- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303089
Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients
Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients: A Cross-Sectional Study.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- XIAW
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants aged 18 years or older;
- Participants with a confirmed diagnosis of Chronic Kidney Disease;
- Participants were able to speak and read Chinese.;
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of current smokers
Time Frame: Baseline
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A true or false sheet in the questionnaire.
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Baseline
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Abstinence rates
Time Frame: Baseline
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A true or false sheet in the questionnaire.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Nicotine dependence
Time Frame: Baseline
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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.
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Baseline
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Perceptions of tobacco harm
Time Frame: Baseline
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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.
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Baseline
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knowledge of tobacco-related diseases
Time Frame: Baseline
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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.
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Baseline
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Smoking related attitudes
Time Frame: Baseline
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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.
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Baseline
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Self-efficacy level
Time Frame: Baseline
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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.
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Baseline
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Withdrawal symptoms
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei Xia, PhD, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- zzwee-quit (CKD) 23152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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