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Alzheimer's Disease Multiple Intervention Trial (ADMIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Regenstrief Institute, IU Center for Aging Research
Sponsor:
Collaborator:
Information provided by:
Regenstrief Institute, IU Center for Aging Research
ClinicalTrials.gov Identifier:
NCT01314950
First received: March 10, 2011
Last updated: August 16, 2011
Last verified: August 2011

March 10, 2011
August 16, 2011
July 2010
June 2015   (final data collection date for primary outcome measure)
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01314950 on ClinicalTrials.gov Archive Site
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • One Leg Stand, eyes open [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Mini Mental State Examination [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Word List Learning [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Delayed Word List Recall [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Grip Strength [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Cooperative Studies Resource Use Scale [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • PHQ - 9 [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    Depression
  • GAD - 7 [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    Anxiety
  • Comorbid Conditions [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Alzheimer's Disease Multiple Intervention Trial
Alzheimer's Disease Multiple Intervention Trial

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.
  • 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.
  • 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).
    Intervention: Behavioral: Best practices primary care
  • 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.
    Intervention: Behavioral: Home based occupational therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact: Carrie S Morris, MS, OTR 317-423-5639 cespangl@iupui.edu
United States
 
NCT01314950
R01 AG034946-01A1, R01AG034946-01A1
Yes
Christopher Callahan, MD, Indiana University School of Medicine
Regenstrief Institute, IU Center for Aging Research
National Institute on Aging (NIA)
Principal Investigator: Christopher M Callahan, MD Indiana University School of Medicine
Regenstrief Institute, IU Center for Aging Research
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP