Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001051639
Ethics application status
Approved
Date submitted
29/08/2023
Date registered
28/09/2023
Date last updated
28/09/2023
Date data sharing statement initially provided
28/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Precision Atrial Fibrillation App to support Atrial Fibrillation Management
Scientific title
Acceptability, functionality and usability of a Next Generation Precision Health Platform to support Atrial Fibrillation Management
Secondary ID [1] 310393 0
None
Universal Trial Number (UTN)
Trial acronym
Precison AF App
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
 331141 0
Condition category
Condition code
Cardiovascular 327919 327919 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will develop and pre-test an interventional iOS & Android Precision AF App designed to help participants with a diagnosis of AF to learn more about their disease and provide the cardiologist feedback on patient's rhythm and risk factors.

The app will consist of two levels (Levels 1 and 2), over the course of 24 weeks. During the initial two-week ‘onboarding period’ (Level 1) AF education will be provided and data will be gathered to set an individual foundation; followed by 22 weeks of active tracking and intervention (Level 2).

The Precision AF App designed by cardiologists, exercise physiologists, nutritionists and precision health leaders will help improve and better manage atrial fibrillation (AF).

The app provides resources on AF and guides on healthy lifestyle and provides tailored exercise programs. The resources in the App for AF knowledge, risk factor management, exercise and lifestyle change have been specifically designed for the study. There are 16 videos specifically created for the App. However, the participants are also directed to freely available resources on the website of Heart Foundation, Australia.

Once enrolled in the study, the participant will be instructed to download the smartphone application (Precision AF App). Upon installing the app they will be given a unique code to access the app. Once the participant has accessed the app they will be taken through a process which includes instructions on App usage and following Bluetooth devices. KardiaMobile App (supports KardiaMobile ECG Device), Smart Scale and Blood Pressure Monitor). The Bluetooth devices, KardiaMobile ECG Device, Smart Scale and Blood Pressure Monitor, will be provided to participants as part of the study.

The participant will also be asked to track their food choices and alcohol intake through the Precision AF App. Further visual guides (images/documents) and videos and/or links to dietary support will be incorporated in the app.

Regular self-reported physical activity (at baseline (first week of level II) and then repeated every 4 weeks (weeks 5, 9, 13, 17, 21), alongside the participants daily recorded step counts will be captured. Based on the participants level of fitness they will be assigned to one of three predefined exercise categories: light; moderate or vigorous intensity. The fitness level will be determined based on a proprietary algorithm being developed as part of the App. The frequency and duration of exercise will be suggested based on their assessed activity category. The predominant exercise is walking. Resistance exercises are suggested for participants with high levels of fitness. Exercise videos on how to increase amount of walking, safety, and monitoring are all incorporated in the form of proprietary educational videos. The participants can contact the research team through the App with queries, that will be answered by an exercise physiologist specialised in AF management.

The data from the smart scale and BP measurements will be automatically pulled into the App. The data from Withing mats and Kardiamobile will be automatically imported through an API into the RedCap database.

The data from the App is automatically imported into the backend and RedCap which will be monitored every 2 business days. The data on each aspect of the usage of the App e.g.. video viewing will be captured and analysed. There is provision to contact participants and their treating cardiologist based on information collected. The treating cardiologist will have access to the information at the backend of the App.
Intervention code [1] 326794 0
Treatment: Devices
Intervention code [2] 326933 0
Lifestyle
Intervention code [3] 326934 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335769 0
Usability of Precision AF App and its components in participants with AF. This is assessed using the mHealth Satisfaction Questionnaire
Timepoint [1] 335769 0
The outcome will be assessed following the completion of the App (24 weeks post-commencement of app use).
Primary outcome [2] 335770 0
Ability of Precision AF App to determine change in AF specific health literacy as assessed by the Atrial Fibrillation health literacy questionnaire (AFHLQ).
Timepoint [2] 335770 0
The outcome will be assessed following the
1) completion of level 1 after AF educational videos have been viewed
2) completion of the App (24 weeks post-commencement of app use).
Primary outcome [3] 335771 0
Ability of the Precision AF App and precision health platform to track risk factor and lifestyle change (composite primary outcome). Each of the following parameters will be given a score of 1 or 0. The proportion of risk factors improved will be assessed. The denominator will be determined the presence or absence of risk factor.
a) Weight loss for obese/overweight individuals with BMI>27 (10% loss or BMI<27)
b) Exercise capacity improvement by 2 MET equivalent (IPAQ).
c) Alcohol intake reduced to <3SD/week (for participants consuming>3SD/week)
d) BP control as per AHA guidelines for hypertensive participants
d) Change in Withings mat indices
Timepoint [3] 335771 0
The outcome will be assessed following the completion of the App (24 weeks post-commencement of app use).
Secondary outcome [1] 425546 0
Ability of the precision health platform to track compliance to oral anticoagulation (Hill-Bone Medication Adherence Scale (HB-MAS),

This is primary outcome.
Timepoint [1] 425546 0
The outcome will be assessed following the completion of the App (24 weeks post-commencement of app use) with baseline as comparator.
Secondary outcome [2] 425548 0
Ability of the precision health platform to track rate and rhythm control as assessed by proportion of planned weekly transmissions from Kardiamobile.

This is primary outcome.
Timepoint [2] 425548 0
The outcome will be assessed following the completion of the App (24 weeks post-commencement of app use).
Secondary outcome [3] 425549 0
Ability of precision health platform to determine change in symptoms of atrial fibrillation using the Atrial Fibrillation Symptom Severity (AFSS) questionnaire.
Timepoint [3] 425549 0
The outcome will be assessed following the completion of the App (24 weeks post-commencement of app use) with baseline as comparator.
Secondary outcome [4] 426381 0
Ability of precision health platform to determine change in Quality of life and treatment satisfaction using the Atrial Fibrillation Effect on Quality of Life (AFEQT questionnaire). This gives a composite score.
Timepoint [4] 426381 0
The outcome will be assessed following the completion of the App (24 weeks post-commencement of app use) with baseline as comparator.

Eligibility
Key inclusion criteria
• Confirmed diagnosis of paroxysmal and persistent AF with a diagnosis of non-valvular AF
• From age 18 years to less than equal to 80 years
• Willing to commit an average of 15-20 minutes throughout the day, on most days for the Precision AF App
• Availability of compatible mobile/tablet to access digital platform
• Willingness to use electronic communication
• Capacity to provide informed consent
• Understanding of written and verbal English
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age greater than 80 years
• Long persistent or permanent AF. Long persistent AF is defined as continuous AF lasting greater than 12 months. Permanent AF is defined as when it is decided to adopt a rate control strategy
• Valvular AF defined by presence of moderate to severe mitral stenosis or severe mitral regurgitation or severe aortic stenoses or regurgitation or prosthetic heart valve
• LVEF less than 30%
• Active malignancy
• Aphasia
• Severe depression or psychiatric disorders
• Severe renal impairment (eGFR less than 30)
• Severe cognitive impairment (clinical diagnosis)
• AF ablation planned during the study period

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 25383 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 25384 0
Westmead Hospital - Westmead
Recruitment hospital [3] 25385 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 41124 0
2145 - Westmead
Recruitment postcode(s) [2] 41125 0
3084 - Heidelberg
Recruitment postcode(s) [3] 41123 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 314592 0
Government body
Name [1] 314592 0
Medical Research Future Fund - NHMRC
Country [1] 314592 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace, Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 316557 0
None
Name [1] 316557 0
Address [1] 316557 0
Country [1] 316557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313627 0
Central Adelaide Local Health Network
Ethics committee address [1] 313627 0
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 313627 0
Australia
Date submitted for ethics approval [1] 313627 0
23/08/2022
Approval date [1] 313627 0
28/10/2022
Ethics approval number [1] 313627 0
2022/HRE00214

Summary
Brief summary
Atrial fibrillation (AF) is a complex heart rhythm disease. We have shown the utility of a multi-disciplinary approach for patients with AF, but applicability in real world settings with poor health literacy and unmet social needs is unknown. We hypothesize that a precision health platform can deliver integrated care in AF successfully. Therefore, we test a precision health model of care focusing on patient empowerment and self-management by promoting critical health literacy and personalised medicine utilizing a Precision Health Platform (Precision AF App). This novel approach moves away from a resource intensive multi-disciplinary approach and emphasizes health behaviour change to achieve the comprehensive AF management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128794 0
A/Prof Rajiv Mahajan
Address 128794 0
Lyell McEwin HospitalLevel 2, University of Adelaide Education AreaHaydown RoadElizabeth Vale, SA, 5112
Country 128794 0
Australia
Phone 128794 0
+61 416701492
Fax 128794 0
Email 128794 0
rajiv.mahjan@adelaide.edu.au
Contact person for public queries
Name 128795 0
A/Prof Rajiv Mahajan
Address 128795 0
Lyell McEwin HospitalLevel 2, University of Adelaide Education AreaHaydown RoadElizabeth Vale, SA, 5112
Country 128795 0
Australia
Phone 128795 0
+61 8 81829439
Fax 128795 0
Email 128795 0
rajiv.mahajan@adelaide.edu.au
Contact person for scientific queries
Name 128796 0
A/Prof Rajiv Mahajan
Address 128796 0
Lyell McEwin HospitalLevel 2, University of Adelaide Education AreaHaydown RoadElizabeth Vale, SA, 5112
Country 128796 0
Australia
Phone 128796 0
+61 416701492
Fax 128796 0
Email 128796 0
rajiv.mahajan@adelaide.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
This data will be de-identified and reported as aggregate.


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.