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CompletedNCT00246896Updated Jul 27, 2006

Care Management for Patients With Alzheimer Disease and Their Family Caregivers

An interventional study of care management in Alzheimer's Disease and Dementia, sponsored by Agency for Healthcare Research and Quality (AHRQ). Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2006-07-27.

Sponsored by Agency for Healthcare Research and Quality (AHRQ) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Alzheimer's Disease
  • Dementia

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 220 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ) is the lead sponsor of 32 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Alzheimers Disease

Exclusion criteria

Exclusion Criteria:

  • Inability to understand English
  • No telephone
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
220 participants

Interventions

  • Behavioralcare management
06

What researchers measure

Primary outcomes

  1. Neuropsychiatric Inventory

  2. Cornell Depression in Dementia Scale

  3. Activities of Daily Living

Secondary outcomes

  1. Nursing home placement

  2. hospitalization

07

Study locations

1 site
  • Indiana University
    Indianapolis, Indiana 46202, United States
08

References and documents

Publications

  • 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. PubMed 16684985 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00246896
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
First posted
Nov 1, 2005
Start date
Aug 2001
Completion
Aug 2005
Last update
Jul 27, 2006

Study contacts

Christopher M. Callahan, M.D.
principal investigator · Indiana University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

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