Alzheimer's Disease Multiple Intervention Trial

NCT01314950 | Completed DMC

• 1 other identifier: R01AG034946-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (13)

• Short Physical Performance Battery (SPPB)

  Baseline, 6 months, 12 months, 18 months, and 24 months

• Tandem Stand, eyes closed

  Baseline, 6 months, 12 months, 18 months, and 24 months

• One Leg Stand, eyes open

  Baseline, 6 months, 12 months, 18 months, and 24 months

• Mini Mental State Examination

  Baseline, 6 months, 12 months, 18 months, and 24 months

• Word List Learning

  Baseline, 6 months, 12 months, 18 months, and 24 months

Study Arms (2)

Best practices primary care

ACTIVE COMPARATOR

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

Home based occupational therapy

EXPERIMENTAL

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

Interventions

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.

Home based occupational therapy

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.

Best practices primary care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age 18 or older
• English speaking
• Hear well enough to answer questions in person or by telephone
• Community-dwelling
• Willing to receive home visits

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator
• Regenstrief Institute, Inc.: collaborator

Study Sites (1)

Wishard Health Services

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

• 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.

  PMID: 16684985 BACKGROUND

• 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.

  PMID: 19689236 BACKGROUND

• 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.

  PMID: 15331812 BACKGROUND

• 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.

  PMID: 27893087 DERIVED

• 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.

  PMID: 22737979 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christopher M Callahan, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 15, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Locations

US (1)