NCT02240225

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 11, 2014

Last Update Submit

September 11, 2014

Conditions

Chronic Obstructive Pulmonary DiseaseHypercapnic Respiratory Failure

Keywords

COPD;SRI;Reliability;validity;

Outcome Measures

Primary Outcomes (1)

  • Reliability of Severe Respiratory Insufficiency Questionnaire

    2 weeks

Secondary Outcomes (2)

  • Construct validity of Severe Respiratory Insufficiency Questionnaire

    2 weeks

  • Criterion validity of Severe Respiratory Insufficiency Questionnaire

    2 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Central Study Contacts

Zhou LuQian, Doctor

CONTACT

+86-15622236759zhlx09@163.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Guangzhou Institute of Respiratory Disease

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 15, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

CN(1)