A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device

Status unconfirmed · Not applicable

Conditions studied: Respiratory Disease

In brief

This goal of this study is to assess the suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) device for patients on injectable medications in the home-setting, for the management of respiratory disorders. The HealthBeacon ICMS is composed of the Smart Sharps Bin, Companion App and Care Team support. The Smart Sharps Bin a digitally connected sharps container and is pre-programmed with a patient's injection schedule. It creates a time-stamped record of each used injection deposited into it to calculate a patients' adherence to treatment. Following disposal, the next date of injection and rotating injection site is updated without requiring any extra work on behalf of the patient. The system also proactively supports enhanced compliance through a series of smart dose reminders and intervention calls, to help patients stay on track. Clinical teams can then review patient adherence data remotely via an online platform. The main aims of this study include the following: * To demonstrate the suitability of the HealthBeacon ICMS as an RTM device for respiratory patients through successful billing and reimbursement for physicians * To provide data to support the reimbursement of the HealthBeacon ICMS by Private Payors in the future Participants prescribed injectable medication for the treatment of a diagnosed respiratory condition will be enrolled by the Principal Investigator (PI) and referred to HealthBeacon. Participants will then be provided with access to the HealthBeacon ICMS to remotely track and support their adherence to treatment in the home-setting. Participants will use the system for 6 months and their adherence data during this time will be collected, which the PI and clinical team involved will be able to remotely access and review. At various stages of the study, the applicable RTM codes will be billed for, for each participant. These stages include when providing each participant with access to the HealthBeacon system, including the Smart Sharps Bin, when providing each participant with education on how to use the device, and when the clinical team monitors each individual patients' adherence data collected by the HealthBeacon system on a monthly basis.

Key facts

Study ID

NCT05592769

Run by

HealthBeacon Plc

People needed

10

Starts

2022-11-10

Expected to finish

2023-11-01

Last updated by the study team

2023-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be prescribed an at-home injectable biologic medication for the treatment of a respiratory condition.
• Participants must be able to provide informed consent to participate in the study
• Participants must be Medicare/Medicaid patients
• Participants must be 18 years old or older.
• Participants must have access to a smart phone and be familiar with the use of mobile-phone applications
• Participants must ensure they have a suitable place to store their HealthBeacon Smart Sharps Bin in their home setting, where it can remain plugged into a power source
• Participants must ensure they have network coverage in the area where they will keep their HealthBeacon Smart Sharps Bin

You may not qualify if…

• Participants under the age of 18
• Participants who are unable to understand the study, comply with the requirements of the study and provide informed consent to participate in it
• Participants who live somewhere with no/very poor network coverage

Where it is running

• Modena Allergy & Asthma — La Jolla, California, United States

Full record on ClinicalTrials.gov

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