- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05905666
Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy
June 6, 2023 updated by: Chii Jeng, Taipei Medical University WanFang Hospital
Effectiveness of Health Education and Counseling on Stages of Change in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy of Smoking Cessation: A Prospective Self-control Study
Most male smokers with coronary heart disease resume smoking after hospital discharge.
The main reason for failure to quit smoking is lack of motivation.
However, few studies have used individual health education models to explore the effectiveness of smoking cessation according to the stage of change in smoking cessation behavior of patients.
The purpose of this study was to examine the effectiveness of health education and counseling on the stages of change, smoking decisional balance, and self-efficacy of smoking cessation in smokers with no intention of quitting.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients diagnosed with coronary heart disease by a medical center and smoked habitually were recruited as participants through convenience sampling.
The research period was divided into a control stage (first to fourth week: standard of care) and the experimental stage (fifth to eighth week: health education and counseling).
In the control stage, participants only received standard nursing care.
In the experimental stage, intervention measures (health education and counseling) were implemented.
The baseline data were the pretest data collected in the control stage.
Four weeks later, a posttest was performed, namely the pretest of the experimental stage.
Subsequently, 4 weeks of health education and counseling were introduced to smokers according to different stages.
After 4 weeks of intervention, participants were asked to fill out the posttest questionnaire again to measure the stages of change for smoking cessation, smoking decisional balance, and self-efficacy of smoking cessation.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
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
-
-
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Taipei, Taiwan, 110
- Taipei Medical University
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-
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
Description
Inclusion Criteria:
- Patients diagnosed with coronary heart disease by a medical center and smoked habitually
Exclusion Criteria:
-
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: self-controlled design
The research period was divided into a control stage (first to fourth week: standard of care) and the experimental stage (fifth to eighth week: health education and counseling).
|
In the control stage, participants only received standard nursing care.
In the experimental stage, intervention measures (health education and counseling) were implemented.
The baseline data were the pretest data collected in the control stage.
Four weeks later, a posttest was performed, namely the pretest of the experimental stage.
Subsequently, 4 weeks of health education and counseling were introduced to smokers according to different stages.
After 4 weeks of intervention, participants were asked to fill out the posttest questionnaire again to measure the stages of change for smoking cessation, smoking decisional balance, and self-efficacy of smoking cessation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of smoking decisional balance
Time Frame: The changes of smoking decisional balance was measured at the first week, 4th week and the 8th week.
|
The Chinese version of the smoking decisional balance scale is used to measure the changes of smoking decisional balance.This scale encompassed six items, consisting of the pro and con dimensions.
|
The changes of smoking decisional balance was measured at the first week, 4th week and the 8th week.
|
Changes of self-efficacy of smoking cessation
Time Frame: The changes of self-efficacy of smoking cessation was measured at the first week, 4th week and the 8th week.
|
The self-efficacy of smoking scale is used to measure the level of confidence to resist smoking.
The scale comprised 14 items.
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The changes of self-efficacy of smoking cessation was measured at the first week, 4th week and the 8th week.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 29, 2020
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGH-OP108004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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