Early Diagnosis and Treatment Standardization of Delirium

September 20, 2019 updated by: Bong-Jin Hahm, Seoul National University Hospital
  1. Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors
  2. Design a guideline for delirium, diagnosis or treatment

Study Overview

Status

Completed

Conditions

Detailed Description

The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.

Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.

Study Type

Observational

Enrollment (Anticipated)

250

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.

Description

Inclusion Criteria:

  • Curable malignant gastric cancer

Exclusion Criteria:

  • Gastrointestinal stromal tumor
  • Uncurable cancer

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delirium Rating Scale-98
Time Frame: Till 1 year after surgery
Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium
Till 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional assessment of cancer therapy - gastric cancer
Time Frame: Till 1 year after surgery
Quality of life measuring tool for gastric cancer
Till 1 year after surgery

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

May 17, 2016

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (ACTUAL)

June 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072016105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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