Engaging Caregivers in Dementia Care

Engaging Caregivers in the Care of Veterans With Dementia

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Dementia Care Management

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center
Active Comparator: Dementia Care Management; CG education, continuous support, communication and coping skills training, and veteran monitoring, via CG report, of medication, symptoms, and service needs.	Behavioral: Dementia Care Management; 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.).; Other Names: Telehealth Education Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Memory and Behavior Problems Checklist (RMBPC)	Frequency of care recipient dementia-related behaviors and associated caregiver distress	Change in frequency and distress from baseline to 3 and 6 month follow-up
Neuropsychiatric Inventory Questionnaire (NPI-Q)	Frequency of care recipient neuropsychiatric symptoms and associated caregiver distress	Change in frequency and distress from baseline to 3 and 6 month follow-up
Zarit Burden Interview	Perceived caregiver burden	Change in burden from baseline to 3 and 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pearlin Stress and Coping Scale	Caregiver coping strategies	Change in coping skills from baseline to 3 and 6 month follow-up
Lawton Caregiving and Stress Process Scales	Caregiver mastery	Change in caregiver mastery from baseine to 3 and 6 month follow-up

Collaborators and Investigators

• Sponsor: Corporal Michael J. Crescenz VA Medical Center
• Investigators: Principal Investigator: Shahrzad Mavandadi, PhD, Corporal Michael J. Crescenz VA Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 01247