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Completed

NCT Number: NCT04937127

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

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.

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Key information

Conditions

Neuro-Degenerative Disease Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

EHPAD Résidence du Prévot, Châteaugiron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-LEARN training

Behavioral

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

Usual Care

Other

usual care

Primary outcomes

  1. Measurement of agitation of patients in the nursing home

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Frequency and severity of Psychobehavioural Symptoms associated with Dementia

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 months, 6 months and 9 months

    number of transfers to acute or emergency departments

  6. Impact of I-Learn training on hospital admissions

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2021
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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