Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy
Primary Purpose
Coronary Heart Disease, Smoking Cessation, Smoking Behaviors
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
health education and counseling
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring self-efficacy, counseling, health education, smoking cessation behavior
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with coronary heart disease by a medical center and smoked habitually Exclusion Criteria: -
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
self-controlled design
Arm Description
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).
Outcomes
Primary Outcome Measures
Changes of smoking decisional balance
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.
Changes of self-efficacy of smoking cessation
The self-efficacy of smoking scale is used to measure the level of confidence to resist smoking. The scale comprised 14 items.
Secondary Outcome Measures
Full Information
NCT ID
NCT05905666
First Posted
June 6, 2023
Last Updated
June 6, 2023
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05905666
Brief Title
Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Smoking Cessation, Smoking Behaviors
Keywords
self-efficacy, counseling, health education, smoking cessation behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self-controlled design
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
health education and counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of smoking decisional balance
Description
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.
Time Frame
The changes of smoking decisional balance was measured at the first week, 4th week and the 8th week.
Title
Changes of self-efficacy of smoking cessation
Description
The self-efficacy of smoking scale is used to measure the level of confidence to resist smoking. The scale comprised 14 items.
Time Frame
The changes of self-efficacy of smoking cessation was measured at the first week, 4th week and the 8th week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with coronary heart disease by a medical center and smoked habitually
Exclusion Criteria:
-
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy
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