← Back to Search

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

Must not have

Unable to communicate verbally (e.g., coma, mechanical ventilation)

Delirium on admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hospital discharge through 30 days after discharge

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 70 years old or older.

Exclusion Criteria

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

Select...

I cannot speak due to my current health condition.

Select...

I was experiencing confusion or altered mental state when admitted.

Select...

I am not able to fully participate in treatments due to a severe condition.

Select...

I have not had recent heart or brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of hospital admission through hospital discharge (typically up to 30 days after hospital admission, may extend to 60 or more days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Delirium Incidence

Delirium Severity

Secondary study objectives

30-Day Readmission

Caregiving Strain

Cognitive Function - Subjective Reporting

+10 more

Other study objectives

Antipsychotic use

Restraint use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met