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KNOW Communication Intervention for Alzheimer's Disease

N/A

Waitlist Available

Led By Sara Czaja, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Patient: Age ≥ 65

Patient: Score of ≥9 on the University of California-San Diego Brief Assessment of Capacity to Consent

Must not have

Presence of significant sensory, language, or motor deficit (e.g., visual or hearing loss, paralysis, aphasia)

Patient is in the late stage of dementia (i.e., severe cognitive impairment), is bed-bound, or has a nursing home admission planned within 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (within 2 weeks), 3-month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will develop a communication-based intervention to improve understanding of Alzheimer's Disease, engagement in advance care planning, and receipt of goal-concordant care at the end-of-life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on a communication-based intervention rather than medication or medical procedures, traditional physical side effects are not expected. However, discussing sensitive topics such as end-of-life care may cause emotional distress.

Eligibility Criteria

Inclusion Criteria

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

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I am 65 years old or older.

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I am capable of making my own health decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am not fluent in English.

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I am 17 years old or younger.

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I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (within 2 weeks), 3-month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (within 2 weeks), 3-month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (within 2 weeks), 3-month 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 in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures

Change in care partners' engagement in advance care planning, as measured by the Van Scoy and Sudore measure which adapts the Decision Maker subscale of the Advance Care Planning Engagement Survey

Change in discussion of advance directives

+3 more

Secondary study objectives

Change in care partner burden (care partner only), as measured by the Zarit Burden Interview

Change in communication quality, as measured by the Family Communication Subscale of the Cancer Communication Assessment Tool for Patients and Families (CCAT-PF)

Change in concordance on healthcare values, as measured by the Health Care Values Rating Scale

+3 more