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Behavioral Intervention
Novel Healthcare Approaches for Delirium in Elders (ENHANCE Trial)
N/A
Recruiting
Led By Sharon K Inouye, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 70 years of age
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of hospital discharge through 30 days after discharge
Awards & highlights
ENHANCE Trial Summary
This trial will compare two programs to prevent delirium in older hospital patients & measure their effectiveness & implementation.
Who is the study for?
This trial is for people aged 70 or older who are hospitalized and expected to stay at least 72 hours. They must have a family member available to help, be able to give consent, and have at least one risk factor for delirium but not already be delirious upon admission.Check my eligibility
What is being tested?
The study compares two programs: HELP, which supports elderly patients in hospitals, and FAM-HELP, which includes family in the care process. It aims to see if involving families can better prevent or reduce the severity of delirium.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focusing on elder care support systems rather than drugs or medical procedures, there are no direct side effects like those associated with medications.
ENHANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 70 years old or older.
ENHANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delirium Incidence
Delirium Severity
Secondary outcome measures
30-Day Readmission
Caregiving Strain
Cognitive Function - Subjective Reporting
+10 moreOther outcome measures
Antipsychotic use
Restraint use
ENHANCE Trial Design
2Treatment groups
Active Control
Group I: Hospital Elder Life Program (HELP)Active Control1 Intervention
Hospital Elder Life Program (HELP) is built upon multicomponent, non-pharmacologic strategies that target delirium risk factors to optimize cognitive and clinical function during hospitalization.
Group II: Family-Augmented Hospital Elder Life Program (FAM-HELP)Active Control1 Intervention
The FAM-HELP program will incorporate a family member and/or care partner, who will play a central role with providing bedside support for delirium risk reduction. Family members and care partners will provide social and emotional support along with augmentation of HELP-based protocols.
Find a Location
Who is running the clinical trial?
University of UtahOTHER
1,100 Previous Clinical Trials
1,775,901 Total Patients Enrolled
1 Trials studying Implementation Science
284 Patients Enrolled for Implementation Science
Indiana UniversityOTHER
980 Previous Clinical Trials
978,762 Total Patients Enrolled
1 Trials studying Implementation Science
1,463 Patients Enrolled for Implementation Science
UnityPoint Health - Meriter HospitalUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot speak due to my current health condition.I am 70 years old or older.I am not able to fully participate in treatments due to a severe condition.I was experiencing confusion or altered mental state when admitted.I have not had recent heart or brain surgery.I have at least one risk factor for delirium, such as memory problems or dehydration.
Research Study Groups:
This trial has the following groups:- Group 1: Hospital Elder Life Program (HELP)
- Group 2: Family-Augmented Hospital Elder Life Program (FAM-HELP)
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.
Is there an ongoing recruitment of participants for this trial?
"At this juncture, clinicaltrials.gov outlines that this medical study is not recruiting patients - it was initiated on September 1st 2023 and last updated June 28th 2023. However, there are 1444 other studies actively looking for candidates right now."
Answered by AI
Is this clinical research being conducted in multiple Canadian locations?
"This trial has enrolled patients from a total of 7 medical institutions, including MaineHealth in Portland, Michigan Medicine in Ann Arbor and Hospital of the University of Pennsylvania in Philadelphia. Additionally, there are four other locations participating."
Answered by AI
What is the primary intent of this experiment?
"The primary endpoint for the trial, which covers a period of 14 days from enrolment to hospital discharge, is delirium severity. Secondary measures include: persistent delirium assessed by the long-form Confusion Assessment Method (AM), patient's Delirium Burden as calculated using DEL-B-P and caregiver strain evaluated with MCSI."
Answered by AI
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