Family caregivers may hold key to preventing Post-Surgery confusion in seniors
NCT ID NCT07202208
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests a simple, family-led protocol called 'Delirium Zero' to prevent delirium (sudden confusion) in older adults after hip fracture surgery. About 140 patients over 65 will be randomly assigned to either standard care or the Delirium Zero protocol, which includes an orientation poster, a visible clock, and a checklist for family caregivers. The goal is to see if this low-cost approach can reduce the risk of delirium during hospital recovery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The participants will be patients over 65 years old * Admitted to the orthopedic hospitalization units of La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) and Manises Hospital (Manises Health Department, Spain). * Who are undergoing surgery for hip fracture * Accompanied by a family member/caregiver who understands Spanish and knows how to read and write it. Exclusion Criteria: \- Delirium at the time of admission to the trauma guard (assessed with the CAM scale). Have previously been diagnosed with severe cognitive impairment according to the Pfeiffer scale, which corresponds to a score of 8-10 points. * Have previously been diagnosed with any serious mental disorder (schizophrenic disorders, schizotypal disorders, persistent delusional disorders, substance-induced delusional disorders, schizoaffective disorders, other non-organic psychotic disorders, bipolar disorder, serious depressive episode with psychotic symptoms, and severe recurrent depressive disorders). - that they have delirium at the time of admission to the trauma room. * That they have a language barrier, deep aphasia, coma, or terminal illness. * That they have been previously enrolled in this study. * That before the surgery they were admitted to a different hospital unit than those participating in the study, although they may then be transferred to one of these trauma units. * That they present brain alterations (tumors, occupying lesions).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Manises
NOT_YET_RECRUITINGManises, Valencia, 46940, Spain
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Hospital Universitario y Politécnico La Fe
RECRUITINGValencia, Valencia, 46026, Spain
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