What side effects are associated with this type of intervention?

Common treatments for dementia include acetylcholinesterase inhibitors like donepezil and galantamine, which can cause side effects such as nausea, diarrhea, insomnia, muscle cramps, and fatigue. Memantine, another common treatment, may lead to dizziness, headache, confusion, and constipation. Antipsychotics, sometimes used to manage neuropsychiatric symptoms, can have serious side effects including increased risk of stroke, sedation, weight gain, and worsening of cognitive function. Non-pharmacological interventions, such as cognitive stimulation and environmental modifications, generally have fewer side effects but may face challenges in compliance and effectiveness due to the variability in individual responses.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of dementia, particularly Alzheimer's disease. These include acetylcholinesterase inhibitors such as donepezil (Aricept) and galantamine, which help to slow cognitive decline. Memantine, an NMDA receptor antagonist, is also approved for moderate to severe Alzheimer's disease. While the context mentions the use of artificial intelligence to enhance discharge care transitions by providing tailored support to caregivers, specific FDA approvals for AI in dementia care are not detailed. However, these AI interventions aim to improve the quality of care and support for both patients and caregivers.

What other types of research exist?

Promising alternatives to AI for enhancing discharge care transitions for dementia patients include: 1) Smart environments and social robots that support independent living and provide age-friendly care services, 2) Computer-assisted language therapy and constraint-induced aphasia therapy (CIAT) for cognitive and communication support, 3) Pharmacologic treatments like memantine combined with high-intensity therapy, and 4) Augmentative and alternative communication devices, including smartphone and tablet applications for therapy and communication.

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Artificial Intelligence Care Coach for Dementia Caregivers

N/A

Recruiting

Led By Cameron Gettel

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥65 years with a diagnosis of dementia within the electronic health record OR new cognitive impairment identified during an ED visit

Discharge after an ED visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a computer program that helps caregivers when older adults with memory problems leave the emergency room. The program aims to make the transition from hospital to home smoother by offering guidance and support. It focuses on caregivers because they play a key role in managing the care of these patients.

Who is the study for?

This trial is for caregivers of older adults aged 65 or above with dementia or new cognitive impairment identified during an ED visit. Participants must speak English or Spanish, be discharged after an ED visit, and have a smart device with internet to use the NeuViCare AI services. Those showing signs of delirium are not eligible.

What is being tested?

The study is testing the NeuViCare application, which uses artificial intelligence to help manage care transitions after older adults with cognitive impairments are discharged from the emergency department.

What are the potential side effects?

Since this trial involves using an AI-based application rather than medication, traditional side effects like those seen in drug trials may not apply. However, users might experience stress or frustration if they encounter technical difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 or older and have been diagnosed with dementia or noticed new memory problems.

Select...

I was recently discharged from the emergency department.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure

Feasibility of Intervention Measure

Intervention Appropriateness Measure

+1 more

Secondary study objectives

Dementia Knowledge Assessment Scale

Emergency Department revisits

General Self-Efficacy Scale

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention (NeuViCare AI)Experimental Treatment1 Intervention

An anticipated 55 participants will be part of the Intervention arm participants and will engage with NeuViCare AI, including all variations of its 5 components described further below.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dementia include pharmacological approaches like cholinesterase inhibitors and memantine, which work by enhancing neurotransmitter activity to improve cognitive function. Non-pharmacological treatments, such as AI-enhanced discharge care transitions, provide tailored support and information to caregivers, helping manage symptoms and improve the quality of life for both patients and caregivers. These treatments are essential as they address the holistic needs of dementia patients, ensuring comprehensive care that supports cognitive and emotional well-being.

An intervention to promote self-management, independence and self-efficacy in people with early-stage dementia: the Journeying through Dementia RCT.Supporting self-care of long-term conditions in people with dementia: A systematic review.Recruiting Dementia Caregivers Into Clinical Trials: Lessons Learnt From the Australian TRANSCENDENT Trial.