Cross-cultural Adaptation of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home.

NCT05485090 | Completed

• 2 other identifiers: GHRMSA 12092021-A02428-33
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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 short version is used for screening. A score of 11 to 14 indicates a moderate risk of injury, while a score ≥ 15 indicates a high risk of injury;
• 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:
• Caregiver and environment, 2/smoking, 3/fire and burns, 4/nutrition, 5/food poisoning and toxic substances, 6/medication and health problems, 7/wandering and adaptation to temperature changes, 8/trauma, and 9/driving.

Conditions

Major Neurocognitive Disorder

Keywords

Safety; Dementia; Reliability; Validity; Screening

Outcome Measures

Primary Outcomes (1)

• Test-retest Reliability

  The caregiver will complete the questionnaire (adapted Safety Assessment Scale) twice with the same investigator

  10 days

Secondary Outcomes (2)

• Inter-rater Reliability

  10 days

• Internal consistency of the long version of the adapted Safety Assessment Scale

  10 days

Study Arms (2)

Test Phase : Test-Retest Reliability

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

Test Phase : Inter-rater Reliability

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

Interventions

Questionnaire : Adapted Safety Assessment Scale OTHER

Patients caregivers will complete the questionnaire twice : once at enrollment, then 3 to 10 days after enrollment.

Test Phase : Inter-rater Reliability; Test Phase : Test-Retest Reliability

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers of elderly people with a major neurocognitive disorder living at home. Caregivers will be selected by healthcare professionals working in geriatric care.

You may qualify if:

• Patient living at home or hospitalized with a planned return home
• Patient with a major neurocognitive disorder (Diagnostic and Statistical Manual of Mental Disorders, fifth version) :
• evidence of significant cognitive decline from a previous level of performance in one or more cognitive domains (complex attention, social cognition) based on : a concern by the individual, a knowledgeable informant, or the clinician about a significant decline in cognitive function ; and a deficit in cognitive performance, preferably documented by standardized neuropsychological tests or by another quantified clinical assessment
• the cognitive deficits interfere with independence in daily activities. At least, assistance should be required with complex instrumental activities of daily living, such as paying bills or managing medications.
• the cognitive deficits do not occur exclusively in the context of a delirium.
• the cognitive deficits are not better explained by another mental disorder (e.g., major depressive disorder, schizophrenia).
• Patient with at least one caregiver:
• reliable (no suspicion of cognitive or psychiatric disorders and/or inappropriate behavior such as manipulation or abuse)
• able to answer the questionnaire (i.e., knows the patient's lifestyle)
• No objection to participating in the study from the caregiver and the patient (if able to understand the study)
• No objection to guardian participation for patients under guardianship or curatorship

You may not qualify if:

• Patient totally socially isolated or without a reliable caregiver
• Bedridden patients
• For hospitalized patients, no planned return home
• Patients under judicial protection

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

GHRMSA

Mulhouse, 68100, France

Location

Related Links

• Link to the article

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clémence BONNOT, Occupational Therapist

  Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)