Efficiency of E-learning and Role-playing for the Training of Nursing Home Caregivers in the Support of Agitation in Neurodegenerative Diseases

Efficacité du E-learning et du Jeu de rôle Pour la Formation Des Soignants Des EHPAD à l'Accompagnement de l'Agitation Dans Les Maladies neurodégénératives : Essai randomisé en Cluster

This study will investigate the effects of "I-Learn cognition and behaviour" training in the care in agitation in patients with neurodegenerative diseases. This training for caregivers, aims to reduce agitation and psycho-behavioral disorders of patients living in nursing home. In addition, amount of psychotropic drugs prescribed, as well as the number of hospitalizations during the study will be assessed.

Study Overview

• Status: Completed
• Conditions: Neuro-Degenerative Disease
• Intervention / Treatment: Behavioral: I-LEARN training; Other: usual care

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• France
  • Châteaugiron, France, 35000
    • EHPAD Résidence du Prévot
  • Liffré, France, 35340
    • Maison Saint Michel
  • Montlouis-sur-Loire, France, 37270
    • EHPAD La Bourdaisière
  • Pléchâtel, France, 35470
    • Résidence Père Brottier
  • Rochecorbon, France, 37210
    • EHPAD Le Clos Saint-Vincent
  • Tours, France, 37012
    • EHPAD Montconseil
  • Tours, France, 37100
    • EHPAD La Source

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dependent elderly people with a neurodegenerative disease

Description

Inclusion Criteria:

• Diagnosis of Major Neurocognitive Disorder according to DSM 5
• With agitation and NPI agitation item score of 4 or more (frequency X severity)
• Information and verification of the non-opposition of the patient and his guardian / curator if he is under legal protection.

Exclusion Criteria:

• Patient under court protection
• Inability to understand the French language
• Patient whose state of health is not stabilised at the time of inclusion and/or in palliative care

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental Group; The experimental group will be made up of patients from nursing homes whose carers have received I-Learn training.	Behavioral: I-LEARN training; Training of psycho-behavorial disorders care in neurodegenerative diseases: including a theoretical part in e-learning and a practical part; Other: usual care; usual care
Control Group; The control group will consist of nursing homes patients whose caregivers have not received I-Learn training and will continue their usual care, regardless of the practices already implemented.	Other: usual care; usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of agitation of patients in the nursing home	Assessment of agitation using the Cohen-Mansfield Agitation Inventory (CMAI, 1989) by asking caregivers about the patients' behaviour. The minimum value is 0 and the maximum value is 203. the higher the score, the more intense the agitation	Baseline
Measurement of agitation of patients in the nursing home	Assessment of agitation using the Cohen-Mansfield Agitation Inventory (CMAI, 1989) by asking caregivers about the patients' behaviour. The minimum value is 0 and the maximum value is 203. the higher the score, the more intense the agitation	3 months
Measurement of agitation of patients in the nursing home	Assessment of agitation using the Cohen-Mansfield Agitation Inventory (CMAI, 1989) by asking caregivers about the patients' behaviour. The minimum value is 0 and the maximum value is 203. the higher the score, the more intense the agitation	6 months
Measurement of agitation of patients in the nursing home	Assessment of agitation using the Cohen-Mansfield Agitation Inventory (CMAI, 1989) by asking caregivers about the patients' behaviour. The minimum value is 0 and the maximum value is 203. the higher the score, the more intense the agitation	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of Psychobehavioural Symptoms associated with Dementia	Assessment using the Neuro Psychiatric Inventory, care team version (NPI-ES, 2000). 10 behavioural domains and 2 neurovegetative variables are considered. item score = frequency x severity frequency minimum = 1 and maximum = 4 severity minimum = 1 and maximum = 3 A score above 2 is pathological	Baseline, 3 months, 6 months and 9 months
Quality of life of patients	Assessment using the Quality of Life-Alzheimer's Disease (QOL-AD, 2009) 13 questions focus on the patient's quality of life. the patient's current quality of life in each domain is assessed by choosing one of the following four words: poor, fair, good, excellent.	Baseline, 3 months, 6 months and 9 months
Impact of I-Learn on psychotropic drug prescriptions	Changes in the prescriptions given to patients in terms of psychotropic drugs (addition or withdrawal of a neuroleptic, antidepressant, anxiolytic, etc.)	Baseline, 3 months, 6 months and 9 months
Impact of I-Learn on psychotropic drug prescriptions	Changes in the prescriptions given to patients in terms of dosage (increase/decrease of the daily dose)	Baseline, 3 months, 6 months and 9 months
Impact of I-Learn training on hospital admissions	number of transfers to acute or emergency departments	3 months, 6 months and 9 months
Impact of I-Learn training on hospital admissions	reasons for hospitalisation	3 months, 6 months and 9 months
Impact of Psychobehavioural Symptoms Associated with Dementia on the professional practice of health care teams	Assessment using the Neuro Psychiatric Inventory, care team version (NPI-ES, 2000) 10 behavioural domains and 2 neurovegetative variables are considered. item score = frequency x severity fequency minimum = 1 and maximum = 4 severity minimum = 1 and maximum = 3 A score above 2 is pathological	Baseline, 3 months, 6 months and 9 months
Caregiver burnout at work	Assessment using the Maslach Burnout Inventory (MBI, 1986) 22 items For each item, the minimum value is 0 and the maximum value is 6 BURNOUT Questions 1.2.3.6.8.13.14.16.20 Degree of burn out Total below 17 = low Total between 18 and 29 = moderate Total above 30 = high DEPERSONALISATION Questions 5.10.11.15.22 Degree of burn out Total below 5 = low Total between 6 and 11 = moderate Total above 12 = high PERSONAL FULFILMENT Questions 4.7.9.12.17.18.19.21 Degree of burn out Total above 40 = low Total between 34 and 39 = moderate Total below 33 = high Moderate or even high scores are a sign of latent burnout that is taking hold.	Baseline, 6 months and 9 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Céline LOURDEL, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: nursing home; agitation; dependent elderly people; psycho-behavioral disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: DR200087 (I-LEARN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No