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Advance Care Planning Group Visits for Older Adults with Alzheimer's (ENACT Trial)
N/A
Waitlist Available
Led By Hillary Lum, MD, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 and older
Age 70 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
ENACT Trial Summary
This trial is testing whether a group visit intervention can help patients better align their medical care with their values. Patients will meet in groups of 8-10, facilitated by a geriatrician and social worker, for two 2-hour sessions, one month apart.
Who is the study for?
This trial is for older adults aged 70 or above who have visited a primary care clinic in the past year and do not have an advance care planning document on file. Participants must speak English at UCHealth clinics or English/Spanish at Denver Health clinic.Check my eligibility
What is being tested?
The ENACT Group Visit intervention, which includes two group discussions about future medical care preferences facilitated by healthcare professionals, is being tested against receiving mailed resources for advance care planning.See study design
What are the potential side effects?
Since this trial involves discussions rather than medical treatments, there are no direct physical side effects. However, participants may experience emotional discomfort discussing sensitive end-of-life topics.
ENACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am 70 years old or older.
ENACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months
Secondary outcome measures
Composite of advanced care planning documentation
Measure of decision self-efficacy
Measure of readiness for ACP
+1 moreOther outcome measures
Patient Reported Outcome Measurement Information System Global Health Scores
Percent of Recruitment (Reach)
Percent of Retention
+1 moreENACT Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Participants: ENACT Group VisitExperimental Treatment1 Intervention
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
Group II: CaregiversActive Control1 Intervention
Caregivers will be consented via postcard consent to facilitate patient participants' engagement in the trial and group visits. Outcome measure, demographics, and adverse event data will not be collected for this arm, however caregivers will assist participants in providing outcome measure data (responding to surveys, etc.)
Group III: Participants: Mailed ResourcesActive Control1 Intervention
Participants will receive printed advance care planning resources by mail.
Group IV: Clinic StakeholdersActive Control1 Intervention
Clinic stakeholders providing care for participants enrolled in the "Participants: Enact Group Visits" arm. Demographics, and adverse event data will not be collected for this arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ENACT group visit
2017
N/A
~110
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,142,983 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,004,514 Total Patients Enrolled
Hillary Lum, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot travel to the clinic for treatment.I prefer to communicate in English.This criterion does not apply to my personal medical condition.I am 18 years old or older.I am 70 years old or older.I have visited a clinic at least once in the past year.I am unable to understand and agree to the study's details on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Caregivers
- Group 2: Participants: Mailed Resources
- Group 3: Participants: ENACT Group Visit
- Group 4: Clinic Stakeholders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting participants for this experiment?
"The clinical trial is currently in the process of enrolling participants, which began on July 14th 2022. The information was last modified on October 20th 2022 according to clinicaltrials.gov."
Answered by AI
What is the aggregate size of participants in this experiment?
"Affirmative. According to the information posted on clinicaltrials.gov, enrollment for this medical trial first began on July 14th 2022 and is ongoing as of October 20th 2022. The research team is seeking 600 participants from 8 different sites."
Answered by AI
Are there any Canadian locations currently carrying out this research?
"The trial is currently running at 8 different sites, including UCHealth in Aurora, UC Health Lone Tree Seniors in Lone Tree, and UC Health AF Williams Family Medicine in Denver. Other locations are included as well."
Answered by AI
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