Effectiveness of Care Management in Alzheimer Patients (AIDALZ)
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|ClinicalTrials.gov Identifier: NCT01081743|
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : August 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease or Associated Disorder Mild to Moderately Severe Dementia||Other: Intervention of the social worker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||November 24, 2009|
|Actual Primary Completion Date :||October 2, 2013|
|Actual Study Completion Date :||October 2, 2013|
|Experimental: Social worker||
Other: Intervention of the social worker
Systematic home visits and regular follow-ups by phone from a social worker
No Intervention: Control
Control group is followed-up as usually (usual care)
- NeuroPsychiatric Inventory (NPI) [ Time Frame: 1 year ]Evaluation of frequency, severity and repercussion of several behavioural problems
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081743
|ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)|
|Bordeaux, France, 33076|