Alzheimer's Disease Multiple Intervention Trial (ADMIT)
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|ClinicalTrials.gov Identifier: NCT01314950|
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Behavioral: Home based occupational therapy Behavioral: Best practices primary care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Alzheimer's Disease Multiple Intervention Trial|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Best practices primary care
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
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.
Experimental: Home based occupational therapy
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.
- Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) [ Time Frame: 24 months ]
- Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ]Includes Side by Side Stand, Semi-Tandem Stand, Tandem Stand, Repeated Chair Stands, and 3 or 4 meter walk
- 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 [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ]Depression
- GAD - 7 [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ]Anxiety
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314950
|United States, Indiana|
|Wishard Health Services|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Christopher M Callahan, MD||Indiana University School of Medicine|