Actively Recruiting
Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery
Led by Cardenal Herrera University · Updated on 2025-10-01
140
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
Sponsors
C
Cardenal Herrera University
Lead Sponsor
H
Hospital Universitario La Fe
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of this research will be to investigate whether the control of care provided by the family/caregiver can prevent the onset of delirium in individuals undergoing surgical intervention for hip fracture. The research will be a randomized, single-blind, parallel, two-arm clinical trial that compares two conditions: intervention group, hereafter IG (Delirium Zero protocol based on a space-temporal orientation poster for the patient, a clock hung on the wall next to the orientation poster, and a checklist for the preventive measures taken by the caregiver/family), and control group, hereafter CG (standard of care). The participants will be patients over 65 years old, admitted to the trauma hospitalization units of the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain), operated on for hip fracture and accompanied by a relative/caregiver. The research will be carried out at the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) because it is the reference hospital for the Valencian Community, and because the rooms in this center are private, which allows for no interference between the intervention under study (in GI) or the standard care (GC).
CONDITIONS
Official Title
Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 65 years old
- Admitted to the orthopedic hospitalization units of La Fe University and Polytechnic Hospital in Valencia, Spain
- Undergoing surgery for hip fracture
- Accompanied by a family member or caregiver who understands Spanish and can read and write it
You will not qualify if you...
- Previously diagnosed with severe cognitive impairment (Pfeiffer scale score 8-10)
- Previously diagnosed with a serious mental disorder such as schizophrenia, bipolar disorder, or severe depressive disorder with psychotic symptoms
- Having delirium at the time of admission to the trauma room
- Having a language barrier, deep aphasia, coma, or terminal illness
- Previously enrolled in this study
- Admitted to a different hospital unit before surgery other than the trauma units participating in the study
- Stayed in the emergency room for more than 36 hours before entering the trauma hospitalization unit
- Presenting brain alterations such as tumors or occupying lesions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
Research Team
L
Laura García Garcés Principal Investigator., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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