LeukemiaNCT05826288
Oncology Care at Home for BMT and CAR-T
A study testing BioIntelliSense BioButton Rechargable and Memora Health two-way patient engagement platform provided by RC in people with Leukemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Leukemia
- What is being tested?
- BioIntelliSense BioButton Rechargable and Memora Health two-way patient engagement platform provided by RC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years to 89 years old
- 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
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- 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
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Design of a Patient-Centered Approach to Manage Bone Marrow Transplant Patients and CAR-T Cell Therapy in a Home Setting
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.
Read the detailed description
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:
- Conditions
- Leukemia
- Being tested
- BioIntelliSense BioButton Rechargable, Memora Health two-way patient engagement platform provided by RC
- Keywords
- Bone Marrow Transplant (BMT), Chimeric Antigen Receptor T-cell therapy (CAR-T)
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioIntelliSense BioButton RechargableOther
Also called Remote Patient Monitoring (RPM)
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 RCOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post BMT or CAR-T patients receiving care at UCHealth | Experimental | 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. Receives: Other: BioIntelliSense BioButton Rechargable; Other: Memora Health two-way patient engagement platform provided by RC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reporting symptoms
Determine the number of patients reporting symptoms via EPRO
Measured: 90 Days
Number of alerts generated through RPM systems
Measured: 30 days
Number of potential febrile events detected via RPM
Measured: 90 Days
Number of potential infections detected via RPM
Measured: 90 Days
Number of potential neurotoxicity events detected via RPM
Measured: 90 Days
Number of potential cytokine release syndrome (CRS) events detected via RPM
Measured: 90 Days
Number of febrile neutropenia events confirmed by clinical evaluation
Measured: 90 Days
Number of infections confirmed by clinical evaluation
Measured: 90 Days
Number of neurotoxicity events confirmed by clinical evaluation
Measured: 90 Days
Number of CRS events confirmed by clinical evaluation
Measured: 30 days
Number of tech support contacts received from patients/caregivers
Measured: 90 Days
Minutes RPM devices spent off-body
Measured: 90 Days
Secondary outcomes (9)
Total number of patient interactions with RC
Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls
Measured: 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
Measured: 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
Measured: 90 Days
Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants
Measured: 90 Days
Number of hospital admissions during study period
Measured: 90 Days
Length of stay for hospital admissions during study period
Measured: up to 90 days
Total days in hospital during study period
Measured: 90 Days
Number of emergency room visits during study period
Measured: 90 Days
Number of ICU admissions during study period
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start29 Mar 2023
- Primary completion4 Aug 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Reimagine Care
- Responsible party
- Sponsor
- Investigators
- Glen Peterson, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826288
- Sponsor's protocol ID
- 22-1832.cc
- Status last verified
- Feb 2025
- First submitted
- 23 Mar 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Patient-Centered Approach to Manage Bone Marrow Transplant Patients and CAR-T Cell Therapy in a Home Setting
- ClinicalTrials.gov ID
- NCT05826288
- Acronym / sponsor ID
- 22-1832.cc
- Conditions
- Leukemia
- Keywords
- Bone Marrow Transplant (BMT), Chimeric Antigen Receptor T-cell therapy (CAR-T)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Reimagine Care
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post BMT or CAR-T patients receiving care at UCHealth | Experimental | Other: BioIntelliSense BioButton Rechargable, Other: Memora Health two-way patient engagement platform provided by RCParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 years to 89 years old
- 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)
Key exclusion criteria (2 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioIntelliSense BioButton RechargableAlso: Remote Patient Monitoring (RPM)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 | Post BMT or CAR-T patients receiving care at UCHealth |
| Memora Health two-way patient engagement platform provided by RCThe 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 | Post BMT or CAR-T patients receiving care at UCHealth |
Primary outcome
Number of patients reporting symptoms
Time frame: 90 Days
Determine the number of patients reporting symptoms via EPRO
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
9 secondary outcomes
Total number of patient interactions with RC
Time frame: 90 Days
EPRO patient response rates
Time frame: 90 Days
Patient retention rate
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Peterson principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioIntelliSense BioButton Rechargable and Memora Health two-way patient engagement platform provided by RC in people with Leukemia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients reporting symptoms (time frame: 90 Days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.