Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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