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Evaluating Healthcare Approaches for Hospitalized Elders

This study is looking at ways to prevent delirium (a sudden state of confusion) in older adults who are in the hospital. It compares two approaches: the Hospital Elder Life Program (HELP), which is standard care, and a new approach called FAM-HELP. FAM-HELP involves family members and care partners in the HELP activities, like helping with walking, eating, and keeping patients oriented. The study wants to see if FAM-HELP is better than HELP at reducing how often delirium happens and how severe it is. You might be able to join if you are at least 70 years old, expect to be in the hospital for at least 72 hours, and have a family member or care partner who can be at the hospital. The study plans to enroll 1900 people, but its current status is unclear.

Study design
This is an interventional study comparing two behavioral approaches, HELP and FAM-HELP, with a planned enrollment of 1900 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Delirium incidence and severity will be measured from the day you join the study through the day you leave the hospital, up to 14 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05929703

Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders

Recruiting
NAAges 70+InterventionalPrevention
University of Michigan
~1,900 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:HELPFAM-HELP

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delirium Incidence
Measured over Day of trial enrollment through day of hospital discharge, up to 14 days
+1 more outcome measured

Conditions

Delirium
Neurocognitive Disorders
Mild Cognitive Impairment
Alzheimer Disease
Aging
Family Support
Family Members
Caregiver Burden
Implementation Science
Patient Satisfaction

Explore related trials

Alzheimer's DiseaseDeliriumMild cognitive disorderNeurocognitive disorder

Where it's being run

7 sites across 6 states
Pennsylvania2
California1
Maine1
Michigan1
Utah1
Wisconsin1

Study leadership

  • Sharon K Inouye, MD · PRINCIPAL_INVESTIGATOR · Hebrew SeniorLife
  • Phillip E Vlisides, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Eva Schmitt, PhD
[email protected]
617-971-5390
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Delirium IncidenceDay of trial enrollment through day of hospital discharge, up to 14 days

    Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM), supplemented by a validated chart review approach for delirium.

  • Delirium SeverityDay of trial enrollment through day of hospital discharge, up to 14 days

    Delirium severity will be scored using the Confusion Assessment Method Long Form Severity Score (CAM-S) (n, 0-19, with higher number indicating more severe delirium). Score derived from the same CAM instrument and items used for delirium incidence.