Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05485090
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2022-08-01
Brief Title:
Cross-cultural Adaptation of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study Overview
Official Title:
Cross-cultural Adaptation Into French of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTRAD
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
1 Caregiver and environment 2smoking 3fire and burns 4nutrition 5food poisoning and toxic substances 6medication and health problems 7wandering and adaptation to temperature changes 8trauma and 9driving
The short version includes some of the questions from sections 1 to 7 of the long version
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 2smoking 3fire and burns 4nutrition 5food poisoning and toxic substances 6medication and health problems 7wandering and adaptation to temperature changes 8trauma and 9driving
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A02428-33 | OTHER | ANSM | None |