Nurse Managed Clinic for Dementia Patients and Family Caregivers

This study has been completed.
Sponsor:
Collaborator:
GRECC
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012831
First received: March 14, 2001
Last updated: August 1, 2012
Last verified: December 2005
  Purpose

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.


Condition
Alzheimer's Disease
Caregivers
Dementia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Nurse Managed Clinic for Dementia Patients and Family Caregivers

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 120
Study Completion Date: June 2001

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012831

Locations
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
GRECC
Investigators
Principal Investigator: Melitta K. Maddox, MSN Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012831     History of Changes
Other Study ID Numbers: NRI 95-143
Study First Received: March 14, 2001
Last Updated: August 1, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014