Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients (BTP)

September 9, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Cochin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort group

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
Use once a day from inclusion to week 7.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who agreed to participate in research
Time Frame: Inclusion
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
Time Frame: From inclusion to week 7
Average of weighings/week
From inclusion to week 7
Assessment of the patient's anxiety regarding the device
Time Frame: week 7
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
Time Frame: week 7
Symptom Usability Scale (0 - 100 ; Higher score mean a better outcome)
week 7
Evaluation of the implementation of the study by the patient
Time Frame: week 7
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
Time Frame: From inclusion to week 7
Number of alerts generated/patient.
From inclusion to week 7
Evaluation of the consequences in care of alerts generated by the plateform
Time Frame: From inclusion to week 7
Number of calls made/patient.
From inclusion to week 7
Evaluation of the consequences in care of alerts generated by the plateform
Time Frame: From inclusion to week 7
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
Time Frame: From inclusion to week 7
Number and type of consultations, hospitalizations, additional assessments resulting from the generation of an alert.
From inclusion to week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Withings

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230916
  • 2023-A01684-41 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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