Smoking CessationNCT06303089
Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients
An observational study of Smoking Cessation, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Questionnaires set
- How many people
- 567 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2024to 15 Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Kidney Disease Patients
Who may be able to join
- Participants aged 18 years or older;
- Participants with a confirmed diagnosis of Chronic Kidney Disease;
- Participants were able to speak and read Chinese.;
Who cannot join
- Participants who with psychiatric illness, disorders of consciousness, communication impairments, were unable to communicate effectively;
- Participants who have acute and life-threatening exacerbations which require urgent treatment;
- Patients who currently involved in other smoking cessation programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients: A Cross-Sectional Study.
The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation.
Read the detailed description
Participants will be invited to recall their smoking status and tobacco-related KAP. Smokers need to identify their smoking cessation behavior.
First part: participants need to finish the questionnaire, which includes the demographic information sheet, characteristics of smoking sheet, and tobacco-related KAP. Including (a) patients' knowledge of health risks of tobacco and tobacco-related diseases (the delphi method was used to construct this knowledge questionnaire); and (b) perceptions of tobacco harm.
Second part: smokers need to finish the questionnaire, which includes history of smoking cessation sheet, attitudes towards tobacco control smoking cessation, nicotine dependence sheet, tobacco withdrawal symptoms sheet, intention to quit smoking sheet, ability to quit smoking sheet, alcohol use disorders and physical activity.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaires set
- Keywords
- Chronic kidney disease, Smoking cessation behavior, Cross-sectional study, Tobacco-related knowledge, attitudes, and practice, Tobacco exposure
- Medical subject headings
- Smoking Cessation, Renal Insufficiency, Chronic, Behavior
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, characteristics of smoking sheet, tobacco-related knowledge, perceptions of tobacco harm. Smokers will be asked the history of smoking cessation sheet, the Fagerstrom Test of Nicotine Dependence, Smoking Self-efficacy Questionnaire, Cigarette Withdrawal Scale, Intention to Quit Smoking sheet, Motivation to Quit Smoking sheet, Alcohol Use Disorders Identification Test, and International Physical Activity Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires assessed Chronic Kidney Disease patients | Participants who met the inclusion criteria below will be invited to fill in tobacco exposure questionnaires, smokers will be invited to complete smoking cessation questionnaires set.
1. Participants aged 18 years or older;
2. Participants with a confirmed diagnosis of Chronic Kidney Disease; Receives: Other: Questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of current smokers
A true or false sheet in the questionnaire.
Measured: Baseline
Abstinence rates
A true or false sheet in the questionnaire.
Measured: Baseline
Secondary outcomes (6)
Nicotine dependence
The Fagerstrom Test for Nicotine Dependence (FTND) was applied to assess nicotine dependence, which has a set of 6 items with an overall score ranging from 0-10. High dependence was defined as an FTND score ≥7; medium dependence, a score ranging from 4-6; low dependence, a score ranging from 0-3.
Measured: Baseline
Perceptions of tobacco harm
Knowledge of health hazards of active and passive smoking was applied to assess perceptions of tobacco harm. The questionnaire has a set of 17 items which was developed according to the literature review content. Participants were asked to answer whether the knowledge about tobacco harm contained in the entry is correct: yes, no, or don't know. the higher percentages of correct responses to each item of the knowledge subscale means the better mastery of self-awareness of the hazard of smoking.
Measured: Baseline
knowledge of tobacco-related diseases
Tobacco-related chronic kidney disease (CKD) was applied to assess knowledge of tobacco-related diseases. The questionnaire has a set of 23 items which was developed according to the literature review content (The delphi method was used to construct this knowledge level questionnaire). This questionnaire was categorized into three subscales, namely cigarette smoking increases the risk of CKD (15 items), e-cigarettes and nephrotoxicity (2 items) and health benefits of smoking cessation for patients with CKD (6 items), with the answer: know, know a little, do not know or not sure. Higher scores of both subscales indicate the greater mastery of knowledge of tobacco-related diseases.
Measured: Baseline
Smoking related attitudes
Smoking Rationalization Beliefs (SRBs) refer to the relevant attitudes that smokers use to rationalize their smoking behavior and maintain their smoking status. The simplification of the scale with 8 items, each question use a five-point likert scale with 1 being 'strongly agree' and 5 being 'strongly disagree'. The higher the score was, the lower the SRBs.
Measured: Baseline
Self-efficacy level
Smoking Self-Efficacy Questionnaire (SEQ-12) was applied to assess the self-efficacy level. The SEQ-12 is a self-report inventory consisting of 12 items measuring the confidence of current and exsmokers in their ability to abstain from smoking in high-risk situations. The instrument is intended to measure two dimensions: internal stimuli (6 items) and external stimuli (6 items). Responses were solicited with a five-point Likert scale ranging from 1=not at all sure to 5=absolutely sure, where greater values indicated that the respondent perceived greater confidence in resisting smoking in the context.
Measured: Baseline
Withdrawal symptoms
The 9-item version of Minnesota Nicotine Withdrawal Scale (MNWS) was used for detection of withdrawal symptoms, which was revealed to have two domains of negative affect and insomnia and three individual items. Participants rated the symptoms by using a 5-point Likert-type (0=not present to 4=severe). Higher values of the MNWS indicate more severe nicotine withdrawal symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start5 Apr 2024
- Primary completion31 Jan 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 567 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
- NCT06303089
- Sponsor's protocol ID
- zzwee-quit (CKD) 23152
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2024
- Last updated
- 23 Apr 2025
- 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients: A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT06303089
- Acronym / sponsor ID
- zzwee-quit (CKD) 23152
- Conditions
- Smoking Cessation
- Keywords
- Chronic kidney disease, Smoking cessation behavior, Cross-sectional study, Tobacco-related knowledge, attitudes, and practice, Tobacco exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 12 Mar 2024 (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 describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation.
Detailed description
Participants will be invited to recall their smoking status and tobacco-related KAP. Smokers need to identify their smoking cessation behavior.
First part: participants need to finish the questionnaire, which includes the demographic information sheet, characteristics of smoking sheet, and tobacco-related KAP. Including (a) patients' knowledge of health risks of tobacco and tobacco-related diseases (the delphi method was used to construct this knowledge questionnaire); and (b) perceptions of tobacco harm.
Second part: smokers need to finish the questionnaire, which includes history of smoking cessation sheet, attitudes towards tobacco control smoking cessation, nicotine dependence sheet, tobacco withdrawal symptoms sheet, intention to quit smoking sheet, ability to quit smoking sheet, alcohol use disorders and physical activity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed Chronic Kidney Disease patients | – | Other: Questionnaires setParticipants who met the inclusion criteria below will be invited to fill in tobacco exposure questionnaires, smokers will be invited to complete smoking cessation questionnaires set. 1. Participants aged 18 years or older; 2. Participants with a confirmed diagnosis of Chronic Kidney Disease; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Kidney Disease Patients
Key inclusion criteria (3 listed)
- Participants aged 18 years or older;
- Participants with a confirmed diagnosis of Chronic Kidney Disease;
- Participants were able to speak and read Chinese.;
Key exclusion criteria (3 listed)
- Participants who with psychiatric illness, disorders of consciousness, communication impairments, were unable to communicate effectively;
- Participants who have acute and life-threatening exacerbations which require urgent treatment;
- Patients who currently involved in other smoking cessation programs.
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, characteristics of smoking sheet, tobacco-related knowledge, perceptions of tobacco harm. Smokers will be asked the history of smoking cessation sheet, the Fagerstrom Test of Nicotine Dependence, Smoking Self-efficacy Questionnaire, Cigarette Withdrawal Scale, Intention to Quit Smoking sheet, Motivation to Quit Smoking sheet, Alcohol Use Disorders Identification Test, and International Physical Activity Questionnaire. | Other | Questionnaires assessed Chronic Kidney Disease patients |
Primary outcome
Prevalence of current smokers
Time frame: Baseline
A true or false sheet in the questionnaire.
Abstinence rates
Time frame: Baseline
A true or false sheet in the questionnaire.
6 secondary outcomes
Nicotine dependence
Time frame: Baseline
Perceptions of tobacco harm
Time frame: Baseline
knowledge of tobacco-related diseases
Time frame: Baseline
Smoking related attitudes
Time frame: Baseline
Self-efficacy level
Time frame: Baseline
Withdrawal symptoms
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 23 Apr 2025.
- Individual participant dataSharing planned: Yes. The non-identified individual participant data will be shared after the outcomes have been published.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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 Smoking Cessation, 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 3 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 23 Apr 2025. 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?
Prevalence of current smokers (time frame: Baseline). The study lists 2 primary outcomes in all. 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 23 Apr 2025.