Cross-cultural Adaptation of the Safety Assessment Scale for Elderly People With a Major Neurocog… (NCT05485090) | Clinical Trial Compass
CompletedNot Applicable
Cross-cultural Adaptation of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home.
France116 participantsStarted 2022-08-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 guardiansh…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Test-retest Reliability
Timeframe: 10 days
Trial details
NCT IDNCT05485090
SponsorGroupe Hospitalier de la Region de Mulhouse et Sud Alsace