Care Management for Patients With Alzheimer Disease and Their Family Caregivers

Sponsor
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00246896
Collaborator
(none)
220
1
48
4.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: care management
N/A

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
A Program of Collaborative Care for Alzheimer Disease
Study Start Date :
Aug 1, 2001
Study Completion Date :
Aug 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Neuropsychiatric Inventory []

  2. Cornell Depression in Dementia Scale []

  3. Activities of Daily Living []

Secondary Outcome Measures

  1. Nursing home placement []

  2. hospitalization []

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 0 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Alzheimers Disease
Exclusion Criteria:
  • Inability to understand English

  • No telephone

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Christopher M. Callahan, M.D., Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00246896
Other Study ID Numbers:
  • R01HS010884
First Posted:
Nov 1, 2005
Last Update Posted:
Jul 27, 2006
Last Verified:
Oct 1, 2005
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2006