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

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT04937127
Collaborator
(none)
168
7
8.7
24
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: I-LEARN training
  • Other: usual care

Study Design

Study Type:
Observational
Anticipated Enrollment :
168 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 8, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Measurement of agitation of patients in the nursing home [Baseline]

    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

  2. Measurement of agitation of patients in the nursing home [3 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

  3. Measurement of agitation of patients in the nursing home [6 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

  4. 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

  1. 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

  2. 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.

  3. 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 psychotropic drugs (addition or withdrawal of a neuroleptic, antidepressant, anxiolytic, etc.)

  4. 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)

  5. Impact of I-Learn training on hospital admissions [3 months, 6 months and 9 months]

    number of transfers to acute or emergency departments

  6. Impact of I-Learn training on hospital admissions [3 months, 6 months and 9 months]

    reasons for hospitalisation

  7. 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

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 EHPAD Résidence du Prévot Châteaugiron France 35000
2 Maison Saint Michel Liffré France 35340
3 EHPAD La Bourdaisière Montlouis-sur-Loire France 37270
4 Résidence Père Brottier Pléchâtel France 35470
5 EHPAD Le Clos Saint-Vincent Rochecorbon France 37210
6 EHPAD Montconseil Tours France 37012
7 EHPAD La Source Tours France 37100

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

  • Principal Investigator: Céline LOURDEL, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT04937127
Other Study ID Numbers:
  • DR200087 (I-LEARN)
First Posted:
Jun 23, 2021
Last Update Posted:
Dec 3, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Tours
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021