Assessment of Depression (iCGI) in Older People, According to Their Presentation in a Wheelchair or an Ordinary Chair. (WHEELDEP)
Primary Purpose
Depression in Old Age
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Wheelchair
Sponsored by
About this trial
This is an interventional other trial for Depression in Old Age focused on measuring elderly depression, stigma, iCGI
Eligibility Criteria
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.
Sites / Locations
- EPSM Saint AvéRecruiting
- Centre Hospitalier Guillaume RegnierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
wheelchair group
Control group
Arm Description
Patients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview;
Patients included in the control group will sit in a regular chair during the interview.
Outcomes
Primary Outcome Measures
psychiatrists' assessment of depression severity with the iCGI scale
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04979299
First Posted
July 15, 2021
Last Updated
August 5, 2022
Sponsor
Hospital Center Guillaume Régnier
1. Study Identification
Unique Protocol Identification Number
NCT04979299
Brief Title
Assessment of Depression (iCGI) in Older People, According to Their Presentation in a Wheelchair or an Ordinary Chair.
Acronym
WHEELDEP
Official Title
Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Center Guillaume Régnier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age
Keywords
elderly depression, stigma, iCGI
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We procede in a randomization 1:1, stratified by site. In one group, patients will be seated in a wheelchair and in the second group, patients will be seated in an regular chair. Allocation concealment will be ensured by the use of sequentially numbered, opaque, sealed envelopes (SNOSE).
Masking
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
wheelchair group
Arm Type
Experimental
Arm Description
Patients included in the " wheelchair " group will be asked to sit in a wheelchair during the interview;
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients included in the control group will sit in a regular chair during the interview.
Intervention Type
Other
Intervention Name(s)
Wheelchair
Intervention Description
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.
Primary Outcome Measure Information:
Title
psychiatrists' assessment of depression severity with the iCGI scale
Description
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.
Time Frame
after including all patients in the study, up to 24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel RG ROBERT, MD
Phone
02.99.33.39.37
Ext
+33
Email
g.robert@ch-guillaumeregnier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie AN ALLETON
Phone
0222514121
Ext
+33
Email
n.alleton@ch-guillaumeregnier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel RG ROBERT, MD
Organizational Affiliation
Centre Hospitalier Guillaume Régnier
Official's Role
Principal Investigator
Facility Information:
Facility Name
EPSM Saint Avé
City
Saint-Avé
State/Province
Bretagne
ZIP/Postal Code
56890
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Alexis RICHARD, MD
Phone
02.97.54.48.54
Ext
+33
Email
FrancoisAlexis.RICHARD@epsm-morbihan.fr
Facility Name
Centre Hospitalier Guillaume Regnier
City
Rennes
State/Province
Ile Et Vilaine
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel ROBERT, MD
Phone
0299393337
Ext
+33
Email
g.robert@ch-guillaumeregnier.fr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
21896496
Citation
Krendl AC, Kensinger EA, Ambady N. How does the brain regulate negative bias to stigma? Soc Cogn Affect Neurosci. 2012 Aug;7(6):715-26. doi: 10.1093/scan/nsr046. Epub 2011 Sep 5.
Results Reference
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PubMed Identifier
26361202
Citation
Henderson C, Noblett J, Parke H, Clement S, Caffrey A, Gale-Grant O, Schulze B, Druss B, Thornicroft G. Mental health-related stigma in health care and mental health-care settings. Lancet Psychiatry. 2014 Nov;1(6):467-82. doi: 10.1016/S2215-0366(14)00023-6. Epub 2014 Nov 5.
Results Reference
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PubMed Identifier
4809670
Citation
MacDonald ML, Butler AK. Reversal of helplessness: producing walking behavior in nursing home wheelchair residents using behavior modification procedures. J Gerontol. 1974 Jan;29(1):97-101. doi: 10.1093/geronj/29.1.97. No abstract available.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
17284321
Citation
Kadouri A, Corruble E, Falissard B. The improved Clinical Global Impression Scale (iCGI): development and validation in depression. BMC Psychiatry. 2007 Feb 6;7:7. doi: 10.1186/1471-244X-7-7.
Results Reference
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PubMed Identifier
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Citation
Laux G; VIVALDI Study Group. The antidepressant agomelatine in daily practice: results of the non-interventional study VIVALDI. Pharmacopsychiatry. 2012 Nov;45(7):284-91. doi: 10.1055/s-0032-1309003. Epub 2012 May 16.
Results Reference
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PubMed Identifier
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Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
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Assessment of Depression (iCGI) in Older People, According to Their Presentation in a Wheelchair or an Ordinary Chair.
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