An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury
NCT ID: NCT04495686
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
171 participants
INTERVENTIONAL
2021-03-03
2025-09-30
Brief Summary
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Our project studies the benefits of telehealth as a new way for caregivers to receive coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support program delivered using telehealth (for example phones, tablets, computers). Caregivers of both Alzheimer's disease and TBI-related dementia will be included, and the program will be evaluated for effectiveness in both groups as well as in a control group. The information from our study will help improve quality of life for caregivers and individuals with dementia, including military members and Veterans. Our results will also help both civilian and military health professionals develop effective programs to support families living with dementia. Policy makers and organizational leaders can use the information to fund programs that best help families and communities facing dementia and TBI dementia.
Detailed Description
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An emergent body of research associates traumatic brain injury (TBI) with increased dementia risk. Veterans with a history of TBI are therefore at increased risk of developing dementia, putting their family members at risk for the established negative impacts of caregiving. Coordinated care programs have proven beneficial for both members of the dementia caregiving dyad, yet access barriers remain. Many caregivers have competing role responsibilities that conflict with consistent dementia care access, others are located in rural areas without access to specialized dementia care.
To surmount access barriers and countervail the negative impacts of caregiving, we propose an innovative, non-pharmacological intervention: a telehealth-delivered dementia care coordination program that provides family and caregiver support and will improve the quality of life (QoL) for both caregivers and PWD. A goal of our project is to fill an existing service gap by providing coordinated dementia care to an underserved population: caregivers of persons with TBI dementia.
Our study will test three primary hypotheses: 1) Caregivers of persons with dementia who participate in the telehealth care coordination program will experience greater improvements in study caregiver outcomes (depression, burden, reactions to BSD and QoL) than caregivers of PWD receiving best medical treatment (BMT); 2) Caregivers who participate in the program will experience greater satisfaction with care than caregivers in the BMT group; 3) The program will comparable benefits for caregivers of persons with Alzheimer's disease and related dementia (PWD-ADRD) and persons with TBI dementia (PWD-TBI).
In addition, our study includes three exploratory hypotheses: 1) Certain caregiver characteristics (external locus of control; lower self-efficacy, sense of hope, and self-perceived caregiver aptitude) will be negatively associated with improvements in caregiver study outcomes; 2) Caregivers in the intervention group will experience greater reductions in emergency/unnecessary health care utilization then caregivers in the BMT group; 3) The intervention will impart sustained caregiver benefits in primary study outcomes.
Project specific aims include: 1) Evaluate the benefits of a telehealth-delivered care coordination program intervention for caregivers of PWD relative to best medical treatment; 2) Evaluate the impact of the intervention on caregiver satisfaction; 3) Determine the comparative effectiveness of the care coordination program between caregivers of persons with ADRD those with TBI dementia; 4) Explore caregiver characteristics that influence intervention outcomes (burden, depression, QoL, responses to BSD); and 5) Investigate whether the intervention reduces emergency and unplanned health care utilization.
Our research strategy is a prospective, randomized, unblinded study investigating the benefits of a 12-month telehealth-delivered dementia care coordination intervention, with follow up assessments to examine the longevity of the intervention impacts. We will enroll 3 study groups: 50 caregivers of PWD-ADRD receiving the telehealth coordinated care intervention; 50 caregivers of PWD-ADRD receiving best medical treatment, and 25 caregivers of PWD-TBI receiving the intervention. We will collect baseline,12-, and 18-month data to examine intervention effectiveness on caregiver study outcomes and test the prolonged intervention effects.
Our study uses an innovative telehealth approach to provide care for families living with dementia. Family support has important implications at the individual, family, community, and national level. Strategies to reduce caregiver burden and improve QoL for civilian and military families can lead to greater satisfaction with care and prolong caregivers' capacity to keep their loved ones at home, reducing burdens on public payment systems, including the VA. Dissemination of study results will inform state and local policy and finance decisions that can help improve the lives of the growing population of persons with dementia or TBI dementia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Caregiver PWD-ADRD TCCI
Participants in the Caregiver PWD-ADRD telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.
Telehealth-delivered Care Coordination Program
Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs.
DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform.
Caregiver for PWD-ADRD (BMT)
Participants in the Caregiver PWD-ADRD best medical treatment (BMT) group will not receive care coordination.
No interventions assigned to this group
Caregiver for PWD-TBI TCCI
Participants in the Caregiver PWD-TBI telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.
Telehealth-delivered Care Coordination Program
Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs.
DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform.
Caregiver for PWD-TBI (BMT)
Participants in the Caregiver PWD-TBI best medical treatment (BMT) group will not receive care coordination.
No interventions assigned to this group
Interventions
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Telehealth-delivered Care Coordination Program
Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs.
DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform.
Eligibility Criteria
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Inclusion Criteria
* Self-identified primary caregiver for a community-dwelling patient with dementia (PWD)
* Must be an unpaid caregiver
* Basic spoken and written English language skills
* aged 55 years or older
* Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD)
* Mild to moderate dementia, including mixed dementia
* 0-1 appointments in the multi-disciplinary long-term University of Virginia (UVA) Memory Disorder follow-up clinic (MDC)
* aged 21 years or older
* Diagnosis of major neurocognitive disorder (MND), mild neurocognitive disorder, or Alzheimer's disease and related dementias (ADRD)
* Diagnosis of mild to moderate dementia, including mixed dementia
* Diagnosed with mild complicated, moderate or sever traumatic brain injury (TBI)
* TBI event at or after the age of brain maturity, ≥25 years of age
Exclusion Criteria
* Any condition which would make the caregiver, in the opinion of the investigator, unsuitable for the study
* No access to high-speed/broadband internet service capable of operating study teleconferencing software available
21 Years
ALL
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
University of Virginia
OTHER
Responsible Party
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Carol Manning
Harrison Distinguished Teaching Professor of Neurology, Vice Chair for Faculty Development, Director Memory Disorders Clinic
Principal Investigators
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Carol Manning, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Department of Neurology
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Gallagher VT, Reilly SE, Arp A, Rossetti A, Thompson R, Manning CA. Randomized clinical trial of the individualized coordination and empowerment for care partners of persons with dementia (ICECaP) intervention: impact on preparedness for caregiving. Aging Clin Exp Res. 2025 Mar 1;37(1):64. doi: 10.1007/s40520-025-02959-z.
Thompson RC, Gallagher VT, Reilly SE, Arp AM, Manning CA. Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP): Feasibility and acceptability. Contemp Clin Trials. 2025 Jan;148:107770. doi: 10.1016/j.cct.2024.107770. Epub 2024 Dec 2.
Gallagher VT, Arp A, Thompson R, Rossetti A, Patrie J, Reilly SE, Manning CA. Randomized Clinical Trial of ICECaP (Individualized Coordination and Empowerment for Care Partners of Persons with Dementia): Primary Mental Health and Burden Outcomes. medRxiv [Preprint]. 2024 Aug 16:2024.08.15.24312041. doi: 10.1101/2024.08.15.24312041.
Other Identifiers
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IRB-HSR #15372
Identifier Type: -
Identifier Source: org_study_id