NCT05929703 Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders
| NCT ID | NCT05929703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,900 participants in total. It began in 2023-12-04 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Sharon K Inouye, MD
PRINCIPAL INVESTIGATOR
Hebrew SeniorLife
Frequently Asked Questions
Who can join the NCT05929703 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05929703 currently recruiting?
Yes, NCT05929703 is actively recruiting participants. Contact the research team at EvaSchmitt@hsl.harvard.edu for enrollment information.
Where is the NCT05929703 trial being conducted?
This trial is being conducted at Orange, United States, Portland, United States, Ann Arbor, United States, Philadelphia, United States and 3 additional locations.
Who is sponsoring the NCT05929703 clinical trial?
NCT05929703 is sponsored by University of Michigan. The principal investigator is Sharon K Inouye, MD at Hebrew SeniorLife. The trial plans to enroll 1,900 participants.