Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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A unique multinational study was conducted simultaneously in the USA, England and Australia. The goals of the study were to answer two questions: Does psychosocial support for the family enhance the effectiveness of drug treatment for Alzheimer's disease? Is the added value of psychosocial support the same in all 3 countries?

Detailed Description
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This study is a single-blind prospective randomized trial with 150 patient/caregiver pairs (50 in each country). Eligibility criteria at baseline require that the primary caregiver is the spouse of the patient; the patient must have a diagnosis of AD, be in the in mild to moderate stage of dementia, be living with the caregiver, and be willing to take Donepezil (Aricept). These participants were randomly assigned to one of two groups: in one group, the intervention consists of drug treatment for the patient plus psychosocial intervention for the caregiver; in the other group the intervention consists solely of drug treatment for the patient. The intervention for the caregiver consists of 5 scheduled individual and family counseling sessions within 3 months of baseline, and unlimited consultations on request. Assessments were conducted every 3 months for the first year and every 6 months for a second year. There are 3 sources of data: an interview of the caregiver by an independent rater, an assessment of the patient, and a count of the amount of medication used. Thus we will be able to assess the effect of adding counseling to medication for the caregiver, for the patient, and on compliance with medication use.

Official Title
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Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease

Conditions
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Alzheimer Disease, Caregivers

Intervention / Treatment
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* Behavioral: Psychosocial information, counseling, and support
* Drug: Donepezil (Aricept)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers Exclusion Criteria: Severe psychological or physical illness Unwillingness by either spouse to participate in all aspects of the study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Psychosocial information, counseling, and support|nan|
|Drug: Donepezil (Aricept)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver: Changes in depression, measured with the Beck Depression Inventory |  | every 3 months for the first year, and every 6 months for the second year | 
| Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale |  | every 3 months for the first year, and every 6 months for the second year | 
| Patient: Changes in cognition measured by ADAS-cog |  | every 3 months for the first year, and every 6 months for the second year | 
| Patient: Changes in abilities with activities of daily living measured by ADCS-ADL |  | every 3 months for the first year, and every 6 months for the second year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery |  | every 3 months for the first year, and every 6 months for the second year | 
| Patient: Time to nursing home placement |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, Counseling