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.
Eligible Conditions
- Dementia
- Alzheimer's Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 6 Secondary · Reporting Duration: Baseline, Post-Intervention (within 2 weeks), 3-month follow up
Week 2
Change in advance care planning preparedness, as measured by the Advance Care Planning Engagement Survey: Process Measures
Change in caregiver burden (caregivers only), as measured by the Zarit Burden Interview
Change in caregivers' 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 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
Change in discussion of advance directives
Change in knowledge about dementia trajectory, as measured by the Alzheimer's Disease Knowledge Scale
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures
Change in perceived need for advanced care planning (ACP), as measured by the Decisional Balance scale
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS)
Change in psychological distress/depression, as measured by the Center for Epidemiological Studies Depression Scale
Change in the number of patients who have completed advance directives
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
KNOW Intervention
1 of 1
Experimental Treatment
90 Total Participants · 1 Treatment Group
Primary Treatment: KNOW · No Placebo Group · N/A
KNOW Intervention
Behavioral
Experimental Group · 1 Intervention: KNOW · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-intervention (within 2 weeks), 3-month follow up
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,415 Previous Clinical Trials
3,486,079 Total Patients Enrolled
218 Trials studying Dementia
902,417 Patients Enrolled for Dementia
Weill Medical College of Cornell UniversityLead Sponsor
990 Previous Clinical Trials
1,339,279 Total Patients Enrolled
5 Trials studying Dementia
2,957 Patients Enrolled for Dementia
Sara Czaja, PhDPrincipal InvestigatorWeill Medical College of Cornell University
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The Montreal Cognitive Assessment (MoCA) score is ≥16.
The person has the capacity to consent to a low risk study, as indicated by a score of ≥9 on the University of California-San Diego Brief Assessment of Capacity to Consent.
ADRD is diagnosed when a person has a gradual or sudden onset of memory loss and other changes in thinking abilities that affect daily life.
Residents in nursing homes may have the capacity to make decisions about their health care, as indicated by guidelines that have been shown to be reliable.
The person the ADRD patient indicates who provides their informal (unpaid) care.
The text states that the care provider must provide care to the patient for a minimum of eight hours per week for at least the past six months.
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Conditions
Cancer Related
Treatments