NCT05929703Recruiting
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1900 (estimated)
- First submitted
- 20 Jun 2023
- Start date
- Dec 2023
- Primary completion date
- May 2027
- Lead sponsor
- University of Michigan
- Diseases
- Alzheimer disease
- NCT number
- NCT05929703
What you commit to
- Study type: Interventional
- Planned participants: 1900
- From Dec 2023 to the primary completion date, May 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unable to participate fully in interventions (e.g., terminal condition, advanced dementia)
- Cardiac or intracranial surgery (due to competing causes of delirium)
- Active neurologic disease (as primary reason for admission)
Other
- Delirium on admission
- Unable to communicate verbally (e.g., coma, mechanical ventilation)
- Staff safety concerns (e.g., violent behavior)
Who the study is looking for
- 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)
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Meriter Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Saddleback Medical Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| MaineHealth Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.