Prevention of Delirium Among Elderly Patients With Hip Fractures

March 18, 2018 updated by: Xiaoxiao Zhou, Zhoupu Hospital, Pudong New Area, Shanghai, China

Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Zhoupu Hospital Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
routine care
Experimental: experimental group
Care bundle
Other: Care bundle
Care bundle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhoupu Hospital, Pudong New Area, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 18, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YuFengbinDelirium

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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