Viewing Study NCT05079958



Ignite Creation Date: 2024-05-06 @ 4:44 PM
Last Modification Date: 2024-10-26 @ 2:15 PM
Study NCT ID: NCT05079958
Status: UNKNOWN
Last Update Posted: 2021-10-15
First Post: 2021-08-02

Brief Title: Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation
Sponsor: Cathay General Hospital
Organization: Cathay General Hospital

Study Overview

Official Title: Effects of Cognitive-behavioral Education and Exercise Interventions on Smoking Cessation and Physical and Mental Health in Patients With Coronary Heart Disease Application of the Transtheoretical Model
Status: UNKNOWN
Status Verified Date: 2021-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patients smoking behavior and explore the effect of Cognitive-Behavioral Education Course and Exercise Program on Smoking cessation physical health and mental health of smokers with CAD
Detailed Description: Smoking is a major risk factor of coronary artery disease CAD and is responsible for the death of one in three patients with cardiovascular diseases Smoking cessation is one of the most favorable methods for reducing the risk of cardiovascular diseases even for patients with a heart disease quitting smoking can reduce the chance of a relapse of said disease However the Health Promotion Administration revealed that among male patients with acute myocardial infarction AMI 795 had smoked and 356 continued to smoke after an episode of AMI Although previous studies confirmed that health education and exercises can increase smoking cessation rates patients lack of motivation to quit smoking has resulted in a failure rate of 655 Therefore identifying methods to strengthen patients motivation to quit smoking is a key to successfully achieving smoking cessation

The purpose of the study is to adopt the Trans-theoretical Model to facilitate step-by-step changes in a patients smoking behavior and explore the effect of Cognitive-Behavioral Education Course and Exercise Program on Smoking cessation physical health and mental health of smokers with CAD This study is composed of three stages in three years period recruiting patients who meet the selection criteria from the cardiology department of a medical center in northern Taiwan For the first stage a cross-sectional method will be employed to investigate the relationship between smoking status and various physiological and psychological indicators in patients with CAD For the second stage subjects who are at the smoking cessation stage of precontemplation and contemplation will be recruited

A quasi-experimental design will be used to determine the effects of a four-week cognitive-behavioral education course related to smoking cessation on the participants smoking cessation behavior smoking decision-making and self-efficacy in smoking cessation For the third stage subjects from Stages 1 and 2 who are at the preparation and action stage will be recruited and randomly divided into experimental or control group to identify the effect of a 12-week brisk walking on improving the participants immediate short-term three-month and six month long-term health status The primary indicator used for health status evaluation is smoking cessation success rate the secondary indicators used are physiological status ie nicotine addiction lung carbon monoxide concentration heart rate variability and smoking withdrawal syndrome and psychological status ie depression and resilience SPSS for Window 240 software will be used in statistical analysis The type one error is 005 In inferences analysis chi-square test Pearson correlation coefficient independent t test one-way ANOVA and post hoc comparison scheffe test will be used to examine the variance among groups Finally ANCOVA and GEE mode will be used to test the effectiveness of intervention at stage 1 and stage 2 respectively

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None