Engaging Caregivers in Dementia Care
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dementia Care Management
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
Eligibility Criteria
Inclusion Criteria:
- Patient and caregiver 18 years of age or older
- Patient is community dwelling
- Patient has a confirmed dementia diagnosis and/or significant cognitive impairment (per provider or CG report) that is verified upon the RA's cognitive screening assessment (per veteran (BOMC, score of 16 or above) or informant (AD8, score of 2 or above) and/or chart review
- CG lives with and/or provides care for the patient for an average of at least 4 hours per day.
- Veteran provides assent to contact his/her representative to pursue study participation
- Veteran representative as caregiver is willing and able to provide informed consent
Exclusion Criteria:
- Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)
Sites / Locations
- Philadelphia VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
Dementia Care Management
Arm Description
Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center
CG education, continuous support, communication and coping skills training, and veteran monitoring, via CG report, of medication, symptoms, and service needs.
Outcomes
Primary Outcome Measures
Revised Memory and Behavior Problems Checklist (RMBPC)
Frequency of care recipient dementia-related behaviors and associated caregiver distress
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Frequency of care recipient neuropsychiatric symptoms and associated caregiver distress
Zarit Burden Interview
Perceived caregiver burden
Secondary Outcome Measures
Pearlin Stress and Coping Scale
Caregiver coping strategies
Lawton Caregiving and Stress Process Scales
Caregiver mastery
Full Information
NCT ID
NCT02552563
First Posted
September 4, 2015
Last Updated
September 26, 2022
Sponsor
Corporal Michael J. Crescenz VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02552563
Brief Title
Engaging Caregivers in Dementia Care
Official Title
Engaging Caregivers in the Care of Veterans With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study seeks to examine the extent to which, relative to usual care, a dementia care management program for veterans and their caregivers (CGs)improves patient (e.g., behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden, affect) outcomes.
Detailed Description
Dementia care guidelines and pharmacological and non-pharmacological treatments have been shown to reduce symptom burden and rates of institutionalization for individuals with dementia. However, there remain a variety of factors that complicate dementia care management in primary care settings. Patient-centered, integrated care management programs that involve caregiver (CG) education and psychosocial support may help facilitate access to and use of services and improve outcomes. The aims of this pilot were to examine 1) whether, relative to usual care (UC), a dementia care management program is associated with improved CG (e.g., mastery, burden, affect) and patient (e.g., behavioral symptoms) outcomes, 2) if, relative to UC, participants enrolled in the program have greater perceived access to and use of medical, social, and community/VA services, and 3) whether the dementia care management program is feasible and acceptable to participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center
Arm Title
Dementia Care Management
Arm Type
Active Comparator
Arm Description
CG education, continuous support, communication and coping skills training, and veteran monitoring, via CG report, of medication, symptoms, and service needs.
Intervention Type
Behavioral
Intervention Name(s)
Dementia Care Management
Other Intervention Name(s)
Telehealth Education Program
Intervention Description
The intervention involves two main components. The first component includes individualized dementia care management that involves regular and extended contact between the CG, care manager, and when appropriate, Veteran's primary care provider (PCP). The care manager monitors Veterans' symptoms via CG report, provides psychoeducation and support to CGs, influences adherence to guidelines by providing timely and tailored information to PCPs, and suggests appropriate care strategies and service referrals. The second major component is the Telehealth Education Program (TEP). For this pilot study, the program was modified for use with individual CGs and was formatted so that CGs could select from a menu of up to 7 modules covering various content areas evaluated during the course of the care management assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, long-term planning, etc.).
Primary Outcome Measure Information:
Title
Revised Memory and Behavior Problems Checklist (RMBPC)
Description
Frequency of care recipient dementia-related behaviors and associated caregiver distress
Time Frame
Change in frequency and distress from baseline to 3 and 6 month follow-up
Title
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Description
Frequency of care recipient neuropsychiatric symptoms and associated caregiver distress
Time Frame
Change in frequency and distress from baseline to 3 and 6 month follow-up
Title
Zarit Burden Interview
Description
Perceived caregiver burden
Time Frame
Change in burden from baseline to 3 and 6 month follow-up
Secondary Outcome Measure Information:
Title
Pearlin Stress and Coping Scale
Description
Caregiver coping strategies
Time Frame
Change in coping skills from baseline to 3 and 6 month follow-up
Title
Lawton Caregiving and Stress Process Scales
Description
Caregiver mastery
Time Frame
Change in caregiver mastery from baseine to 3 and 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient and caregiver 18 years of age or older
Patient is community dwelling
Patient has a confirmed dementia diagnosis and/or significant cognitive impairment (per provider or CG report) that is verified upon the RA's cognitive screening assessment (per veteran (BOMC, score of 16 or above) or informant (AD8, score of 2 or above) and/or chart review
CG lives with and/or provides care for the patient for an average of at least 4 hours per day.
Veteran provides assent to contact his/her representative to pursue study participation
Veteran representative as caregiver is willing and able to provide informed consent
Exclusion Criteria:
Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahrzad Mavandadi, PhD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Engaging Caregivers in Dementia Care
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