Clinical trial NCT01314950: Alzheimer's Disease Multiple Intervention Trial
Official title: Alzheimer's Disease Multiple Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Regenstrief Institute, Inc.
First posted: 2011-03-15
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI)
timeFrame: 24 months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Tandem Stand, eyes closed
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: One Leg Stand, eyes open
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Mini Mental State Examination
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Word List Learning
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Delayed Word List Recall
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Grip Strength
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Alzheimer's Disease Cooperative Studies Resource Use Scale
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: PHQ - 9
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: GAD - 7
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Comorbid Conditions
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Adverse Events
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Wishard Health Services
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Christopher M Callahan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.
citation: Callahan CM, Boustani M, Sachs GA, Hendrie HC. Integrating care for older adults with cognitive impairment. Curr Alzheimer Res. 2009 Aug;6(4):368-74. doi: 10.2174/156720509788929228.
citation: Guerriero Austrom M, Damush TM, Hartwell CW, Perkins T, Unverzagt F, Boustani M, Hendrie HC, Callahan CM. Development and implementation of nonpharmacologic protocols for the management of patients with Alzheimer's disease and their families in a multiracial primary care setting. Gerontologist. 2004 Aug;44(4):548-53. doi: 10.1093/geront/44.4.548.
citation: Callahan CM, Boustani MA, Schmid AA, LaMantia MA, Austrom MG, Miller DK, Gao S, Ferguson DY, Lane KA, Hendrie HC. Targeting Functional Decline in Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2017 Feb 7;166(3):164-171. doi: 10.7326/M16-0830. Epub 2016 Nov 22.
citation: Callahan CM, Boustani MA, Schmid AA, Austrom MG, Miller DK, Gao S, Morris CS, Vogel M, Hendrie HC. Alzheimer's disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial. Trials. 2012 Jun 27;13:92. doi: 10.1186/1745-6215-13-92.