NCT02552563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

September 4, 2015

Last Update Submit

September 26, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Zarit Burden Interview

    Perceived caregiver burden

    Change in burden from baseline to 3 and 6 month follow-up

Secondary Outcomes (2)

  • Pearlin Stress and Coping Scale

    Change in coping skills from baseline to 3 and 6 month follow-up

  • Lawton Caregiving and Stress Process Scales

    Change in caregiver mastery from baseine to 3 and 6 month follow-up

Study Arms (2)

Usual Care

NO INTERVENTION

Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center

Dementia Care Management

ACTIVE COMPARATOR

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

Interventions

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.).

Also known as: Telehealth Education Program
Dementia Care Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Shahrzad Mavandadi, PhD

    Corporal Michael J. Crescenz VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Health Science Specialist

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 17, 2015

Study Start

February 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations