Clinical trial NCT06133426: Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients
Official title: Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Myeloma Multiple
Keywords: Hematology
Connected scale
Remote monitoring
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Withings
First posted: 2023-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of feasibility and acceptability, non-comparative, non-controlled, non-randomized
Primary purpose: PREVENTION

Brief summary: In this research, we will evaluate the feasibility of following by remote monitoring, using a connected scale, in hematology patients suffering from myeloma or lymphoma and requiring treatment with chemotherapy. 30 patients will be included in the research and will all use a connected scale for the duration of their participation (7 weeks +/- 1 week). During their participation, patients will be asked to weigh themselves once a day, ideally at a set time. Patient data will be accessible by the medical team via a remote monitoring platform.

Alerts will be generated in the event of abnormal development of certain clinical parameters (weight, heart rate, etc.) allowing early treatment to be implemented by the medical team.

At the end of their participation, we will evaluate patients' support and perception of this tool, as well as the healthcare consequences of the alerts generated by the remote monitoring platform.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 and over (male or female)
* Patient suffering from aggressive non-Hodgkin's lymphoma or multiple myeloma with a plan for systemic chemotherapy or having started two cycles or less or patient with the need for therapeutic intensification under the cover of autograft in the context of myeloma or lymphoma
* Patient who can be contacted by telephone during their participation in the research
* Patient able to return home at the end of their initial hospitalization
* Patient affiliated to social security
* Patient able to read and speak French
* Patient having signed free, informed and written consent

Exclusion Criteria:

* Patient with an estimated life expectancy \< 3 months
* Patient with moderate to severe cognitive impairment (assessed by MMSE \< 20)
* Patient with a psychiatric or physical disability that does not allow the use of the device
* Patient with a pacemaker
* Patient participating in another intervention research project
* Pregnant patient
* Patient deprived of liberty
* Patient under legal protection (guardianship or curatorship)

Primary outcomes:
measure: Percentage of patients who agreed to participate in research
timeFrame: Inclusion
Secondary outcomes:
measure: Frequency of use of the connected scale during the patient's participation in the research
timeFrame: From inclusion to week 7
measure: Assessment of the patient's anxiety regarding the device
timeFrame: week 7
measure: Evaluation of the ease of use of the device perceived by the patient
timeFrame: week 7
measure: Evaluation of the implementation of the study by the patient
timeFrame: week 7
measure: Evaluation of the consequences in care of alerts generated by the plateform
timeFrame: From inclusion to week 7
measure: Evaluation of the consequences in care of alerts generated by the plateform
timeFrame: From inclusion to week 7
measure: Evaluation of the consequences in care of alerts generated by the plateform
timeFrame: From inclusion to week 7
measure: Evaluation of the consequences in care of alerts generated by the plateform
timeFrame: From inclusion to week 7
Other outcomes:
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