Clinical trial NCT00467766: Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
Official title: Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Caregivers
Keywords: dementia
Counseling
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2007-05-01
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver: Changes in depression, measured with the Beck Depression Inventory
timeFrame: every 3 months for the first year, and every 6 months for the second year
measure: Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale
timeFrame: every 3 months for the first year, and every 6 months for the second year
measure: Patient: Changes in cognition measured by ADAS-cog
timeFrame: every 3 months for the first year, and every 6 months for the second year
measure: Patient: Changes in abilities with activities of daily living measured by ADCS-ADL
timeFrame: every 3 months for the first year, and every 6 months for the second year
Secondary outcomes:
measure: Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery
timeFrame: every 3 months for the first year, and every 6 months for the second year
measure: Patient: Time to nursing home placement
Other outcomes:
Locations:
city: New York
country: United States
facility: Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine
state: New York
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Manchester
country: United Kingdom
facility: University of Manchester, Division of Psychiatry
Study officials:
affiliation: NYU School of Medicine
name: Mary S. Mittelman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mittelman MS, Haley WE, Clay OJ, Roth DL. Improving caregiver well-being delays nursing home placement of patients with Alzheimer disease. Neurology. 2006 Nov 14;67(9):1592-9. doi: 10.1212/01.wnl.0000242727.81172.91.
citation: Mittelman MS, Roth DL, Coon DW, Haley WE. Sustained benefit of supportive intervention for depressive symptoms in caregivers of patients with Alzheimer's disease. Am J Psychiatry. 2004 May;161(5):850-6. doi: 10.1176/appi.ajp.161.5.850.
citation: Jang Y, Clay OJ, Roth DL, Haley WE, Mittelman MS. Neuroticism and longitudinal change in caregiver depression: impact of a spouse-caregiver intervention program. Gerontologist. 2004 Jun;44(3):311-7. doi: 10.1093/geront/44.3.311.
citation: Roth DL, Mittelman MS, Clay OJ, Madan A, Haley WE. Changes in social support as mediators of the impact of a psychosocial intervention for spouse caregivers of persons with Alzheimer's disease. Psychol Aging. 2005 Dec;20(4):634-44. doi: 10.1037/0882-7974.20.4.634.