Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601140
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring EMOCARE and the Patient Health Questionnaire PHQ-9 Score in Patients with Mild to Moderate Depressive Episode
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Concordance Between Measures Obtained by a Medical Device for Emotional Monitoring EMOCARE and the Patient Health Questionnaire PHQ-9 Score in Patients with Mild to Moderate Depressive Episode Prospective Multicentric Comparative Single Blind Clinical Investigation EMC1 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMC1
Brief Summary:
The aim of this clinical investigation is to find out whether the EMOCARE emotional monitoring software provides consistent results compared with the tools available for assessing the emotional state of patients suffering from mild to moderately severe depressive episod It will also provide information on how patients feel about the use of passive monitoring software without the active involvement of patient The main questions it aims to answer are as follows
Does EMOCARE provide consistent results compared with tools already used in current practice What are the medical problems encountered by participants when using EMOCARE
The researchers will compare EMCOCARE to various questionnaires usually used in the management of patients suffering from depression PHQ-9 MADRS GAD-7 BDI-II EQ-5D-5L
Participants who agree to take part in the study during a selection visit will be able to
1 Install the software on a digital interface smartphone computer etc and activate or deactivate it whenever they wish during the 6-week follow-up period
2 Attend 2 scheduled appointments at the centre a first appointment then a second 6 weeks later to complete a series of questionnaires being questioned by the doctor and fill in other questionnaires on their own
3 At home answer questionnaires independently 2 weeks and 4 weeks after the first appointment
4 Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling
5 Keep a diary with the symptoms they have experienced any medical consultations they have made or changes in drug treatment
Does EMOCARE provide consistent results compared with tools already used in current practice What are the medical problems encountered by participants when using EMOCARE
The researchers will compare EMCOCARE to various questionnaires usually used in the management of patients suffering from depression PHQ-9 MADRS GAD-7 BDI-II EQ-5D-5L
Participants who agree to take part in the study during a selection visit will be able to
1 Install the software on a digital interface smartphone computer etc and activate or deactivate it whenever they wish during the 6-week follow-up period
2 Attend 2 scheduled appointments at the centre a first appointment then a second 6 weeks later to complete a series of questionnaires being questioned by the doctor and fill in other questionnaires on their own
3 At home answer questionnaires independently 2 weeks and 4 weeks after the first appointment
4 Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling
5 Keep a diary with the symptoms they have experienced any medical consultations they have made or changes in drug treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None