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Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

NCT05929703

RecruitingNA

Sponsor: University of Michigan

Conditions: Delirium, Neurocognitive Disorders, Mild Cognitive Impairment, Alzheimer Disease, Aging

Interventions: HELP, FAM-HELP

Countries: United States

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 overview

Sex: ALL

Age: 70 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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)
Locations (7)
  • Orange, California, United States
  • Portland, Maine, United States
  • Ann Arbor, Michigan, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Salt Lake City, Utah, United States
  • Madison, Wisconsin, United States