NCT05311969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

March 11, 2022

Last Update Submit

October 26, 2023

Conditions

Keywords

executive functionsnursing homeresidentdependence

Outcome Measures

Primary Outcomes (1)

  • Prevalence of executive functions impairment

    12 months

Secondary Outcomes (3)

  • Rate of passed tests

    12 months

  • Correlation between executive functions impairment and percentage of dependence residents Correlation between executive functions impairment and percentage of residents with

    12 months

  • Correlation between executive functions impairment and behavioral disorders

    12 months

Study Arms (1)

groups/cohort

EXPERIMENTAL

participants will perform the various neuropsychological tests provided for in the protocol

Other: cognitive evaluations and non cognitive evaluations

Interventions

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

groups/cohort

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

KORIAN La Côte Sauvage

Ars-en-Ré, 17590, France

Location

Korian Villa Louisa

Bordeaux, 33000, France

Location

Korian Villa Evora

Chartres, 28000, France

Location

Korian Le Catelli

L'Huisserie, 53970, France

Location

Korian Doubs Rivage

Montbéliard, 25200, France

Location

Korian Bois Robillard

Nantes, 44300, France

Location

Korian Le Baron

Orléans, 45000, France

Location

Korian Les Arcades

Paris, 75012, France

Location

Related Publications (18)

  • Miyake A, Friedman NP, Emerson MJ, Witzki AH, Howerter A, Wager TD. The unity and diversity of executive functions and their contributions to complex "Frontal Lobe" tasks: a latent variable analysis. Cogn Psychol. 2000 Aug;41(1):49-100. doi: 10.1006/cogp.1999.0734.

    PMID: 10945922BACKGROUND
  • Belleville S, Rouleau N, Van der Linden M. Use of the Hayling task to measure inhibition of prepotent responses in normal aging and Alzheimer's disease. Brain Cogn. 2006 Nov;62(2):113-9. doi: 10.1016/j.bandc.2006.04.006. Epub 2006 Jun 6.

    PMID: 16757076BACKGROUND
  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PMID: 7991117BACKGROUND
  • Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6. doi: 10.1212/wnl.55.11.1621.

    PMID: 11113214BACKGROUND
  • Fisk JE, Sharp CA. Age-related impairment in executive functioning: updating, inhibition, shifting, and access. J Clin Exp Neuropsychol. 2004 Oct;26(7):874-90. doi: 10.1080/13803390490510680.

    PMID: 15742539BACKGROUND
  • KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

    PMID: 14044222BACKGROUND
  • Makino T, Umegaki H, Suzuki Y, Yanagawa M, Nonogaki Z, Nakashima H, Kuzuya M. Relationship between small cerebral white matter lesions and cognitive function in patients with Alzheimer's disease and amnestic mild cognitive impairment. Geriatr Gerontol Int. 2014 Oct;14(4):819-26. doi: 10.1111/ggi.12176. Epub 2013 Nov 12.

    PMID: 24215176BACKGROUND
  • Blanco Martin E, Ugarriza Serrano I, Elcoroaristizabal Martin X, Galdos Alcelay L, Molano Salazar A, Bereincua Gandarias R, Ingles Borda S, Uterga Valiente JM, Indakoetxea Juanbeltz MB, Moraza Lopez J, Barandiaran Amillano M, Fernandez-Martinez M. Dysexecutive syndrome in amnesic mild cognitive impairment: a multicenter study. BMC Neurol. 2016 Jun 4;16:88. doi: 10.1186/s12883-016-0607-2.

    PMID: 27260328BACKGROUND
  • Perry RJ, Hodges JR. Differentiating frontal and temporal variant frontotemporal dementia from Alzheimer's disease. Neurology. 2000 Jun 27;54(12):2277-84. doi: 10.1212/wnl.54.12.2277.

    PMID: 10881252BACKGROUND
  • Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.

    PMID: 12461757BACKGROUND
  • Roussel M, Lhommee E, Narme P, Czernecki V, Gall DL, Krystkowiak P, Diouf M, Godefroy O; GREFEX study group. Dysexecutive syndrome in Parkinson's disease: the GREFEX study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2017 Sep;24(5):496-507. doi: 10.1080/13825585.2016.1226248. Epub 2016 Sep 1.

    PMID: 27585478BACKGROUND
  • Salthouse TA, Toth J, Daniels K, Parks C, Pak R, Wolbrette M, Hocking KJ. Effects of aging on efficiency of task switching in a variant of the trail making test. Neuropsychology. 2000 Jan;14(1):102-11.

    PMID: 10674802BACKGROUND
  • Stuss DT. Functions of the frontal lobes: relation to executive functions. J Int Neuropsychol Soc. 2011 Sep;17(5):759-65. doi: 10.1017/S1355617711000695. Epub 2011 May 24.

    PMID: 21729406BACKGROUND
  • Stuss DT, Alexander MP, Shallice T, Picton TW, Binns MA, Macdonald R, Borowiec A, Katz DI. Multiple frontal systems controlling response speed. Neuropsychologia. 2005;43(3):396-417. doi: 10.1016/j.neuropsychologia.2004.06.010.

    PMID: 15707616BACKGROUND
  • Tomaszewski Farias S, Cahn-Weiner DA, Harvey DJ, Reed BR, Mungas D, Kramer JH, Chui H. Longitudinal changes in memory and executive functioning are associated with longitudinal change in instrumental activities of daily living in older adults. Clin Neuropsychol. 2009 Apr;23(3):446-61. doi: 10.1080/13854040802360558. Epub 2008 Sep 23.

    PMID: 18821181BACKGROUND
  • Torralva T, Roca M, Gleichgerrcht E, Bekinschtein T, Manes F. A neuropsychological battery to detect specific executive and social cognitive impairments in early frontotemporal dementia. Brain. 2009 May;132(Pt 5):1299-309. doi: 10.1093/brain/awp041. Epub 2009 Mar 31.

    PMID: 19336463BACKGROUND
  • Torralva T, Roca M, Gleichgerrcht E, Lopez P, Manes F. INECO Frontal Screening (IFS): a brief, sensitive, and specific tool to assess executive functions in dementia. J Int Neuropsychol Soc. 2009 Sep;15(5):777-86. doi: 10.1017/S1355617709990415. Epub 2009 Jul 28.

    PMID: 19635178BACKGROUND
  • Tosto G, Zimmerman ME, Hamilton JL, Carmichael OT, Brickman AM; Alzheimer's Disease Neuroimaging Initiative. The effect of white matter hyperintensities on neurodegeneration in mild cognitive impairment. Alzheimers Dement. 2015 Dec;11(12):1510-1519. doi: 10.1016/j.jalz.2015.05.014. Epub 2015 Jun 13.

    PMID: 26079417BACKGROUND

Study Officials

  • Gilles BERRUT

    Gerontopôle des Pays de la Loire

    STUDY DIRECTOR
  • Leila LAIFA-MARY

    Korian

    PRINCIPAL INVESTIGATOR
  • Priscilla CLOT-FAYBESSE

    Korian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

April 5, 2022

Study Start

April 11, 2022

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations