NCT05905666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

June 6, 2023

Last Update Submit

June 6, 2023

Conditions

Keywords

self-efficacycounselinghealth educationsmoking cessation behavior

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    The self-efficacy of smoking scale is used to measure the level of confidence to resist smoking. The scale comprised 14 items.

    The changes of self-efficacy of smoking cessation was measured at the first week, 4th week and the 8th week.

Study Arms (1)

self-controlled design

EXPERIMENTAL

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).

Behavioral: health education and counseling

Interventions

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.

self-controlled design

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with coronary heart disease by a medical center and smoked habitually

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Coronary DiseaseSmoking CessationSmokingHealth Education

Interventions

Counseling

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

December 29, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 15, 2023

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations