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

171 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Telehealth-delivered Care Coordination Program for caregivers of people with dementia and brain injury?

Research shows that care coordination programs, like MIND at Home, can help reduce the burden on caregivers of people with memory disorders. Additionally, a pilot project using technology-assisted care coordination found high satisfaction among caregivers, suggesting it may be a useful support model. ^{1 2 3 4 5}

Is telehealth support for dementia caregivers safe?

The studies on telehealth support for dementia caregivers, such as care coordination programs, do not report any safety concerns, suggesting it is generally safe for use. ^{1 2 3 5 6}

How is the Telehealth-delivered Care Coordination Program treatment different from other treatments for dementia and brain injury caregivers?

This treatment is unique because it uses telehealth (remote healthcare services via technology) to provide care coordination, which helps organize and manage care for caregivers of people with dementia or brain injuries. Unlike traditional in-person support, this program offers convenience and accessibility, allowing caregivers to receive support and education from home. ^{1 2 5 7 8}

Research Team

Carol Manning, PhD

Principal Investigator

University of Virginia Department of Neurology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 '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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Care coordination assisted by technology for multiethnic caregivers of persons with dementia: a pilot clinical demonstration project on caregiver burden and depression. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of care coordination on patients with Alzheimer disease and their caregivers. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Health Services Utilization in Older Adults with Dementia Receiving Care Coordination: The MIND at Home Trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of TeleFAMILIES: a telehealth intervention for caregivers of community-dwelling people with dementia. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Telephone-Delivered, Community-Based Collaborative Care Management Program for Caregivers of Older Adults with Dementia. [2018]

7. United States 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. [2022]

8. Canada 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. [2022]