None listed
Conditions
Brief summary
This trial will utilise information from Boston Scientific Cardiac Implantable electronic Devices remote monitoring and Heart Logic Algorithm and the NOTIFY-HF smart phone web-application to assist in the early identification of fluid overload. Evidence shows that heart failure decompensation events begin 4-6 weeks before the development of symptoms such as breathlessness or fluid retention. The aim of this research project is to use this information obtained from your device via remote monitoring to provide feedback via push notifications to participants on their heart failure status. The app, NOTIFY-HF, will provide a weekly update in an easy-to-understand manner with the hope of instigating behavioural changes that result in improvements in heart failure management. The central hypothesis of the study is that push notifications guided by HeartLogic data will promote behavioural change that leads to improvements in heart failure.
Interventions
Push notifications to patients with Heart Logic Score feedback.
Patients in the intervention arm will be registered for a web-app that will reside on their mobile phone home screen. Push notifications will be sent via this mechanism on a weekly basis for a minimum of 12 months following enrolment in the trial. The content of the notification will be determined based on their Heart Logic (HL) score, which will be transmitted via their pre-existing Boston Scientific HL compatible Cardiac Implanta
Push notifications to patients with Heart Logic Score feedback. Patients in the intervention arm will be registered for a web-app that will reside on their mobile phone home screen. Push notifications will be sent via this mechanism on a weekly basis for a minimum of 12 months following enrolment in the trial. The content of the notification will be determined based on their Heart Logic (HL) score, which will be transmitted via their pre-existing Boston Scientific HL compatible Cardiac Implantable Electronic Device (CIED) Home Monitoring via their Latitude platform. The participants will receive feedback on their HL score and be categorised into 3 groups via a "traffic light system" - green, amber and red. Participants with a normal HL score will be in the green zone, and will receive encouragement. Those with an abnormal HL score will receive a notification advising them of this, and be prompted to complete a symptom screening score. Those without symptoms will be categorized as 'Amber' and their notification will provide them with strategies for risk management, be reminded to take their medications, and given information on red flags to look out for. Those who are identified as having symptoms with an abnormal HL score will be categorised in the 'Red' group and will receive a notification advising the participant to seek medical review within 48 hours. The intervention will be automated process using the Zedoc platform that has been developed by The Clinician. In the event that push notifications are not read by the participant, the Zedoc platform will alert the investigators and a reminder notification can be sent. Failure to respond following a reminder will result in a phone call to check that there are no technical issues prohibiting delivery of the notifications.
Sponsors
Liverpool Hospital Department of Cardiology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years or older • English speaking • Compatible Boston CIED capable of heart failure diagnostics (HeartLogic) and remote monitoring • Heart Failure with reduced ejection fraction (HFrEF) with Ejection Fraction (EF) <50% or EF >50% with previous admission with heart failure with preserved ejection fraction (HFpEF) or EF >50% and prescribed oral loop diuretic • 45 days post CIED implantation • Compatible mobile phone with access to an internet connection • Willingness to give written informed consent and willingness to participate to and comply with the study.
Exclusion criteria
• Any non-cardiac disease that is likely to reduce life expectancy to less than 1 year • Cognitive impairment • Participation in another clinical trial that in the opinion of the investigator may interfere with participation in NOTIFY-HF
Outcome results
None listed