Alzheimer Disease or Associated DisorderAIDALZNCT01081743
Effectiveness of Care Management in Alzheimer Patients
A study testing Intervention of the social worker in people with Alzheimer Disease or Associated Disorder and Mild to Moderately Severe Dementia, run by Institut de Sante Publique, d'Epidemiologie et de Developpement at 1 site in France.
Trial summary
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease or Associated Disorder, Mild to Moderately Severe Dementia
- What is being tested?
- Intervention of the social worker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2009to 2 Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Alzheimer's Disease or other dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] criteria of dementia)
- Presence of an informal caregiver
- Mild to moderately severe dementia (MMSE [10-28])
- Diagnosis of dementia made by a specialist ≤ 6 months
- Patient affiliated to the national health insurance system
Who cannot join
- Institutionalized patient
- Patient on legal guardianship
- Behavioural problem with important clinical repercussion
- Psychotic syndrome
- Severe and unstable general pathology
Trial locations and contacts
1 site in 1 country.
France1 site
ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)
Bordeaux, 33076
About this study
Official title: Evaluation de la Mise en Place d'un Auxiliaire d'évaluation Dans la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées en France
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.
Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.
Read more
Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.
Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.
Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.
- Being tested
- Intervention of the social worker
- Keywords
- Alzheimer, Dementia, Mild to moderately severe, New diagnosis, Prevention of behavioural problems
- 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.
Intervention of the social workerOther
Systematic home visits and regular follow-ups by phone from a social worker
| Study group | Role | What they receive |
|---|---|---|
| Social worker | Experimental | Not described Receives: Other: Intervention of the social worker |
| Control | No intervention | Control group is followed-up as usually (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NeuroPsychiatric Inventory (NPI)
Evaluation of frequency, severity and repercussion of several behavioural problems
Measured: 1 year
Secondary outcomes (12)
Cohen-Mansfield Agitation Inventory (CMAI)
Measured: 1 year
Apathy Inventory
Measured: 1 year
Disablement Assessment for Dementia (DAD)
Measured: 1 year
Mini Mental State Examination (MMSE)
Measured: 1 year
Global Deterioration Scale (GDS)
Measured: 1 year
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 1 year
Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD)
Measured: 1 year
Burden Interview of Zarit
Measured: 1 year
Resource utilization in dementia scale (RUD Lite)
Measured: 1 year
Medical Outcome Study Short Form 36-item health survey (MOS SF-36)
Measured: 1 year
Institutionalization
Measured: 1 year
Tiredness scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study start24 Nov 2009
- Primary completion2 Oct 2013
- Study completion2 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease or Associated DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Sante Publique, d'Epidemiologie et de Developpement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081743
- Sponsor's protocol ID
- RCB : 2009-A00326-51
- Acronym
- AIDALZ
- Status last verified
- Aug 2017
- First submitted
- 4 Mar 2010
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de la Mise en Place d'un Auxiliaire d'évaluation Dans la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées en France
- ClinicalTrials.gov ID
- NCT01081743
- Acronym / sponsor ID
- AIDALZ / RCB : 2009-A00326-51
- Keywords
- Alzheimer, Dementia, Mild to moderately severe, New diagnosis, Prevention of behavioural problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Institut de Sante Publique, d'Epidemiologie et de DeveloppementUniversity, hospital or other
- Study start
- 24 Nov 2009 (actual)
- Primary completion
- 2 Oct 2013 (actual)
- Study completion
- 2 Oct 2013 (actual)
- First posted
- 5 Mar 2010 (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.
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.
Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.
Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.
Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.
Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social worker | Experimental | Other: Intervention of the social worker |
| Control | No intervention | –Control group is followed-up as usually (usual care) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Alzheimer's Disease or other dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] criteria of dementia)
- Presence of an informal caregiver
- Mild to moderately severe dementia (MMSE [10-28])
- Diagnosis of dementia made by a specialist ≤ 6 months
- Patient affiliated to the national health insurance system
Key exclusion criteria (5 listed)
- Institutionalized patient
- Patient on legal guardianship
- Behavioural problem with important clinical repercussion
- Psychotic syndrome
- Severe and unstable general pathology
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 |
|---|---|---|
| Intervention of the social workerSystematic home visits and regular follow-ups by phone from a social worker | Other | Social worker |
Primary outcome
NeuroPsychiatric Inventory (NPI)
Time frame: 1 year
Evaluation of frequency, severity and repercussion of several behavioural problems
12 secondary outcomes
Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: 1 year
Apathy Inventory
Time frame: 1 year
Disablement Assessment for Dementia (DAD)
Time frame: 1 year
Mini Mental State Examination (MMSE)
Time frame: 1 year
Global Deterioration Scale (GDS)
Time frame: 1 year
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 1 year
Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD)
Time frame: 1 year
Burden Interview of Zarit
Time frame: 1 year
Resource utilization in dementia scale (RUD Lite)
Time frame: 1 year
Medical Outcome Study Short Form 36-item health survey (MOS SF-36)
Time frame: 1 year
Institutionalization
Time frame: 1 year
Tiredness scale
Time frame: 1 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 28 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention of the social worker in people with Alzheimer Disease or Associated Disorder and Mild to Moderately Severe Dementia, run by Institut de Sante Publique, d'Epidemiologie et de Developpement 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 5 inclusion and 5 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 28 Aug 2017. 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 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) (time frame: 1 year). 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 28 Aug 2017.