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

NCT04937127 | Completed

• 1 other identifier: DR200087 (I-LEARN)
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 7

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.

Conditions

Neuro-Degenerative Disease

Keywords

agitation; dependent elderly people; psycho-behavioral disorders; nursing home

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Frequency and severity of Psychobehavioural Symptoms associated with Dementia

  Baseline, 3 months, 6 months and 9 months

• Quality of life of patients

  Baseline, 3 months, 6 months and 9 months

• Impact of I-Learn on psychotropic drug prescriptions

  Baseline, 3 months, 6 months and 9 months

• Impact of I-Learn on psychotropic drug prescriptions

  Baseline, 3 months, 6 months and 9 months

• Impact of I-Learn training on hospital admissions

  3 months, 6 months and 9 months

Study Arms (2)

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; Other: 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

Interventions

I-LEARN training BEHAVIORAL

Training of psycho-behavorial disorders care in neurodegenerative diseases: including a theoretical part in e-learning and a practical part

Experimental Group

usual care OTHER

usual care

Control Group; Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dependent elderly people with a neurodegenerative disease

You may qualify if:

• 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.

You may not qualify if:

• Patient under court protection
• Inability to understand the French language

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (7)

EHPAD Résidence du Prévot

Châteaugiron, 35000, France

Location

Maison Saint Michel

Liffré, 35340, France

Location

EHPAD La Bourdaisière

Montlouis-sur-Loire, 37270, France

Location

Résidence Père Brottier

Pléchâtel, 35470, France

Location

EHPAD Le Clos Saint-Vincent

Rochecorbon, 37210, France

Location

EHPAD Montconseil

Tours, 37012, France

Location

EHPAD La Source

Tours, 37100, France

Location

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Céline LOURDEL

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 23, 2021
• Study Start: November 8, 2021
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

FR (7)