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

Neuro-Degenerative Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937127
• Other study ID #: DR200087 (I-LEARN)
• Status: Completed
• Start date: November 8, 2021
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuro-Degenerative Disease
• Neurodegenerative Diseases

Intervention

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

Locations

Country	Name	City	State
France	EHPAD Résidence du Prévot	Châteaugiron
France	Maison Saint Michel	Liffré
France	EHPAD La Bourdaisière	Montlouis-sur-Loire
France	Résidence Père Brottier	Pléchâtel
France	EHPAD Le Clos Saint-Vincent	Rochecorbon
France	EHPAD La Source	Tours
France	EHPAD Montconseil	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Impact of I-Learn training on hospital admissions	number of transfers to acute or emergency departments	3 months, 6 months and 9 months
Secondary	Impact of I-Learn training on hospital admissions	reasons for hospitalisation	3 months, 6 months and 9 months
Secondary	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
Secondary	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