An observational study in Major Neurocognitive Disorder, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Observational
The main objective of this study is to adapt the Canadian French version of the safety assessment scale for use in France. The Safety Assessment Scale was developped for community healthcare providers working with elderly people with dementia who are being cared for at home, to assess the risk of accidents. The short version of the Safety Assessment Scale is a screening tool and the longer version provides an in-depth evaluation of safety.
This scale is a risk assessment grid for accidents and injuries at home for elderly people with major neurocognitive disorders, available in English and French (Canadian). There are two versions:
The long version is used for in-depth assessment when the score on the short version indicates a moderate or high risk of injury. The questionnaire is divided into nine sections:
The short version includes some of the questions from sections 1 to 7 of the long version.
Secondary objectives:
The other objectives of this study are to assess the test-retest reliability and the inter-rater reliability of the translated scale and to evaluate the internal consistency of the long version of the translated scale.
Conduct of research:
Caregivers of patients with major neurocognitive disorders included in the study will complete the adapted scale with an investigator. A pre-test phase will be carried out with 10 caregivers: the caregivers will complete the questionnaire only once with an investigator.
After this phase, the translated Safety Assessment Scale will be corrected if there are difficulties in understanding certain words or sentences. The new scale will then be evaluated on two cohorts of 53 caregivers (cohort 1: caregivers will complete the adapted scale twice with the same investigator; cohorte 2: caregivers will complete the adapted scale twice with two different investigators).
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 116 is below the median of 250 across 482 observational studies indexed under Dementia.
Browse Dementia studies →Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Caregivers of elderly people with a major neurocognitive disorder living at home. Caregivers will be selected by healthcare professionals working in geriatric care.
Patient with a major neurocognitive disorder (Diagnostic and Statistical Manual of Mental Disorders, fifth version) :
Patient with at least one caregiver:
Exclusion Criteria:
Caregivers will complete the questionnaire twice with the same investigator. The interval between the two questionnaires is 3 to 10 days.
Other: Questionnaire : Adapted Safety Assessment Scale
Caregivers will complete the questionnaire twice with two different investigators. The interval between the two questionnaires is 3 to 10 days.
Other: Questionnaire : Adapted Safety Assessment Scale
Patients caregivers will complete the questionnaire twice : once at enrollment, then 3 to 10 days after enrollment.
Test-retest Reliability
The caregiver will complete the questionnaire (adapted Safety Assessment Scale) twice with the same investigator
Time frame: 10 days
Inter-rater Reliability
The caregiver will complete the questionnaire (adapted Safety Assessment Scale) twice with two different investigators.
Time frame: 10 days
Internal consistency of the long version of the adapted Safety Assessment Scale
The internal consistency of the items will be evaluated within each of the 9 sections of the scale by calculating the Cronbach's alpha coefficient.
Time frame: 10 days
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace