Engaging Caregivers in Dementia Care

September 26, 2022 updated by: Shahrzad Mavandadi, Corporal Michael J. Crescenz VA Medical Center

Engaging Caregivers in the Care of Veterans With Dementia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change in frequency and distress from baseline to 3 and 6 month follow-up
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
Change in frequency and distress from baseline to 3 and 6 month follow-up
Zarit Burden Interview
Time Frame: Change in burden from baseline to 3 and 6 month follow-up
Perceived caregiver burden
Change in burden from baseline to 3 and 6 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pearlin Stress and Coping Scale
Time Frame: Change in coping skills from baseline to 3 and 6 month follow-up
Caregiver coping strategies
Change in coping skills from baseline to 3 and 6 month follow-up
Lawton Caregiving and Stress Process Scales
Time Frame: Change in caregiver mastery from baseine to 3 and 6 month follow-up
Caregiver mastery
Change in caregiver mastery from baseine to 3 and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corporal Michael J. Crescenz VA Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shahrzad Mavandadi, PhD, Corporal Michael J. Crescenz VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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