Telehealth Support for Dementia and Brain Injury Caregivers

Overseen By Colleen Webber

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: No internet, Unwilling, Unsuitable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how telehealth can assist caregivers of individuals with dementia, including Alzheimer's and brain injuries. The focus is to determine if remote support can reduce stress and improve caregivers' quality of life. Participants will either engage in a year-long telehealth-delivered care coordination program or continue with standard care. Ideal participants are unpaid caregivers who provide primary support to someone with dementia and have internet access for telehealth sessions. The study's findings could lead to improved support programs for both civilian and military families managing dementia. As an unphased trial, this study offers caregivers the opportunity to contribute to pioneering research that could enhance support systems for families dealing with dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on providing telehealth support for caregivers, so it's unlikely that medication changes are required.

What prior data suggests that this telehealth program is safe for caregivers?

Research has shown that telehealth programs for caregivers are generally safe and easy to use. Studies have found that telehealth can reduce stress and improve caregivers' quality of life. These programs use technology such as phones, tablets, or computers to connect caregivers with support services, and no major safety issues have been reported. Although more research is needed to understand all possible effects, telehealth is considered a safe way to support caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth-delivered Care Coordination Program because it offers a unique, virtual approach to supporting caregivers of individuals with dementia and brain injuries. Unlike traditional in-person support services, this program leverages telehealth to provide continuous, remote care coordination, making it more accessible and convenient for caregivers who may have difficulty attending in-person sessions. By assigning a dedicated dementia care coordinator, the program ensures personalized support tailored to each caregiver's needs, potentially enhancing their ability to manage caregiving responsibilities more effectively. This innovative method aims to reduce caregiver stress and improve outcomes for both caregivers and patients.

What evidence suggests that telehealth-delivered care coordination is effective for dementia caregivers?

Research has shown that telehealth programs can greatly improve the well-being of caregivers for people with dementia. These programs enhance mental health, improve caregiving skills, and lower stress levels. In this trial, participants in the Caregiver PWD-ADRD TCCI and Caregiver for PWD-TBI TCCI groups will complete a 12-month telehealth-delivered care coordination program. This program supports caregivers by offering organized help through digital tools like phones or computers. While more research is needed to fully understand the effects on patients, current evidence suggests these programs benefit caregivers. This method could be especially helpful for those caring for individuals with Alzheimer's or dementia related to brain injuries. ^{1 2 6 7 8}

Who Is on the Research Team?

Carol Manning, PhD

Principal Investigator

University of Virginia Department of Neurology

Are You a Good Fit for This Trial?

This trial is for unpaid caregivers over 18 years old who are the primary caregiver for someone with dementia living in the community. They must have basic English skills. It's not specified who can't join, but typically those not meeting these criteria would be excluded.

Inclusion Criteria

Must be an unpaid caregiver

Self-identified primary caregiver for a community-dwelling patient with dementia (PWD)

Caregiver

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month telehealth-delivered dementia care coordination program

12 months

Telehealth sessions throughout the 12 months

Follow-up

Participants are monitored for the longevity of intervention impacts

6 months

Follow-up assessments at 12 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth-delivered Care Coordination Program

Trial Overview The study tests a telehealth-delivered care coordination program to support caregivers of individuals with Alzheimer's and TBI-related dementia. Caregivers will use devices like phones or computers to access this program for a year.

How Is the Trial Designed?

Group I: Caregiver for PWD-TBI TCCI Experimental Treatment 1 Intervention

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.

Group II: Caregiver PWD-ADRD TCCI Experimental Treatment 1 Intervention

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.

Group III: Caregiver for PWD-TBI (BMT) Active Control 1 Intervention

Participants in the Caregiver PWD-TBI best medical treatment (BMT) group will not receive care coordination.

Group IV: Caregiver for PWD-ADRD (BMT) Active Control 1 Intervention

Participants in the Caregiver PWD-ADRD best medical treatment (BMT) group will not receive care coordination.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

The MIND at Home intervention, which involved care coordination for caregivers of individuals with memory disorders, did not significantly reduce unmet caregiving needs or burden compared to a control group over 18 months, based on a study of 289 caregiver-care recipient pairs.

However, caregivers in the MIND at Home group reported a potentially meaningful reduction in the number of hours spent caring for the care recipient, suggesting some positive impact on caregiver time management despite no significant changes in overall caregiver burden or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. Tanner, JA., Black, BS., Johnston, D., et al.[2022]

Telehealth interventions significantly reduced depression levels in 1379 individuals with dementia, with a strong effect size (SMD -0.63), indicating their potential effectiveness in managing mental health in this population.

Caregivers also reported improved perceived competency (SMD 0.27), suggesting that telehealth can enhance their confidence in providing care, although no significant effects were found on cognitive function or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of telehealth intervention for people with dementia and their carers: A systematic review and meta-analysis of randomized controlled studies. Saragih, ID., Tonapa, SI., Porta, CM., et al.[2022]

The care coordination and caregiver support intervention did not reduce overall acute medical service use for patients with Alzheimer disease, but it did lead to increased total charges and inpatient admissions related to Alzheimer's diagnosis.

However, the intervention showed potential benefits by reducing emergency department visits and decreasing acute visits for depression among caregivers, suggesting improved caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of care coordination on patients with Alzheimer disease and their caregivers. Chen, B., Cheng, X., Streetman-Loy, B., et al.[2021]

The 'Partner in Balance' (PiB) program, which combines face-to-face coaching with online modules, was well-received by both caregivers and coaches, with a participation rate of 51.9% among eligible caregivers, indicating its potential effectiveness in supporting early-stage dementia caregivers.

Despite overall satisfaction, challenges such as recruitment barriers and the need for tailored content for specific subgroups, like younger caregivers, were identified, suggesting that further adaptation and awareness of blended care programs are necessary for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial. Boots, LM., de Vugt, ME., Smeets, CM., et al.[2022]

The novel dementia care coordination program did not significantly reduce the use of acute care or inpatient services, but it did lead to an increase in outpatient dementia and mental health visits over 18 months, indicating improved access to specialized care.

Participants in the intervention group significantly increased their use of home and community-based support services, suggesting that the program may help individuals with dementia remain in their homes longer and receive necessary support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Services Utilization in Older Adults with Dementia Receiving Care Coordination: The MIND at Home Trial. Amjad, H., Wong, SK., Roth, DL., et al.[2019]

The TeleFAMILIES telehealth intervention significantly reduced caregiver burden and depressive symptoms among 216 caregivers of persons with dementia, with notable improvements in scores on the Zarit Burden Interview and Center for Epidemiologic Studies Depression Scale.

Caregivers using the TeleFAMILIES program experienced greater improvements in managing behavioral symptoms of dementia compared to those receiving in-person support, highlighting the effectiveness and convenience of telehealth services in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of TeleFAMILIES: a telehealth intervention for caregivers of community-dwelling people with dementia. Rice, JD., Sperling, SA., Brown, DS., et al.[2022]

A community-based, telephone-delivered dementia care management program significantly reduced caregiver burden over time compared to standard clinical evaluation, based on a study involving 440 caregivers of older adults with dementia.

Caregivers in the intervention group also reported fewer challenging behaviors from care recipients and less distress in response to these behaviors at the 3-month follow-up, indicating improved outcomes for both caregivers and care recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Telephone-Delivered, Community-Based Collaborative Care Management Program for Caregivers of Older Adults with Dementia. Mavandadi, S., Wray, LO., DiFilippo, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04495686

An Innovative Supportive Care Model for Dementia and ... Our study will test three primary hypotheses: 1) Caregivers of persons with dementia who participate in the telehealth care coordination program will experience ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8164532/

Telehealth Interventions for Family Caregivers of Persons ... Telehealth is an effective tool in delivering caregiver interventions and leads to significant improvement in caregiver outcomes.

3. clinicaltrial.be clinicaltrial.be/en/details/3235?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

An Innovative Supportive Care Model for Dementia and ... Our study will test three primary hypotheses: 1) Caregivers of persons with dementia who participate in the telehealth care coordination program ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/1357633X251357054

Effectiveness of telehealth interventions for family ... Telehealth may be a valuable option for supporting family caregivers of older adults in improving psychological well-being, caregiving competence, and reducing ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6996201/

In-Home Video Telehealth for Dementia Management Positive caregiver outcomes were noted but evidence for patient-level outcomes and cost data are mostly lacking. Summary: More research is needed to demonstrate ...

6. academic.oup.com academic.oup.com/innovateage/article/doi/10.1093/geroni/igaf057/8166514

Traumatic Brain Injury-Alzheimer's Disease ... - Oxford Academic The TBI-AD/ADRD Caregiver Support Intervention (TACSI) is a novel intervention that provides one-on-one telehealth support to caregivers of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667032122000087

Experience of the healthcare system for caregivers of ... This study improves our understanding of the experience of engaging with the healthcare system for caregivers and persons with dementia.

8. journalaim.com journalaim.com/FullHtml/aim-23962

Objectives, Outcomes, Facilitators, and Barriers ... Evaluation of a telephone-delivered, community-based collaborative care management program for caregivers of older adults with dementia. Am J Geriatr ...