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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (within 2 weeks), 3-month follow up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: KNOW InterventionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,462 Total Patients Enrolled
7 Trials studying Dementia
3,114 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,973 Total Patients Enrolled
266 Trials studying Dementia
23,625,270 Patients Enrolled for Dementia
Sara Czaja, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

KNOW Clinical Trial Eligibility Overview. Trial Name: NCT05143255 — N/A
Dementia Research Study Groups: KNOW Intervention
Dementia Clinical Trial 2023: KNOW Highlights & Side Effects. Trial Name: NCT05143255 — N/A
KNOW 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143255 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this experiment hoping to accomplish?

"The primary aim of this clinical trial, monitored at Baseline and Post-Intervention (within 2 weeks) as well as 3 months later is to assess the Alteration in conversation about advance directives. Secondary objectives include gauging Variance in consensus regarding healthcare values through utilization of the Health Care Values Rating Scale - differences between responses from ADRD patients and their caregivers being viewed as concordance if a one point discrepancy or less per item is present; Evaluation on perceived necessity for advanced care planning with the Decisional Balance scale, where scores can vary from 12 (low importance) to 60 (high importance); and Estimation of caregiver burden"

Answered by AI

Is it currently feasible to join this clinical investigation?

"As evidenced by the information posted on clinicaltrials.gov, this trial is presently seeking volunteers for participation. The details of the study were first made available to participants in March 2021 and was revised as recently as May 2022."

Answered by AI

How many participants are being monitored during this trial?

"Affirmative. Clinicaltrials.gov stipulates that this clinical trial, which was initially advertised on March 24th 2022, is currently recruiting participants with the goal of getting 90 patients from one site involved in the study."

Answered by AI
~60 spots leftby Sep 2024