Neuro-Degenerative DiseaseNCT04937127
Efficiency of E-learning and Role-playing for the Training of Nursing Home Caregivers in the Support of Agitation in Neurodegenerative Diseases
An observational study of Neuro-Degenerative Disease, run by University Hospital, Tours at 7 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- I-LEARN training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 7 sitesFrance
- Study dates
- 8 Nov 2021to 9 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Dependent elderly people with a neurodegenerative disease
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
EHPAD Résidence du Prévot
Châteaugiron, 35000
Maison Saint Michel
Liffré, 35340
EHPAD La Bourdaisière
Montlouis-sur-Loire, 37270
Résidence Père Brottier
Pléchâtel, 35470
EHPAD Le Clos Saint-Vincent
Rochecorbon, 37210
EHPAD Montconseil
Tours, 37012
EHPAD La Source
Tours, 37100
About this study
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
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
- Being tested
- I-LEARN training, usual care
- Keywords
- agitation, dependent elderly people, psycho-behavioral disorders, nursing home
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-LEARN trainingBehavioural
Training of psycho-behavorial disorders care in neurodegenerative diseases: including a theoretical part in e-learning and a practical part
usual careOther
usual care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | The experimental group will be made up of patients from nursing homes whose carers have received I-Learn training. Receives: 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. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 months
Secondary outcomes (8)
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
Measured: Baseline, 3 months, 6 months and 9 months
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.
Measured: Baseline, 3 months, 6 months and 9 months
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.)
Measured: Baseline, 3 months, 6 months and 9 months
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)
Measured: Baseline, 3 months, 6 months and 9 months
Impact of I-Learn training on hospital admissions
number of transfers to acute or emergency departments
Measured: 3 months, 6 months and 9 months
Impact of I-Learn training on hospital admissions
reasons for hospitalisation
Measured: 3 months, 6 months and 9 months
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
Measured: Baseline, 3 months, 6 months and 9 months
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.
Measured: Baseline, 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start8 Nov 2021
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline LOURDEL, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937127
- Sponsor's protocol ID
- DR200087 (I-LEARN)
- Status last verified
- Jan 2023
- First submitted
- 8 Jun 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04937127
- Acronym / sponsor ID
- DR200087 (I-LEARN)
- Conditions
- Neuro-Degenerative Disease
- Keywords
- agitation, dependent elderly people, psycho-behavioral disorders, nursing home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Behavioral: I-LEARN training, Other: usual careThe experimental group will be made up of patients from nursing homes whose carers have received I-Learn training. |
| Control Group | – | Other: usual careThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dependent elderly people with a neurodegenerative disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-LEARN trainingTraining of psycho-behavorial disorders care in neurodegenerative diseases: including a theoretical part in e-learning and a practical part | Behavioural | Experimental Group |
| usual careusual care | Other | Control Group, Experimental Group |
Primary outcome
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
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
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
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
8 secondary outcomes
Frequency and severity of Psychobehavioural Symptoms associated with Dementia
Time frame: Baseline, 3 months, 6 months and 9 months
Quality of life of patients
Time frame: Baseline, 3 months, 6 months and 9 months
Impact of I-Learn on psychotropic drug prescriptions
Time frame: Baseline, 3 months, 6 months and 9 months
Impact of I-Learn on psychotropic drug prescriptions
Time frame: Baseline, 3 months, 6 months and 9 months
Impact of I-Learn training on hospital admissions
Time frame: 3 months, 6 months and 9 months
Impact of I-Learn training on hospital admissions
Time frame: 3 months, 6 months and 9 months
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
Caregiver burnout at work
Time frame: Baseline, 6 months and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline LOURDEL principal investigator
University Hospital, Tours
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Degenerative Disease, run by University Hospital, Tours at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of agitation of patients in the nursing home (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.