Clinical trial NCT02552563: Engaging Caregivers in Dementia Care
Official title: Engaging Caregivers in the Care of Veterans With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2015-09-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Revised Memory and Behavior Problems Checklist (RMBPC)
timeFrame: Change in frequency and distress from baseline to 3 and 6 month follow-up
measure: Neuropsychiatric Inventory Questionnaire (NPI-Q)
timeFrame: Change in frequency and distress from baseline to 3 and 6 month follow-up
measure: Zarit Burden Interview
timeFrame: Change in burden from baseline to 3 and 6 month follow-up
Secondary outcomes:
measure: Pearlin Stress and Coping Scale
timeFrame: Change in coping skills from baseline to 3 and 6 month follow-up
measure: Lawton Caregiving and Stress Process Scales
timeFrame: Change in caregiver mastery from baseine to 3 and 6 month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center
name: Shahrzad Mavandadi, PhD
role: PRINCIPAL_INVESTIGATOR
References: