Actively Recruiting
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Led by University of Michigan · Updated on 2026-03-24
1900
Participants Needed
7
Research Sites
190 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
The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following: 1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity. 2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes. 3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.
CONDITIONS
Official Title
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of informed consent
- At least 70 years of age
- Anticipated length of hospital stay at least 72 hours
- Family member or care partner available to be on-site in the hospital
- At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment)
- Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment)
You will not qualify if you...
- Delirium on admission
- Unable to communicate verbally (e.g., coma, mechanical ventilation)
- Unable to participate fully in interventions (e.g., terminal condition, advanced dementia)
- Staff safety concerns (e.g., violent behavior)
- Cardiac or intracranial surgery (due to competing causes of delirium)
AI-Screening
AI-Powered Screening
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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
CONTACT
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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