Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT05929703

Conditions

Delirium

Neurocognitive Disorders

Mild Cognitive Impairment

Alzheimer Disease

Aging

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

HELP

FAM-HELP

Study Details

Brief 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.

Conditions

Delirium

Neurocognitive Disorders

Mild Cognitive Impairment

Alzheimer Disease

Aging

Study ID

NCT05929703

Start date

Dec 4, 2023

Status verified date

Mar, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Hospital Elder Life Program (HELP)

Hospital Elder Life Program (HELP) is built upon multicomponent, non-pharmacologic strategies that target delirium risk factors to optimize cognitive and clinical function during hospitalization.

active comparator: Family-Augmented Hospital Elder Life Program (FAM-HELP)

The FAM-HELP program will incorporate a family member and/or care partner, who will play a central role with providing bedside support for delirium risk reduction. Family members and care partners will provide social and emotional support along with augmentation of HELP-based protocols.

Interventions

HELP

This is usual (standard) care across hospitals in this trial. A multidisciplinary team of nurse specialists, social workers, and volunteers implement daily protocols focused on orientation, cognitive stimulation, early mobilization, sleep enhancement, support with visual and hearing aids, mealtime assistance, hydration, reduction in polypharmacy, and nursing-based delirium prevention protocols.

FAM-HELP

Family members and care partners will provide daily emotional and social support during hospitalization. Additionally, family members and care partners will engage in HELP-based protocols throughout the day. The rationale for this protocol augmentation is two-fold: (1) HELP may not consistently have available volunteers (e.g., short-staffing) during a hospital stay, and (2) patients may be more likely to engage in therapeutic activities with a family member given the connection and comfort level.

Primary outcome measure

  • Delirium Incidence [ Time Frame: Day of trial enrollment through day of hospital discharge, up to 14 days ]
  • Delirium Severity [ Time Frame: Day of trial enrollment through day of hospital discharge, up to 14 days ]

Central Contacts and Locations

Central contacts

Eva Schmitt, PhD

617-971-5390EvaSchmitt@hsl.harvard.edu

Locations

Saddleback Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Elizabeth Chassagne, BSN, RN, NE-BC

949-452-3969EChassagne@memorialcare.org

MaineHealth

Recruiting

Portland, Maine, United States, 04102

Contacts

Emily Carter, MD

207-662-3157Emily.Carter1@mainehealth.org

Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jocelyn Wiggins, MD

734-647-7299wiggi@med.umich.edu

Shenbagam Dewar, MBBS

734-647-7299sdewar@med.umich.edu

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Rebecca Trotta, PhD

215-615-4925Rebecca.Trotta@pennmedicine.upenn.edu

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Lyn Weinberg, MD

412-235-5810Lyn.WEINBERG@ahn.org

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Roxanne Weiss, MD

210-462-6266Roxanne.Weiss@hsc.utah.edu

Meriter Hospital

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Carrie Bennett, DNP

(608) 417-5724carrie.bennett@unitypoint.org

More Information

Sponsor

University of Michigan

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • Delirium
  • Clinical Trial
  • Comparative Effectiveness Research
  • Implementation Science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-24.