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
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Behavioral: Home based occupational therapy
Behavioral: Best practices primary care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alzheimer's Disease Multiple Intervention Trial

Resource links provided by NLM:


Further study details as provided by Regenstrief Institute, IU Center for Aging Research:

Primary Outcome Measures:
  • Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: July 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314950

Contacts
Contact: Carrie S Morris, MS, OTR 317-423-5639 cespangl@iupui.edu

Locations
United States, Indiana
Wishard Health Services Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Carrie S Morris, MS, OTR    317-423-5639    cespangl@iupui.edu   
Principal Investigator: Christopher M Callahan, MD         
Sponsors and Collaborators
Regenstrief Institute, IU Center for Aging Research
Investigators
Principal Investigator: Christopher M Callahan, MD Indiana University School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Callahan, MD, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT01314950     History of Changes
Other Study ID Numbers: R01 AG034946-01A1, R01AG034946-01A1
Study First Received: March 10, 2011
Last Updated: August 16, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014