Bone Marrow TransplantNCT05662631
Remote Monitoring and Home-based Health Care for Treatment of Bone Marrow Transplant Patients
A study testing BioIntellisense BioSticker in people with Bone Marrow Transplant, run by University of Colorado, Denver at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Bone Marrow Transplant
- What is being tested?
- BioIntellisense BioSticker
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 16 Oct 2022
- 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)
- 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
Show all 10Show fewer
- 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
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Technology-assisted, In-home Remote Patient Monitoring, Telemedicine, and Home-based Health Care for Treatment of Bone Marrow Transplant Patients.
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.
Read the detailed 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.
- Conditions
- Bone Marrow Transplant
- Being tested
- BioIntellisense BioSticker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioIntellisense BioStickerDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Transplant Participants | Experimental | 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. Receives: Device: BioIntellisense BioSticker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days
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.
Measured: Up to 90 days
Number of patients with infection, but without need for hospitalization
Number with infection, without hospitalization, while using device, for comparison with alerts.
Measured: Up to 90 days
Number of patients with infection, with need for hospitalization
Number with infection, with hospitalization, while using device, for comparison with alerts.
Measured: Up to 90 days
Secondary outcomes (3)
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start31 Mar 2022
- Primary completion16 Oct 2022
- Study completion16 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow TransplantStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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 E Peterson, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662631
- Sponsor's protocol ID
- 21-5081.cc
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-assisted, In-home Remote Patient Monitoring, Telemedicine, and Home-based Health Care for Treatment of Bone Marrow Transplant Patients.
- ClinicalTrials.gov ID
- NCT05662631
- Acronym / sponsor ID
- 21-5081.cc
- Conditions
- Bone Marrow Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Reimagine Care
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 16 Oct 2022 (actual)
- Study completion
- 16 Oct 2022 (actual)
- First posted
- 22 Dec 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Transplant Participants | Experimental | Device: BioIntellisense BioStickerStudy 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (1 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.
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 BioStickerAlso: BioStickerThis 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. | Device | Bone Marrow Transplant Participants |
Primary outcome
Number of patients without infection
Time frame: Up to 90 days
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.
Number of alerts detected through RPM
Time frame: Up to 90 days
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.
Number of patients with infection, but without need for hospitalization
Time frame: Up to 90 days
Number with infection, without hospitalization, while using device, for comparison with alerts.
Number of patients with infection, with need for hospitalization
Time frame: Up to 90 days
Number with infection, with hospitalization, while using device, for comparison with alerts.
3 secondary outcomes
Patient satisfaction: Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Baseline
Transplant Evaluation Rating Scale (TERS)
Time frame: Baseline
Patient satisfaction: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT)
Time frame: Day 30, Day 90
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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 E 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 BioSticker in people with Bone Marrow Transplant, 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 10 inclusion and 1 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 27 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 without infection (time frame: Up to 90 days). The study lists 4 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 27 Feb 2025.