ALZHEIMER DiseaseNCT00824967
Non Pharmacological Management of Behavioural Symptoms in Nursing Home
A study testing Training and valuation of the treating personnel in people with ALZHEIMER Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly. Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- ALZHEIMER Disease
- What is being tested?
- Training and valuation of the treating personnel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Oct 2009
- Phase
- Interventional
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer disease
Who cannot join
- Not alzheimer disease
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nice - 4 avenue Reine Victoria
Nice, Alpes-Maritimes, 06001
About this study
Official title: Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.
Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.
Read the detailed description
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.
Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.
Methods: The trial was conducted in 16 nursing homes; 306 patients with a diagnosis of dementia and presenting BPSD were selected. Nursing homes were randomly allocated to an intervention group or a control group. An eight-week staff education and training programme was conducted in the nursing homes in the intervention group. The main outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI) and an observation scale score. Assessments were done at baseline (W0), at the end of the 'intervention' period (W8) and 12 weeks after (W20).
- Conditions
- ALZHEIMER Disease
- Being tested
- Training and valuation of the treating personnel
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and valuation of the treating personnelOther
Training and valuation of the treating personnel
| Study group | Role | What they receive |
|---|---|---|
| 1- The reference group | No intervention | one will take care of the patient in a habitual way: no consultation additional, step of exam on top of that... |
| 2- The intervention group | Other | Training and valuation of the treating personnel Receives: Other: Training and valuation of the treating personnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention
Measured: 8 weeks after intervention
Secondary outcomes (1)
Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention
Measured: 16 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALZHEIMER DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe ROBERT, PhD, Principal investigator, CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824967
- Sponsor's protocol ID
- 07-PP-03
- Status last verified
- Jan 2009
- First submitted
- 16 Jan 2009
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD
- ClinicalTrials.gov ID
- NCT00824967
- Acronym / sponsor ID
- 07-PP-03
- Conditions
- ALZHEIMER Disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Jan 2009 (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.
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.
Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.
Detailed description
Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.
Objective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.
Methods: The trial was conducted in 16 nursing homes; 306 patients with a diagnosis of dementia and presenting BPSD were selected. Nursing homes were randomly allocated to an intervention group or a control group. An eight-week staff education and training programme was conducted in the nursing homes in the intervention group. The main outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI) and an observation scale score. Assessments were done at baseline (W0), at the end of the 'intervention' period (W8) and 12 weeks after (W20).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- The reference group | No intervention | –one will take care of the patient in a habitual way: no consultation additional, step of exam on top of that... |
| 2- The intervention group | Other | Other: Training and valuation of the treating personnelTraining and valuation of the treating personnel |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alzheimer disease
Key exclusion criteria (1 listed)
- Not alzheimer disease
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 |
|---|---|---|
| Training and valuation of the treating personnelTraining and valuation of the treating personnel | Other | 2- The intervention group |
Primary outcome
Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention
Time frame: 8 weeks after intervention
1 secondary outcome
Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention
Time frame: 16 weeks after intervention
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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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.
Philippe ROBERT, PhD principal investigator
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and valuation of the treating personnel in people with ALZHEIMER Disease, run by Centre Hospitalier Universitaire de Nice at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early. Results are not available in the source record.
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?
Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention (time frame: 8 weeks after intervention). 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 26 Mar 2012.