Clinical Trials Directory

Trials / Completed

CompletedNCT05485090

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
116 (actual)
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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: 1. 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. The short version includes some of the questions from sections 1 to 7 of the long version.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
OTHERQuestionnaire : Adapted Safety Assessment ScalePatients caregivers will complete the questionnaire twice : once at enrollment, then 3 to 10 days after enrollment.

Timeline

Start date
2022-08-01
Primary completion
2023-12-08
Completion
2023-12-08
First posted
2022-08-03
Last updated
2025-11-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05485090. Inclusion in this directory is not an endorsement.