Alzheimer's Disease Multiple Intervention Trial

Alzheimer's Disease Clinical Trial

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Official title:

Alzheimer's Disease Multiple Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314950
• Other study ID #: R01AG034946-01A1
• Secondary ID: R01AG034946-01A1
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: March 7, 2016
• Start date: July 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wishard Health Services	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA), Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI)		24 months	No
Secondary	Short Physical Performance Battery (SPPB)	Includes Side by Side Stand, Semi-Tandem Stand, Tandem Stand, Repeated Chair Stands, and 3 or 4 meter walk	Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Tandem Stand, eyes closed		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	One Leg Stand, eyes open		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Mini Mental State Examination		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Word List Learning		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Delayed Word List Recall		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Grip Strength		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Neuropsychiatric Inventory (NPI)		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Alzheimer's Disease Cooperative Studies Resource Use Scale		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	PHQ - 9	Depression	Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	GAD - 7	Anxiety	Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Comorbid Conditions		Baseline, 6 months, 12 months, 18 months, and 24 months	No
Secondary	Adverse Events		Baseline, 6 months, 12 months, 18 months, and 24 months	Yes