Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome

Recruiting

• Conditions: Attention Disorder

• Registration Number: NCT06498297
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-04
• Study Completion: 2025-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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.

Exclusion Criteria

• Presence of written opposition from the patient (and/or their legal representative if applicable) in their medical file.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speed of improvement of the 4AT of the entire population	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.

Trial Locations

Locations (1)

Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France; 🇫🇷 Strasbourg, France