Virtual Support Program for Dementia

(ABCV Trial)

Overseen By Alexia M Torke, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Hospice, Long-term care, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual support program designed to assist caregivers of people with dementia. The program provides monthly virtual visits with a nurse or social worker for the first three months, then adjusts the frequency based on needs. Known as the Aging Brain Care Virtual Program, it aims to manage dementia symptoms, reduce caregiver stress, and assist with future care planning. Suitable participants are those caring for someone aged 65 or older with Alzheimer's or related dementias and who can access the program via phone or computer. As an unphased trial, this study offers caregivers the chance to access innovative support and contribute to research that could enhance care for dementia patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It focuses on managing medications as part of the program, so it's best to discuss your specific situation with the trial coordinators.

What prior data suggests that this virtual support program is safe for dementia care?

Research has shown that virtual programs like the Aging Brain Care Virtual Program are generally safe for participants. This program aids caregivers of people with dementia through online meetings and personalized care plans.

While specific safety data for this program is unavailable, similar virtual dementia care programs have demonstrated positive results. These programs are well-received and enhance the emotional and social well-being of caregivers and those they care for.

This trial is in the "Not Applicable" phase, focusing on the program's effectiveness rather than testing a new drug or treatment with unknown risks. Joining these virtual support programs is considered low-risk, as they primarily involve communication and guidance from trained professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Aging Brain Care Virtual Program because it offers a fresh approach to supporting dementia patients and their caregivers through virtual care coordination. Unlike traditional treatments that often focus directly on the patient, this program emphasizes caregiver support and education, aiming to improve overall care and quality of life indirectly. By leveraging virtual technology, the program can reach a broader audience, making it more accessible and convenient for caregivers who may have difficulty attending in-person sessions. This innovative approach could set a new standard for how we support families affected by dementia, potentially leading to better outcomes for both patients and caregivers.

What evidence suggests that the Aging Brain Care Virtual Program is effective for dementia care?

Research has shown that the Aging Brain Care Virtual (ABCV) program, which participants in this trial may receive, can help manage dementia. Specifically, studies found that people in the program improved in thinking, physical health, behavior, and mood after three months. A team of diverse health professionals collaborates to provide care, aiming to reduce caregiver stress and manage medications and other health issues. This approach is designed to enhance care for people with dementia living at home. Evidence suggests the program offers valuable support for both patients and their caregivers. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexia M Torke, MD

Principal Investigator

Regenstrief Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with dementia or Alzheimer's Disease. Participants will engage in a virtual care program over one year, managed by nurses or social workers. The program includes regular check-ins and personalized plans to manage symptoms and caregiver stress.

Inclusion Criteria

I am 65 years old or older.

Active primary care patient with a visit in the past 14 months

I have been diagnosed with Alzheimer's or a similar dementia.

Exclusion Criteria

Patient enrolled in hospice at the study start or living in a long-term care nursing facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Virtual intervention delivered by RN or SW care coordinators over one year, with monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need.

12 months

Monthly visits for 3 months, then quarterly

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Aging Brain Care Virtual Program

Trial Overview The Aging Brain Care Virtual Program is being tested to see if it can help manage dementia and Alzheimer's symptoms through monthly virtual visits initially, then quarterly as needed. It focuses on behavioral management, stress relief for caregivers, medication oversight, comorbidity handling, and future care planning.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Care Partners in the intervention group will be approached and offered care coordination through the Aging Brain Care Virtual program

Group II: Control Active Control 1 Intervention

Care partners in the control group will not be approached, but outcomes data will be collected from the EMR for comparison with the intervention group.

Aging Brain Care Virtual Program is already approved in United States for the following indications:

Approved in United States as Aging Brain Care Virtual Program for:

• Management of dementia symptoms
• Caregiver support
• Behavioral/psychological symptom management
• Medication management
• Comorbidity management
• Advance care planning

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The individualized Meeting Centers Support Program (iMCSP) effectively improved the neuropsychiatric symptoms of people with dementia and reduced the emotional burden on their caregivers, particularly through the DemenTalent initiative.

Caregivers using iMCSP reported higher happiness levels compared to those receiving no day care support, indicating that personalized interventions can enhance the well-being of both individuals with dementia and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization, effect, and benefit of the individualized Meeting Centers Support Program for people with dementia and caregivers. Dröes, RM., van Rijn, A., Rus, E., et al.[2023]

In a study of 123 patients treated with donepezil for Alzheimer's dementia, 21% discontinued treatment due to adverse events (AEs), highlighting the need for careful monitoring during the initial months of therapy.

The most common AEs leading to discontinuation were nausea/vomiting, diarrhea, and loss of appetite, indicating that these side effects are significant considerations in the management of patients on donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. Carøe, TK., Moe, C.[2018]

Patients with dementia who received services from a memory clinic had more emergency department visits over 12 months compared to a matched group, but hospitalization rates were similar, indicating potential challenges in managing their health.

Caregivers reported that the educational and social support provided by the memory clinic was valuable, suggesting that the embedded dementia navigator model effectively addresses caregiver needs and may help mitigate the increasing burden as the disease progresses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Caregiver Outcomes and Experiences With Team-Based Memory Care: A Mixed Methods Study. Liu, TL., Yates, TD., Taylor, YJ., et al.[2021]

A year-long study involving the use of a Connected Health platform for people with dementia (PwD) and their informal caregivers showed no significant changes in overall well-being, indicating that both groups remained stable over time.

While some minor changes were noted in functional status for PwD and sleep quality for caregivers, these changes were not directly linked to the use of the Connected Health platform, suggesting that the technology may not have a significant impact on improving well-being in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smart Health Platform for Measuring Health and Well-Being Improvement in People With Dementia and Their Informal Caregivers: Usability Study. Guisado-Fernandez, E., Blake, C., Mackey, L., et al.[2020]

A review of 22 studies found that combined telephone and internet interventions for caregivers of individuals with dementia were more effective in reducing depression and caregiver burden compared to using either method alone.

The results suggest that multicomponent interventions delivered through both formats can enhance self-efficacy among caregivers, highlighting the need for further research on targeted interventions for specific types of dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effect of telephone, internet or combined support for carers of people living with Alzheimer's, vascular or mixed dementia in the community. Jackson, D., Roberts, G., Wu, ML., et al.[2022]

The Aging Brain Care (ABC) Medical Home program successfully served 1,650 older adults with dementia or depression, showing that structured collaborative care can improve health outcomes in this population.

After 18 months, 66% of participants with high depression scores experienced a significant reduction in symptoms, and 51% of caregivers reported reduced stress, indicating the program's effectiveness in addressing both patient and caregiver needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aging Brain Care Medical Home: Preliminary Data. LaMantia, MA., Alder, CA., Callahan, CM., et al.[2015]

Virtual support programs for caregivers of individuals with Alzheimer's and related dementias have been successfully implemented during the COVID-19 pandemic, showing positive reception from both facilitators and caregivers.

Despite some challenges like technological issues, these virtual platforms have enhanced feelings of connectedness among caregivers and may continue to be a valuable resource even after the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dementia Caregiver Virtual Support-An Implementation Evaluation of Two Pragmatic Models during COVID-19. Weems, JA., Rhodes, S., Powers, JS.[2021]

A pilot study involving 93 caregivers of dementia patients demonstrated that virtual support meetings, held three times a week for three months, were highly effective, with 86-100% satisfaction reported by participants.

The program provided caregivers with essential management guidelines and education about dementia, suggesting that such virtual interventions can significantly alleviate caregiver burden and improve their confidence in providing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Support in Dementia: A Possible Viable Strategy for Caregivers. Ferretti, C., Nitrini, R., Brucki, SMD.[2021]

The Alzheimer's and Dementia Care Program (ADC Program) is an effective model for comprehensive dementia care, but its implementation faces barriers that need to be addressed for wider adoption across the U.S.

Key factors for successful implementation include strong engagement from site leaders, the diverse roles of Dementia Care Specialists, and the necessity for adequate funding and support mechanisms to sustain comprehensive care over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of a successful dementia care program: Lessons from early adopters. Lees Haggerty, K., Campetti, R., Stoeckle, RJ., et al.[2023]

In a pilot study involving 47 participants aged 60 and over with dementia, person-centered care (PCC) significantly improved behavioral and neuropsychiatric symptoms and care quality compared to usual care after 4-5 days.

Sustained improvements in care quality were observed for patients with longer hospital stays, indicating that PCC can be beneficial for enhancing the overall care experience for individuals with dementia in acute hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. Chenoweth, L., Williams, A., Fry, M., et al.[2022]

The telephone clinic, led by pharmacists, effectively evaluates the ongoing effectiveness of antidementia medications by reviewing patient adherence and caregiver feedback, which helps determine if a medication-discontinuation trial is appropriate.

This innovative approach enhances collaboration among healthcare providers and improves patient-centered care, potentially leading to better management of antidementia therapy and more efficient use of medication resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-managed telephone clinic review of antidementia medication effectiveness. Oderda, L., Holman, C., Nichols, B., et al.[2016]

A systematic review of 5 studies found that the prevalence of adverse drug events (ADEs) in older inpatients with dementia is alarmingly high at 81.5%, indicating a significant safety concern for this population.

The prevalence of adverse drug reactions (ADRs) varied between 12.7% and 24.0%, highlighting the need for better assessment methods and tailored tools to prevent these reactions in older patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. Sakiris, MA., Sawan, M., Hilmer, SN., et al.[2021]

The My Healthy Brain program, an 8-week group-based lifestyle intervention delivered via live video, effectively targets multiple lifestyle risk factors for dementia in older adults with cognitive decline or mild cognitive impairment.

Participants reported that the program was feasible and acceptable, suggesting it has the potential to improve lifestyle, cognitive, and psychosocial outcomes for at-risk older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. Mace, RA., Hopkins, SW., Reynolds, GO., et al.[2023]

The Montefiore-Einstein Center for the Aging Brain successfully implemented an interdisciplinary approach to dementia care, involving a team of specialists that provided comprehensive evaluations and management plans for 366 patients in their first year.

This model was well-received by patients, caregivers, and primary care physicians, indicating that such a collaborative care strategy is both feasible and effective in an outpatient setting for managing dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montefiore-Einstein Center for the Aging Brain: Preliminary Data. Verghese, J., Malik, R., Zwerling, J.[2019]

Citations

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protocol for the Aging Brain Care Virtual (ABCV) program - PMC If successful, the ABCV program will provide robust evidence supporting the effectiveness of virtually delivered, high-quality dementia care in ...

2. medicine.iu.edu medicine.iu.edu/internal-medicine/specialties/general/geriatrics/programs/image/aging-brain-care

Aging Brain Care | imAGE | Geriatrics | IU School of Medicine The Aging Brain Care (ABC) program is an evidence-based population brain health management program that uses an interdisciplinary care team.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40987722/

protocol for the Aging Brain Care Virtual (ABCV) program Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners ...

4. mcknightshomecare.com mcknightshomecare.com/news/aging-brain-care-model-an-effective-tactic-for-at-home-dementia-care-study-finds/

Aging Brain Care model an effective tactic for at- ... After three months in the program, participants, on average, had improved cognitive, physical, behavioral and psychological symptoms related to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06245499

Aging Brain Care Virtual Program (ABCV) A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11869813/

Comprehensive Dementia Care Models: State of the Science ... The MIND at Home® Program shows positive outcomes across cognitive, emotional, and social domains for PLWD and their care partners (Samus et al.

7. trialx.com trialx.com/clinical-trials/listings/289463/aging-brain-care-virtual-program/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Aging Brain Care Virtual Program | Clinical Research Trial ... The program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly ...