Care Management for Patients With Alzheimer Disease and Their Family Caregivers
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ClinicalTrials.gov Identifier: NCT00246896 |
Recruitment Status
:
Completed
First Posted
: November 1, 2005
Last Update Posted
: July 27, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Dementia | Behavioral: care management | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 220 participants |
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 : | August 2001 |
Study Completion Date : | August 2005 |

- Neuropsychiatric Inventory
- Cornell Depression in Dementia Scale
- Activities of Daily Living
- Nursing home placement
- hospitalization

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Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Alzheimers Disease
Exclusion Criteria:
- Inability to understand English
- No telephone

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246896
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Christopher M. Callahan, M.D. | Indiana University |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00246896 History of Changes |
Other Study ID Numbers: |
R01HS010884 ( U.S. AHRQ Grant/Contract ) |
First Posted: | November 1, 2005 Key Record Dates |
Last Update Posted: | July 27, 2006 |
Last Verified: | October 2005 |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |