An interventional study of Home based occupational therapy and Best practices primary care in Alzheimer's Disease, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 180 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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Patient Inclusion Criteria:
Caregiver Inclusion Criteria
Exclusion Criteria:
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
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
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.
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.
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI)
Time frame: 24 months
Short Physical Performance Battery (SPPB)
Includes Side by Side Stand, Semi-Tandem Stand, Tandem Stand, Repeated Chair Stands, and 3 or 4 meter walk
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Tandem Stand, eyes closed
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
One Leg Stand, eyes open
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Mini Mental State Examination
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Word List Learning
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Delayed Word List Recall
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Grip Strength
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Neuropsychiatric Inventory (NPI)
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Alzheimer's Disease Cooperative Studies Resource Use Scale
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
PHQ - 9
Depression
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
GAD - 7
Anxiety
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Comorbid Conditions
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Adverse Events
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Indiana University