Clinical trial NCT04937127: Efficiency of E-learning and Role-playing for the Training of Nursing Home Caregivers in the Support of Agitation in Neurodegenerative Diseases
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuro-Degenerative Disease
Keywords: agitation
dependent elderly people
psycho-behavioral disorders
nursing home
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dependent elderly people with a neurodegenerative disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of agitation of patients in the nursing home
timeFrame: Baseline
measure: Measurement of agitation of patients in the nursing home
timeFrame: 3 months
measure: Measurement of agitation of patients in the nursing home
timeFrame: 6 months
measure: Measurement of agitation of patients in the nursing home
timeFrame: 9 months
Secondary outcomes:
measure: Frequency and severity of Psychobehavioural Symptoms associated with Dementia
timeFrame: Baseline, 3 months, 6 months and 9 months
measure: Quality of life of patients
timeFrame: Baseline, 3 months, 6 months and 9 months
measure: Impact of I-Learn on psychotropic drug prescriptions
timeFrame: Baseline, 3 months, 6 months and 9 months
measure: Impact of I-Learn on psychotropic drug prescriptions
timeFrame: Baseline, 3 months, 6 months and 9 months
measure: Impact of I-Learn training on hospital admissions
timeFrame: 3 months, 6 months and 9 months
measure: Impact of I-Learn training on hospital admissions
timeFrame: 3 months, 6 months and 9 months
measure: Impact of Psychobehavioural Symptoms Associated with Dementia on the professional practice of health care teams
timeFrame: Baseline, 3 months, 6 months and 9 months
measure: Caregiver burnout at work
timeFrame: Baseline, 6 months and 9 months
Other outcomes:
Locations:
city: Châteaugiron
country: France
facility: EHPAD Résidence du Prévot
city: Liffré
country: France
facility: Maison Saint Michel
city: Montlouis-sur-Loire
country: France
facility: EHPAD La Bourdaisière
city: Pléchâtel
country: France
facility: Résidence Père Brottier
city: Rochecorbon
country: France
facility: EHPAD Le Clos Saint-Vincent
city: Tours
country: France
facility: EHPAD Montconseil
city: Tours
country: France
facility: EHPAD La Source
Study officials:
affiliation: University Hospital, Tours
name: Céline LOURDEL
role: PRINCIPAL_INVESTIGATOR
References: