Virtual Support Program for Dementia

(ABCV Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Alexia M Torke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Disqualifiers: Hospice, Long-term care, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial involves frequent online meetings with nurses or social workers to help patients with dementia and their caregivers. The care coordinators assess needs and provide support to manage symptoms, stress, medications, other health issues, and future care planning.

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 data supports the effectiveness of the Aging Brain Care Virtual Program for dementia treatment?

The Aging Brain Care Medical Home program showed that 66% of participants with high depression scores experienced a significant reduction in symptoms, and 51% of caregivers of individuals with dementia had reduced stress. This suggests that similar virtual support programs could help improve mental health and reduce caregiver stress in dementia care. ^{1 2 3 4 5}

Is the Virtual Support Program for Dementia safe for humans?

The Aging Brain Care Medical Home program, which is similar to the Virtual Support Program for Dementia, has been implemented with older adults and showed progress in improving health without reported safety issues. This suggests that such programs are generally safe for human participants. ^{1 6 7 8 9}

How is the Aging Brain Care Virtual Program treatment different from other dementia treatments?

The Aging Brain Care Virtual Program is unique because it offers a comprehensive virtual support system for both people with dementia and their caregivers, focusing on personalized care and education through technology, which can be more accessible and cost-effective compared to traditional in-person care. ^{10 11 12 13 14}

Research Team

Alexia M Torke, MD

Principal Investigator

Regenstrief Institute, Inc.

Eligibility Criteria

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

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

I am 65 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Aging Brain Care Virtual Program (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

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+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

The Aging Brain Care Medical Home: Preliminary Data. [2015]

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

Outcomes of Person-centered Care for Persons with Dementia in the Acute Care Setting: A Pilot Study. [2022]

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

Montefiore-Einstein Center for the Aging Brain: Preliminary Data. [2019]

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

Patient and Caregiver Outcomes and Experiences With Team-Based Memory Care: A Mixed Methods Study. [2021]

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

Pharmacist-managed telephone clinic review of antidementia medication effectiveness. [2016]

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

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. [2018]

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

Dissemination of a successful dementia care program: Lessons from early adopters. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Utilization, effect, and benefit of the individualized Meeting Centers Support Program for people with dementia and caregivers. [2023]

11. Canada 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. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Dementia Caregiver Virtual Support-An Implementation Evaluation of Two Pragmatic Models during COVID-19. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Support in Dementia: A Possible Viable Strategy for Caregivers. [2021]

14. Netherlands 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. [2022]