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Prevention of Delirium Among Elderly Patients With Hip Fractures

Primary Purpose

Delirium, Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Care bundle
Sponsored by
Zhoupu Hospital, Pudong New Area, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Hip fractures, Delirium, Aged, Care bundle

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhoupu Hospital Shanghai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

Care bundle

routine care

Outcomes

Primary Outcome Measures

incidence of delirium among elderly patients with hip fractures
study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
March 18, 2018
Sponsor
Zhoupu Hospital, Pudong New Area, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03470662
Brief Title
Prevention of Delirium Among Elderly Patients With Hip Fractures
Official Title
Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhoupu Hospital, Pudong New Area, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Hip Fractures
Keywords
Hip fractures, Delirium, Aged, Care bundle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Care bundle
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Care bundle
Intervention Description
Care bundle
Primary Outcome Measure Information:
Title
incidence of delirium among elderly patients with hip fractures
Description
study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Zhoupu Hospital Shanghai
City
Shanghai
Country
China

12. IPD Sharing Statement

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Prevention of Delirium Among Elderly Patients With Hip Fractures

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