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NCT05929703
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Conditions: Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging, Family Support, Family Members, Caregiver Burden, Implementation Science, Patient Satisfaction
Sex: All
Ages: 70 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1900
Sponsor: University of Michigan
Location: Saddleback Medical Center Orange California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
* Active neurologic disease (as primary reason for admission)
Source: ClinicalTrials.gov (NCT05929703). StuddyBuddy aggregates publicly available trial information.