University of Colorado Hospital
Aurora, Colorado, 80045, United States
NCT Number: NCT05826288
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.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Time frame: 90 Days
Determine the number of patients reporting symptoms via EPRO
Time frame: 30 days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 30 days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls
Time frame: 90 Days
The percentage of outbound text messages requesting a response that are responded to by persons activated on the program
Time frame: 90 Days
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
Time frame: 90 Days
Time frame: up to 90 days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 Days
Time frame: 90 days
Number and percent of patients who report overall satisfaction with the intervention based on responses to survey items
Time frame: up to 90 days
Number and percent of caregivers who report overall satisfaction with the intervention based on responses to survey items
Time frame: 90 days
Number and percent of providers who report overall satisfaction with the intervention based on responses to survey items
Time frame: 90 days
Number and percent of patients who report overall improvement in perceived quality of life in responses to survey items
University of Colorado, Denver
Other
Design of a Patient-Centered Approach to Manage Bone Marrow Transplant Patients and CAR-T Cell Therapy in a Home Setting
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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