Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2023-03-29
2024-12-31
Brief Summary
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Detailed Description
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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:
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Post BMT or CAR-T patients receiving care at UCHealth
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.
BioIntelliSense BioButton Rechargable
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.
Memora Health two-way patient engagement platform provided by RC
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.
Interventions
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BioIntelliSense BioButton Rechargable
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.
Memora Health two-way patient engagement platform provided by RC
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bone marrow transplant recipients (allogeneic and autologous) or CAR-T patients
* 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 self-reported reliable telephone and home internet service and a stable wireless network
* Patient agrees to not submerge the BioButton Rechargeable 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 applications and accepting the terms and conditions
* Patient has SMS texting capacity and an unlimited texting plan or other plan sufficient for study text messaging without undue patient burden
* Patient is willing to complete and log a self-check of temperature twice daily and return the log to the study team at the end of the study
* Patient is willing to be available for the duration of the study
* Patient has access to reliable transportation to the hospital 24/7
Exclusion Criteria
* Patients may also be excluded from study participation if in the opinion of the PI they have a medical condition that may impede their ability to adhere to the study protocol.
18 Years
89 Years
ALL
No
Sponsors
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Reimagine Care
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Glen Peterson
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Countries
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Other Identifiers
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22-1832.cc
Identifier Type: -
Identifier Source: org_study_id
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