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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoma, Non-Hodgkin, Myeloma Multiple

Intervention / Treatment
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* Device: Connected scale Body Comp Pro from Withings


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study of feasibility and acceptability, non-comparative, non-controlled, non-randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort group<br>Patients 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. | Device: Connected scale Body Comp Pro from Withings<br>* Use once a day from inclusion to week 7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who agreed to participate in research | Number of included patients / Number of indormed patients | Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of use of the connected scale during the patient's participation in the research | Average of weighings/week | From inclusion to week 7 | 
| Assessment of the patient's anxiety regarding the device | Specific 5 points Likert Scale (1 - 5 ; Higher score mean a worse outcome) | week 7 | 
| Evaluation of the ease of use of the device perceived by the patient | Symptom Usability Scale (0 - 100 ; Higher score mean a better outcome) | week 7 | 
| Evaluation of the implementation of the study by the patient | FIM (Feasibility of Intervention Measure), AIM (Acceptability of Intervention Measure) and IAM (Intervention Appropriateness Measure) / (1 - 5 ; Higher score mean a better outcome) | week 7 | 
| Evaluation of the consequences in care of alerts generated by the plateform | Number of alerts generated/patient. | From inclusion to week 7 | 
| Evaluation of the consequences in care of alerts generated by the plateform | Number of calls made/patient. | From inclusion to week 7 | 
| Evaluation of the consequences in care of alerts generated by the plateform | Average time spent per call following the generation of an alert. | From inclusion to week 7 | 
| Evaluation of the consequences in care of alerts generated by the plateform | Number and type of consultations, hospitalizations, additional assessments resulting from the generation of an alert. | From inclusion to week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematology, Connected scale, Remote monitoring