Attention DisorderRob'GazetteNCT06498297
Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome
An observational study of Attention Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. There are patient-specific predisposing factors and precipitating factors. Elderly people, due to their comorbidities, are more at risk. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Attention Disorder
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2023to 24 Apr 2025
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient aged 75 and over hospitalized at the HUS in the SMRG department during the period from January 1, 2021 to April 31, 2023 and havin passed at least a 4AT during hospitalization.
Who may be able to join
- Patient aged 75 and over
- Hospitalized at the HUS in the SMRG department during the period from January 1, 2021 to April 31, 2023
- Passed at least a 4AT during hospitalization
- Absence of written opposition in the patient's medical file (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Who cannot join
- Presence of written opposition from the patient (and/or their legal representative if applicable) in their medical file.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
Strasbourg, 67091
Alexandre BOUSSUGE, MD, 33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr
Alexandre BOUSSUGE, MD
About this study
Official title: Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome, Assessed by the 4 "A" Test, in Patients Aged Over 75 Years Hospitalized in the Medical and Health Care Department. Geriatric Rehabilitation.
Confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. There are patient-specific predisposing factors and precipitating factors. Elderly people, due to their comorbidities, are more at risk. Confusion syndrome affects approximately 23% of elderly patients in the medical department, 33% in the rehabilitation department and its occurrence is preventable in 30 to 40% of cases. The health expenditure generated by its occurrence was estimated at 182 billion dollars per year by combining the expenditure of 18 European countries in 2011. The occurrence of a delirium increases the duration of hospitalization, increases the risk of falls, loss of autonomy, can lead to an impairment of quality of life at 6 months and is linked to excess mortality.
The gold standard for making the diagnosis of delirium is the use of the DSM-5 criteria, but their use is time-consuming and requires that staff be trained in their use. The 4 "A" test (tool to help identify confusional syndrome) can be used to monitor confusional syndromes; it has the advantage of being able to be taken in less than 3 minutes.
Concerning the management of a confusional syndrome, a non-pharmacological multi-component approach is recommended as first line for its prevention but there is no treatment to date. A tool to help with temporo-spatial reorientation (La Rob'Gazette) has been set up in the Medical Care and Geriatric Rehabilitation (SMRG) departments of the HUS
- Conditions
- Attention Disorder
- Keywords
- Attention Disorder, Confusion syndrome, Attentional disorders, Disorganization of cognitive functions
- Medical subject headings
- Cognition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of improvement of the 4AT of the entire population
The analysis will be undertaken on patients for whom at least two 4AT measurements are available (in order to be able to calculate a change). It will be based on a mixed linear model including the variable to be tested, time and their interaction. Variables deemed clinically relevant or statistically significant at the threshold of p < 0.10 will be included in a multivariate model. Then the non-significant and irrelevant variables will be removed from the model. The significance threshold will be 0.05 for this final model.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start24 Oct 2023
- Primary completionApr 2025 (estimated)
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498297
- Sponsor's protocol ID
- 9065
- Acronym
- Rob'Gazette
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome, Assessed by the 4 "A" Test, in Patients Aged Over 75 Years Hospitalized in the Medical and Health Care Department. Geriatric Rehabilitation.
- ClinicalTrials.gov ID
- NCT06498297
- Acronym / sponsor ID
- Rob'Gazette / 9065
- Conditions
- Attention Disorder
- Keywords
- Attention Disorder, Confusion syndrome, Attentional disorders, Disorganization of cognitive functions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 12 Jul 2024 (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.
Confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. There are patient-specific predisposing factors and precipitating factors. Elderly people, due to their comorbidities, are more at risk. Confusion syndrome affects approximately 23% of elderly patients in the medical department, 33% in the rehabilitation department and its occurrence is preventable in 30 to 40% of cases. The health expenditure generated by its occurrence was estimated at 182 billion dollars per year by combining the expenditure of 18 European countries in 2011. The occurrence of a delirium increases the duration of hospitalization, increases the risk of falls, loss of autonomy, can lead to an impairment of quality of life at 6 months and is linked to excess mortality.
The gold standard for making the diagnosis of delirium is the use of the DSM-5 criteria, but their use is time-consuming and requires that staff be trained in their use. The 4 "A" test (tool to help identify confusional syndrome) can be used to monitor confusional syndromes; it has the advantage of being able to be taken in less than 3 minutes.
Concerning the management of a confusional syndrome, a non-pharmacological multi-component approach is recommended as first line for its prevention but there is no treatment to date. A tool to help with temporo-spatial reorientation (La Rob'Gazette) has been set up in the Medical Care and Geriatric Rehabilitation (SMRG) departments of the HUS
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient aged 75 and over hospitalized at the HUS in the SMRG department during the period from January 1, 2021 to April 31, 2023 and havin passed at least a 4AT during hospitalization.
Key inclusion criteria (4 listed)
- Patient aged 75 and over
- Hospitalized at the HUS in the SMRG department during the period from January 1, 2021 to April 31, 2023
- Passed at least a 4AT during hospitalization
- Absence of written opposition in the patient's medical file (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Key exclusion criteria (1 listed)
- Presence of written opposition from the patient (and/or their legal representative if applicable) in their medical file.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Speed of improvement of the 4AT of the entire population
Time frame: Up to 2 years
The analysis will be undertaken on patients for whom at least two 4AT measurements are available (in order to be able to calculate a change). It will be based on a mixed linear model including the variable to be tested, time and their interaction. Variables deemed clinically relevant or statistically significant at the threshold of p < 0.10 will be included in a multivariate model. Then the non-significant and irrelevant variables will be removed from the model. The significance threshold will be 0.05 for this final model.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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.
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 Attention Disorder, run by University Hospital, Strasbourg, France 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre BOUSSUGE, MD (33 3 88 11 54 61, alexandre.boussuge@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of improvement of the 4AT of the entire population (time frame: Up to 2 years). 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 12 Jul 2024.