Validation of Chinese SRI Questionnaire | NCT02240225

Studies
Validation of Chinese SRI Questionnaire

NCT02240225

Sponsor

Guangzhou Institute of Respiratory Disease

Status

Unknown status

Last Update Posted

Sep 15, 2014Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Hypercapnic Respiratory Failure

Interventions

Not provided

Countries

China

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Oct 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Sep 11, 2014

First Submission Date that Met QC Criteria

Sep 11, 2014

First Posted Date

Sep 15, 2014Estimated

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

Sep 11, 2014

Last Update Posted Date

Sep 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

LuQian Zhou, Assistant professor of Guangzhou Institute of Respiratory Disease, Guangzhou Institute of Respiratory DiseasePrincipal Investigator

Lead Sponsor

Guangzhou Institute of Respiratory DiseaseOTHER

Collaborators

Name	Class
Southern Medical University, China	OTHER
Second Affiliated Hospital, Sun Yat-Sen University	OTHER
Third Affiliated Hospital, Sun Yat-Sen University	OTHER

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

Assessment of health-related quality of life in COPD patients with severe chronic respiratory failure requires appropriate and highly specific measurement tools. We attempt to validate the Chinese version of the Severe Respiratory Insufficiency Questionnaire (SRI)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability of Severe Respiratory Insufficiency Questionnaire		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Construct validity of Severe Respiratory Insufficiency Questionnaire		2 weeks
Criterion validity of Severe Respiratory Insufficiency Questionnaire		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult COPD Patients with chronic hypercapnic respiratory failure established on home noninvasive ventilation for at least 1 month
Patients are in a clinically stable state,without any changes of medication during the previous 4 weeks.

Exclusion Criteria:

patient's refusal to participate
Patients with evidence of acute respiratory failure i.e.patients with worsening of symptoms during the previous 2 weeks, a pH ,7.35, or with signs of respiratory infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult COPD patients with chronic hypercapnic respiratory failure receiving home noninvasive ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhou LuQian, Doctor	Contact	+86-15622236759		zhlx09@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangzhou Institute of Respiratory Disease	Recruiting	Guangzhou	Guangdong	510120	China

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided