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Trial registered on ANZCTR


Registration number
ACTRN12617001285347
Ethics application status
Approved
Date submitted
25/08/2017
Date registered
6/09/2017
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial to determine the efficacy of Perx, an iPhone application for promoting medication adherence.
Scientific title
A randomized controlled trial to determine the efficacy of Perx, an iPhone application for promoting medication adherence among sufferers of chronic disease.
Secondary ID [1] 292736 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 304503 0
Chronic kidney disease 304504 0
Type 2 Diabetes Mellitus 304505 0
Chronic Obstructive Pulmonary Disease 304506 0
Condition category
Condition code
Cardiovascular 303840 303840 0 0
Coronary heart disease
Cardiovascular 303841 303841 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 303842 303842 0 0
Hypertension
Respiratory 303843 303843 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 303844 303844 0 0
Diabetes
Renal and Urogenital 303845 303845 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be educated on the importance of medication compliance as per standard care at baseline. Participants randomised to the 'Perx' intervention group will be asked to download the Perx iPhone application (app). They will be trained in its use during a 45 minute face-to-face session at baseline with the research nurse. The participants will enter their personal and medication information (name, dose, timing) into the app under the supervision of their physician or research nurse. Once this is completed, users will begin to receive reminders each time their medication is due based on the information they entered initially. If they verify they have taken their medication at the scheduled time they will be eligible to receive an opportunity to win an intermittent reward through a gamified interaction. Users get rewarded with a game every time they verify that they've taken their medication at the right time. To verify medication adherence, the app requests the user to take a real-time, in-app photo of their medication within plus/minus an hour of when their medication is due. This photo cannot be taken from their existing gallery. The photos are saved on the Perx server and checked by Perx app designers.
The frequency of games is dependent on their schedule (typically 1-3 times per day). This game is a short mini-game on screen such as a virtual ring toss or a match-3 scratch card. They play by using their phone screen.
Participants in the Perx group will use the Perx app for the 12 month duration of the study.
Intervention code [1] 298980 0
Behaviour
Comparator / control treatment
The control group will receive education on medication compliance as per standard care at baseline.
Control group
Active

Outcomes
Primary outcome [1] 303202 0
To determine efficacy of Perx on medication adherence through manual pill counts (number of pills prescribed vs number of pills taken will be compared).
Timepoint [1] 303202 0
12 months since baseline.
Secondary outcome [1] 338227 0
To assess the acceptability of Perx to participants using a four item Perx Acceptability Questionnaire. This questionnaire has been designed specifically for use in this study.
Timepoint [1] 338227 0
3, 6, 9 and 12 months since baseline.
Secondary outcome [2] 338228 0
To assess the acceptability of Perx to participants' physicians using a two item Perx Physician Questionnaire. This questionnaire has been designed specifically for use in this study.
Timepoint [2] 338228 0
12 months since baseline.
Secondary outcome [3] 338356 0
To assess the effect of using Perx on hospitalization rates. Hospitalisation data will be collected by study medical officers in consultation with the participant or through access to patient medical records.
Timepoint [3] 338356 0
12 months since baseline.
Secondary outcome [4] 338359 0
To determine the effect of using Perx on pathological measures of cardiovascular disease. A venous blood sample will be collected and analysed for blood lipid levels.
Timepoint [4] 338359 0
3, 6, 9 and 12 months since baseline.
Secondary outcome [5] 338362 0
To determine the effect of using Perx on pathological measures of Type 2 Diabetes Mellitus. A venous blood sample will be collected and analysed for fasting blood glucose, HbA1c and lipid levels.
Timepoint [5] 338362 0
12 months since baseline.
Secondary outcome [6] 338363 0
To determine the effect of using Perx on pathological measures of chronic kidney disease. A venous blood sample will be collected and analysed for blood microalbumin and serum creatinine.
Timepoint [6] 338363 0
3, 6, 9 and 12 months since baseline.
Secondary outcome [7] 338364 0
To determine the effect of using Perx on pathological measures of chronic obstructive pulmonary disease by performing lung function tests.
Timepoint [7] 338364 0
3, 6, 9 and 12 months since baseline.

Eligibility
Key inclusion criteria
- Diagnosed with at least one of the following chronic conditions: type 2 diabetes mellitus (T2DM), heart failure, hypertension (HT), chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD)
- Taking a minimum of three different medications
- Able to visit the clinic monthly over a 12 month period.
- iPhone accessibility
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Absence of a chronic disease controlled with medication
- Unable to correctly use the Perx app or an iPhone
- Inability to read and write English
- Participants may also be excluded, if in the opinion of the study Investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the Participant (e.g. psychiatric illness, substance abuse)
- Unable to commit to the appointment schedule or perform the tasks required in the study

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)
Randomisation will occur centrally using computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by FileMarker Pro 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
Sample Size Determination: At least 124 participants (62 in each group) will be required to detect a 20% difference in medication compliance between groups (assuming a 40% standard deviation and 20% drop-out).

Statistical Analyses: Data will be analysed for normality using the Shapiro-Wilk test. For analysis of differences between treatments, an analysis of co-variance (ANCOVA), or the non-parametric equivalent will be used. For within group changes, repeated measures ANOVA will be used. As well as an analysis of completers (those that attend the final visit), an intention to treat (ITT) analysis will also be included. For the ITT analysis, dropouts will be treated using a variety of sensitivity analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/02/2018
Actual
Date of last participant enrolment
Anticipated
1/04/2019
Actual
Date of last data collection
Anticipated
1/04/2020
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8870 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 8871 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 8872 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 17120 0
2050 - Camperdown
Recruitment postcode(s) [2] 17121 0
2139 - Concord
Recruitment postcode(s) [3] 17122 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 297372 0
Government body
Name [1] 297372 0
Sydney Local Health District
Country [1] 297372 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
50 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 296350 0
Hospital
Name [1] 296350 0
Liverpool Hospital
Address [1] 296350 0
Corner of Elizabeth and Goulburn Streets
Liverpool NSW 2170
Country [1] 296350 0
Australia
Other collaborator category [1] 279685 0
Hospital
Name [1] 279685 0
Concord General Repatriation Hospital
Address [1] 279685 0
Hospital Rd
Concord NSW 2139
Country [1] 279685 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298476 0
Sydney Local Health District, RPA division
Ethics committee address [1] 298476 0
Ethics committee country [1] 298476 0
Australia
Date submitted for ethics approval [1] 298476 0
12/07/2017
Approval date [1] 298476 0
14/09/2017
Ethics approval number [1] 298476 0
Protocol No X17-0229 & HREC/17/RPAH/372

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

Contacts
Principal investigator
Name 77202 0
Miss Mary Gail Del Olmo
Address 77202 0
The Boden Institute
Level 2 Charles Perkins Centre D17
University of Sydney NSW 2006
Country 77202 0
Australia
Phone 77202 0
+61 2 86271962
Fax 77202 0
+61 2 86270141
Email 77202 0
Mary.Delolmo@health.nsw.gov.au
Contact person for public queries
Name 77203 0
Mary Gail Del Olmo
Address 77203 0
The Boden Institute
Level 2 Charles Perkins Centre D17
University of Sydney NSW 2006
Country 77203 0
Australia
Phone 77203 0
+61 2 86271962
Fax 77203 0
+61 2 86270141
Email 77203 0
Mary.Delolmo@health.nsw.gov.au
Contact person for scientific queries
Name 77204 0
Ian Caterson
Address 77204 0
The Boden Institute
Level 2 Charles Perkins Centre D17
University of Sydney NSW 2006
Country 77204 0
Australia
Phone 77204 0
+61 2 8627 1944
Fax 77204 0
+61 2 86270141
Email 77204 0
ian.caterson@sydney.edu.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
No additional documents have been identified.