Respiratory DiseaseNCT05592769
A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device
A study testing HealthBeacon Injection Care Management System (ICMS) in people with Respiratory Disease, run by HealthBeacon Plc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- HealthBeacon Injection Care Management System (ICMS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device for Patients on Injectable Therapy for Respiratory Disease
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.
Read more
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.
Read the detailed description
The HealthBeacon ICMS is an adherence support platform for patients on injectable medications in the home-setting. The Smart Sharps Bin electronically records each time a used injection device is deposited into it by means of an infra-red sensor and camera. This data is compared to an individuals' treatment schedule pre-programmed to the unit, to determine the patient's adherence to therapy. The bin also issues reminders to patients when doses are due by means of a blue light on its upper surface. Smart Short Message Service (SMS) dose reminders are also provided to help patients stay on track. The bin displays patients personal adherence score, date of their next injection and at which rotating injection site on a small screen on its upper surface. When a used injection is deposited into the Smart Sharps Bin, patients' adherence automatically updates as does the date of their next injection. This information is also visible for patients to review in the HealthBeacon Companion App (the "App"). Within the App, patients can also tailor their dose reminder preferences, see a log of all doses taken, access educational materials and view their injection schedule details. They may also remotely self-report a dose as taken in the App, if they were away from their Smart Sharps Bin at the time of injection. Patients' adherence data, as collected by the HealthBeacon ICMS, is then available for referring physicians and clinical teams to remotely review, providing teams with greater insight and more accurate information regarding patient compliance. HealthBeacon also remotely monitor the capacity of the Smart Sharps Bins, and provide patients with replacement bins when they reach full capacity whilst arranging collection of full bins through HealthBeacon's mail-back program.
The Centres for Medicare and Medicaid Services (CMS) released the Remote Therapeutic Monitoring (RTM) codes in January 2021 to enable enhanced reimbursement of remote monitoring services. Unlike existing Remote Physiological Monitoring (RPM) codes which required collection of physiological data points, the RTM codes enable reimbursement of devices which monitor therapy adherence, in particular for respiratory and/or musculoskeletal system conditions.
As a remote device to track and support adherence to medications, the HealthBeacon ICMS is well positioned to fulfil the definition of an RTM device. Key steps in the patient referral and usage pathway, including providing access to the HealthBeacon system, initial set up and education on how to use it, and its remote adherence monitoring capabilities, correspond to separate billing events under the RTM codes. Therefore, HealthBeacon believe the system can be successfully implemented as an RTM device with reimbursement for physicians. This study aims to demonstrate this by providing real-world data on patient usage of the system, implementation into clinical practice and primarily by assessing the outcome of the billing process under the RTM codes.
- Conditions
- Respiratory Disease
- Being tested
- HealthBeacon Injection Care Management System (ICMS)
- Keywords
- Remote Therapeutic Monitoring, RTM, Severe Asthma, Biologic medication, Injectable medication, Adherence, Compliance, Persistence, Remote monitoring
- Medical subject headings
- Respiration Disorders, Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthBeacon Injection Care Management System (ICMS)Device
All participants will receive access to the HealthBeacon ICMS to remotely monitor adherence to therapy in the home setting. The system includes the following items/services:
- The HealthBeacon Smart Sharps Bin
- The HealthBeacon Companion App
- HealthBeacon Care Team Support (including smart dose reminders and intervention calls)
- Waste Management Services
Participants will also be issued the following interventions to enable collection of the secondary endpoints:
-Participant Feedback Questionnaire (issued electronically upon study completion, to gather feedback on the HealthBeacon ICMS)
| Study group | Role | What they receive |
|---|---|---|
| HealthBeacon Injection Care Management System (ICMS) Arm | Experimental | All participants enrolled will be recruited to this study arm and provided with access to the HealthBeacon ICMS. Receives: Device: HealthBeacon Injection Care Management System (ICMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of billing for the HealthBeacon Injection Care Management System (ICMS) under Remote Therapeutic Monitoring (RTM) reimbursement codes
Data on the outcome of the billing process for the HealthBeacon ICMS as an RTM device for each participant will be collected throughout the study and the rate of successful reimbursement assessed.Data gathered through this process may also include information on the criteria for successful billing and insights into the reimbursement pathway with real-world examples.
Measured: 1 year
Secondary outcomes (3)
Compliance Data
Compliance data to prescribed treatments will be collected, including adherence and persistence data at both an individual and group level.
Measured: 1 year
Participant Feedback
Feedback on the acceptability and utility of the HealthBeacon ICMS will be collected upon completion of each participant's time in the study. Feedback will be collected via electronic questionnaire.
Measured: 1 year
Physician Feedback
Physician feedback on integration of the HealthBeacon ICMS into clinical workflows and benefits of the system as an RTM device for remote monitoring of patient compliance will be collected upon study completion. Feedback will be collected via electronic questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start10 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be enrolled to the one study arm, in which they will all be provided with access to the HealthBeacon Injection Care Management System (ICMS). Participants will be identified and enrolled from the clinical site by the Study Personnel.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthBeacon Plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Modena Allergy & Asthma
- Responsible party
- Sponsor
- Investigators
- Brian Modena, Dr, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592769
- Sponsor's protocol ID
- HBMODENA001
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device for Patients on Injectable Therapy for Respiratory Disease
- ClinicalTrials.gov ID
- NCT05592769
- Acronym / sponsor ID
- HBMODENA001
- Conditions
- Respiratory Disease
- Keywords
- Remote Therapeutic Monitoring, RTM, Severe Asthma, Biologic medication, Injectable medication, Adherence, Compliance, Persistence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HealthBeacon PlcIndustry (pharma, biotech, devices)
- Collaborators
- Modena Allergy & Asthma
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HealthBeacon ICMS is an adherence support platform for patients on injectable medications in the home-setting. The Smart Sharps Bin electronically records each time a used injection device is deposited into it by means of an infra-red sensor and camera. This data is compared to an individuals' treatment schedule pre-programmed to the unit, to determine the patient's adherence to therapy. The bin also issues reminders to patients when doses are due by means of a blue light on its upper surface. Smart Short Message Service (SMS) dose reminders are also provided to help patients stay on track. The bin displays patients personal adherence score, date of their next injection and at which rotating injection site on a small screen on its upper surface. When a used injection is deposited into the Smart Sharps Bin, patients' adherence automatically updates as does the date of their next injection. This information is also visible for patients to review in the HealthBeacon Companion App (the "App"). Within the App, patients can also tailor their dose reminder preferences, see a log of all doses taken, access educational materials and view their injection schedule details. They may also remotely self-report a dose as taken in the App, if they were away from their Smart Sharps Bin at the time of injection. Patients' adherence data, as collected by the HealthBeacon ICMS, is then available for referring physicians and clinical teams to remotely review, providing teams with greater insight and more accurate information regarding patient compliance. HealthBeacon also remotely monitor the capacity of the Smart Sharps Bins, and provide patients with replacement bins when they reach full capacity whilst arranging collection of full bins through HealthBeacon's mail-back program.
The Centres for Medicare and Medicaid Services (CMS) released the Remote Therapeutic Monitoring (RTM) codes in January 2021 to enable enhanced reimbursement of remote monitoring services. Unlike existing Remote Physiological Monitoring (RPM) codes which required collection of physiological data points, the RTM codes enable reimbursement of devices which monitor therapy adherence, in particular for respiratory and/or musculoskeletal system conditions.
As a remote device to track and support adherence to medications, the HealthBeacon ICMS is well positioned to fulfil the definition of an RTM device. Key steps in the patient referral and usage pathway, including providing access to the HealthBeacon system, initial set up and education on how to use it, and its remote adherence monitoring capabilities, correspond to separate billing events under the RTM codes. Therefore, HealthBeacon believe the system can be successfully implemented as an RTM device with reimbursement for physicians. This study aims to demonstrate this by providing real-world data on patient usage of the system, implementation into clinical practice and primarily by assessing the outcome of the billing process under the RTM codes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be enrolled to the one study arm, in which they will all be provided with access to the HealthBeacon Injection Care Management System (ICMS). Participants will be identified and enrolled from the clinical site by the Study Personnel.
| Arm | Type | Receives |
|---|---|---|
| HealthBeacon Injection Care Management System (ICMS) Arm | Experimental | Device: HealthBeacon Injection Care Management System (ICMS)All participants enrolled will be recruited to this study arm and provided with access to the HealthBeacon ICMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthBeacon Injection Care Management System (ICMS)All participants will receive access to the HealthBeacon ICMS to remotely monitor adherence to therapy in the home setting. The system includes the following items/services: * The HealthBeacon Smart Sharps Bin * The HealthBeacon Companion App * HealthBeacon Care Team Support (including smart dose reminders and intervention calls) * Waste Management Services Participants will also be issued the following interventions to enable collection of the secondary endpoints: -Participant Feedback Questionnaire (issued electronically upon study completion, to gather feedback on the HealthBeacon ICMS) | Device | HealthBeacon Injection Care Management System (ICMS) Arm |
Primary outcome
Outcome of billing for the HealthBeacon Injection Care Management System (ICMS) under Remote Therapeutic Monitoring (RTM) reimbursement codes
Time frame: 1 year
Data on the outcome of the billing process for the HealthBeacon ICMS as an RTM device for each participant will be collected throughout the study and the rate of successful reimbursement assessed.Data gathered through this process may also include information on the criteria for successful billing and insights into the reimbursement pathway with real-world examples.
3 secondary outcomes
Compliance Data
Time frame: 1 year
Participant Feedback
Time frame: 1 year
Physician Feedback
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Modena, Dr principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthBeacon Injection Care Management System (ICMS) in people with Respiratory Disease, run by HealthBeacon Plc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of billing for the HealthBeacon Injection Care Management System (ICMS) under Remote Therapeutic Monitoring (RTM) reimbursement codes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.