Clinical trial NCT05662631: Remote Monitoring and Home-based Health Care for Treatment of Bone Marrow Transplant Patients
Official title: Technology-assisted, In-home Remote Patient Monitoring, Telemedicine, and Home-based Health Care for Treatment of Bone Marrow Transplant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplant
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Reimagine Care
First posted: 2022-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Number of patients without infection
timeFrame: Up to 90 days
measure: Number of alerts detected through RPM
timeFrame: Up to 90 days
measure: Number of patients with infection, but without need for hospitalization
timeFrame: Up to 90 days
measure: Number of patients with infection, with need for hospitalization
timeFrame: Up to 90 days
Secondary outcomes:
measure: Patient satisfaction: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Baseline
measure: Transplant Evaluation Rating Scale (TERS)
timeFrame: Baseline
measure: Patient satisfaction: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT)
timeFrame: Day 30, Day 90
Other outcomes:
measure: Cost of service provision
timeFrame: Up to 90 days
measure: Days in hospital in first 90 day post-transplant
timeFrame: Up to 90 days
measure: Length of hospital stay
timeFrame: Up to 90 days
measure: Number of ICU admissions post-transplant
timeFrame: Up to 90 days
measure: Death rates associated with admission for febrile neutropenia
timeFrame: Up to 90 days
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Glen E Peterson
role: PRINCIPAL_INVESTIGATOR
References: