Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 11:45 PM
Study NCT ID:
NCT05311969
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Impaired Executive Functions
Sponsor:
Fondation Korian pour le Bien Vieillir
Organization:
Study Overview
Official Title:
Prevalence of Impaired Executive Functions in Institutionalized Elderly
Status:
COMPLETED
Status Verified Date:
2023-10
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:
EXEPA
Brief Summary:
The evaluation of executive functions, as well as the means of stimulating and preserving them, are at the heart of the challenges for maintaining a level of functional autonomy in the elderly, but also during the loss of this functional autonomy and when entering a situation of dependence and/or dementia. Research that has demonstrated the preponderant role of executive functions on functional abilities are examples of this. Components such as planning, organization, initiation, mental flexibility appear to be strongly correlated with the effective performance of complex activities of daily living. In addition, the capacities for autonomy were found to be significantly reduced, and significantly with the severity of the executive deficits. In addition, if these data have since contributed to determining a level of impairment of the executive processes specific to an early loss of autonomy, they are so in the context of early diagnosis of dementia and validation of a detection tool, early loss of autonomy. The scientific advances of the last five years contribute to a better understanding of the impact of executive disorders, but on the other hand, the diversity of the explanatory phenomena of these disorders considerably complicates their nosology within neuro-evolutionary pathologies. Ultimately, an analysis of executive function disorders must take into account cognitive and behavioral aspects, that is to say, beyond performance on tests identified as involving executive functions, behavioral disorders, emotional status and level of autonomy in activities of daily living. In the state of our knowledge, the consideration of executive functions represents a strategic point at the crossroads of the evaluation of the act of care and treatment. Establishing data on the prevalence of alterations in the executive functions of residents, exploring the possibilities of evaluation with a battery of tests little used in this context and linking "executive" profiles and clinical situations seems to us a relevant and interesting first step. However essential to provide a beginning of answer to these questions. This study being an exploratory study. The results of this study will constitute new prevalence data in the population of residents of nursing homes. The aim here is to establish data on the prevalence of alterations in the executive functions of residents, to explore the possibilities of evaluation with a battery of tests little used in this context and to relate the profiles "executives" and clinical situations. This in order to develop a methodology to draw up a general assessment, and to make comparisons of the different profiles, inter/intra pathologies and stages of evolution. Thus, a more in-depth knowledge of the specific profiles of Nursing Home residents will also lead to the reflection of pharmacological and non-pharmacological therapeutic strategies. Finally, it will ultimately be a question of presenting an inventory of the situation of Nursing Home to alert public policies. The main objective is to study the prevalence of impaired executive functions in nursing home residents. The secondary objectives are to explore the feasibility of carrying out executive function tests and to examine the coorelationbetween the levels of impairment of executive functions and the clinical and functional characteristics of residents.
Detailed Description:
Participants will be recruited by the investigating doctor and the healthcare team. Participants must meet the defined inclusion criteria The steps:
1. Screening Pre-selection of participants potentially eligible for the study (inclusion/non-inclusion criteria) and collection of data from medical records and the healthcare database.
The information can be collected by the nursing coordinator of the Nursing home. The diagnosis will be determined by the investigating physician of each center and the inclusion criteria checked.
2. Pre-inclusion-inclusion visit
* Confirmation of eligibility criteria for participants selected for the screening phase
* Delivery of Consent forms for reading, for explanation of the study methods (procedure, context, objective, constraints), and to answer any questions. If the participant agrees to participate in the study. The consent forms must be signed and dated before any act carried out within the framework of the research. A time of reflection can be granted before the signature. The evaluation of global cognitive functioning with the Mini Mental State Examination will be carried out. Each potentially eligible participant will be given an information note on the conduct of the study followed by an informed consent form that he and the investigator will need to sign before the start of the study.
The course of the study for the participant will consist of 4 visits with the psychologist and/or the doctor:
Pre-inclusion consultation, Visit 0: during which the participant will take a questionnaire carried out by the psychologist to assess overall cognitive functioning, and the inclusion consultation by the on-site investigator doctor to check whether the participant corresponds to all study criteria. Following this visit, the participant may choose to participate in the research by signing the consent form.
The visits will take place as follows, spread over 14 to a maximum of 65 days from Pré-inclusion
3. Visits
Visit 1. (20 to 45 minutes, up to 15 days after Visit 0). This visit will allow to do:
* a clinical assessment with the investigating doctor,
* a behavioral assessment by the nursing staff or the psychologist.
* four cognitive tests for a total duration of approximately 15 minutes carried out by the psychologist.
* Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 1.
Visit 2. (About 25 minutes, 7 to 10 days after visit Visit 1). This visit will allow you to:
* an evaluation of executive functions by the neuropsychologist with four new cognitive tests:
* Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 2.
Visit 3. (About 30 minutes, 7 to 10 days after visit Visit 2). This visit will allow you to:
* a final evaluation of executive functions by the neuropsychologist with four new cognitive tests:
* Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 3.
1. Screening Pre-selection of participants potentially eligible for the study (inclusion/non-inclusion criteria) and collection of data from medical records and the healthcare database.
The information can be collected by the nursing coordinator of the Nursing home. The diagnosis will be determined by the investigating physician of each center and the inclusion criteria checked.
2. Pre-inclusion-inclusion visit
* Confirmation of eligibility criteria for participants selected for the screening phase
* Delivery of Consent forms for reading, for explanation of the study methods (procedure, context, objective, constraints), and to answer any questions. If the participant agrees to participate in the study. The consent forms must be signed and dated before any act carried out within the framework of the research. A time of reflection can be granted before the signature. The evaluation of global cognitive functioning with the Mini Mental State Examination will be carried out. Each potentially eligible participant will be given an information note on the conduct of the study followed by an informed consent form that he and the investigator will need to sign before the start of the study.
The course of the study for the participant will consist of 4 visits with the psychologist and/or the doctor:
Pre-inclusion consultation, Visit 0: during which the participant will take a questionnaire carried out by the psychologist to assess overall cognitive functioning, and the inclusion consultation by the on-site investigator doctor to check whether the participant corresponds to all study criteria. Following this visit, the participant may choose to participate in the research by signing the consent form.
The visits will take place as follows, spread over 14 to a maximum of 65 days from Pré-inclusion
3. Visits
Visit 1. (20 to 45 minutes, up to 15 days after Visit 0). This visit will allow to do:
* a clinical assessment with the investigating doctor,
* a behavioral assessment by the nursing staff or the psychologist.
* four cognitive tests for a total duration of approximately 15 minutes carried out by the psychologist.
* Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 1.
Visit 2. (About 25 minutes, 7 to 10 days after visit Visit 1). This visit will allow you to:
* an evaluation of executive functions by the neuropsychologist with four new cognitive tests:
* Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 2.
Visit 3. (About 30 minutes, 7 to 10 days after visit Visit 2). This visit will allow you to:
* a final evaluation of executive functions by the neuropsychologist with four new cognitive tests:
* Additional visit (10 days later maximum): only if one or more tests have not been carried out or completed during visit 3.
Study Oversight
Has Oversight DMC:
False
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?: