Application and Revision of Montreal Cognitive Assessment... | NCT02483754

Studies
Application and Revision of Montreal Cognitive Assessment in Chinese Retirees

NCT02483754

Sponsor

Xijing Hospital

Status

Completed

Last Update Posted

Jan 26, 2017Estimated

Enrollment

304Actual

Phase

Not provided

Conditions

Mild Cognitive Impairment

Interventions

Not provided

Countries

Not provided

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 24, 2015

First Posted Date

Jun 29, 2015Estimated

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

Jan 24, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study was designed to employ MOCA to screen mild cognitive impairment (MCI) in military retirees and to analyze the associated risk factors. As such, MOCA was revised to be validated for the Chinese context.

Detailed Description

Three hundred and four retired military cadres were investigated using a random cluster sampling technique including personal information, prevalence, MOCA scale, and related neuropsychiatry scale. Thirty retirees were random chosen and tested again with the revised MOCA scale one month later.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

304Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
original MOCA		The Chinese retired military cadres were surveyed with the revised MOCA scale.
revised MOCA		The random part of participants were surveyed with the revised MOCA scale.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MCI occurrence rate	Three hundred and four retired military cadres from 9 Xi'an military sanatoria were investigated，assessed up to 8 months	up to 8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged >=60 years old retired military cadres lived in Xian,Shaanxi,China questionnaires completed

Exclusion Criteria:

deaf-mute

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Three hundred and four retired military cadres.They can be divided by age, level of education and physical exercise and cerebral apoplexy to evaluate their mild cognitive impairment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaoming Wang, Doctor	Air Force Military Medical University, China	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided