Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Recruiting now · Not applicable
Conditions studied: Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support, Family Members, Caregiver Burden, Implementation Science, Patient Satisfaction
In brief
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.
Key facts
- Study ID
- NCT05929703
- Run by
- University of Michigan
- People needed
- 1900
- Starts
- 2023-12-04
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-03-24
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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)
Where it is running
- Saddleback Medical Center — Orange, California, United States (enrolling)
- MaineHealth — Portland, Maine, United States (enrolling)
- Michigan Medicine — Ann Arbor, Michigan, United States (enrolling)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
- Meriter Hospital — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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