Study: NCT05193084

Intervention type: DEVICE
Intervention: Heartfelt Device
Description: The Heartfelt Device is a CE marked device that measures the volume of the foot/lower leg. By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Feet identification software, complemented by manual checks, ensures that photographs are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. For this study, no personal identifiable data will be stored on the device or on the servers used by the device.~The volume readings collected can be presented to the clinical team on a web interface. This is not presented against identifiable data, but only participant ID. However, in the current pilot, volume readings will not be reviewed by the clinical team until the point of data analysis, after the study period.

Intervention type: DEVICE
Intervention: Heartfelt Device
Description: The Heartfelt Device is a CE marked device that measures the volume of the foot/lower leg. By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Feet identification software, complemented by manual checks, ensures that photographs are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. For this study, no personal identifiable data will be stored on the device or on the servers used by the device.~The volume readings collected can be presented to the clinical team on a web interface. This is not presented against identifiable data, but only participant ID. However, in the current pilot, volume readings will not be reviewed by the clinical team until the point of data analysis, after the study period.

Intervention type: DEVICE
Intervention: Connected weighing scales
Description: The connected weighing scales are Xiaomi Smart Scales (CE marked, manufactured by Anhui Huami Informeyshn Technologies).~The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional(s) (the fact that a participant has not used scales regularly in the past is not an exclusion criteria). The weighing scales display weight so that the participants can record the weight in their own heart failure records (paper weight diary).~The study team will check the patient's paper weight diary in case they choose to use another set of scales.~The participant will be able to see the weight readings on the weighing scales during the study.~The scales will record patient weight as well as the date and time of the measurements.

Intervention type: DEVICE
Intervention: Connected weighing scales
Description: The connected weighing scales are Xiaomi Smart Scales (CE marked, manufactured by Anhui Huami Informeyshn Technologies).~The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional(s) (the fact that a participant has not used scales regularly in the past is not an exclusion criteria). The weighing scales display weight so that the participants can record the weight in their own heart failure records (paper weight diary).~The study team will check the patient's paper weight diary in case they choose to use another set of scales.~The participant will be able to see the weight readings on the weighing scales during the study.~The scales will record patient weight as well as the date and time of the measurements.