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Care Management for Patients With Alzheimer Disease and Their Family Caregivers

Primary Purpose

Alzheimer's Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
care management
Sponsored by
Agency for Healthcare Research and Quality (AHRQ)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Alzheimers Disease Exclusion Criteria: Inability to understand English No telephone

Sites / Locations

  • Indiana University

Outcomes

Primary Outcome Measures

Neuropsychiatric Inventory
Cornell Depression in Dementia Scale
Activities of Daily Living

Secondary Outcome Measures

Nursing home placement
hospitalization

Full Information

First Posted
October 28, 2005
Last Updated
July 26, 2006
Sponsor
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00246896
Brief Title
Care Management for Patients With Alzheimer Disease and Their Family Caregivers
Official Title
A Program of Collaborative Care for Alzheimer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

5. Study Description

Brief Summary
This is a clinical trial to test the effectiveness of current guideline for the care of older adults with Alzheimer's disease. The study focuses on the primary care setting using a nurse care manager to facilitate guideline-level care. We are hypothesizing that patients who receive guideline-level care will have fewer behavioral problems than those who receive the usual care provided in primary care settings
Detailed Description
The specific aim of this proposal is to conduct a four-year randomized controlled clinical trial to test the efficacy of an integrated program of collaborative care as compared to usual care in improving the process and outcomes of care for older adults with dementia in a primary care setting. The program involves three primary components: (1) A comprehensive screening and diagnosis program in which all older adults aged 65 and older from Wishard's Community Health Centers will be screened for dementia. Patients with evidence of dementia will receive further evaluation to determine an explicit diagnosis. Roudebush VA Medical Center patients aged 65 and older with a diagnosis of dementia will receive further evaluation to determine an explicit diagnosis. (2) A multidisciplinary team approach to care for patients with dementia. This care will be coordinated through a geriatric nurse practitioner or a clinical nurse specialist working in the primary care clinic. The team includes primary care and specialist physicians, psychologist, other health care workers, and relevant social service agencies working to adhere to recommended standards of care for primary care patients with dementia. (3) A proactive longitudinal tracking program in which objective measures of process and outcomes of care are fed back to the collaborative care team so that appropriate changes in the course of therapy can be undertaken. Although authoritative guidelines for the care of patients with Alzheimer Disease and related disorders have been published, there are no clinical trials that test the impact of close adherence to these guidelines on the outcomes of care for a group of vulnerable older adults in an urban primary care setting. We are hypothesizing that patients with dementia and their caregivers who are exposed to this program will: (1) be more likely to receive the emerging standard of care for dementia, including an explicit diagnosis of dementia and an appropriate level of evaluation, education, and management; (2) be less impaired by psychopathology and behavior disturbances; (3) be less functionally impaired at 1-year and 2-year follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
care management
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory
Title
Cornell Depression in Dementia Scale
Title
Activities of Daily Living
Secondary Outcome Measure Information:
Title
Nursing home placement
Title
hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Alzheimers Disease Exclusion Criteria: Inability to understand English No telephone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M. Callahan, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16684985
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.
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Care Management for Patients With Alzheimer Disease and Their Family Caregivers

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