Remote Monitoring and Home-based Health Care for Treatment of Bone Marrow Transplant Patients

NCT ID: NCT05662631

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-10-16

Brief Summary

This study is designed to assess the potential for successfully using technology-assisted in-home oncology care, including remote patient monitoring (RPM), telemedicine, and home-based health care services to support improved care management and appropriate referral to treatment for bone marrow transplant (BMT) patients.

Detailed Description

Study participants will complete an onboarding session into the Oncology at Home care program prior to discharge from the hospital. During the onboarding process, participants will be introduced to the RC care team, confirm understanding of their customized care plan treatment and goals as established by their BMT care provider, will receive an oral thermometer for use during the study, and will complete patient education. Working with the study team and RC RN, participants will receive, affix, activate, and test a wearable RPM device (the BioIntellisense BioSticker) prior to discharge from the BMT unit. As the BioSticker needs to be replaced every 30 days, patients will also receive three additional BioStickers new in packaging for use during months 2 and 3 as well as to have a back-up device in case of malfunction. Patients will return the BioSticker to BioIntelliSense with the postage paid return envelope provided at discharge.

The BioSticker will report skin temperature data once per hour, along with additional vital sign information (heart rate, respiratory rate, estimated body temperature, frequency of severe cough episodes, activity level, body position, sleep duration, degree of incline while sleeping, step count, step symmetry, step strength, and on/off body times). Participants will be expected to wear the BioSticker 24 hours per day, 7 days per week, and to also track and log their temperature manually with the oral thermometer according to usual care practice at a minimum of twice per day.

RPM data will be monitored 24 hours per day, 7 days per week by Reimagine Care, Inc. Advanced Practice Providers (APPs) from the Reimagine Care, Inc. Virtual Care Center (VCC). During daytime business hours, APPs will monitor in real time from the VCC. After business hours and on weekends, APPs will be on call and will be automatically notified through a mobile device in case of elevated temperature or other alert of interest. APPs on call will keep the notification device with them at all times.

Conditions

Bone Marrow Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Bone Marrow Transplant Participants

Study participants will complete an onboarding session into the Oncology at Home care program prior to discharge from the hospital. During the onboarding process, participants will be introduced to the RC care team, confirm understanding of their customized care plan treatment and goals as established by their BMT care provider, will receive an oral thermometer for use during the study, and will complete patient education. Working with the study team and RC RN, participants will receive, affix, activate, and test a wearable RPM device (the BioIntellisense BioSticker) prior to discharge from the BMT unit. As the BioSticker needs to be replaced every 30 days, patients will also receive three additional BioStickers new in packaging for use during months 2 and 3 as well as to have a back-up device in case of malfunction. Patients will return the BioSticker to BioIntelliSense with the postage paid return envelope provided at discharge.

Group Type: EXPERIMENTAL

BioIntellisense BioSticker

Intervention Type: DEVICE

This study uses the BioIntellisense BioSticker for RPM, in combination with the BioSync mobile app on participants' mobile phones for data transmission, augmented by use of the BioHub as a backup transmission device. RPM monitoring of device data is accomplished through use of the AlertWatch software system.

BioSticker System TheBioSticker ® System is an FDA-approved remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings. This includes heart rate, respiratory rate, skin temperature, estimated body temperature, frequency of severe cough episodes, activity level, sleep duration, body position, degree of incline while sleeping, step count, step symmetry, step strength, and on/off body times and other symptomatic and biometric data. Data are securely transmitted using AES-CTR 128 bit encryption via wireless connection from the device for storage, review, and further analysis.

Interventions

BioIntellisense BioSticker

This study uses the BioIntellisense BioSticker for RPM, in combination with the BioSync mobile app on participants' mobile phones for data transmission, augmented by use of the BioHub as a backup transmission device. RPM monitoring of device data is accomplished through use of the AlertWatch software system.

BioSticker System TheBioSticker ® System is an FDA-approved remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings. This includes heart rate, respiratory rate, skin temperature, estimated body temperature, frequency of severe cough episodes, activity level, sleep duration, body position, degree of incline while sleeping, step count, step symmetry, step strength, and on/off body times and other symptomatic and biometric data. Data are securely transmitted using AES-CTR 128 bit encryption via wireless connection from the device for storage, review, and further analysis.

Intervention Type: DEVICE

Other Intervention Names

BioSticker

Eligibility Criteria

Inclusion Criteria

• Age 18 years to 89 years old
• Bone marrow transplant recipients (allogeneic)
• Determined by care provider to be stable for discharge to home setting for outpatient care according to clinical practice standard operating procedures (SOPs)
• Residing in the Denver metro area for the duration of the study within 45 minutes of the AMC
• Has in-home caregiver support 24/7 (i.e., does not live alone)
• Has reliable telephone and home internet service and stable wireless network
• Patient has agreed to not submerge the BioSticker device in more than 3 feet of water or submerge for longer than 30 minutes at a time.
• Patient owns or possesses, as the primary user with reliable daily access, a mobile device (iOS or Android) capable of running the study's mobile application and accepting the terms and conditions
• Patient is willing to complete a self-check temperature log to comply and be available for the duration of the study
• Has access to reliable transportation to the hospital 24/7

Exclusion Criteria

Patients will be excluded from study participation if the PI or designated care provider believes study participation would not be in the patient's best interest for clinical reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reimagine Care

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen E Peterson

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

21-5081.cc

Identifier Type: -

Identifier Source: org_study_id