The Validity of the Thai Version of the Confusion Assessm... | NCT01267630

Studies
The Validity of the Thai Version of the Confusion Assessment Method

NCT01267630

Sponsor

Chiang Mai University

Status

Unknown status

Last Update Posted

Jun 23, 2011Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ANE10-08-06A-11	Other Identifier	Ethic committee, Faculty of Medicine, Chiang Mai University

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Nov 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Dec 27, 2010

First Submission Date that Met QC Criteria

Dec 27, 2010

First Posted Date

Dec 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly.

Detailed Description

The incidence of delirium in intensive care unit varied between 20 and 80% depending on many factors such as types of study, diagnostic tools, severity of patients.The occurrence of delirium is common in elderly patients. However, the prevalence of delirium in the intensive care has not been reported in Thailand. There is no common tool used for detecting delirium in Thai ICU. Currently, CAM-ICU has been developed for nonpsychiatric physician and other health care professionals to detect delirium. The sensitivity and specificity of CAM-ICU was 91-93% and 89-100% respectively. In addition, it has been translated to many version to diagnose deliriums for all over the world. In Thailand, there is no common tool used for detecting delirium in ICU. The use of CAM-ICU may be useful in Thai ICU settings.

Conditions Module

Conditions

Delirium

Keywords

Delirium of Mixed Origin
Subacute Delirium
Mental Disorders, Organic
Organic Brain Syndrome, Nonpsychotic
Organic Mental Disorders
Organic Mental Disorders, Psychotic
Psychoses, Traumatic
Cognition Disorder
Confusion state
Disorientation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical ICU		Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours .

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and Specificity of Thai version of the CAM-ICU for diagnosis of ICU delirium		within 48 hours after admission

Secondary Outcomes

Measure	Description	Time Frame
The prevalence of elderly delirium patients in intensive care unit		within 48 hours after ICU admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥ 55 years old

Exclusion Criteria:

Severe visual or auditory impairment
Comatose or moribund patients
Unable to communicate with Thai language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tanyong Pipanmekaporn	Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chiang Mai University Hospital		Maung	Chiang Mai	50200	Thailand
Department of Anesthesiology, Faculty of Medicine

Type	Date	Date Unknown
Release	Feb 10, 2012
Reset	Mar 21, 2012
Release	Aug 18, 2013
Reset	Oct 25, 2013

Submission Tracking

Estimated Results First Submitted Date

Feb 10, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 10, 2012			Mar 21, 2012
Aug 18, 2013

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D019965	Neurocognitive Disorders
D003072	Cognition Disorders
D003221	Confusion

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided