Remote Monitoring and Home-based Health Care for Treatment of Bone Marrow Transplant Patients
Condition: Bone Marrow Transplant
Study type: Interventional

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.
    

Intervention name(s): BioIntellisense BioSticker
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): BioSticker
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility