OncopediatricsTELEDOMNCT06697262
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
A study testing Remote temperature monitoring device and Home temperature monitoring by a nurse in people with Oncopediatrics and Febrile Neutropenia, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Oncopediatrics, Febrile Neutropenia
- What is being tested?
- Remote temperature monitoring device and Home temperature monitoring by a nurse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patient
- Aged 0 to 17 inclusive
- Followed in the Pediatric Onco-Hematology Department
- Primo-diagnosed with solid or hematological cancer (incident case)
- Having received a first cycle of chemotherapy
- Whose family has psycho-social vulnerabilities assessed by the Froger et al. tool, indicating a need for an IDE to support the family in monitoring the patient.
Who cannot join
- Patient:
- with a dermatosis contraindicating the use of the device
- Refusing to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of a Telemonitoring Device on the Occurrence of Fever at Home in Children at Risk of Chemotherapy-Induced Neutropenia: A Pilot Randomized Controlled Trial
The goal of this clinical trial is to evaluate the feasibility of the study, measured by the acceptability rate of patients to be recruited in a study proposing temperature monitoring at home, by a remote monitoring device or by the visit of an IDE at home (in association with the usual educational sessions), to children at risk of febrile neutropenia, from families with psycho-social vulnerabilities.
The main questions it aims to answer are:
Read more
- Will participants adhere to the telemonitoring system?
- Is the intervention feasible, in terms of the device's failure to record temperature data?
- Will parents behave appropriately when using the device?
- How satisfied will parents and caregivers be?
- What will be the physical tolerance of the device?
- On an exploratory basis, will the remote monitoring system be effective for months?
Researchers will compare :
- patients using the telemonitoring device for continuous temperature monitoring at home, in combination with education sessions on temperature monitoring and the device
- with patient with temperature monitoring at home by a nurse, 2 times a day, in combination with education sessions on temperature monitoring (without the telemonitoring device at home)
- Conditions
- Oncopediatrics, Febrile Neutropenia
- Being tested
- Remote temperature monitoring device, Home temperature monitoring by a nurse
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote temperature monitoring deviceDevice
- Use of the Tucky® remote monitoring device for continuous temperature monitoring at home,
- In combination with education sessions on temperature monitoring and the device.
Home temperature monitoring by a nurseDiagnostic test
- Home temperature monitoring by a nyrse, twice a day,
- In association with education sessions on temperature monitoring.
| Study group | Role | What they receive |
|---|---|---|
| remote temperature monitoring device | Experimental | Not described Receives: Device: Remote temperature monitoring device |
| home temperature monitoring by a nurse | Active comparator | Not described Receives: Diagnostic Test: Home temperature monitoring by a nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
study acceptability rate
number of patients included/number of eligible patients offered the study.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncopediatricsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697262
- Sponsor's protocol ID
- 2024/CHU/03
- Acronym
- TELEDOM
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No