Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01684-41 | Other Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Withings | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connected scale "Body Comp Pro" from Withings | Device | Use once a day from inclusion to week 7. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who agreed to participate in research | Number of included patients / Number of indormed patients | Inclusion |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rudy BIRSEN, Dr | Contact | 01.58.41.42.90 | +33 | rudy.birsen@aphp.fr |
| Elodie LEMADRE, Mrs | Contact | 01.44.84.17.34 | +33 | elodie.lemadre@aphp.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochin Hospital | Recruiting | Paris | 75014 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
Pilot study of feasibility and acceptability, non-comparative, non-controlled, non-randomized
Not provided
Not provided
Not provided
Not provided
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 |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |