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Completed

NCT Number: NCT01314950

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wishard Health Services

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home based occupational therapy

Behavioral

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.

Best practices primary care

Behavioral

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.

Primary outcomes

  1. Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI)

    Time frame: 24 months

Secondary outcomes

  1. 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

  2. Tandem Stand, eyes closed

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  3. One Leg Stand, eyes open

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  4. Mini Mental State Examination

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  5. Word List Learning

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  6. Delayed Word List Recall

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  7. Grip Strength

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  8. Neuropsychiatric Inventory (NPI)

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  9. Alzheimer's Disease Cooperative Studies Resource Use Scale

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  10. PHQ - 9

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

    Depression

  11. GAD - 7

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

    Anxiety

  12. Comorbid Conditions

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

  13. Adverse Events

    Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)
  • Regenstrief Institute, Inc.

Registry information

Acronym: ADMIT

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2011
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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