NCT05592769

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

October 20, 2022

Last Update Submit

February 28, 2023

Conditions

Respiratory Disease

Keywords

Remote Therapeutic MonitoringRTMSevere AsthmaBiologic medicationInjectable medicationAdherenceCompliancePersistenceRemote monitoring

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (3)

  • Compliance Data

    1 year

  • Participant Feedback

    1 year

  • Physician Feedback

    1 year

Study Arms (1)

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.

Device: HealthBeacon Injection Care Management System (ICMS)

Interventions

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)

HealthBeacon Injection Care Management System (ICMS) Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Modena Allergy & Asthma

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Respiration DisordersAsthmaPatient Compliance

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Brian Modena, Dr

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

November 10, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

March 1, 2023

Record last verified: 2022-11

Locations

US(1)