Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- psychiatrists' assessment of depression severity with the iCGI scale
研究概览
简要总结
This study aims to test for a " wheelchair effect ", as a potential impact of stigma, during the evaluation of clinical global impression of depression.Elderly patients will be asked to sit in a wheelchair, or in a regular chair during recording a 5 minute video of spontaneous speech collected the iCGI semi-structured interview.
The videos are showed to 10 different psychiatrists whom each proceed to 10 iCGI rating assessments.The psychiatrists are blinded evaluators. They are not aware of the real objective of the study.
详细描述
This is a multicentric, randomized study of depression severity assessments (by iCGI) for wheelchair sitting elderly patients versus regular chair sitting elderly patients.The iCGI is a validated scale to assess depression severity through 5 min videos viewing of semi-structured interviews. The frame of the interviews is made to obtain the material provided by the patients expected to facilitate the formation of an "impression", an empathetic feeling, based on phenomenological concepts. The clinical interview is close to day-to-day clinical practice.
Patients are randomized (1:1) into 2 groups: "wheelchair" group and control group.
After randomization, a 5-minute video of spontaneous speech collecting the semi-structured iCGI interview is recorded.
These videos will square the participant's face, torso, and thighs, with a ¾ angle, in order to visualise the patient and the chair he is sitting in. The face will not be blurred in order to access non his non-verbal communication.
The videos are viewed by 10 different psychiatrists whom each proceed to 10 iCGI rating assessments, The psychiatrists are blinded evaluators. They are not aware of the objective of the study focusing on the impact of the wheelchair. They will be decepted with the information that the study aim to evaluate the iCGI, as a new version of the CGI with elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants included in the wheelchair group settle into a hospital wheelchair. The wheelchair comes from a batch of two, without specific brand, standard color.
The videos are showed to 10 different psychiatrists whom each proceed to 10 iCGI rating assessments, after receiving methodological informations.
The psychiatrists are blinded evaluators. They are not aware of the objective of the study focusing on the impact of the wheelchair. They will be decepted with the information that the study aim to evaluate the iCGI, as a new version of the CGI with elderly patients (we will procede to a feedback afterward).
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalised or ambulatory patients
- •Suffering mild to severe depression, according to PHQ-9 (Patient Health Questionnaire-9) score ⩾ 5 [11].
- •Ability to understand the protocol.
- •Signed consent of the participant regarding the given information.
- •Subscription to the social security system.
排除标准
- •Walking disability (including walking with human help required).
- •Severe cognitive impairment diagnosed with MMSE (Mini Mental State Examination) score <18 within the last three months.
- •Historical or current schizophrenia diagnosis recorded on the medical file.
- •Historical or current neurological disease recorded on the medical file : Neurodegenerative disorders, stroke, epilepsy.
- •Patients under guardianship or trusteeship.
结局指标
主要结局
psychiatrists' assessment of depression severity with the iCGI scale
时间窗: after including all patients in the study, up to 24 month
The iCGI is a validated scale to assess depression severity through 5 min videos viewing of semi-structured interviews. We will compare the iCGI in the " wheelchair " group and the control group. Analyzes will be based on each group's mean score.
次要结局
未报告次要终点