- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05477888
Psychometric Properties of the Chinese Version of Penn State [Electronic] Cigarette Dependence Index
September 5, 2023 updated by: Wei XIA, PhD, Sun Yat-sen University
The purpose of this study is to realize the first evaluation of the psychometric characteristics of the Chinese version of the the Penn State University Electronic Cigarette Dependence Index Scale.
Study Overview
Detailed Description
This study will use forward translation, reverse translation, and comprehensive methods to Chinese-translate the Penn State University Electronic Cigarette Dependence Index Scale to form a Chinese version of the Penn State University Electronic Cigarette Dependence Index Scale that is more in line with the Chinese language and cultural environment.
This study will also verify its reliability and validity in a large sample population to form a formal version of the scale.
The scale will provide an effective tool for evaluating the degree of e-cigarette dependence among young people and adolescents in my country.
Study Type
Observational
Enrollment (Actual)
320
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510080
- XIAW
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
A total number of 275 adults who used nicotine-containing e-cigarettes at least once a week for the past month and have smoked daily for the last 3 months
Description
Inclusion Criteria:
- (1)≥18 years old;
- (2)Those who used e-cigarettes at least once a week for the past month;
- (3)Be able to read and communicate in Chinese.
Exclusion Criteria:
- Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Questionnaires assessed e-cigarette users
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Participants will be asked to respond to the demographic information sheet,e-cigarette using characteristics sheet,the Penn State Electronic Cigarette Dependence Index (PS-ECDI ).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
E-cigarette dependence
Time Frame: Baseline
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The Penn State Electronic Cigarette Dependence Index is a validated self-reported instrument assessing e-cigarette dependence.Possible scales range from 0(no dependence) to 20(high dependency).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported addiction
Time Frame: Baseline
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Measured by a 0-100 point scale:the higher the score of the participant, the more severe the dependence on e-cigarettes.
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Baseline
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Time to first vape
Time Frame: Baseline
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Corroborative evidence for e-cigarette dependence:the shorter the time interval, the greater the dependence on e-cigarettes.
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Baseline
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Vapes/day and vaping days/week
Time Frame: Baseline
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Corroborative evidence for e-cigarette dependence:the higher the frequency, the more severe the dependence on e-cigarettes.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wei Xia, PhD, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2022
Primary Completion (Actual)
March 27, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
July 24, 2022
First Submitted That Met QC Criteria
July 27, 2022
First Posted (Actual)
July 28, 2022
Study Record Updates
Last Update Posted (Actual)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- wjn-ChiCTR2200060896
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The non-identified individual participant data will be shared after the outcomes have been published.
IPD Sharing Time Frame
After the publication of the study.
IPD Sharing Access Criteria
Researchers should contact the PI for approval of the study protocol.
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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