Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Targeted and tailored interventions to improve medication adherence compared to standard care in patients with chronic diseases
Query!
Secondary ID [1]
281907
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hypertension
288272
0
Query!
Dyslipidaemia
288327
0
Query!
Type II Diabetes
288328
0
Query!
Other cardiovascular diseases
288329
0
Query!
Condition category
Condition code
Cardiovascular
288657
288657
0
0
Query!
Hypertension
Query!
Cardiovascular
288658
288658
0
0
Query!
Other cardiovascular diseases
Query!
Metabolic and Endocrine
288659
288659
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
286474
0
Behaviour
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
288807
0
Medication adherence as assessed by mean MAQ (Medication Adherence Questionnaire) scores
Query!
Assessment method [1]
288807
0
Query!
Timepoint [1]
288807
0
Baseline and at 3 and 6 months after implementation of intervention at baseline
Query!
Secondary outcome [1]
301042
0
Changes in adherence behaviour over time as assessed by individual mean MAQ scores
Query!
Assessment method [1]
301042
0
Query!
Timepoint [1]
301042
0
Baseline and at 3 and 6 months after implementation of intervention at baseline
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Patients who do not adequately understand the study information (in the opinion of the researcher)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table by computer software.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
11/03/2013
Query!
Actual
25/03/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
10/02/2014
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Funding & Sponsors
Funding source category [1]
286697
0
University
Query!
Name [1]
286697
0
The University of Queensland
Query!
Address [1]
286697
0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Query!
Country [1]
286697
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of Queensland
Query!
Address
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Query!
Country
Australia
Query!
Secondary sponsor category [1]
285468
0
None
Query!
Name [1]
285468
0
Query!
Address [1]
285468
0
Query!
Country [1]
285468
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
288762
0
University of Queensland School of Pharmacy Research Ethics Committee
Query!
Ethics committee address [1]
288762
0
20 Cornwall St, Woolloongabba Qld 4102
Query!
Ethics committee country [1]
288762
0
Australia
Query!
Date submitted for ethics approval [1]
288762
0
08/02/2013
Query!
Approval date [1]
288762
0
Query!
Ethics approval number [1]
288762
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
34998
0
Ms Thi-My-Uyen Nguyen
Query!
Address
34998
0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Query!
Country
34998
0
Australia
Query!
Phone
34998
0
+61 07 3346 1996
Query!
Fax
34998
0
Query!
Email
34998
0
[email protected]
Query!
Contact person for public queries
Name
18245
0
Ms Thi-My-Uyen Nguyen
Query!
Address
18245
0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Query!
Country
18245
0
Australia
Query!
Phone
18245
0
+61 07 3346 1996
Query!
Fax
18245
0
Query!
Email
18245
0
[email protected]
Query!
Contact person for scientific queries
Name
9173
0
Ms Thi-My-Uyen Nguyen
Query!
Address
9173
0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba Qld 4102
Query!
Country
9173
0
Australia
Query!
Phone
9173
0
+61 07 3346 1996
Query!
Fax
9173
0
Query!
Email
9173
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Validated adherence scales used in a measurement-guided medication management approach to target and tailor a medication adherence intervention: A randomised controlled trial.
2016
https://dx.doi.org/10.1136/bmjopen-2016-013375
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF