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Alzheimer's DiseaseNCT00012831

Nurse Managed Clinic for Dementia Patients and Family Caregivers

An observational study of Alzheimer's Disease and Caregivers, run by US Department of Veterans Affairs 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 study evaluates the effectiveness of a nurse-managed interdisciplinary (nursing and occupational therapy) clinic serving community dwelling dementia patients and their spouse caregivers. Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Alzheimer's Disease, Caregivers, Dementia
How many people
120 participants
Where
1 siteUnited States
Study dates
Start not givento Jun 2001
Phase
Observational
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects are veterans with a diagnosis of Alzheimer's Disease, cared for in their homes by spouse caregivers.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417

Other trials in United States

About this study

This study evaluates the effectiveness of a nurse-managed interdisciplinary (nursing and occupational therapy) clinic serving community dwelling dementia patients and their spouse caregivers. It is grounded in a nursing self-care model that guides nurses to identify interventions that fit with the capabilities of individual patients and compensate for their specific deficits. The occupational therapy assessment uses the Allen Cognitive Levels that identify the abilities and deficits of a particular functional level so that the strategies and approaches taught to caregivers can be tailored to the specific needs of the patient.

Read the detailed description

Background:

This study evaluates the effectiveness of a nurse-managed interdisciplinary (nursing and occupational therapy) clinic serving community dwelling dementia patients and their spouse caregivers. It is grounded in a nursing self-care model that guides nurses to identify interventions that fit with the capabilities of individual patients and compensate for their specific deficits. The occupational therapy assessment uses the Allen Cognitive Levels that identify the abilities and deficits of a particular functional level so that the strategies and approaches taught to caregivers can be tailored to the specific needs of the patient.

Objectives:

The ultimate objective of the study is to increase caregiver competence, maintain optimal function of dementia patients, and show that this nurse managed clinical model can improve the quality of life for both the Alzheimer patients and their caregivers in a cost-effective manner.

Methods:

The study is being conducted as a block design, randomized trial of the Dementia Care Clinic (DCC) compared with the standard interdisciplinary GRECC care. A total of 120 dementia patient/spouse caregiver dyads will be enrolled in the study. Twelve dyads are enrolled in each seven-week block during which a clinic visit and four weekly caregiver education sessions are held for each of the two cohort groups. Follow up clinic visits are made at six months and one year. Data collection interviews are conducted before the first clinic visit, and at three, six, and twelve months. Patient depressed mood is measured by the Yesavage Geriatric Depression Scale (GDS). The Revised Memory and Behavior Problems Checklist is used to measure patient behavior changes and the effect of the behaviors on the caregiver. Positive and negative effects of caregiving are measured by the Zarit Burden Interview, the Center of Epidemiological Studies Depression Scale (CES-D), Phillips Beliefs about Caregiving Scale, and brief scales of perceived mastery, preparedness, and competence in caregiving.

The project will employ multiple independent repeated measures analyses of covariance (RMANCOVA) in which pre-intervention levels of the dependent measures under consideration will be controlled as covariates. Group x time interaction effects will also be examined to test for changing effects of the intervention over the study period. Multiple regression analyses will be used to examine the relationship of cost data to subject and experimental factors.

Status:

Recruitment was completed for the study in 2000. Each cohort of patients and their spouse caregivers have been followed for one year. Baseline data is being analyzed and portions have been presented at recent conferences. Study data is currently being analyzed and analysis is scheduled for completion in December of 2001.

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.

Study groups in NCT00012831
Study groupRoleWhat they receive
Group 1Not described

Timeline

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

  1. First posted16 Mar 2001 (estimated)
  2. Study completionJun 2001

Resources

More details

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

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00012831
Sponsor's protocol ID
NRI 95-143
Status last verified
Dec 2005
First submitted
14 Mar 2001
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease and Caregivers, run by US Department of Veterans Affairs 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 0 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 7 Apr 2015. 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.

Where can I read the original study information?
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 7 Apr 2015.

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