Alzheimer's Disease Multiple Intervention Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Alzheimer's Disease Multiple Intervention Trial

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Home based occupational therapy
* Behavioral: Best practices primary care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best practices primary care<br>Best practices primary care encompasses the collaborative care intervention tested in a prior clinical trial (Callahan CM et al. JAMA 2006). | Behavioral: Best practices primary care<br>* Collaborative care is provided by an advanced practice nurse working in collaborations with a family caregiver, the primary care physician, and geriatric medicine specialists. Caregivers complete a formal assessment of problematic behaviors to assess current symptoms and stressors, and the care manager makes recommendations based on these results and using standardized protocols. Protocols focus first on non-pharmacologic interventions. If these interventions fail, the care manager collaborates with the primary care physician and/or specialists to institute protocol-based drug therapy or other strategies. Patients and caregivers are also offered access to support groups.<br>|
| Experimental: Home based occupational therapy<br>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. | Behavioral: Home based occupational therapy<br>* An occupational therapist (OT) will deliver the home-based intervention. There are three cycles of intervention over two years, with each cycle delivering eight 60-90 minute home sessions. Cycle one takes place over 16 weeks, cycle two over 32 weeks, and cycle three over one year. Telephone calls take place in intervening weeks, with additional phone calls allowed to assist with problem solving and interval problems. At minimum, the OT will perform an assessment at the beginning of each cycle in order to tailor the home based component for individual dyads at each cycle. The OT will collaborate with the patients and caregivers to develop client centered goals with homework each week in order to encourage carryover of strategies, home environmental modifications, or home exercise programs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | Includes Side by Side Stand, Semi-Tandem Stand, Tandem Stand, Repeated Chair Stands, and 3 or 4 meter walk | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Tandem Stand, eyes closed |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| One Leg Stand, eyes open |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Mini Mental State Examination |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Word List Learning |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Delayed Word List Recall |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Grip Strength |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Neuropsychiatric Inventory (NPI) |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Alzheimer's Disease Cooperative Studies Resource Use Scale |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| PHQ - 9 | Depression | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| GAD - 7 | Anxiety | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Comorbid Conditions |  | Baseline, 6 months, 12 months, 18 months, and 24 months | 
| Adverse Events |  | Baseline, 6 months, 12 months, 18 months, and 24 months |