An interventional study of BioIntelliSense BioButton Rechargable and Memora Health two-way patient engagement platform provided by RC in Leukemia, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
To assess the potential for successfully using technology-assisted in-home oncology care to provide improved care coordination and management, and appropriate referral to treatment for patients receiving bone marrow transplant (BMT) or chimeric antigen receptor (CAR) T-cell therapy (CAR-T). The technology-assisted in-home oncology care program includes remote patient monitoring (RPM), telemedicine, and home-based health care services.
The objective of this study is to assess the potential for successfully using technology-assisted in-home oncology care to provide improved care coordination and management, and appropriate referral to treatment for patients receiving bone marrow transplant (BMT) or chimeric antigen receptor (CAR) T-cell therapy (CAR-T). The technology-assisted in-home oncology care program includes remote patient monitoring (RPM), telemedicine, and home-based health care services.
The study focuses on evaluating the technical feasibility, operational feasibility, and perceived patient, caregiver and healthcare provider experience of a combined package of technology-assisted in-home oncology care services to monitor for febrile neutropenia, infection, cyotokine release syndrome, neurotoxicity or other symptomatic episodes needing management up to 90 days post allogeneic BMT, up to 30 days post autologous BMT, and up to 30 days post CAR-T. It includes the following specific aims and hypotheses:
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
This study's enrollment of 11 is below the median of 38 across 4,268 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Participants will be recruited for this study from among three discrete patient populations: * Allogeneic BMT patients receiving care at UCHealth who are planning to reside in the Denver metro area within 45 minutes of the Anschutz Medical Campus (AMC) for at least 90 days post-transplant. * Autologous BMT patients receiving care at UCHealth who are planning to reside in the Denver metro Area within 45 minutes of the AMC for at least 30 days post-transplant. * CAR-T patients receiving care at UCHealth who are planning to reside in the Denver metro area within 45 minutes of the AMC for at least 30 days post treatment.
Other: BioIntelliSense BioButton Rechargable · Other: Memora Health two-way patient engagement platform provided by RC
This study uses the BioIntelliSense BioButton Rechargeable 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.
Also known as: Remote Patient Monitoring (RPM)
The Memora Health platform is designed to automate complex care workflows, making them simple for patients and clinicians to navigate. It utilizes a multi-modal communications system that primarily relies on two-way text messaging and artificial intelligence.
Number of patients reporting symptoms
Determine the number of patients reporting symptoms via EPRO
Time frame: 90 Days
Number of alerts generated through RPM systems
Time frame: 30 days
Number of potential febrile events detected via RPM
Time frame: 90 Days
Number of potential infections detected via RPM
Time frame: 90 Days
Number of potential neurotoxicity events detected via RPM
Time frame: 90 Days
Number of potential cytokine release syndrome (CRS) events detected via RPM
Time frame: 90 Days
Number of febrile neutropenia events confirmed by clinical evaluation
Time frame: 90 Days
Number of infections confirmed by clinical evaluation
Time frame: 90 Days
Number of neurotoxicity events confirmed by clinical evaluation
Time frame: 90 Days
Number of CRS events confirmed by clinical evaluation
Time frame: 30 days
Number of tech support contacts received from patients/caregivers
Time frame: 90 Days
Minutes RPM devices spent off-body
Time frame: 90 Days
Total number of patient interactions with RC
Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls
Time frame: 90 Days
EPRO patient response rates
The percentage of outbound text messages requesting a response that are responded to by persons activated on the program
Time frame: 90 Days
Patient retention rate
The percentage of patients that remain actively engaged with the program by exchanging at least one text message or having at least one telehealth encounter with the VCC per week
Time frame: 90 Days
Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants
Time frame: 90 Days
Number of hospital admissions during study period
Time frame: 90 Days
Length of stay for hospital admissions during study period
Time frame: up to 90 days
Total days in hospital during study period
Time frame: 90 Days
Number of emergency room visits during study period
Time frame: 90 Days
Number of ICU admissions during study period
Time frame: 90 Days
Overall patient satisfaction
Number and percent of patients who report overall satisfaction with the intervention based on responses to survey items
Time frame: 90 days
Overall caregiver satisfaction
Number and percent of caregivers who report overall satisfaction with the intervention based on responses to survey items
Time frame: up to 90 days
Overall health care provider satisfaction
Number and percent of providers who report overall satisfaction with the intervention based on responses to survey items
Time frame: 90 days
Perceived quality of life
Number and percent of patients who report overall improvement in perceived quality of life in responses to survey items
Time frame: 90 days
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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