Major Neurocognitive DisorderESTRADNCT05485090
Cross-cultural Adaptation of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home.
An observational study of Major Neurocognitive Disorder, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Neurocognitive Disorder
- What is being tested?
- Questionnaire : Adapted Safety Assessment Scale
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2022to 8 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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
Who cannot join
- Patient totally socially isolated or without a reliable caregiver
- Bedridden patients
- For hospitalized patients, no planned return home
- Patients under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-cultural Adaptation Into French of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home.
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:
Read more
- 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.
The short version includes some of the questions from sections 1 to 7 of the long version.
Read the 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
- Major Neurocognitive Disorder
- Being tested
- Questionnaire : Adapted Safety Assessment Scale
- Keywords
- Safety, Dementia, Reliability, Validity, Screening
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire : Adapted Safety Assessment ScaleOther
Patients caregivers will complete the questionnaire twice : once at enrollment, then 3 to 10 days after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaire : Adapted Safety Assessment Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest Reliability
The caregiver will complete the questionnaire (adapted Safety Assessment Scale) twice with the same investigator
Measured: 10 days
Secondary outcomes (2)
Inter-rater Reliability
The caregiver will complete the questionnaire (adapted Safety Assessment Scale) twice with two different investigators.
Measured: 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Neurocognitive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémence BONNOT, Occupational Therapist, Principal investigator, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485090
- Sponsor's protocol ID
- GHRMSA 1209
- Other IDs
- 2021-A02428-33
- Acronym
- ESTRAD
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation Into French of the Safety Assessment Scale for Elderly People With a Major Neurocognitive Disorder Living at Home.
- ClinicalTrials.gov ID
- NCT05485090
- Acronym / sponsor ID
- ESTRAD / GHRMSA 1209
- Conditions
- Major Neurocognitive Disorder
- Keywords
- Safety, Dementia, Reliability, Validity, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Phase : Test-Retest Reliability | – | Other: Questionnaire : Adapted Safety Assessment ScaleCaregivers will complete the questionnaire twice with the same investigator. The interval between the two questionnaires is 3 to 10 days. |
| Test Phase : Inter-rater Reliability | – | Other: Questionnaire : Adapted Safety Assessment ScaleCaregivers will complete the questionnaire twice with two different investigators. The interval between the two questionnaires is 3 to 10 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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) :
- Patient with at least one caregiver:
- 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
Key exclusion criteria (4 listed)
- Patient totally socially isolated or without a reliable caregiver
- Bedridden patients
- For hospitalized patients, no planned return home
- Patients under judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire : Adapted Safety Assessment ScalePatients caregivers will complete the questionnaire twice : once at enrollment, then 3 to 10 days after enrollment. | Other | Test Phase : Inter-rater Reliability, Test Phase : Test-Retest Reliability |
Primary outcome
Test-retest Reliability
Time frame: 10 days
The caregiver will complete the questionnaire (adapted Safety Assessment Scale) twice with the same investigator
2 secondary outcomes
Inter-rater Reliability
Time frame: 10 days
Internal consistency of the long version of the adapted Safety Assessment Scale
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Link to the articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence BONNOT, Occupational Therapist principal investigator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Neurocognitive Disorder, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest Reliability (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.