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Prevention of Delirium Among Elderly Patients With Hip Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470662
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoxiao Zhou, Zhoupu Hospital, Pudong New Area, Shanghai, China

Study Description
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Brief Summary:

Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.

Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017．There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.


Condition or disease Intervention/treatment Phase
Delirium Hip Fractures Other: Care bundle Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
Care bundle
 Other: Care bundle
Care bundle
No Intervention: control group
routine care


Outcome Measures
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Primary Outcome Measures :
  1. incidence of delirium among elderly patients with hip fractures [ Time Frame: 3 weeks ]
    study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥65 years
  • with hip fractures
  • treated surgically

Exclusion Criteria:

  • <65 years
  • psychiatric history
  • ICU post-operation
  • refuse to join this study
  • have delirium pre-operation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470662


Locations
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China
Zhoupu Hospital Shanghai
Shanghai, China
Sponsors and Collaborators
Zhoupu Hospital, Pudong New Area, Shanghai, China
More Information
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Responsible Party: Xiaoxiao Zhou, Director of Orthopaedics Department, Zhoupu Hospital, Pudong New Area, Shanghai, China
ClinicalTrials.gov Identifier: NCT03470662    
Other Study ID Numbers: YuFengbinDelirium
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoxiao Zhou, Zhoupu Hospital, Pudong New Area, Shanghai, China:
Hip fractures
Delirium
Aged
Care bundle
Additional relevant MeSH terms:
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Delirium
Fractures, Bone
Hip Fractures
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Hip Injuries
Leg Injuries