Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012831
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Nurse Managed Clinic for Dementia Patients and Family Caregivers
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Nurse Managed Clinic for Dementia Patients and Family Caregivers
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patientspouse 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
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 patientspouse 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None