Actively Recruiting
Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial
Led by Cardenal Herrera University · Updated on 2025-10-01
140
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating whether care provided by family members or caregivers can prevent delirium in patients over 65 undergoing surgery for hip fracture. This randomized, single-blind clinical trial compares two groups: one receiving the Delirium Zero protocol, and the other receiving standard care. The study is conducted in private rooms at La Fe University and Polytechnic Hospital, enabling clear comparison between the two approaches. The Delirium Zero protocol includes a patient orientation poster updated daily by the caregiver, a clock displayed next to the poster, and a checklist for caregivers to record preventive measures each day. Nurses will provide and collect the checklist daily until the patient is discharged. The control group receives the hospital's standard care to prevent delirium, along with educational materials on prevention strategies. Participants are involved from admission to the trauma unit until hospital discharge or up to six weeks. Researchers will monitor the appearance, severity, duration, and number of delirium episodes during this time. They will also track adherence to the Delirium Zero protocol. The study's total participation time depends on hospital stay length but includes daily monitoring and data collection related to delirium and caregiving activities.
CONDITIONS
Brief 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 aged 65 years or older
- 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 and can read and write Spanish
You will not qualify if you...
- Diagnosed with severe cognitive impairment (Pfeiffer scale score 8-10)
- Diagnosed with serious mental disorders such as schizophrenia, bipolar disorder, or severe depressive episodes with psychotic symptoms
- Presenting delirium at admission to the trauma unit
- Having a language barrier, deep aphasia, coma, or terminal illness
- Previously enrolled in this study
- Admitted to a different hospital unit before surgery
- Stayed in the emergency room for more than 36 hours before entering the trauma unit
- Presence of brain alterations like tumors or occupying lesions
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From admission to trauma unit until hospital discharge or up to 6 weeks, whichever comes first
Participants undergo hip fracture surgery and receive either the 'Delirium Zero' protocol in addition to standard care or standard care alone to prevent the onset of delirium during hospitalization.
Daily visits during hospital stay
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
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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