title
Targeted and tailored interventions to improve medication adherence compared to standard care in patients with chronic diseases
Secondary ID [1] 281907 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 288272 0
Dyslipidaemia 288327 0
Type II Diabetes 288328 0
Other cardiovascular diseases 288329 0
Condition category
Condition code
Cardiovascular 288657 288657 0 0
Hypertension
Cardiovascular 288658 288658 0 0
Other cardiovascular diseases
Metabolic and Endocrine 288659 288659 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions to improve medication adherence tailored to the identified patient reasons for non-adherence.

These interventions may include implementing dose administration aids, telephone reminders, health coaching or motivational interviewing. The selected intervention will depend on the patient's reasons for non-adherence.

Dose administration aids as an intervention will be implemented by explaining to the patient what a dose administration aid looks like and how it works, which will take approximately 10 minutes. If the patient agrees the patient will be referred onto the pharmacy to initiate dose administration aids for this patient. The pharmacy will create a medication profile for the patient by liaising with the patient's general practitioner. The patient's prescriptions will be kept by the pharmacy and dispensed. Dose administration aids will be packed on a fortnightly basis and patients will pick up the packs as needed. (This is the standard procedure of dose administration aids in a pharmacy and the delivery of these packs will be the responsibility of the pharmacy). From the researcher's own experience in packing dose administration aids, the initiation of the dose administration aid will take several hours.

Telephone reminders will be implemented by initiating fortnightly phone calls discussing medication-taking behaviour after baseline.

Health coaching or motivational interviewing will involve setting goals of medication-taking behaviour, which will be conducted at baseline and 3 and 6 months if appropriate. This will be facilitated in the private counselling area of the pharmacy and will involve a 20 minute one-on-one interview with the researcher (who is also a pharmacist).

These interventions will be implemented at baseline and if necessary 3 and 6 months after baseline. The interventions will be implemented over the total trial duration of 6 months.
Intervention code [1] 286474 0
Behaviour
Comparator / control treatment
Standard treatment: patients will receive standard pharmacist counselling on their medication and medical condition at baseline by the researcher/pharmacist and when they have prescription refills for an overall duration of 6 months.
Control group
Active

Outcomes
Primary outcome [1] 288807 0
Medication adherence as assessed by mean MAQ (Medication Adherence Questionnaire) scores
Timepoint [1] 288807 0
Baseline and at 3 and 6 months after implementation of intervention at baseline
Secondary outcome [1] 301042 0
Changes in adherence behaviour over time as assessed by individual mean MAQ scores
Timepoint [1] 301042 0
Baseline and at 3 and 6 months after implementation of intervention at baseline

Eligibility
Key inclusion criteria
- Patients attending one of the study pharmacies
- Patients over 18 years of age
- Diagnosed with at least one of the following chronic diseases: hypertension, type 2 diabetes, dyslipidaemia or cardiovascular disease
- Patients taking a medication for one of the above chronic diseases from the following drug groups: ACE-inhibitors, calcium channel blockers, beta-blockers, oral hypoglycaemic drugs, lipid lowering agents
- Patients with a newly initiated medication (from above) within the previous four to twelve weeks
- Consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who do not adequately understand the study information (in the opinion of the researcher)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The proposed trial will screen patients attending a number of community pharmacies within Brisbane and surrounding suburbs to identify patients with chronic disease(s) newly initiated on a medication. These patients will be screened to identify their adherence behaviour using a validated adherence scale (MAQ). Based on their adherence, patients will be assigned into one of three groups: adherent, intervention or control. Patients who are identified as non-adherent will be randomised into the intervention or control group.

ALLOCATION IS NOT CONCEALED
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table by computer software.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286697 0
University
Name [1] 286697 0
The University of Queensland
Address [1] 286697 0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Country [1] 286697 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 285468 0
None
Name [1] 285468 0
Address [1] 285468 0
Country [1] 285468 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288762 0
University of Queensland School of Pharmacy Research Ethics Committee
Ethics committee address [1] 288762 0
20 Cornwall St, Woolloongabba Qld 4102
Ethics committee country [1] 288762 0
Australia
Date submitted for ethics approval [1] 288762 0
08/02/2013
Approval date [1] 288762 0
Ethics approval number [1] 288762 0

Summary
Brief summary
The aim of the study is to identify patients with poor medication-taking behaviour and implement personalised interventions to improve medication-taking behaviour.

We hope to learn about changes in medication-taking behaviour over time and to determine the degree to which improvements in this behaviour are sustained. We also want to learn if using the MAQ and Beliefs about Medicines Questionnaire - Specific was helpful to improve medication-taking behaviour.

We hypothesise that:
- Personalising interventions to patients known to have poor medication-taking behaviour will improve medication-taking behaviour at three months.
- Improvements in medication-taking behaviour at three months will not be sustained at six months.
- Medication-taking behaviour, and the reasons for poor medication-taking behaviour, will change over time in all groups studied.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34998 0
Ms Thi-My-Uyen Nguyen
Address 34998 0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Country 34998 0
Australia
Phone 34998 0
+61 07 3346 1996
Fax 34998 0
Email 34998 0
t.nguyen63@uq.edu.au
Contact person for public queries
Name 18245 0
Ms Thi-My-Uyen Nguyen
Address 18245 0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Country 18245 0
Australia
Phone 18245 0
+61 07 3346 1996
Fax 18245 0
Email 18245 0
t.nguyen63@uq.edu.au
Contact person for scientific queries
Name 9173 0
Ms Thi-My-Uyen Nguyen
Address 9173 0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Country 9173 0
Australia
Phone 9173 0
+61 07 3346 1996
Fax 9173 0
Email 9173 0
t.nguyen63@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary