Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001239954
Ethics application status
Approved
Date submitted
2/09/2020
Date registered
19/11/2020
Date last updated
28/02/2024
Date data sharing statement initially provided
19/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Providing therapy with dose administration aids and existing cardiovascular medicines - Pilot
Scientific title
Providing therapy with dose administration aids and existing cardiovascular medicines (PAX) - Pilot
Secondary ID [1] 302209 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PAX Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 318899 0
Medication adherence 319352 0
Condition category
Condition code
Cardiovascular 316881 316881 0 0
Other cardiovascular diseases
Public Health 316882 316882 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION: Letter to patients inviting them to receive a home-delivered dose administration aid.

This will be an 8 month pilot study designed as a “trial within cohort” (TwiC) randomised controlled trial (RCT). The TWiC design involves embedding a RCT within an established cohort (general practice in this case) to test the effectiveness of an intervention under pragmatic patient care environments, and to utilise information routinely collected in an existing cohort. The key difference compared to a standard RCT is that a patient subset is randomly selected to be offered the study intervention, with the outcomes of this subset compared to the remaining eligible patients in the cohort who receive usual care (i.e. control). In this way much more realistic and generalisable results are obtained, while maintaining randomisation. Patients on greater than equal to five medications will be identified in the medical records of participating GPs, at least one of which must be a cardiovascular medication. A GP and Study Coordinator will screen electronic medical records of potentially eligible participants using the inclusion and exclusion criteria. Eligible participants will be randomised to the intervention (i.e. a patient directed invitation letter from the GP) or control arms. Participants in the intervention arm (N is equal to 100 patients) will be sent a letter from the GP inviting them to try using a Dose Administration Aid (DAA), such as a Doseaid sachet. Those randomised to the control arm will not receive a letter and will form the standard care group.
Participants, who have received the letter and decide to take up the DoseAid offer, will contact the research team. A research team member will then contact them, providing further education, allowing them to seek clarification and obtaining verbal consent for the trial. The GP will prescribe the participants’ usual medications and provide the script to the local Pharmacy. The Pharmacy will then provide education to participants as required and consent them for a DoseAid as per usual care processes. DoseAid is a Queensland based company, licensed by the Therapeutic Goods Administration and is GMP-compliant. DoseAid will supply the medications and sort them into individually-labelled sachets with easy tear packaging by day, dose and time. These sachets are then rolled up in chronological date and time order. DoseAid will send the sachets to the Pharmacy and the latter will directly mail the sachets to participants in the intervention group. Participants will receive their DoseAid sachets monthly for 8 months.
Prescription Possession Ratio (PPR) will be measured at 8 months to monitor adherence. PPR is defined as the percentage of time that an individual has a valid prescription script according to practice prescription records in a given observation period.
Intervention code [1] 318499 0
Prevention
Intervention code [2] 318500 0
Behaviour
Comparator / control treatment
Patients randomised to the control group will receive usual care which involves continuation of current care provided by their general practitioner and scheduled visits as per standard practice.
Control group
Active

Outcomes
Primary outcome [1] 324984 0
The primary outcome will be difference between the intervention and usual care groups (intention to treat [ITT]) in prescription possession ratio at 8-months. Prescription Possession Ratio (PPR) is defined as the percentage of time that an individual has a valid prescription script according to practice prescription records in a given observation period. It will be assessing using the practice practice prescription records.
Timepoint [1] 324984 0
End of study will occur after all patients in the intervention group finish 8 months follow-up in the intervention group.
Secondary outcome [1] 386458 0
Systolic and diastolic blood pressure.
Timepoint [1] 386458 0
At baseline when all eligible patients are randomised and at end of study after all patients in the intervention group finish 8 months follow-up in the intervention group. This data is not composite and will be extracted from the general practice electronic health records system.
Secondary outcome [2] 386459 0
Number of GP Visits (including Telehealth appointments). This data will be extracted from the general practice electronic health records system.
Timepoint [2] 386459 0
At end of study after all patients in the intervention group finish 8 months follow-up in the intervention group. This data will be extracted from the general practice electronic health records system.
Secondary outcome [3] 386460 0
Intervention participant and prescriber acceptability of the DoseAid and study processes via end of study feedback. Semi-structured phone interviews will be conducted with trial participants and providers to understand their perspectives on the intervention and the use of DoseAids and to seek their views on how DoseAids could be more effectively implemented in practice.
Timepoint [3] 386460 0
Data will be gathered following an interview guide at the end of the study i.e after all patients in the intervention group finish 8 months follow-up in the intervention group.
Secondary outcome [4] 387699 0
Cholesterol
Timepoint [4] 387699 0
At baseline when all eligible patients are randomised and at end of study after all patients in the intervention group finish 8 months follow-up in the intervention group. This data is not composite and will be extracted from the general practice electronic health records system.
Secondary outcome [5] 387700 0
Blood sugar levels (HbA1c & fasting glucose)
Timepoint [5] 387700 0
At baseline when all eligible patients are randomised and at end of study after all patients in the intervention group finish 8 months follow-up in the intervention group. This data is not composite and will be extracted from the general practice electronic health records system.

Eligibility
Key inclusion criteria
Participant inclusion criteria:
1. Community dwelling adults aged greater than equal to 18 years old
2. Prescribed at least 5 medicines, with at least 1 cardiovascular indication which includes medications for coronary artery disease, stroke, peripheral vascular disease, hypertension, hypercholesterolaemia, diabetes, arrhythmias, heart failure and valvular heart disease. Broadly this includes Pharmaceutical Benefits Scheme Anatomical Therapeutic Chemical Classifications A10, B01, B02, C01-C10.
3. Stable medical conditions and stable medications for at least 6 months prior to enrolment
4. Ability to give informed consent


Site selection criteria:
Primary care practices using electronic health records that have the ability to generate practice-level reports of the target population and have regular data extractions performed via MedicineInsight or network processes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant exclusion criteria:
1. Responsible primary care or other responsible physician believes it is not appropriate for the patient to participate in the study.
2. A medical illness, which in the view of the treating physician, has an anticipated life expectancy of less than 8 months.
3. Patients using any other dose administration aid (e.g. webster pack, automated devices)
4. Patients with physical disabilities precluding use of the DoseAid (e.g. tearing the sachets) and without a carer to assist them.
5. Patients with significant cognitive or psychiatric conditions precluding informed consent and use of DoseAid

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)
The site coordinator and the GP will determine if a patient is eligible for inclusion in the trial. They will inform the staff at the central administration site where the randomisation of the list of eligible patients will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be centrally computer generated.
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
The analysis for the primary outcome will be conducted according to the principle of intention-to-treat on aggregated de-identified data. The primary analysis will be a comparison between groups of Prescription Possession Ratio (PPR) at 8 months using Poisson regression model.
Secondary analyses will include comparison of means between groups for systolic and diastolic blood pressure, cholesterol; blood sugar levels (HbA1c & fasting glucose) at the end of study with adjustment for baseline values.

Reporting of process measures will be conducted to inform a larger trial:
• Proportion of those invited who participate
• Contamination of control sample by those who inadvertently crossover into the intervention e.g. participants who obtain a non-study dose administration aid.

There will be no pre-defined subgroup analyses. We will plan an exploratory analysis including by gender and age.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2020
Actual
12/12/2020
Date of last participant enrolment
Anticipated
8/01/2021
Actual
1/06/2021
Date of last data collection
Anticipated
30/09/2021
Actual
12/12/2021
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306630 0
Charities/Societies/Foundations
Name [1] 306630 0
National Heart Foundation
Country [1] 306630 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King St
Newtown NSW 2042
Australia

Postal Address:
PO Box M201
Missenden Rd
NSW 2050
Australia
Country
Australia
Secondary sponsor category [1] 307184 0
None
Name [1] 307184 0
Address [1] 307184 0
Country [1] 307184 0
Other collaborator category [1] 281464 0
University
Name [1] 281464 0
The University of New South Wales
Address [1] 281464 0
The University of New South Wales
PO Box 259
Paddington, NSW 2021
Australia
Country [1] 281464 0
Australia
Other collaborator category [2] 281465 0
University
Name [2] 281465 0
Westmead Applied Research Centre, University of Sydney
Address [2] 281465 0
Westmead Applied Research Centre
REN Building Westmead Hospital
Darcy Road, Westmead NSW 2145
Country [2] 281465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306816 0
Western Sydney Local Health District HREC
Ethics committee address [1] 306816 0
Ethics committee country [1] 306816 0
Australia
Date submitted for ethics approval [1] 306816 0
15/07/2020
Approval date [1] 306816 0
28/09/2020
Ethics approval number [1] 306816 0
2020/PID01290

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

Contacts
Principal investigator
Name 105106 0
Dr Sonali Gnanenthiran
Address 105106 0
The George Institute for Global Health AUSTRALIA
Level 5, 1 King St, Newtown NSW 2042 Australia
Country 105106 0
Australia
Phone 105106 0
+61 280524533
Fax 105106 0
Email 105106 0
[email protected]
Contact person for public queries
Name 105107 0
Baldeep Kaur
Address 105107 0
The George Institute for Global Health AUSTRALIA
Level 5, 1 King St, Newtown NSW 2042 Australia
Country 105107 0
Australia
Phone 105107 0
+61 280524533
Fax 105107 0
Email 105107 0
[email protected]
Contact person for scientific queries
Name 105108 0
Sonali Gnanenthiran
Address 105108 0
The George Institute for Global Health AUSTRALIA
Level 5, 1 King St, Newtown NSW 2042 Australia
Country 105108 0
Australia
Phone 105108 0
+61 280524533
Fax 105108 0
Email 105108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data is potentially available for sharing pending relevant ethics approvals and sign-off from the principle investigator.
When will data be available (start and end dates)?
Data will be available 3 years following closure of the study, estimated to be available from 31st March 2024.
Available to whom?
Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from pharmaceutical industry. Requesters must have demonstrated experience in medical research. Researchers must be able to demonstrate through their peer review publications in the area of interest and their ability to carry out the proposed use of requested data.
Available for what types of analyses?
The data sharing will only be for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.
How or where can data be obtained?
In the first instance, potential requesters are strongly encouraged to approach the relevant study investigators informally to discuss feasibility of data sharing. Study investigators can refer such requests to the Institute’s Data Access Coordinator (Director, Research Strategy and Services). Contact [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9399Other  [email protected] Manual of operations by request from the PI - Dr S... [More Details]



Results publications and other study-related documents

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