NCT05662631

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

Technology-assisted, In-home Remote Patient Monitoring, Telemedicine, and Home-based Health Care for Treatment of Bone Marrow Transplant Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-03-31
• Primary completion: 2022-10-16
• Completion: 2022-10-16
• First posted: 2022-12-22
• Last updated: 2025-02-27

Locations

1 site across 1 country: United States