No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
70 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
1,900 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for older adults who are at least 70 years old and are expected to be in the hospital for at least three days. They should have some risks for confusion, like trouble thinking or seeing, and need to have a family member or caregiver who can be with them in the hospital. However, it won’t include anyone who is already confused when they arrive or can't communicate clearly.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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, …
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)
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