Assessment of Depression (iCGI) in Older People, According to Their Presentation in a Wheelchair or an Ordinary Chair. (WHEELDEP)

June 6, 2024 updated by: Hospital Center Guillaume Régnier

Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The 10 videos each psychiatrist have to assess are randomly selected following the next rules :

  • Un unbalanced number of wheelchair and regular chair videos, so as they don't guess the study directly focuses on the wheelchair.
  • The wheelchair/regular chair video ratio is 7/3 or 3/7 for each psychiatrist.
  • Each video is visualised once by one psychiatrist. Our objective is to highlight an assessment bias related to physical disability in depression in the elderly with the aim of improving the practices of all professionals involved.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bretagne
      • Saint-Avé, Bretagne, France, 56890
        • EPSM Saint Avé
    • Ile Et Vilaine
      • Rennes, Ile Et Vilaine, France, 35000
        • Centre Hospitalier Guillaume Régnier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wheelchair group
Patients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview;
Other: Wheelchair
Patient will be asked to sit in a wheelchair, and a 5-minute video recording of spontaneous speech capturing the semi-structured iCGI interview is made.
No Intervention: Control group
Patients included in the control group will sit in a regular chair during the interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychiatrists' assessment of depression severity with the iCGI scale
Time Frame: 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.
after including all patients in the study, up to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Center Guillaume Régnier

Investigators

  • Principal Investigator: Gabriel RG ROBERT, MD, Centre Hospitalier Guillaume Régnier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC21_01GR_WHEELDEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data about study protocol and clinical information will be available on request from other researchers.

IPD Sharing Time Frame

Data will be availablefrom the moment a scientific publication is accepted to five years later.

IPD Sharing Access Criteria

acces to data will be granted to researchers aiming to perform another analysis or to review the topic, or to perform a meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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