Health TrialsbyHealthPanel

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

ConditionsLymphoma, Non-HodgkinMyeloma Multiple
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Connected scale "Body Comp Pro" from Withings

    Device

    Use once a day from inclusion to week 7.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cohort groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients who agreed to participate in research

Number of included patients / Number of indormed patients

Time frame
Inclusion

Secondary outcomes

1

Frequency of use of the connected scale during the patient's participation in the research

Average of weighings/week

Time frame
From inclusion to week 7
2

Assessment of the patient's anxiety regarding the device

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

Time frame
week 7
3

Evaluation of the ease of use of the device perceived by the patient

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

Time frame
week 7
4

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)

Time frame
week 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Withings

Collaborator

Source ClinicalTrials.gov
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