Alzheimer's Disease Multiple Intervention Trial
Alzheimer's Disease Multiple Intervention Trial
Overall Status:
Recruiting
Brief Description:
The purpose of this study is to conduct a 2-year, randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease. The trial will compare a control group receiving best practices primary care with an intervention group receiving best practices primary care plus a home-based occupational therapy intervention.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
45 Years | N/A | Both | No |
Inclusion Criteria:
- Current patient at Wishard Health Services in central Indiana
- Diagnosis of possible or probable Alzheimer's disease
- Age 45 or older
- English speaking
- Hearing adequate 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
- Live in Indianapolis metro area and are planning to continue care at a primary care clinic
Caregivers
- Age 18 or older
- English speaking
- Hearing adequate to answer questions in person or by telephone
- Community-dwelling
- Willing to receive home visits
Participants
Exclusion Criteria:
- Not a current patient at Wishard Health Services
- Non-English speaking
- Currently enrolled in another study
- Non-community dwelling or residing in a skilled nursing facility
Detailed Description:
The current study will test a home-based intervention designed to slow the rate of functional decline among older adults with Alzheimer's disease. A previous clinical trial demonstrated the effectiveness of collaborative primary care for older adults with Alzheimer's. In the prior trial, guideline-level medical care resulted in improved quality of care and improved behavioral and psychological symptoms over 1 year among patients and their caregivers. Despite significant differences among study groups on neuropsychiatric test scores, no significant difference in functional decline was found between groups. Both study groups experienced a significant decline in function over 18 months.
This study also builds on recently reported research that demonstrated the short-term efficacy of home-based occupational therapy among older adults with dementia. These trials showed that older adults with dementia, including Alzheimer's disease, can both participate in and benefit from occupational therapy-based interventions delivered in the home.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.7794767, -86.1700894 | Wishard Health Services | Indianapolis | Indiana | 46202 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Regenstrief Institute, IU Center for Aging Research |
Collaborator Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Christopher M Callahan, MD | Principal Investigator | Indiana University School of Medicine |
Study Contact:
| Name | Phone | |
|---|---|---|
Carrie S. Morris, MS, OTR | 317-423-5639 |
Locations
ClinicalTrials.gov ID
NCT01314950 (follow link to view full record on ct.gov in new window)
Official Title:
Alzheimer's Disease Multiple Intervention Trial
Study Start Date:
July 2010
Study End Date:
June 2015
Enrollment:
180
Trial References:
