Remote Temperature Monitoring of Patients At Risk for Dev... | NCT06752512

Studies
Remote Temperature Monitoring of Patients At Risk for Developing Fever

NCT06752512

Sponsor

AION Biosystems

Status

Recruiting

Last Update Posted

Dec 30, 2024Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Fever
Cancer
Remote Patient Monitoring

Interventions

Remote Patient Monitoring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2023Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

Dec 22, 2024

First Submission Date that Met QC Criteria

Dec 22, 2024

First Posted Date

Dec 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2024

Last Update Posted Date

Dec 30, 2024Actual

Name	Class
Ellis Medicine	OTHER

Description Module

Brief 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 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remote Patient Monitoring	Experimental	Patients assigned remote patient monitoring	Device: Remote Patient Monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote Patient Monitoring	Device	24/7 remote patient monitoring with a wearable thermometer	Remote Patient Monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean number of inpatient days	The number of days the participant was admitted to a hospital while receiving remote patient monitoring	Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment

Secondary Outcomes

Measure	Description	Time Frame
Mean out-of-pocket cost	The patient's out-of-pocket expense for setup of remote patient monitoring	Day of enrollment
Number of CPT codes generated	Number of CPT codes generated for remote patient monitoring

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
David Colburn, Ph.D.	Contact	(757) 641-2019		d.alexander.colburn@aionbioystems.com

Name	Affiliation	Role
Tallat Mahmood, M.D.	Ellis Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ellis Hospital	Recruiting	Schenectady	New York	12308	United States

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever
D009369	Neoplasms
D007239	Infections
D018805	Sepsis

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided