Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• The participants will be patients over 65 years old

• Admitted to the orthopedic hospitalization units of the La Fe University and Polytechnic Hospital (La Fe health department, Valencia, 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.

Locations
Other Locations
Spain
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
Laura García Garcés Principal Investigator., PhD
laura.garcia19@uchceu.es
(+34) 961369000
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 140
Treatments
Experimental: Delirium Zero
In addition to the standard of care that the Control Group receives, the Intervention Group (Delirium Zero) will be subjected to the 'Delirium Zero' protocol.
Active_comparator: Control Group
The Control Group receives the standard of care to prevent delirium.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Politècnic i Universitari la Fe de València
Leads: Cardenal Herrera University

This content was sourced from clinicaltrials.gov