Alzheimer's Disease Multiple Intervention Trial (ADMIT)

Indiana University

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Behavioral: Home based occupational therapy; Behavioral: Best practices primary care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01314950

R01AG034946-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.

Full description

The proposed study builds on our findings from a previous clinical trial that demonstrated the effectiveness of collaborative care for older adults with Alzheimer's disease cared for in primary care practices. In the prior trial, we demonstrated that guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over one year among patients and their caregivers. However, despite finding significant differences among study groups on Neuropsychiatric Inventory scores, we did not find a significant difference between groups in functional decline. Both study groups experienced a significant decline in function over 18 months. The current study proposes to test a home-based intervention specifically designed to slow the rate of functional decline among older adults with Alzheimer's disease.

In addition to building on our past research, the study also builds from recently reported research which demonstrated the short-term efficacy of home-based occupational therapy interventions among older adults with dementia. These trials show that older adults with dementia, including Alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home.

The specific aim of this study is to conduct a two-year, randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention. We will test the primary hypothesis that subjects with Alzheimer's disease in the intervention group will have improved function at two years compared with the best practice primary care control group.

Enrollment: 180 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

• Currently a patient within Wishard Health Services in Central Indiana
• Diagnosed with possible or probable Alzheimer's Disease
• Age 45 or older
• English speaking
• Hear well enough to answer questions in person or by telephone
• Community-dwelling (includes senior communities, but not skilled nursing facilities)
• Caregiver willing to participate in the study
• Willing to receive home visits
• Lives in Indianapolis metro area and planning to continue care at primary care clinic

Caregiver Inclusion Criteria

• Age 18 or older
• English speaking
• Hear well enough to answer questions in person or by telephone
• Community-dwelling
• Willing to receive home visits

Exclusion Criteria:

• Not a current patient within Wishard Health Services
• Does not speak English
• Currently enrolled in another study
• Non-community dwelling, or residing in a skilled nursing facility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Best practices primary care

Active Comparator group

Description:

Best practices primary care encompasses the collaborative care intervention tested in a prior clinical trial (Callahan CM et al. JAMA 2006).

Treatment:

Behavioral: Best practices primary care

Home based occupational therapy

Experimental group

Description:

The intervention group receives all of the components of best practice primary care in addition to a home-based intervention designed to slow functional decline.

Treatment:

Behavioral: Home based occupational therapy