What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Dementia include antipsychotics, vitamin E, and aducanumab. Antipsychotics, such as haloperidol and risperidone, can cause side effects like increased risk of falls, sedation, and worsening of neuropsychiatric symptoms. Vitamin E is generally well-tolerated but offers only modest benefits. Aducanumab, a newer treatment, has side effects including amyloid-related imaging abnormalities (ARIA), headache, falls, and hypersensitivity reactions. These side effects can impact the decision-making process for caregivers, highlighting the importance of informed choices supported by tools like video decision aids.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Alzheimer's Dementia, including cholinesterase inhibitors like donepezil and galantamine, which have shown promise in improving cognitive function. Memantine, another FDA-approved drug, is used to manage symptoms of moderate to severe Alzheimer's by regulating glutamate activity. Additionally, the FDA has permitted the use of digital therapeutics and video decision aids to support caregivers by providing information and reducing decisional conflict. These tools help caregivers make informed decisions and manage the burden associated with Alzheimer's care.

What other types of research exist?

Promising, novel alternatives to Video Decision Aid for Alzheimer's Dementia patients in 2024 include telehealth services, interactive mobile applications, and AI-driven personalized care platforms. These alternatives provide tailored support and information to caregivers, aiming to improve decision-making and reduce caregiver burden.

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Behavioural Intervention

Video Intervention for Dementia Caregivers

N/A

Recruiting

Led By Brad C Dickerson, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

All participants must be age 18 or older.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and month 3 follow up baseline and month 6 follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help caregivers of Alzheimer's patients by using videos that provide information and guidance. The goal is to reduce their uncertainty and burden by making it easier for them to understand their options and make informed decisions.

Who is the study for?

This trial is for caregivers aged 18 or older who speak English and are caring for someone with Alzheimer's Disease, frontotemporal dementia, or a related dementia. They must understand the study and agree to its terms.

What is being tested?

The study tests if a video decision aid can help caregivers of dementia patients by improving their knowledge, easing decision-making, aligning care preferences, and reducing caregiver burden compared to usual care.

What are the potential side effects?

Since this trial involves an educational video intervention rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and month 3 follow up baseline and month 6 follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and month 3 follow up baseline and month 6 follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 3 follow up baseline and month 6 follow up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change and Retention of Change in Advanced Care Planning (ACP) Engagement Survey

Change from Baseline in percent correct and in response confidence on Knowledge of Advanced Dementia Questionnaire.

Change from Baseline in percent correct and in response confidence on Knowledge of Goals of Care Questionnaire.

Secondary study objectives

Change and Retention of Change in Decisional Conflict Scale

Response Rate and Retention of Response Rate for Limited Medical Care and Comfort Care

Response Rate for Advanced Care Planning (ACP) Documents Survey

+1 more

Other study objectives

Change from Baseline self-report measure of affect to post intervention self-report measure of affect

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Video Intervention ArmExperimental Treatment1 Intervention

For participants randomized to the video intervention arm, participants will be shown two videos about Advanced Care Planning, and then they will be asked questions regarding the usefulness of the video and their comfort with the video

Group II: Control ArmActive Control1 Intervention

For participants randomized to the control group arm, participants will review an informational sheet, which covers the same information as the videos shown to the intervention arm.

0 / 1Eligibility 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 Alzheimer's Dementia include cholinesterase inhibitors like donepezil and galantamine, which prevent the breakdown of acetylcholine to enhance cholinergic function, and NMDA receptor antagonists like memantine, which regulate glutamate activity to prevent neuronal damage. These treatments are important as they aim to slow cognitive decline and improve the quality of life for patients. The Video Decision Aid intervention supports caregivers by providing information and reducing decisional conflict, thereby aiding in the effective management of these treatments.

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