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Clinical Trials/NCT05311969
NCT05311969CompletedNot Applicable

Prevalence of Impaired Executive Functions in Institutionalized Elderly

Fondation Korian pour le Bien Vieillir16 sites in 1 country46 target enrollmentStarted: April 11, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
46
Locations
16
Primary Endpoint
Prevalence of executive functions impairment

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
75 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Prevalence of executive functions impairment

Time Frame: 12 months

Secondary Outcomes

  • Rate of passed tests(12 months)
  • Correlation between executive functions impairment and behavioral disorders(12 months)
  • Correlation between executive functions impairment and percentage of dependence residents Correlation between executive functions impairment and percentage of residents with(12 months)

Investigators

Sponsor
Fondation Korian pour le Bien Vieillir
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (16)

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