Prevalence of Impaired Executive Functions (EXEPA)

October 26, 2023 updated by: Fondation Korian pour le Bien Vieillir

Prevalence of Impaired Executive Functions in Institutionalized Elderly

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ars-en-Ré, France, 17590
        • KORIAN La Côte Sauvage
      • Bordeaux, France, 33000
        • Korian Villa Louisa
      • Chartres, France, 28000
        • Korian Villa Evora
      • L'Huisserie, France, 53970
        • Korian Le Catelli
      • Montbéliard, France, 25200
        • Korian Doubs Rivage
      • Nantes, France, 44300
        • Korian Bois Robillard
      • Orléans, France, 45000
        • Korian Le Baron
      • Paris, France, 75012
        • Korian Les Arcades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Permanent resident in Nursing Home or in temporary accommodation for more than 3 months
  • speak and understand the French language
  • Mini Mental State Examination (MMSE) between 7 and 24 dating from 8 maximum days
  • Compulsorily affiliated with a social security scheme
  • Agree to participate in the study in agreement with the trusted person (if applicable)
  • co-signatures of the Consent Form between the investigator and the participant or the person of trust (if applicable)

Exclusion Criteria:

  • Refusal to sign the consent form
  • Resident in a specialized unit for behavioral disorders (Cognitive Behavioral Unit (CBU), Reinforced Accommodation Unit (RAU), Disoriented Elderly Unit (DEU), Centers of Natural Activities Drawn from Useful Occupations (NADUO) et cetera)
  • Communication difficulties, sensory and/or motor deficits
  • Medical contraindication in relation to a psychological state that could be altered due to participation in the study
  • Resident at end of life (life expectancy < 3 months)
  • Resident under legal protection
  • Participation within 48 hours prior to inclusion in another research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: groups/cohort
participants will perform the various neuropsychological tests provided for in the protocol
Other: cognitive evaluations and non cognitive evaluations

Cognitive evaluations with executive functions evaluations :

  • Mini Mental State Examination
  • Stroop Victoria Test
  • Hayling test
  • Frontal Assessment Battery test mental flexibility:
  • Trial Making Test (TMT) A and B
  • Connection test
  • Alphaflex test
  • Verbal and visuospatial working memory
  • Wechsler Adult Intelligence Scale (WAIS) span
  • Visuo-spatial span
  • Visuo-spatial span simplified version
  • Month Of the Year Backwards (MOTYB) Planning
  • Tinker Toy test
  • Clock Test

Non-cognitive evaluations:

The Katz Autonomy Scale Neuropsychiatric Inventory version Care team Geriatric Depression Scale 15-item version Apathy inventory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of executive functions impairment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of passed tests
Time Frame: 12 months
ability of nursing home residents to pass tests provided for in the protocol to evaluate executive functions
12 months
Correlation between executive functions impairment and percentage of dependence residents Correlation between executive functions impairment and percentage of residents with
Time Frame: 12 months
12 months
Correlation between executive functions impairment and behavioral disorders
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Korian pour le Bien Vieillir

Collaborators

Gerontopôle des Pays de la Loire

Investigators

  • Study Director: Gilles BERRUT, Gerontopôle des Pays de la Loire
  • Principal Investigator: Leila LAIFA-MARY, Korian
  • Principal Investigator: Priscilla CLOT-FAYBESSE, Korian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EXEPA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Executive Dysfunctions

Clinical Trials on cognitive evaluations and non cognitive evaluations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe