Alzheimer DiseaseNCT01901263
Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units
An observational study of Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- patients with alzheimer's disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 306 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2012to Oct 2015
- How long will I take part?
- 3 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Alzheimer's disease or associated disorders and BDSP and hospitalized in a CBU
Who may be able to join
- patient hospitalized on CBUs
- patient with the diagnostic criteria for disease related to dementia stage with a Clinical Demential Rating ≥ 1
- patient with a caregiver who is fairly frequent contact with the patient in order to observe the appearance of behavior changes
Who cannot join
- Patient living alone at home
- Patient with risk of death within one year
Trial locations and contacts
3 sites in 1 country.
France3 sites
CH Saint Jean de Dieu
Lyon, 69373
CHU de Saint Etienne
Saint-Etienne, 42000
Hospices Civils de Lyon
Villeurbanne, 69100
About this study
Official title: Initial and Long-term Evaluation of Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units
Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears important to assess their long-term impact on patients care.
Read the detailed description
EXPECTED RESULTS The present study should allow to better understand the long-term impact of CBU on care of patients with Alzheimer disease and BPSD. Moreover, it should allow to identify patients improved by CBU.
- Conditions
- Alzheimer Disease
- Being tested
- patients with alzheimer's disease
- Keywords
- Cognitive and behavioral units, Alzheimer Disease, Dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with alzheimer's diseaseBehavioural
the Neuropsychiatric Inventory (NPI), is uded to assess 10 behavioral disturbances occurring in dementia patients: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions.
| Study group | Role | What they receive |
|---|---|---|
| patient with alzheimer's disease | Cohort of patients with psychological symptoms of dementia hospitalised in Cognitive and Behaviorial Units (CBUs)
Evaluation of these units through the observation of the behavioral and psychological symptoms of dementia evolution : NPI score, caregivers quality of life, caregivers burden, collection of psychotropic drugs, the rehospitalisation rate Receives: Behavioral: patients with alzheimer's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory (NPI) score
impact of CBU effectiveness in reducing BPSD
Measured: one year
Secondary outcomes (4)
CBU effectiveness in reducing BPSD
Measured: 6 months
CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burden
Measured: one year
Psychotropic drugs (in particular neuroleptic drugs) consumption
Measured: one year
rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 306 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes
- Responsible party
- Sponsor
- Investigators
- Isabelle ROUCH, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901263
- Sponsor's protocol ID
- 1208125
- Other IDs
- 13.069bis
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pongan E, Freulon M, Delphin-Combe F, Dibie-Racoupeau F, Martin-Gaujard G, Federico D, Waissi A, Richard G, Jacqueline S, Fabre F, Trombert-Paviot B, Krolak-Salmon P, Laurent B, Rouch I. Initial and long-term evaluation of patients with Alzheimer's after hospitalization in cognitive and behavioural units: the EVITAL study design. BMC Psychiatry. 2014 Nov 15;14:308. doi: 10.1186/s12888-014-0308-6.
PubMed 25398578
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial and Long-term Evaluation of Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units
- ClinicalTrials.gov ID
- NCT01901263
- Acronym / sponsor ID
- 1208125
- Conditions
- Alzheimer Disease
- Keywords
- Cognitive and behavioral units, Alzheimer Disease, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Jul 2013 (estimated)
- 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.
Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears important to assess their long-term impact on patients care.
Detailed description
EXPECTED RESULTS The present study should allow to better understand the long-term impact of CBU on care of patients with Alzheimer disease and BPSD. Moreover, it should allow to identify patients improved by CBU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with alzheimer's disease | – | Behavioral: patients with alzheimer's diseaseCohort of patients with psychological symptoms of dementia hospitalised in Cognitive and Behaviorial Units (CBUs) Evaluation of these units through the observation of the behavioral and psychological symptoms of dementia evolution : NPI score, caregivers quality of life, caregivers burden, collection of psychotropic drugs, the rehospitalisation rate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Alzheimer's disease or associated disorders and BDSP and hospitalized in a CBU
Key inclusion criteria (3 listed)
- patient hospitalized on CBUs
- patient with the diagnostic criteria for disease related to dementia stage with a Clinical Demential Rating ≥ 1
- patient with a caregiver who is fairly frequent contact with the patient in order to observe the appearance of behavior changes
Key exclusion criteria (2 listed)
- Patient living alone at home
- Patient with risk of death within one year
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 |
|---|---|---|
| patients with alzheimer's diseasethe Neuropsychiatric Inventory (NPI), is uded to assess 10 behavioral disturbances occurring in dementia patients: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. | Behavioural | patient with alzheimer's disease |
Primary outcome
Neuropsychiatric Inventory (NPI) score
Time frame: one year
impact of CBU effectiveness in reducing BPSD
4 secondary outcomes
CBU effectiveness in reducing BPSD
Time frame: 6 months
CBU effectiveness on quality of life of patients and caregivers, and on caregivers' burden
Time frame: one year
Psychotropic drugs (in particular neuroleptic drugs) consumption
Time frame: one year
rehospitalisation rate for BPSD of the patients in the year following their hospitalisation in CBU
Time frame: one year
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 2 Dec 2015.
- Derived from this study: PubMed 25398578Pongan E, Freulon M, Delphin-Combe F, Dibie-Racoupeau F, Martin-Gaujard G, Federico D, Waissi A, Richard G, Jacqueline S, Fabre F, Trombert-Paviot B, Krolak-Salmon P, Laurent B, Rouch I. Initial and long-term evaluation of patients with Alzheimer's after hospitalization in cognitive and behavioural units: the EVITAL study design. BMC Psychiatry. 2014 Nov 15;14:308. doi: 10.1186/s12888-014-0308-6.
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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.
Isabelle ROUCH, PhD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 3 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 2 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Neuropsychiatric Inventory (NPI) score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901263, which also lists 1 linked publication.
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 2 Dec 2015.