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 Severe Depressive Episode: Prospective, Multicentric, Comparative, Single Blind Clinical Investigation. EMC1 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Emobot
- 入组人数
- 104
- 试验地点
- 14
- 主要终点
- Change of scores EMOCARE
研究概览
简要总结
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:
- 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.
- 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.
- At home, answer questionnaires independently, 2 weeks and 4 weeks after the first appointment.
- Receive a telephone call from the doctor 3 weeks after the first appointment to find out how the participants are feeling.
- Keep a diary with the symptoms they have experienced, any medical consultations they have made, or changes in drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Patient health questionnaire - 9 (PHQ-9) and (Montgomery Asberg Depression Rating Scale) MADRS assessments will be performed by an investigator who doesn't know the score obtained with EMOCARE
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of both sexes aged 18 or over.
- •Outpatient with unipolar depression (regardless of the time of the episode) (major depressive disorder).
- •Patient with an episode of major depression supported by PHQ-9 score greater than or equal to
- •Patient with an episode of major depression supported by MADRS score greater than or equal to
- •Patient accustomed to regular use of a smartphone and/or computer
- •Patient who, in the opinion of the investigator, will comply with the requirements of the protocol.
- •Patient affiliated to a social security scheme or beneficiary of such a scheme.
- •Patient who has received full information about how the clinical investigation shall be conducted and has signed an informed consent form.
- •Patient who reads and understands French.
- •Patient who has undergone clinical screening adapted to the clinical investigation.
排除标准
- •Patient treated with antipsychotic drugs.
- •Patient with an unstable pathology that could interfere with the study.
- •Patient unable to communicate or cooperate with the investigator due to a low mental level, language difficulties or impaired cerebral function.
- •Patient with an active suicidal tendency or patient who has had a suicidal episode in the last 6 months
- •Patients with borderline personality disorders.
- •Patient with a contra-indication to the product(s) under evaluation.
- •Woman of childbearing age without effective contraception.
- •Pregnant woman, birthing or breastfeeding mother
- •Minor (not emancipated)
- •Incapacitated person
研究组 & 干预措施
EMOCARE
干预措施: EMOCARE software (Device)
结局指标
主要结局
Change of scores EMOCARE
时间窗: From baseline to 6 weeks
Absolute difference
Change of scores PHQ-9 self-administrered
时间窗: From baseline to 6 weeks
Absolute difference
次要结局
- Change of EMOCARE score(From baseline to 2 weeks, from baseline to 4 weeks)
- Number of patient with adverse event(At baseline, at 2 weeks, at 3 weeks, at 4 weeks, at 6 weeks)
- Score EMOCARE(At baseline, at 2 weeks, at 4 weeks)
- Score PHQ-9 self administered(At baseline, at 2 weeks, at 4 weeks, at 6 weeks)
- Change of score PHQ-9 self administered(From baseline to 2 weeks, From baseline to 4 weeks)
- Score PHQ-9 administered by an investigator(At baseline, at 6 weeks)
- Change of score PHQ-9 administered by an investigator(From baseline to 6 weeks)
- Acceptability of medical device questionnaire(At baseline, at 6 weeks)
- Score MADRS administered by an investigator(At baseline, at 6 weeks)
- Change of MADRS administered by an investigator(From baseline to 6 weeks)
- Score BDI-II(At baseline, at 2 weeks, at 4 weeks, at 6 weeks)
- Change of BDI-II(From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks)
- EMOCARE operating time(From baseline to 2 weeks, from baseline to 4 weeks, from baseline to 6 weeks)
- EQ-5D-5L(At baseline, at 6 weeks)
- Score BDI-II(At baseline, at 6 weeks)
- Change of BDI-II(From baseline to 6 weeks)