View Clinical Trial (Medical Research Study)
Alzheimer's Disease Multiple Intervention Trial
| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01314950 |
| Primary Contact: |
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Principal Investigator
Christopher M Callahan, MD
Indiana University School of Medicine
Carrie S Morris, MS, OTR
Phone: 317-423-5639
Email: cespangl@iupui.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Indianapolis, Indiana 46202
United States
Carrie S Morris, MS, OTR
Phone: 317-423-5639
Email: cespangl@iupui.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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