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

90 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment KNOW for Alzheimer's disease?

The research suggests that structured communication interventions, like the KNOW treatment, can improve communication in Alzheimer's patients. Studies show that caregiver training programs and structured conversations can enhance communication relevance and reduce misunderstandings, which are key components of the KNOW treatment. ^{1 2 3 4 5}

How does the KNOW Communication Intervention treatment for Alzheimer's disease differ from other treatments?

The KNOW Communication Intervention is unique because it focuses on improving communication between Alzheimer's patients and their caregivers through specific strategies, rather than using medication. This approach aims to reduce stress and improve interactions by training caregivers in effective communication techniques. ^{1 3 6 7 8}

What is the purpose of this trial?

The proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the Centers for Medicare and Medicaid Services' (CMS) call for increased patient engagement in advance care planning (ACP) as part of standard care. The proposed study will address this public health issue by developing a communication-based intervention designed to improve Alzheimer's Disease and Related Dementias (ADRD) patients' and care partners' engagement in ACP, distress and care partner burden, and completion of advance directives and receipt of goal-concordant care at the end-of-life. Therefore, this study is aligned with the National Institute on Aging's long-term goal to improve the quality of care for ADRD patients and CMS's goal to increase engagement in ACP.

Research Team

Sara Czaja, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Conversation Intervention with Alzheimer's Patients: Increasing the Relevance of Communication. [2022]

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

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

4. England pubmed.ncbi.nlm.nih.gov

AAC to support conversation in persons with moderate Alzheimer's disease. [2021]

5. England 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). [2021]

6. France 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. [2018]

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

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

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

Communication treatment for adults with dementia. [2019]