FeverNCT06752512
Remote Temperature Monitoring of Patients At Risk for Developing Fever
A study testing Remote Patient Monitoring in people with Fever and Cancer, run by AION Biosystems at 1 site in United States.
Trial summary
The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are: does remote temperature monitoring reduce the number of days spent inpatient what out-of-pocket cost can a patient expect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever, Cancer, Remote Patient Monitoring
- What is being tested?
- Remote Patient Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at risk of a fever post discharge.
- Subject is ≥ 18 years or older.
- Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
- Subject is willing to install the TempShield app on his/her phone.
- Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
- Subject is willing to take an oral temperature as directed by their care plan.
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- Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
- Subject or subject caretaker is able and willing to complete subject surveys.
- Subject is willing and able to provide written informed consent in English.
- Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.
- English speakers
Who cannot join
- Unable to provide informed consent
- Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
- Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
- Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
- Subjects receiving prophylactics that could induce fever.
- Subjects with a silicon allergy
- Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.
- Subjects who are not willing to take an oral temperature per their care plan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ellis Hospital
Schenectady, New York, 12308
Elise Currier, (704) 307-1253, curriere4s@ellismedicine.org
About this study
The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are:
- does remote temperature monitoring reduce the number of days spent inpatient
- what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring
- the number of billable CPT codes that will be generated by providing remote temperature monitoring
Read more
Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.
Patients will
- wear the thermometer for the duration of their participation in the study
- have their temperature monitored continuously
- receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician
- respond to texts or calls from remote monitors when an alert is triggered
- Conditions
- Fever, Cancer, Remote Patient Monitoring
- Being tested
- Remote Patient Monitoring
- Keywords
- fever, infection, sepsis, cancer, chemotherapy, immunocompromised, temperature, wearable, remote patient monitoring
- Medical subject headings
- Fever, Neoplasms, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient MonitoringDevice
Also called RPM
24/7 remote patient monitoring with a wearable thermometer
| Study group | Role | What they receive |
|---|---|---|
| Remote Patient Monitoring | Experimental | Patients assigned remote patient monitoring Receives: Device: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of inpatient days
The number of days the participant was admitted to a hospital while receiving remote patient monitoring
Measured: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
Secondary outcomes (2)
Mean out-of-pocket cost
The patient's out-of-pocket expense for setup of remote patient monitoring
Measured: Day of enrollment
Number of CPT codes generated
Number of CPT codes generated for remote patient monitoring
Measured: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start9 Aug 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AION Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ellis Medicine
- Responsible party
- Sponsor
- Investigators
- Tallat Mahmood, M.D., Principal investigator, Ellis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752512
- Sponsor's protocol ID
- ELLIS001
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Temperature Monitoring of Patients At Risk for Developing Fever
- ClinicalTrials.gov ID
- NCT06752512
- Acronym / sponsor ID
- ELLIS001
- Conditions
- Fever, Cancer, Remote Patient Monitoring
- Keywords
- fever, infection, sepsis, cancer, chemotherapy, immunocompromised, temperature, wearable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AION BiosystemsIndustry (pharma, biotech, devices)
- Collaborators
- Ellis Medicine
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 30 Dec 2024 (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.
The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are:
- does remote temperature monitoring reduce the number of days spent inpatient
- what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring
- the number of billable CPT codes that will be generated by providing remote temperature monitoring
Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.
Patients will
- wear the thermometer for the duration of their participation in the study
- have their temperature monitored continuously
- receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician
- respond to texts or calls from remote monitors when an alert is triggered
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Patient Monitoring | Experimental | Device: Remote Patient MonitoringPatients assigned remote patient monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is at risk of a fever post discharge.
- Subject is ≥ 18 years or older.
- Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
- Subject is willing to install the TempShield app on his/her phone.
- Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
Key exclusion criteria (8 listed)
- Unable to provide informed consent
- Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
- Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
- Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
- Subjects receiving prophylactics that could induce fever.
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 |
|---|---|---|
| Remote Patient MonitoringAlso: RPM24/7 remote patient monitoring with a wearable thermometer | Device | Remote Patient Monitoring |
Primary outcome
Mean number of inpatient days
Time frame: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
The number of days the participant was admitted to a hospital while receiving remote patient monitoring
2 secondary outcomes
Mean out-of-pocket cost
Time frame: Day of enrollment
Number of CPT codes generated
Time frame: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- 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.
Tallat Mahmood, M.D. principal investigator
Ellis Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring in people with Fever and Cancer, run by AION Biosystems 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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Colburn, Ph.D. ((757) 641-2019, d.alexander.colburn@aionbioystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of inpatient days (time frame: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment). 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 30 Dec 2024.