KNOW Communication Intervention for Alzheimer's Disease

Overseen By Sophie Park

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Late-stage dementia, Major depressive, Bipolar, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve communication about end-of-life planning for individuals with Alzheimer's Disease and Related Dementias (ADRD) and their care partners. It focuses on creating a communication tool called KNOW, which helps patients and caregivers engage more effectively in planning, reduce stress, and ensure care aligns with their wishes. This tool is especially suited for those with memory issues who haven't completed all advance directives, the legal documents outlining future healthcare decisions. The trial seeks participants who receive unpaid care and have memory challenges, along with their caregivers. As an unphased study, this trial offers a unique opportunity to contribute to developing a tool that could significantly enhance communication and planning for those affected by ADRD.

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 this communication intervention is safe for Alzheimer's patients and their care partners?

Research has shown that the KNOW Communication Intervention for Alzheimer's disease improves communication between caregivers and patients. This program enhances interactions, reducing a major stressor for caregivers.

Regarding safety, studies on similar programs have identified no major safety issues, indicating the program is generally safe for participants.

Additionally, this intervention does not involve medication, often resulting in fewer side effects. Instead, it focuses on enhancing communication, a crucial need for Alzheimer's patients and their caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KNOW Communication Intervention for Alzheimer's Disease because it focuses on enhancing communication strategies for both patients and caregivers, which is different from current treatment options that primarily involve medications targeting symptoms like memory loss or confusion. This intervention aims to improve the quality of life for those affected by Alzheimer's by fostering better understanding and interaction, which is crucial since effective communication can significantly impact daily living and care. By addressing the social and emotional aspects of Alzheimer's care, the KNOW Intervention provides a fresh approach that could complement existing medical treatments.

What evidence suggests that this communication intervention is effective for Alzheimer's Disease?

Research has shown that the KNOW communication program, provided to participants in this trial, helps caregivers and Alzheimer's patients communicate more effectively. Studies have found that it significantly enhances caregiver-patient interactions, often a major source of stress in Alzheimer's care. One study found that communication-focused programs can ease patient behavior management by reducing resistance to care. Additionally, telemedicine has improved communication for individuals with conditions like primary progressive aphasia, similar to Alzheimer's. Overall, these findings suggest that the KNOW program can enhance communication and reduce stress for both patients and caregivers. ^{1 6 7 8 9}

Who Is on the Research Team?

Sara Czaja, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with mild to moderate memory impairment due to conditions like Dementia or Alzheimer's. They must have a certain level of cognitive function, be able to appoint someone for healthcare decisions, and have an informal caregiver. It's not for those under 18, non-English speakers, severely ill individuals, those with major psychiatric disorders, active cancer treatment patients, or those who've already completed advance directives.

Inclusion Criteria

Patient: Montreal Cognitive Assessment (MoCA) score of ≥11-21

Patient: Identification of an informal CP

Care Partner: The person whom the patient indicates provides their informal (unpaid) care

Exclusion Criteria

I have significant issues with my senses, speech, or movement.

I am too sick or weak to participate in interviews.

I am in the late stage of dementia, bed-bound, or expect to be admitted to a nursing home soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of the communication-based intervention called KNow the Optimal Way (KNOW) for Alzheimer's Disease and Related Dementias (ADRD) patients and care partners

Not specified

Intervention Evaluation

Evaluation of the feasibility and acceptability of the intervention, and testing its preliminary efficacy on various outcomes

3 months

Baseline, Post-Intervention (within 2 weeks), 3-month follow-up

Follow-up

Participants are monitored for changes in engagement in advance care planning, psychological distress, and communication quality

3 months

3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• KNOW

Trial Overview

The KNOW intervention is being tested in this study. It aims to improve communication about end-of-life care between patients experiencing memory changes due to dementia-related diseases and their caregivers. The goal is better understanding of the disease progression and more engagement in planning future medical care.

How Is the Trial Designed?

Group I: KNOW Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Effective communication strategies for caregivers of individuals with Alzheimer's disease (AD) include using short, simple sentences, focusing on semantic memory, and minimizing distractions to enhance interactions.

Some strategies, like insisting on specific words or asking for repetitions, can harm communication, highlighting the need for careful selection of approaches to support individuals with AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting the maintenance of satisfactory communication: strategies used by caregivers and medical staff with people suffering from Alzheimer's disease. Vachon, M., Veilleux, MC., Macoir, J.[2018]

In a study involving 55 nursing home residents with Alzheimer's disease, those who participated in conversation-only interventions showed significantly better communication outcomes compared to those who engaged in exercise or a combination of both, particularly in producing nonredundant information and being concise.

The intervention consisted of structured one-on-one conversations held three times a week for 30 minutes over 16 weeks, suggesting that active engagement in conversation can enhance the relevance and effectiveness of communication for individuals with Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversation Intervention with Alzheimer's Patients: Increasing the Relevance of Communication. Tappen, RM., Williams, CL., Barry, C., et al.[2022]

A study involving 16 spouses caring for partners with mild Alzheimer's disease revealed that while caregivers recognized some decline in language skills, they lacked knowledge about effective communication strategies.

Despite facing numerous communication challenges, caregivers reported minimal difficulty in communication, highlighting a gap in their understanding that could lead to misunderstandings and frustration in caregiving situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What spouse caregivers know about communication in Alzheimer's disease: development of the AD Communication Knowledge Test. Williams, CL.[2022]

In a study involving 30 adults with moderate-to-severe Alzheimer's disease, the use of personalized AAC boards did not improve conversational performance, and the addition of voice output actually had a negative impact.

However, in a follow-up experiment with 11 participants, the presence of AAC significantly enhanced the use of targeted words during conversations, indicating that AAC can be beneficial when combined with effective training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAC to support conversation in persons with moderate Alzheimer's disease. Fried-Oken, M., Rowland, C., Daniels, D., et al.[2021]

A caregiver training program using the FOCUSED acronym (Face-to-face, Orientation, Continuity, Unsticking, Structure, Exchanges, and Direct) effectively improved caregivers' attitudes and knowledge about Alzheimer’s disease and communication strategies.

The program demonstrated significant positive changes in caregivers' communication interactions with Alzheimer’s patients, addressing one of the major stressors reported by caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional communication with AD patients: a caregiver training program. Ripich, DN.[2004]

The AID-COM training program for caregivers of individuals with early-stage Alzheimer's disease involved three sessions and was evaluated for its impact on communication strategies.

Participants reported positive changes in their communication effectiveness with the individuals they cared for, indicating that the training program successfully met its goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of AID-COM, a communication-focused program for family carers of people with early-stage Alzheimer's disease: A pilot study (innovative practice). Chesneau, S., Faucher, C., Morin, G., et al.[2021]

A comprehensive cognitive-linguistic intervention program for patients with mild to moderate Alzheimer's disease showed maintained or improved communication skills over four years, suggesting its effectiveness in preserving discourse abilities.

The program, which involved undergraduate students providing support through community activities, highlights the potential role of speech-language pathologists in training non-professional partners to assist individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of four years of exercise, language, and social interventions on Alzheimer discourse. Mahendra, N., Arkin, S.[2022]

A review of over 100 articles from various fields indicates that communication treatment can lead to positive outcomes for aging adults presumed to have dementia, highlighting the potential benefits of these interventions.

Despite the promising results, the studies have significant design and methodological flaws, suggesting that further research is needed before these communication interventions can be widely implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication treatment for adults with dementia. Bourgeois, MS.[2019]

Citations

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withpower.com

withpower.com/trial/phase-dementia-11-2021-3f3f9

KNOW Communication Intervention for Alzheimer's Disease

The program demonstrated significant positive changes in caregivers' communication interactions with Alzheimer's patients, addressing one of the major stressors ...

2.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70088

Efficacy of Communication Bridge‐2 for primary progressive ...

Outcomes demonstrate the feasibility and initial efficacy of a person-centered telemedicine intervention for maximizing communication participation.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5881770/

A Communication Intervention to Reduce Resistiveness in ...

A brief intervention can improve communication and reduce RTC, providing an effective nonpharmacological intervention to manage behavior and improve the ...

4.

uchicagomedicine.org

uchicagomedicine.org/forefront/research-and-discoveries-articles/2025/april/primary-progressive-aphasia-telemedicine-clinical-trial-results

Global telemedicine therapy for dementia shows benefit

Clinical trial results indicate that people living with primary progressive aphasia (PPA) and their communication partners benefit from remote speech language ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1041610224026620

A systematic review of communication strategies for people ...

Interventions around daily care activities had positive effects on communication outcomes. Effects of both types of interventions on neuropsychiatric symptoms ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11947768/

A randomized controlled trial of communication intervention

The study provides a model for rigorous non‐pharmacologic trials for Alzheimer's disease/Alzheimer's disease and related dementias (AD/ADRD).

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nature.com

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Testing the iMplementation Framework fOr behavioral and ...

Outcomes included time in screening phases, intervention adherence (attendance and intervention dose adherence, and safety [adverse events]).

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alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14168

Communication Bridge‐2 randomized controlled trial ...

The literature suggests that primarily non-pharmacological interventions have the potential to improve communication participation and ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1041610224013735

Aspects of communication in Alzheimer's disease: clinical ...

The aim of this review was to highlight the impact of communication deficits in AD, and discuss the need for effective treatments.