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AzTrials

Alzheimer's DiseaseNCT00246896

Care Management for Patients With Alzheimer Disease and Their Family Caregivers

A study testing care management in people with Alzheimer's Disease and Dementia, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Alzheimer's Disease, Dementia
What is being tested?
care management
How many people
220 participants
Where
1 siteUnited States
Study dates
Aug 2001to Aug 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Alzheimers Disease

Who cannot join

  • Inability to understand English
  • No telephone

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Program of Collaborative Care for Alzheimer Disease

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.

Being tested
care management
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • care managementBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychiatric Inventory

  2. Cornell Depression in Dementia Scale

  3. Activities of Daily Living

Secondary outcomes (2)
  1. Nursing home placement

  2. hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2005 (estimated)
  2. Study startAug 2001
  3. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
220 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00246896
Sponsor's protocol ID
R01HS010884
Status last verified
Oct 2005
First submitted
28 Oct 2005
Last updated
27 Jul 2006
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing care management in people with Alzheimer's Disease and Dementia, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychiatric Inventory. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00246896, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2006.

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