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

NCT05662631 | Completed DMC

• 1 other identifier: 21-5081.cc
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Transplant

Outcome Measures

Primary Outcomes (4)

• Number of patients without infection

  Number of patients managed at home while using device who did not have an infection. This measure is collected for comparison with alerts. The device does not prevent infection.

  Up to 90 days

• Number of alerts detected through RPM

  Alert frequency is tracked to evaluate device function for feasibility of use in the clinical workflow. Patient treatment is not alert-based and is dependent on independent clinical confirmation. An alert of interest is defined as any of the following: * Oral temperature greater than or equal to 100.4 F (38.0 C) for 1 hour or one reading of 101 F (38.33C); * Mean skin temperature over 1 hour \> 98.5 F (36.9 C) or 2.5 times standard deviation from patient's baseline over 1 hour; * Mean heart rate over 1 hour \> 120 beats per minute or 30% overpatient's baseline over 1 hour * Mean respiratory rate over 1 hour \> 24 breaths per minute or 30% over patient's baseline over 1 hour, does not return to baseline following exertion; * The "BioIntelliSense Infection-Like AlertSymptoms" alert will also be monitored.

  Up to 90 days

• Number of patients with infection, but without need for hospitalization

  Number with infection, without hospitalization, while using device, for comparison with alerts.

  Up to 90 days

• Number of patients with infection, with need for hospitalization

  Number with infection, with hospitalization, while using device, for comparison with alerts.

  Up to 90 days

Secondary Outcomes (3)

• Patient satisfaction: Functional Assessment of Cancer Therapy-General (FACT-G)

  Baseline

• Transplant Evaluation Rating Scale (TERS)

  Baseline

• Patient satisfaction: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT)

  Day 30, Day 90

Other Outcomes (5)

• Cost of service provision

  Up to 90 days

• Days in hospital in first 90 day post-transplant

  Up to 90 days

• Length of hospital stay

  Up to 90 days

Study Arms (1)

Bone Marrow Transplant Participants

EXPERIMENTAL

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.

Device: BioIntellisense BioSticker

Interventions

BioIntellisense BioSticker 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.

Also known as: BioSticker

Bone Marrow Transplant Participants

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Reimagine Care: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Study Officials

• Glen E Peterson

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 22, 2022
• Study Start: March 31, 2022
• Primary Completion: October 16, 2022
• Study Completion: October 16, 2022
• Last Updated: February 27, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)