Effectiveness of Care Management in Alzheimer Patients (AIDALZ)

This study is currently recruiting participants.

Verified July 2011 by Institut de Sante Publique, d'Epidemiologie et de Developpement

Sponsor:

Information provided by:

Institut de Sante Publique, d'Epidemiologie et de Developpement

ClinicalTrials.gov Identifier:

NCT01081743

First received: March 4, 2010

Last updated: July 5, 2011

Last verified: July 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 4, 2010
Last Updated Date	July 5, 2011
Start Date ^ICMJE	November 2009
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2010)	NeuroPsychiatric Inventory (NPI) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Evaluation of frequency, severity and repercussion of several behavioural problems
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01081743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 4, 2010)	Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Apathy Inventory [ Time Frame: 1 year ] [ Designated as safety issue: No ] Disablement Assessment for Dementia (DAD) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Mini Mental State Examination (MMSE) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Global Deterioration Scale (GDS) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Questionnaire Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Burden Interview of Zarit [ Time Frame: 1 year ] [ Designated as safety issue: No ] Resource utilization in dementia scale (RUD Lite) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Medical Outcome Study Short Form 36-item health survey (MOS SF-36) [ Time Frame: 1 year ] [ Designated as safety issue: No ] Institutionalization [ Time Frame: 1 year ] [ Designated as safety issue: No ] Tiredness scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effectiveness of Care Management in Alzheimer Patients
Official Title ^ICMJE	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
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Alzheimer Disease or Associated Disorder Mild to Moderately Severe Dementia
Intervention ^ICMJE	Other: Intervention of the social worker Systematic home visits and regular follow-ups by phone from a social worker
Study Arm (s)	Experimental: Social worker Intervention: Other: Intervention of the social worker No Intervention: Control Control group is followed-up as usually (usual care)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	400
Estimated Completion Date	December 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01081743
Other Study ID Numbers ^ICMJE	RCB : 2009-A00326-51
Has Data Monitoring Committee	Yes
Responsible Party	DARTIGUES Jean-François/MD, PhD, ISPED
Study Sponsor ^ICMJE	Institut de Sante Publique, d'Epidemiologie et de Developpement
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Institut de Sante Publique, d'Epidemiologie et de Developpement
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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