None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
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