Alzheimer Disease or Associated Disorder Clinical Trial
— AIDALZOfficial 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
| Verified date | August 2017 |
| Source | Institut de Sante Publique, d'Epidemiologie et de Developpement |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | October 2, 2013 |
| Est. primary completion date | October 2, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Institutionalized patient - Patient on legal guardianship - Behavioural problem with important clinical repercussion - Psychotic syndrome - Severe and unstable general pathology |
| Country | Name | City | State |
|---|---|---|---|
| France | ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement) | Bordeaux |
| Lead Sponsor | Collaborator |
|---|---|
| Institut de Sante Publique, d'Epidemiologie et de Developpement |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NeuroPsychiatric Inventory (NPI) | Evaluation of frequency, severity and repercussion of several behavioural problems | 1 year | |
| Secondary | Cohen-Mansfield Agitation Inventory (CMAI) | 1 year | ||
| Secondary | Apathy Inventory | 1 year | ||
| Secondary | Disablement Assessment for Dementia (DAD) | 1 year | ||
| Secondary | Mini Mental State Examination (MMSE) | 1 year | ||
| Secondary | Global Deterioration Scale (GDS) | 1 year | ||
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) | 1 year | ||
| Secondary | Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) | 1 year | ||
| Secondary | Burden Interview of Zarit | 1 year | ||
| Secondary | Resource utilization in dementia scale (RUD Lite) | 1 year | ||
| Secondary | Medical Outcome Study Short Form 36-item health survey (MOS SF-36) | 1 year | ||
| Secondary | Institutionalization | 1 year | ||
| Secondary | Tiredness scale | 1 year |