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

Bone Marrow Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662631
• Other study ID #: 21-5081.cc
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: October 16, 2022

Study information

• Verified date: December 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 16, 2022
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Transplant

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Reimagine Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of service provision	in US dollars.	Up to 90 days
Other	Days in hospital in first 90 day post-transplant	In days	Up to 90 days
Other	Length of hospital stay	In days	Up to 90 days
Other	Number of ICU admissions post-transplant	Number of ICU admissions	Up to 90 days
Other	Death rates associated with admission for febrile neutropenia	Number of	Up to 90 days
Primary	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
Primary	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
Primary	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
Primary	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	Patient satisfaction: Functional Assessment of Cancer Therapy-General (FACT-G)	The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire that measures Health-related quality of life (HRQoL) in cancer patients. Responses to each question are scored on a 5 point likert scale ranging from 0 (Not at all) to 4 (Very much). Possible total scores range from 0-108, with higher scores indicating a better outcome/better QoL.	Baseline
Secondary	Transplant Evaluation Rating Scale (TERS)	The Transplant Evaluation Rating Scale (TERS) measures the predicted impact of psychosocial factors on the successful outcome of transplant. The measurement consists of an expert interview, in which the assessor evaluates 10 distinct domains considered relevant to successful adjustment to the transplant, and rates responses from 1-3. These scores are then weighted for relevance to determine a total weighted score. Possible total scores range from 26.5 to 79.5, with higher scores indicating a worse outcome (greater impairment in psychosocial functioning).	Baseline
Secondary	Patient satisfaction: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT)	The Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT) assesses quality of life in adult cancer patients undergoing blood & bone marrow transplant. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. Possible total scores range from 0-148. Higher scores indicate a better quality of life and a better outcome.	Day 30, Day 90