Engaging Caregivers in Dementia Care

Dementia Clinical Trial

Official title:

Engaging Caregivers in the Care of Veterans With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552563
• Other study ID #: 01247
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: January 2014

Study information

• Verified date: September 2022
• Source: Corporal Michael J. Crescenz VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dementia

Intervention

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.).

Locations

Country	Name	City	State
United States	Philadelphia VA Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corporal Michael J. Crescenz VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Zarit Burden Interview	Perceived caregiver burden	Change in burden from baseline to 3 and 6 month follow-up
Secondary	Pearlin Stress and Coping Scale	Caregiver coping strategies	Change in coping skills from baseline to 3 and 6 month follow-up
Secondary	Lawton Caregiving and Stress Process Scales	Caregiver mastery	Change in caregiver mastery from baseine to 3 and 6 month follow-up