Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients

April 17, 2025 updated by: Wei XIA, PhD, Sun Yat-sen University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

567

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

    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • XIAW

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic Kidney Disease Patients

Description

Inclusion Criteria:

  1. Participants aged 18 years or older;
  2. Participants with a confirmed diagnosis of Chronic Kidney Disease;
  3. Participants were able to speak and read Chinese.;

Exclusion Criteria:

  1. Participants who with psychiatric illness, disorders of consciousness, communication impairments, were unable to communicate effectively;
  2. Participants who have acute and life-threatening exacerbations which require urgent treatment;
  3. Patients who currently involved in other smoking cessation programs.

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 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;
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of current smokers
Time Frame: Baseline
A true or false sheet in the questionnaire.
Baseline
Abstinence rates
Time Frame: Baseline
A true or false sheet in the questionnaire.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine dependence
Time Frame: Baseline
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.
Baseline
Perceptions of tobacco harm
Time Frame: Baseline
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.
Baseline
knowledge of tobacco-related diseases
Time Frame: Baseline
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.
Baseline
Smoking related attitudes
Time Frame: Baseline
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.
Baseline
Self-efficacy level
Time Frame: Baseline
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.
Baseline
Withdrawal symptoms
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

April 5, 2024

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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