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Trial registered on ANZCTR


Registration number
ACTRN12616000661471
Ethics application status
Approved
Date submitted
16/05/2016
Date registered
20/05/2016
Date last updated
19/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study
Scientific title
MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: A randomised controlled trial
Secondary ID [1] 289217 0
None
Universal Trial Number (UTN)
None
Trial acronym
MedApp-CHD Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 298776 0
Condition category
Condition code
Cardiovascular 298829 298829 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two different intervention groups as described below.

1) Basic app: Participants in the basic app group will be provided with and supported to access the basic app in addition to standard care. This app has basic features to provide daily simple timed reminders to take the medications with no further interactivity. The basic app will act similarly to an alarm or a text-message by showing a reminder on the smartphone screen at a set time every day. Participants will be encouraged to set daily reminders to take each cardiovascular medication at the prescribed time. The duration of the intervention period will be 3 months.

2) Interactive app: Participants in the interactive app group will be provided with and supported to access the interactive app in addition to standard care. This interactive app has the ability to provide daily reminders to take medications and, in addition, it has more customisable and interactive features, including features to mark doses as taken or missed, to snooze the reminder, to interact and share data with family members and health professionals, multiple user support, adherence statistics, customisable alert sounds and visual cues like tablets and syringes icons. Participants will be encouraged to set daily reminders to take each cardiovascular medication at the prescribed time. In addition, participants will also be encouraged to track their doses daily by clicking in one of the following options every time a reminder pops-up in the smartphone screen: taken on the schedule, taken on a different time, snooze or skip the dose. The duration of the intervention period will be 3 months. Information about engagement with the app will be obtained by extracting the adherence data from the app at the end of the study.

These apps were selected through a stepwise approach to identify the best available apps to be tested in this trial. A comprehensive and systematic search of all available apps in the Australian iTunes and Google Play app stores was conducted and the apps were selected using a pre-defined set of criteria. The highest quality apps were selected. Both apps are available for free in iTunes and Google Play stores and have ongoing technical support, having been recently updated in April 2016.
Intervention code [1] 294755 0
Prevention
Intervention code [2] 294779 0
Behaviour
Comparator / control treatment
Participants in the control group will continue to receive standard care for their cardiovascular health as determined by their doctors.
Control group
Active

Outcomes
Primary outcome [1] 298298 0
Medication adherence will be measured using the 8-item Morisky Medication Adherence Scale (MMAS-8).
Timepoint [1] 298298 0
3 months post access to the app
Secondary outcome [1] 323821 0
Systolic blood pressure measured using an automated electronic blood pressure monitor
Timepoint [1] 323821 0
3 months post access to the app
Secondary outcome [2] 323822 0
Diastolic blood pressure measured using an automated electronic blood pressure monitor
Timepoint [2] 323822 0
3 months post access to the app
Secondary outcome [3] 323823 0
LDL cholesterol measured on fasting blood samples
Timepoint [3] 323823 0
3 months post access to the app
Secondary outcome [4] 323824 0
Total cholesterol measured on fasting blood samples
Timepoint [4] 323824 0
3 months post access to the app
Secondary outcome [5] 323825 0
Medication adherence measured by prescription refill data obtained through Pharmaceutical Benefits Scheme (PBS) data linkage.
Timepoint [5] 323825 0
3 months post access to the app
Secondary outcome [6] 323877 0
Health services utilisation through Medicare Benefits Scheme (MBS) data linkage
Timepoint [6] 323877 0
3 months post access to the app
Secondary outcome [7] 323878 0
Acceptability of the intervention using a self-reported survey designed for this study
Timepoint [7] 323878 0
3 months post access to the app
Secondary outcome [8] 334207 0
Medication adherence to each and all indicated cardiovascular medications, including anti-platelets, statin, angiotensin conversing enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) and beta-blocker, measured by self-report using a questionnaire designed specifically for this study. At the 3-month follow-up visit, a blinded researcher will ask the participants the names and dosages of all prescribed and over-the-counter medications currently being taken. Participants will also be asked the number of days that each indicated cardiovascular medication was missed in the week prior to the follow-up visit. Participants will be defined as adherent if medication was taken for at least 6 days during the week preceding the study-related visit, accounting for 85% of the days in that week. Participants not taking one of the indicated CV medication due to contra-indications will be considered adherent.
Timepoint [8] 334207 0
3 months post access to the app

Eligibility
Key inclusion criteria
Participants will be eligible if they have a confirmed diagnosis of coronary heart disease, including a prior diagnosis of myocardial infarction, stable or unstable angina, coronary revascularisation procedure or current admission with an acute coronary syndrome event or >50% stenosis in at least one major vessel on the coronary angiogram. In addition, participants will have to meet the following criteria: 1) be an adult (> 18 years), 2) own an active smartphone that operates with iOS or Android operating systems, 3) have sufficient English skills, and 4) provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they already use a medication reminder app or other electronic reminder systems to help them adhere to their medication regimen, e.g. calendar alerts in their phones. In addition, smartphones that are not capable of downloading the apps, for example older Apple iPhones, such as iPhones 4, that operate with older iOS versions, will be excluded, as the basic app is only compatible with iOS version 7.0 or later and the advanced app with iOS version 8.0 or later.

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)
Group allocation will be concealed from study personnel using a central computerised randomisation with 1:1:1 allocation ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed as a computerised randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are focused on the difference between proportion of adherent patients between control and intervention groups (basic and advanced medication reminder groups). The calculations assume a ratio of 2:1 for intervention and control subjects and that 50% of patients are fully adherent to all cardiovascular medication. Analysis of pooled data of previous studies that investigated text-message reminders in a population with coronary heart disease demonstrated significant improvements in adherence with an estimated absolute improvement of 29%. Therefore, a total sample size of 156 patients is needed to provide 90% power to detect an increase in the proportion of adherent patients from 50% to 79%, with a two-sided a of 0.05 and allowing for a 20% loss of follow-up.

Primary analysis will be unadjusted, following an intention-to-treat principle. If necessary, multivariate analyses will be conducted to adjust to any significant difference between groups. Data will be presented as means or medians or as frequencies and proportions. Continuous variables will be analysed using independent t tests and categorical variables using Chi-square tests as appropriate. Mann-Whitney U tests will be used if data are not normally distributed. We will also calculate relative risks, 95% confidence intervals and two-sided p-values for both primary and secondary outcomes. Participants with missing data for medication adherence will be considered non-adherent. Pre-specified sub-group analyses will be performed for age, sex, level of education, adherent/non-adherent participants at baseline, basic app/interactive app, basic app/usual care and interactive app/usual care. Statistical significance will be set at a 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/05/2016
Actual
30/05/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
16/05/2017
Date of last data collection
Anticipated
Actual
22/09/2017
Sample size
Target
156
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5798 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 13241 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 293596 0
University
Name [1] 293596 0
University of Sydney International Postgraduate Research Scholarship
Country [1] 293596 0
Australia
Funding source category [2] 296289 0
Charities/Societies/Foundations
Name [2] 296289 0
National Heart Foundation of Australia
Country [2] 296289 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 292411 0
None
Name [1] 292411 0
None
Address [1] 292411 0
None
Country [1] 292411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295036 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295036 0
Ethics committee country [1] 295036 0
Australia
Date submitted for ethics approval [1] 295036 0
13/01/2016
Approval date [1] 295036 0
05/05/2016
Ethics approval number [1] 295036 0
Research office file number 4566

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

Contacts
Principal investigator
Name 65866 0
A/Prof Clara Chow
Address 65866 0
The George Institute for Global Health
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 65866 0
Australia
Phone 65866 0
+61 2 8052 4525
Fax 65866 0
+61 2 8052 4502
Email 65866 0
cchow@georgeinstitute.org.au
Contact person for public queries
Name 65867 0
Karla Santo
Address 65867 0
The George Institute for Global Health
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 65867 0
Australia
Phone 65867 0
+61 2 8052 4620
Fax 65867 0
+61 2 8052 4502
Email 65867 0
ksanto@georgeinstitute.org.au
Contact person for scientific queries
Name 65868 0
Karla Santo
Address 65868 0
The George Institute for Global Health
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 65868 0
Australia
Phone 65868 0
+61 2 8052 4620
Fax 65868 0
+61 2 8052 4502
Email 65868 0
ksanto@georgeinstitute.org.au

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
EmbaseMEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: A randomised controlled trial protocol.2017https://dx.doi.org/10.1136/bmjopen-2017-017540
N.B. These documents automatically identified may not have been verified by the study sponsor.