care.coach Avatars for Delirium

(AvatarHELP Trial)

No longer recruiting at 1 trial location

Overseen By Victor Wang, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Victor Wang

Disqualifiers: Aggression, Severe hearing and vision impairment, No comprehension of Spanish or English

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Average of 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if care.coach avatars, a digital support tool, can help reduce falls and delirium among older adults in hospitals. The avatars engage patients by following a specialized care program and connecting with hospital systems. The study compares outcomes between patients using the avatars and those receiving usual care. It is suitable for older adults at risk of falling or experiencing delirium who understand English or Spanish. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the care.coach avatar platform is safe?

Research has shown that the care.coach avatar platform aims to improve the safety and well-being of older adults. This platform uses digital avatars to assist with social interaction and personalized care. It has shown promise in reducing falls among high-risk seniors by up to 85%.

While studies have not detailed side effects, the emphasis on improved elder care suggests the platform is generally well-received. The current trial is in an early stage, so information about possible risks is limited. However, the platform has been used in similar situations before without major safety issues, providing some confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the care.coach Avatar because it offers a fresh approach to reducing falls and delirium in hospitalized elders. Unlike traditional methods that might rely on medication or physical restraints, the care.coach Avatar uses an interactive, virtual companion to engage patients. This technology provides real-time support and companionship, which can help keep patients oriented and active, potentially reducing the risk of falls and confusion. By incorporating cutting-edge digital tools into patient care, this approach could transform how we support elderly patients in hospitals.

What evidence suggests that the care.coach Avatar is effective for reducing falls and delirium?

Research has shown that the care.coach avatar, which participants in this trial may receive, can enhance the well-being and safety of older adults by engaging in conversation and assisting with daily activities. These digital companions reduce feelings of loneliness and support self-care. By using trusted connections, they encourage patients to follow health advice, potentially leading to better health outcomes. The avatars employ proven methods to address issues like falls and confusion in seniors, suggesting that care.coach avatars might help reduce these problems by keeping patients engaged and supported. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive care.coach avatar intervention or usual care during their inpatient stay

Average of 4 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for changes in delirium severity and cognitive function

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• care.coach Avatar (HELP-Protocolized)

How Is the Trial Designed?

Group I: care.coach Avatar Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Victor Wang

Lead Sponsor

Trials

1

Recruited

300+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Pace University

Collaborator

Trials

8

Recruited

2,700+

Published Research Related to This Trial

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The University of Connecticut developed a customized online system for tracking and reviewing adverse events in clinical research, which allows for efficient classification and timely reporting of serious incidents.

In the previous academic year, the system reviewed 371 serious adverse events from over 900 studies, demonstrating its effectiveness in ensuring participant safety and providing recommendations for study modifications or suspensions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic identification and classification of adverse events in human research. Silverman, DI., Cirullo, L., DeMartinis, NA., et al.[2006]

A study involving 134 patients found that 90% rated the animated video on patient safety as good or very good, while 100% of those receiving oral information felt the same, indicating high satisfaction with both methods.

Despite the positive feedback for the video, 74% of patients who received both formats preferred the oral presentation, suggesting that while videos can enhance understanding, they should not replace traditional verbal communication for optimal patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating Patient Safety Information Through Video and Oral Formats-A Comparison. Bånnsgård, M., Nouri, A., Finizia, C., et al.[2023]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

An automated vaccine adverse event surveillance system was implemented, which significantly improved the reporting rate of potential vaccine-related adverse events, with 686 alerts generated from 33,420 vaccinations over five months.

Clinicians found the system easy to use, leading to a reporting rate of 0.69 reports per 1,000 vaccine doses, nearly six times higher than the typical rate, suggesting that real-time prompts can enhance the detection and reporting of vaccine adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using electronic medical records to enhance detection and reporting of vaccine adverse events. Hinrichsen, VL., Kruskal, B., O'Brien, MA., et al.[2018]

Citations

1.

care.coach

care.coach/post/case-study-increasing-social-engagement-through-a-digital-avatar-during-covid-19

increasing social engagement through a digital avatar ...

The care.coach avatar is a critical technology to ensure the safety and well-being of senior participants in their homes during the COVID-19 ...

2.

care.coach

care.coach/

care.coach™ | Virtual Companionship & Health Coaching for ...

Behind every pet avatar is a Health Advocate, trained to gently support older adults with both everyday routines and condition-specific care. Everyday support: ...

3.

outcomesrocket.health

outcomesrocket.health/care-coach/2023/01/

Victor Wang, Founder, and CEO of Care.Coach

Victor Wang talks about how Care.Coach uses a digital pet avatar to coach patients to reduce loneliness, and improve their self-care and health outcomes.

4.

care.coach

care.coach/post/using-conversational-avatars-care-coach-engages-people-in-their-own-health-wellbeing-1

Using conversational avatars, care.coach engages people ...

The care.coach device primarily displays an avatar that continually engages each individual through conversation and builds trust and engagement ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12382862/

Understanding the Implementation of CareCoach ...

Online interventions for caregivers of people with early-stage dementia have shown significant improvements in carers' wellbeing, self-efficacy, ...

6.

care.coach

care.coach/privacy-security

Privacy & security

When you'd like privacy, simply ask the avatar to give you privacy, or adjust its privacy settings on-screen (our support team is available to guide you through ...

7.

care.coach

care.coach/post/culturally-adaptive-digital-avatars-for-psychosocial-and-self-management-support-of-high-risk-elders

Culturally adaptive digital avatars for psychosocial and self ...

Discover how culturally adaptive digital avatars from care.coach provide personalized elder care solutions, reducing falls by up to 85% and ...

8.

care.coach

care.coach/post/using-conversational-avatars-care-coach-engages-people-in-their-own-health-wellbeing

Using conversational avatars, care.coach engages people ...

Video of how care.coach, led by CEO Victor Wang, uses conversational avatars to support individuals with complex medical and psychosocial needs, ...