Engaging Caregivers in Dementia Care

Sponsor

Corporal Michael J. Crescenz VA Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02552563

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2011

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Revised Memory and Behavior Problems Checklist (RMBPC) [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) [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 [Change in burden from baseline to 3 and 6 month follow-up]
Perceived caregiver burden

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Philadelphia VA Medical Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Corporal Michael J. Crescenz VA Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Corporal Michael J. Crescenz VA Medical Center

ClinicalTrials.gov Identifier:

NCT02552563

Other Study ID Numbers:

01247

First Posted:

Sep 17, 2015

Last Update Posted:

Sep 17, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Sep 17, 2015