Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000289112p
Ethics application status
Not yet submitted
Date submitted
22/02/2019
Date registered
26/02/2019
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Medicine adherence in chronic heart failure patients
Scientific title
A randomised control trial of progressive personalized reminder system to improve medicine adherence in chronic heart failure
Secondary ID [1] 297329 0
Nil known
Universal Trial Number (UTN)
U1111-1228-1481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 311435 0
Medicine adherence 311436 0
Condition category
Condition code
Cardiovascular 310074 310074 0 0
Other cardiovascular diseases
Public Health 310075 310075 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised study to measure the usefulness of a mobile phone adherence application in decreasing healthcare utility due to increased treatment adherence. Participants in the intervention arm will have access to the NPS MedicineWise application (MedicineWise app) in addition to standard care and will be trained by a member of the research team on how to use the app: this training will include navigating the app's functions. Participants in the intervention arm will be tracked on the app for 9 months (duration of the study) after which they can freely use the app for as long as they want as the app is free to download from app stores.

The proposed intervention has three tiers.

Tier 1: in-app medicine dose reminders from the MedicineWise app
Participants will receive in-app reminders (in the form of notifications and audible alarms) when each medicine dose is due to remind them to take their dose. Participants can acknowledge that they have taken their medicine doses in the app by tapping on a “taken” button that is associated with the dose. Information of either the dose being recorded as taken or missed will be registered and recorded by the MedicineWise app.

Tier 2: personalised ‘push’ notification messages from the MedicineWise app
Medications have been categorised as critical or non-critical to the management of heart failure. If a participant has either missed a dose of a critical medication for 24 hours or a non-critical medication for 3 days, they will receive a personalised ‘push’ notification from the MedicineWise app containing one or more of the following messages: reminding them to take their doses; reminding them to interact with their app; emphasizing the importance of adhering with their medication regimen; how to seek help if they are having difficulty with their medication and/or operating the MedicineWise app.
A research team member will examine the extracted dosage taken data during the 24 hours prior and escalate participants to the Tier 3 program as required.

Tier 3: phone call intervention delivered by Medicines Line pharmacists
Participants who do not respond to MedicineWise app notifications (Tier 1 intervention) and ‘push’ notification messages (Tier 2 intervention) will be contacted by a NPS MedicineWise’s Medicines Line pharmacist by telephone to discuss their medicines and medication adherence.
Intervention code [1] 313578 0
Treatment: Devices
Comparator / control treatment
Participants allocated to the usual care arm will receive standard care for their chronic heart failure as determined by their treating physicians, including prescriptions to treat CHF and advice, as well as lifestyle advice. The participants in this group will have no access to a smartphone medication reminder application.
Control group
Active

Outcomes
Primary outcome [1] 318980 0
The primary outcome is the comparison of medication adherence between the two arms. Medication adherence will be measured by self-reported medication adherence tool Self-Efficacy for Appropriate Medication Use Scale (SEAMS).
This self-reported data will also be verified by the data collected from the intervention arm participants whose adherence rate has been captured by the data collected by the NPS MedicineWise application.
Timepoint [1] 318980 0
9 months post study recruitment
Secondary outcome [1] 366600 0
Composite outcome of death or hospital admission related to chronic heart failure. This will be obtained by patient medical records.
Timepoint [1] 366600 0
9 months post study recruitment
Secondary outcome [2] 366601 0
Health resource utilization (ie. Primary and secondary care contacts, social care contacts and relevant medication use). This outcome will be assessed by obtaining participant specific data from Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) utilisation data from Medicare.
Timepoint [2] 366601 0
9 months post study recruitment
Secondary outcome [3] 366602 0
Health related quality of life, assessed by EQ-5D-5L
Timepoint [3] 366602 0
9 months post study recruitment
Secondary outcome [4] 366603 0
Assessment of exercise tolerance using the 6 min walk test
Timepoint [4] 366603 0
9 months post study recruitment
Secondary outcome [5] 366604 0
Psychological wellbeing as determined by the Depression anxiety and stress scales (DASS)
Timepoint [5] 366604 0
9 months post study recruitment
Secondary outcome [6] 366605 0
Self-care of heart failure assessed by the self care of heart failure index
Timepoint [6] 366605 0
9 months post study recruitment
Secondary outcome [7] 366606 0
Medication knowledge will be assessed by a questionnaire specifically designed for this trial
Timepoint [7] 366606 0
9 months post study recruitment
Secondary outcome [8] 366607 0
Acceptability, utility and engagement with the NPS MedicineWise application. This will be assessed by a questionnaire specifically designed for this trial
Timepoint [8] 366607 0
9 months post study recruitment

Eligibility
Key inclusion criteria
(i) age 18 years or older and able to give written informed consent;
(ii) confirmed diagnosis of systolic heart failure on echocardiography
(iii) NYHA functional class I-III for at least 3 months;
(iv) Left ventricular ejection fraction (LVEF) < 50 % at or around the time of diagnosis of heart failure in keeping with the 2018 Australian Heart Failure guidelines (which will also include patients with an improved or recovered ejection fraction of >50% following treatment)
(v) stable or stabilized condition
(vi) Participant or carer with access to a smartphone or similar smart device and have adequate access for receiving and responding to emails and skype calls.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) palliative heart failure
(ii) NYHA functional class IV
(iii) malignancy or diastolic heart failure
(iv) unable to understand the study information or unable to complete outcome questionnaires (ie. if an interpreter is required)
(v) life expectancy less than 6 months or patients engaged with the palliative care network (vi) use of other medication reminder app or other electronic reminder systems for daily administration of medications;
(vii) participant or carer who do not have access to a smartphone or similar device or do not have adequate access for receiving and responding to emails and skype calls

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Sample size calculations are focused on two different measures and were also done assuming equal numbers of participants in each group. The first measure takes into account an absolute increase in mean adherence of 15 %. In this measure, at two tailed 0.05 significance level with a power of 80 % and standard deviation of 35, the number of participants required in each group is 86. In the second measure, the analysis is by comparing proportions of adherence. Previous studies have estimated the adherence to cardiovascular drugs to be up to 60 %. In this measure, a total sample size of 182 participants is needed to provide 80 % power to detect an increase in the proportion of adherent participants from 60 % to 80 %, with a two tailed 0.05 significance level. Therefore, taking the larger of the two sample sizes (91 participants in each arm), and allowing for a 20 % loss to follow up, a total of 220 participants will be recruited in this study with each arm consisting of 110 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2019
Actual
Date of last participant enrolment
Anticipated
30/08/2019
Actual
Date of last data collection
Anticipated
29/05/2020
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13221 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 13222 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 13223 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 13224 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 13225 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 25778 0
5000 - Adelaide
Recruitment postcode(s) [2] 25779 0
5011 - Woodville
Recruitment postcode(s) [3] 25781 0
5042 - Bedford Park
Recruitment postcode(s) [4] 25780 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 25782 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 301892 0
Government body
Name [1] 301892 0
Department of Industry, Innovations and Science
Address [1] 301892 0
Department of Industry, Innovation and Science, GPO 2013, Canberra, ACT, 2601
Country [1] 301892 0
Australia
Funding source category [2] 301898 0
Commercial sector/Industry
Name [2] 301898 0
VentureWise Pty Ltd
Address [2] 301898 0
Level 7 418A Elizabeth St Surry Hills NSW 2010
Country [2] 301898 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia, School of Pharmacy and Medical Science. GPO Box 2471, Adelaide SA 5001, Australia
Country
Australia
Secondary sponsor category [1] 301651 0
None
Name [1] 301651 0
Address [1] 301651 0
Country [1] 301651 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302582 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 302582 0
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 302582 0
Australia
Date submitted for ethics approval [1] 302582 0
04/03/2019
Approval date [1] 302582 0
Ethics approval number [1] 302582 0

Summary
Brief summary
This research proposal will explore the effectiveness of using the NPS MedicineWise mobile phone application in increasing the medication adherence in chronic heart failure. In increasing the medication adherence, it is expected that patients will be able to decrease the substantial burden on healthcare services.
Trial website
Public notes

Contacts
Principal investigator
Name 90718 0
Dr Vijay Suppiah
Address 90718 0
University of South Australia, School of Pharmacy and Medical Science, GPO Box 2471,
Adelaide SA 5001, Australia
Country 90718 0
Australia
Phone 90718 0
+61 883021130
Fax 90718 0
Email 90718 0
vijay.suppiah@unisa.edu.au
Contact person for public queries
Name 90719 0
Dr Vijay Suppiah
Address 90719 0
University of South Australia, School of Pharmacy and Medical Science, GPO Box 2471, Adelaide SA 5001, Australia
Country 90719 0
Australia
Phone 90719 0
+61 883021130
Fax 90719 0
Email 90719 0
vijay.suppiah@unisa.edu.au
Contact person for scientific queries
Name 90720 0
Dr Vijay Suppiah
Address 90720 0
University of South Australia, School of Pharmacy and Medical Science, GPO Box 2471 , Adelaide SA 5001, Australia
Country 90720 0
Australia
Phone 90720 0
+61 883021130
Fax 90720 0
Email 90720 0
vijay.suppiah@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results