Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-24 @ 8:14 PM
Study NCT ID:
NCT05905666
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2023-06-06', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of smoking decisional balance', 'timeFrame': 'The changes of smoking decisional balance was measured at the first week, 4th week and the 8th week.', '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.'}, {'measure': 'Changes of self-efficacy of smoking cessation', 'timeFrame': 'The changes of self-efficacy of smoking cessation was measured at the first week, 4th week and the 8th week.', 'description': 'The self-efficacy of smoking scale is used to measure the level of confidence to resist smoking. The scale comprised 14 items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self-efficacy', 'counseling', 'health education', 'smoking cessation behavior'], 'conditions': ['Coronary Heart Disease', 'Smoking Cessation', 'Smoking Behaviors']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with coronary heart disease by a medical center and smoked habitually\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05905666', 'briefTitle': 'Health Education and Counseling in Smoking Cessation Behavior, Smoking Decisional Balance, and Self-efficacy', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CGH-OP108004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'self-controlled design', '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).', 'interventionNames': ['Behavioral: health education and counseling']}], 'interventions': [{'name': 'health education and counseling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['self-controlled design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chii Jeng', 'investigatorAffiliation': 'Taipei Medical University WanFang Hospital'}}}}