E-Cig UseNCT05477888
Psychometric Properties of the Chinese Version of Penn State [Electronic] Cigarette Dependence Index
An observational study of E-Cig Use, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use
- What is being tested?
- Questionnaires set
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2022to 30 May 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- (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.
Who cannot join
- Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- E-Cig Use
- Being tested
- Questionnaires set
- Keywords
- Adolescent, Electronic Nicotine Delivery Systems / psychology, Psychometrics
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires setOther
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 ).
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires assessed e-cigarette users | 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. Receives: Other: Questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
E-cigarette dependence
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).
Measured: Baseline
Secondary outcomes (3)
Self-reported addiction
Measured by a 0-100 point scale：the higher the score of the participant, the more severe the dependence on e-cigarettes.
Measured: Baseline
Time to first vape
Corroborative evidence for e-cigarette dependence：the shorter the time interval, the greater the dependence on e-cigarettes.
Measured: Baseline
Vapes/day and vaping days/week
Corroborative evidence for e-cigarette dependence：the higher the frequency, the more severe the dependence on e-cigarettes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start27 May 2022
- Primary completion27 Mar 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477888
- Sponsor's protocol ID
- wjn-ChiCTR2200060896
- Status last verified
- Sep 2023
- First submitted
- 24 Jul 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified individual participant data will be shared after the outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Chinese Version of Penn State [Electronic] Cigarette Dependence Index
- ClinicalTrials.gov ID
- NCT05477888
- Acronym / sponsor ID
- wjn-ChiCTR2200060896
- Conditions
- E-Cig Use
- Keywords
- Adolescent, Electronic Nicotine Delivery Systems / psychology, Psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed e-cigarette users | – | Other: Questionnaires set1. ≥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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (1 listed)
- Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires setParticipants will be asked to respond to the demographic information sheet,e-cigarette using characteristics sheet,the Penn State Electronic Cigarette Dependence Index (PS-ECDI ). | Other | Questionnaires assessed e-cigarette users |
Primary outcome
E-cigarette dependence
Time frame: Baseline
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).
3 secondary outcomes
Self-reported addiction
Time frame: Baseline
Time to first vape
Time frame: Baseline
Vapes/day and vaping days/week
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Yes. The non-identified individual participant data will be shared after the outcomes have been published.
Related trials for E-Cig Use
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Mindful Breaths: Mindfulness for Young Adult Vaping
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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.
Wei Xia, PhD principal investigator
Sun Yat-sen University
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 E-Cig Use, run by Sun Yat-sen University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E-cigarette dependence (time frame: Baseline). 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 6 Sep 2023.