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Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients

Not Applicable
Not yet recruiting
Conditions
Lymphoma, Non-Hodgkin
Myeloma Multiple
Interventions
Device: Connected scale "Body Comp Pro" from Withings
Registration Number
NCT06133426
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
30
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cohort groupConnected scale "Body Comp Pro" from WithingsPatients will be used a connected scale during the duration of their participation in the study. Patients will be invited to use the scale once a day. Patient's data will be accesible by medical team via a specific remote plateform. Alert will be generated according to the evolution of clinical data, permetting a early patient management by the medical team.
Primary Outcome Measures
NameTimeMethod
Percentage of patients who agreed to participate in researchInclusion

Number of included patients / Number of indormed patients

Secondary Outcome Measures
NameTimeMethod
Evaluation of the ease of use of the device perceived by the patientweek 7

Symptom Usability Scale (0 - 100 ; Higher score mean a better outcome)

Assessment of the patient's anxiety regarding the deviceweek 7

Specific 5 points Likert Scale (1 - 5 ; Higher score mean a worse outcome)

Evaluation of the implementation of the study by the patientweek 7

FIM (Feasibility of Intervention Measure), AIM (Acceptability of Intervention Measure) and IAM (Intervention Appropriateness Measure) / (1 - 5 ; Higher score mean a better outcome)

Evaluation of the consequences in care of alerts generated by the plateformFrom inclusion to week 7

Number and type of consultations, hospitalizations, additional assessments resulting from the generation of an alert.

Frequency of use of the connected scale during the patient's participation in the researchFrom inclusion to week 7

Average of weighings/week

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