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
| Registry | NCT06697262, acronym TELEDOM |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 30 (Estimated) |
| Sponsor | Centre Hospitalier Universitaire de la Réunion (Other) |
| Conditions | Oncopediatrics, Febrile Neutropenia |
| Interventions | Remote temperature monitoring device, Home temperature monitoring by a nurse (Device, diagnostic test) |
| Dates | start 2026-05-01 (estimated), primary completion 2028-05-04 (estimated), completion 2028-05-04 (estimated), first posted 2024-11-20, last updated 2026-01-20 |
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All trials for Oncopediatrics All trials for Febrile Neutropenia All trials of Remote temperature monitoring device All trials of Home temperature monitoring by a nurse
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:
* 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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| remote temperature monitoring device | Experimental | Device: Remote temperature monitoring device | |
| home temperature monitoring by a nurse | Active comparator | Diagnostic Test: Home temperature monitoring by a nurse |
Sex: All, ages: 0 Years to 17 Years
Inclusion Criteria: 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. Exclusion Criteria: Patient: * with a dermatosis contraindicating the use of the device * Refusing to participate in the study