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

Lymphoma, Non-Hodgkin Clinical Trial

— BTP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133426
• Other study ID #: APHP230916
• Secondary ID: 2023-A01684-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Rudy BIRSEN, Dr
• Phone: 01.58.41.42.90
• Email: rudy.birsen[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

Device:
• Connected scale "Body Comp Pro" from Withings
Use once a day from inclusion to week 7.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Withings

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who agreed to participate in research	Number of included patients / Number of indormed patients	Inclusion
Secondary	Frequency of use of the connected scale during the patient's participation in the research	Average of weighings/week	From inclusion to week 7
Secondary	Assessment of the patient's anxiety regarding the device	Specific 5 points Likert Scale (1 - 5 ; Higher score mean a worse outcome)	week 7
Secondary	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
Secondary	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
Secondary	Evaluation of the consequences in care of alerts generated by the plateform	Number of alerts generated/patient.	From inclusion to week 7
Secondary	Evaluation of the consequences in care of alerts generated by the plateform	Number of calls made/patient.	From inclusion to week 7
Secondary	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
Secondary	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