Nurse Managed Clinic for Dementia Patients and Family Caregivers

Dementia Clinical Trial

Official title:

Nurse Managed Clinic for Dementia Patients and Family Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012831
• Other study ID #: NRI 95-143
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: June 2001

Study information

• Verified date: December 2005
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Caregivers
• Dementia

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	GRECC

Country where clinical trial is conducted

United States,