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Engaging Caregivers in Dementia Care

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

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Dementia Care Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Engaging Caregivers in the Care of Veterans With Dementia
Study Start Date : February 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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 Name: Telehealth Education Program

Primary Outcome Measures :
  1. 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

  2. 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

  3. Zarit Burden Interview [ Time Frame: Change in burden from baseline to 3 and 6 month follow-up ]
    Perceived caregiver burden

Secondary Outcome Measures :
  1. Pearlin Stress and Coping Scale [ Time Frame: Change in coping skills from baseline to 3 and 6 month follow-up ]
    Caregiver coping strategies

  2. Lawton Caregiving and Stress Process Scales [ Time Frame: Change in caregiver mastery from baseine to 3 and 6 month follow-up ]
    Caregiver mastery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552563

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United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Corporal Michael J. Crescenz VA Medical Center
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Principal Investigator: Shahrzad Mavandadi, PhD Corporal Michael J. Crescenz VA Medical Center
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Responsible Party: Shahrzad Mavandadi, Research Health Science Specialist, Corporal Michael J. Crescenz VA Medical Center
ClinicalTrials.gov Identifier: NCT02552563    
Other Study ID Numbers: 01247
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders