Engaging Caregivers in Dementia Care

• ClinicalTrials.gov Identifier: NCT02552563
• Recruitment Status: Completed
• First Posted: September 17, 2015
• Last Update Posted: September 28, 2022
• Sponsor: Corporal Michael J. Crescenz VA Medical Center
• Information provided by (Responsible Party): Shahrzad Mavandadi, Corporal Michael J. Crescenz VA Medical Center

Tracking Information

• First Submitted Date: September 4, 2015
• First Posted Date: September 17, 2015
• Last Update Posted Date: September 28, 2022
• Study Start Date: February 2011
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2015)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 15, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Engaging Caregivers in Dementia Care
• Official Title: Engaging Caregivers in the Care of Veterans With Dementia
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: 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.).

Other Name: Telehealth Education Program

Study Arms

• 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.
  Intervention: Behavioral: Dementia Care Management

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 15, 2015): 75
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02552563
• Other Study ID Numbers: 01247
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Shahrzad Mavandadi, Corporal Michael J. Crescenz VA Medical Center
• Original Responsible Party: Corporal Michael J. Crescenz VA Medical Center
• Current Study Sponsor: Corporal Michael J. Crescenz VA Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Corporal Michael J. Crescenz VA Medical Center
• Verification Date: September 2022