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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06133426

Collaborator

Withings (Industry)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Myeloma Multiple	Device: Connected scale "Body Comp Pro" from Withings	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot study of feasibility and acceptability, non-comparative, non-controlled, non-randomizedPilot study of feasibility and acceptability, non-comparative, non-controlled, non-randomized

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of patients who agreed to participate in research [Inclusion]
Number of included patients / Number of indormed patients

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)