Assessment of Heart Failure (HF) At-Home Management Solution ADI Cardio Pulmonary Monitoring System (CPM)

Patients will be recruited and begin the study as they are identified and consent to the study. Recruiting will end either by a designated date set at the initiation of the study or when 30 patients have been enrolled in the study.

The duration of the study for each patient will be approximately 60 days beginning with the baseline/initial visit and concluding 30 days after the patient has completed device use. The patient will use the device given to the once a day during the first 60 days the study and following that time patient records will be reviewed retrospectively for CHF events for the 60 days plus an additional 30 days after their last measurement. Each patient will also receive weekly calls from the research team to check in on device functionality and assure adherence to the protocol.

At visit 1, the start of the study, baseline information will be collected, importantly including accurate weight and notes about congestion and fluid buildup. The study will be re-described to the participant. The research team will then set up the device for the individual patient by making adjustments (as needed) to address patient specific anatomy), ensuring that the sensors are all contacting the appropriate chest areas, and confirming the measurements on the CPM Web application. The patient will be shown how to apply and replace the adhesive on the device, how to position the device, how to take a measurement with the device, and how to store the device on the Base Station. The trained provider will then register the baseline reading for the CHF device using the CHF Mobile App.

Informational materials about using the device, refreshing adhesives, and meanings of LEDs and chimes on the device will also be given to the patient. The patient will be instructed to follow the normal regimen prescribed by their by their physician, but to add taking a measurement with their CPM at the same time each day (preferably when they first wake up).

Between visits, caregivers will not have any access to the data being collected on the CHF Device. They should perform their usual standard of care on these patients. Participants will also receive calls from the research team to check in about the progress of the study (i.e., if protocols are being followed correctly, if the CPM device is working properly, and if adherence is satisfactory. This check-in, conversation topics should focus on any ease-of-use issues and address any compliance-based issues.