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

Completed

• Conditions: Neuro-Degenerative Disease
• Interventions: Behavioral: I-LEARN training; Other: usual care

• Registration Number: NCT04937127
• Lead Sponsor: University Hospital, Tours

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-23
• Study Start: 2021-11-08
• Status Verified: 2023-01
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group	I-LEARN training	The experimental group will be made up of patients from nursing homes whose carers have received I-Learn training.
Control Group	usual care	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.
Experimental Group	usual care	The experimental group will be made up of patients from nursing homes whose carers have received I-Learn training.

Primary Outcome Measures

Name	Time	Method
Measurement of agitation of patients in the nursing home	9 months	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

Secondary Outcome Measures

Name	Time	Method
Impact of Psychobehavioural Symptoms Associated with Dementia on the professional practice of health care teams	Baseline, 3 months, 6 months and 9 months	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
Caregiver burnout at work	Baseline, 6 months and 9 months	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.
Frequency and severity of Psychobehavioural Symptoms associated with Dementia	Baseline, 3 months, 6 months and 9 months	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
Quality of life of patients	Baseline, 3 months, 6 months and 9 months	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.
Impact of I-Learn on psychotropic drug prescriptions	Baseline, 3 months, 6 months and 9 months	Changes in the prescriptions given to patients in terms of dosage (increase/decrease of the daily dose)
Impact of I-Learn training on hospital admissions	3 months, 6 months and 9 months	reasons for hospitalisation

Trial Locations

Locations (7)

EHPAD Résidence du Prévot; 🇫🇷 Châteaugiron, France

EHPAD Le Clos Saint-Vincent; 🇫🇷 Rochecorbon, France

EHPAD La Source; 🇫🇷 Tours, France

EHPAD La Bourdaisière; 🇫🇷 Montlouis-sur-Loire, France

Maison Saint Michel; 🇫🇷 Liffré, France

Résidence Père Brottier; 🇫🇷 Pléchâtel, France

EHPAD Montconseil; 🇫🇷 Tours, France