NCT05477888

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

July 24, 2022

Last Update Submit

September 5, 2023

Conditions

Keywords

AdolescentElectronic Nicotine Delivery Systems / psychologyPsychometrics

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline

Secondary Outcomes (3)

  • Self-reported addiction

    Baseline

  • Time to first vape

    Baseline

  • Vapes/day and vaping days/week

    Baseline

Study Arms (1)

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.

Other: Questionnaires set

Interventions

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 ).

Questionnaires assessed e-cigarette users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • (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.

You may not qualify if:

  • Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

XIAW

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinal cotinine and exhaled carbon monoxide

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Wei Xia, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A.P.

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 28, 2022

Study Start

May 27, 2022

Primary Completion

March 27, 2023

Study Completion

May 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

The non-identified individual participant data will be shared after the outcomes have been published.

Shared Documents
SAP
Time Frame
After the publication of the study.
Access Criteria
Researchers should contact the PI for approval of the study protocol.

Locations