Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
ID05929703

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)

Led by University of Michigan · Updated on 2026-03-24

1900

Participants Needed

7

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

H

Hebrew SeniorLife

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare the traditional Hospital Elder Life Program (HELP) with a family-augmented version called FAM-HELP to prevent delirium in older hospitalized patients. Delirium is a common and serious complication during hospital stays for older adults that can lead to loss of independence and increased healthcare costs. The study focuses on determining which program better reduces delirium incidence and severity, improves patient and family outcomes, and explores how FAM-HELP works in different hospital settings. The HELP program uses a team of nurse specialists, social workers, and volunteers to provide daily non-drug care such as orientation, cognitive stimulation, mobility assistance, sleep support, help with vision and hearing aids, hydration, and nutrition. The FAM-HELP program adds family members or care partners who support patients emotionally and socially throughout the hospital stay and assist with HELP activities to enhance patient engagement. Both programs are delivered during hospitalization, with family involvement being the key difference. Participants aged 70 and older with at least one delirium risk factor and an expected hospital stay of 72 hours or more will be involved. They will be monitored for delirium occurrence and severity daily up to 14 days during hospitalization. Additional assessments will track delirium duration, caregiver strain, cognitive function, hospital experience, physical function, falls, hospital stay length, discharge outcomes, and readmission up to 30 days after discharge. The study uses a randomized, double-blind design to compare outcomes between HELP and FAM-HELP groups.

CONDITIONS

Brief Title

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide informed consent
  • Be at least 70 years old
  • Expect to stay in the hospital for at least 72 hours
  • Have a family member or care partner available to be present in the hospital
  • Have at least one delirium risk factor such as cognitive or functional impairment, dehydration, or vision or hearing problems
  • Be able to complete a baseline cognitive function assessment
Not Eligible

You will not qualify if you...

  • Have delirium at the time of hospital admission
  • Unable to communicate verbally, such as being in a coma or on mechanical ventilation
  • Unable to fully participate in interventions due to conditions like advanced dementia or terminal illness
  • Present safety concerns for staff, such as violent behavior
  • Have undergone cardiac or brain surgery due to other causes of delirium

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 14 days or until hospital discharge

Participants receive either the Hospital Elder Life Program (HELP) or the Family-Augmented HELP (FAM-HELP), which involve daily protocols to prevent delirium through cognitive stimulation, early mobilization, sleep enhancement, and social support during hospitalization.

Daily visits during hospitalization

Follow-up

Duration - Up to 30 days after hospital discharge

Participants and their family members or care partners are monitored for delirium outcomes, cognitive function, caregiving strain, and hospital experience after discharge.

1 to 2 visits after discharge

Trial Site Locations

Total: 7 locations

1

Saddleback Medical Center

Orange, California, United States, 92868

Actively Recruiting

2

MaineHealth

Portland, Maine, United States, 04102

Actively Recruiting

3

Michigan Medicine

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

4

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

5

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

6

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

7

Meriter Hospital

Madison, Wisconsin, United States, 53715

Actively Recruiting

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Research Team

E

Eva Schmitt, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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