Chronic Obstructive Pulmonary DiseaseVCSRINCT02240225
Validation of Chinese SRI Questionnaire
An observational study of Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Oct 2014
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult COPD patients with chronic hypercapnic respiratory failure receiving home noninvasive ventilation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, 510120
Chen RongChang, Doctor, 008613902273260, icelucy@126.com
Chen Rongchang, Doctor
About this study
Official title: Validation of Chinese Severe Respiratory Insufficiency （SRI）Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure
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)
- Keywords
- COPD;SRI;Reliability;validity;
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of Severe Respiratory Insufficiency Questionnaire
Measured: 2 weeks
Secondary outcomes (2)
Construct validity of Severe Respiratory Insufficiency Questionnaire
Measured: 2 weeks
Criterion validity of Severe Respiratory Insufficiency Questionnaire
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China, Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Shaoguan People's Hospital, Dongguan People's Hospital, The center hospital of Wuhan
- Responsible party
- Principal investigator, LuQian Zhou, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240225
- Sponsor's protocol ID
- GZIRD-20140910
- Acronym
- VCSRI
- Status last verified
- Sep 2014
- First submitted
- 11 Sep 2014
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Chinese Severe Respiratory Insufficiency （SRI）Questionnaire for COPD Patients With Chronic Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT02240225
- Acronym / sponsor ID
- VCSRI / GZIRD-20140910
- Keywords
- COPD;SRI;Reliability;validity;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Southern Medical University, China, Second Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Shaoguan People's Hospital, Dongguan People's Hospital, The center hospital of Wuhan
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult COPD patients with chronic hypercapnic respiratory failure receiving home noninvasive ventilation
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of Severe Respiratory Insufficiency Questionnaire
Time frame: 2 weeks
2 secondary outcomes
Construct validity of Severe Respiratory Insufficiency Questionnaire
Time frame: 2 weeks
Criterion validity of Severe Respiratory Insufficiency Questionnaire
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou LuQian, Doctor (+86-15622236759, zhlx09@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of Severe Respiratory Insufficiency Questionnaire (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2014.