Clinical trial NCT04495686: An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury
Official title: An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia, Mixed
Dementia Mild
Dementia Moderate
Traumatic Brain Injury
Alzheimer Disease
Keywords: dementia
traumatic brain injury
caregiver
alzheimers
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2020-08-03
Enrollment: 171
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There are an increasing number of people in the U.S. with Alzheimer's disease and other dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military personnel, and TBIs increase a person's risk for dementia. Providing care for a person with dementia is stressful. Dementia caregivers can experience difficulties including stress, depression, and reduced quality of life. Coordinated dementia care is known to benefit people with dementia and their caregivers. However, many caregivers do not have access to these supportive programs.

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: More than 150,000 Virginians live with dementia. Most persons with dementia (PWD) are cared for by an unpaid family caregiver. These caregivers' provision of daily assistance to PWD is a critical part of the state's dementia care capabilities. Caregivers of PWD experience an array of negative biopsychosocial impacts related to their caregiving responsibilities that undermine their own well-being and their care capacity. They are often unprepared to manage the behavioral symptoms of dementia (BSD); unmanaged symptoms are associated with increased use of emergency care and institutional placement, which are burdensome outcomes for PWD, families, and public health systems.

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.

Eligibility criteria: Caregiver Inclusion Criteria:

* Must be at least 18 years of age
* Self-identified primary caregiver for a community-dwelling patient with dementia (PWD)
* Must be an unpaid caregiver
* Basic spoken and written English language skills

Caregiver Exclusion Criteria:

* Unwilling or unable to fulfill the requirements of the study
* 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

Patient with Dementia Inclusion Criteria:

* 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)

Patient with Dementia and TBI Inclusion Criteria:

* 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

No exclusion criteria for patients with dementia and/or traumatic brain injury.

Primary outcomes:
measure: Depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
timeFrame: Change outcome measure at Baseline and 12 months and 18 months
measure: Caregiver Burden: Zarit Burden Interview (ZBI)
timeFrame: Change outcome measure at Baseline and 12 months and 18 months
measure: Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)
timeFrame: Change outcome measure at Baseline and 12 months and 18 months
measure: Quality of Life: WHO (Five) Well-Being Index (WHO-5)
timeFrame: Change outcome measure at Baseline and 12 months and 18 months
measure: Satisfaction with Care: Caregiver Satisfaction Survey (CSS)
timeFrame: Change outcome measure at 12 months and 18 months
Secondary outcomes:
measure: Healthcare Resource Utilization: Resource Utilization in Dementia, (RUD) questionnaire version 4.0.
timeFrame: Baseline, 12 months
measure: Neuropsychiatric Symptoms and Caregiver Reactions: Neuropsychiatric Inventory Questionnaire (NPI-Q).
timeFrame: Baseline, 12 months
measure: Anxiety: Geriatric Anxiety Inventory (GAI).
timeFrame: Baseline, 12 months
measure: Dementia Knowledge: Dementia Knowledge Assessment Tool Version 2 (DKAT2).
timeFrame: Baseline, 12 months
measure: Preparedness for Caregiving: Preparedness for Caregiving Scale (PCS).
timeFrame: Baseline, 12 months
measure: Self-Efficacy: General Self-Efficacy scale (GSE).
timeFrame: Baseline, 12 months
measure: Optimism/Pessimism: Life-Orientation Test-Revised (LOT-R)
timeFrame: Baseline, 12 months
measure: Basic Activities of Daily Living: Katz Index of Independence in Activities of Daily Living (Katz).
timeFrame: Baseline, 12 months
measure: Instrumental Activities of Daily Living: Lawton Instrumental Activities of Daily Living Scale (Lawton).
timeFrame: Baseline, 12 months
measure: Quality of Life in PWD: Quality of Life in Alzheimer's Disease (QoL-AD).
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia Department of Neurology
name: Carol Manning, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: