Study on the Effect of Smoking Cessation in COPD Patients After Shared Decision Making Intervention

NCT ID: NCT05374629

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2022-02-10

Brief Summary

There was no significant difference in the effectiveness of smoking cessation in COPD patients under a single session of SDM compared with a single session of smoking cessation education but significant improvement in the psychological dependence of smoking cessation shows that both groups. More intensive and more frequent interventions should be provided in the future.

Detailed Description

According to the World Health Organization (WHO), in 2016, 251 million people worldwide suffered from Chronic Obstructive Pulmonary Disease (COPD), accounting for 5% of the total number of global deaths, with an average of every 101 person dies from obstructive pulmonary disease in second. In 2020, the Taiwan Ministry of Health and Welfare's death cause statistics ranked COPD the eighth among the top ten causes of death in Taiwan, with 5,657 deaths. Among the main causes of death for people over 65 years old, it was found that COPD increases the risk with age. Since 2018, my country has It has entered an aging society since 2000, and the cause of death from chronic lower respiratory diseases aged 75-84 and over 85 has risen to the sixth and seventh respectively.

The purpose of this study is to explore the effect of shared decision-making services to the patients with COPD, and to understand the demographic variables, smoking-related variables, disease severity, and psychological dependence. The main purpose is to explore the association between the demographic variables of patients with COPD, smoking-related variables, disease severity variables including the severity of expiratory airflow obstruction, and the severity of the patient's current symptoms, and further analyze the differences of smoking cessation behavior and smoking psychological dependence index after giving smoking cessation Shared Decision Making.

The study involved a 3-months, single session intervention in a two-armed, randomized controlled trial, approved by the Institutional Review Board (IRB) of Cathay General Hospital (Taipei, Taiwan). Two groups of subjects participated: one with a Shared Decision Making smoking cessation intervention, and the other with usual care only.

A Chi-square test or t-test was employed to assess differences in sociodemographic variables, baseline physiological and biochemical detection and smoking behaviors. The paired t-test was used to assess the smoking cessation behavior, and examine variables related to smoking behavior with Pearson correlation. Finally, the linear regression was used to detected the association of smoking behavior with disease severity and smoking psychological dependence after adjusting for demographic variables.

All tests were analyzed at a 95% significance level (p<0.05). Intention-to-treat analysis was not used since the ethical policy stated that non-compliers who refused to continue to participate had to be excluded from the analysis. Analyses were conducted using PASW 22.0 software for windows (SPSS, Chicago, IL, USA).

Conditions

Copd; Smoking Cessation; Psychological Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The Intervention group had Shared Decision Making of smoking cessation.

The intervention group had the shared decision-making of smoking cessation which was guided by the smoking cessation health educator, and it containing the nicotine addiction, the impact of smoking on health, the methods and difficulties about smoking cessation, and the way of decision.

Group Type: EXPERIMENTAL

Use different methods of teaching

Intervention Type: BEHAVIORAL

Both groups will receive a smoking cessation education guideline and post-test three months after the intervention.

The control group received routine smoking cessation health education

The control group received routine smoking cessation health education by another smoking cessation health educator, and it containing the harm of smoking, the benefits of quitting smoking, smoking cessation methods, and second-generation smoking cessation .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Use different methods of teaching

Both groups will receive a smoking cessation education guideline and post-test three months after the intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients with COPD diagnosed by a physician.
• self-reported as a smoker
• 30 years old or above
• speak Chinese and Taiwanese
• agree to accept the questionnaire and inform consent.

Exclusion Criteria

• Suffering from acute mental illness.
• Alcohol or other drug addicts.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cathay General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yen-Ping Tsai

Role: PRINCIPAL_INVESTIGATOR

Cathay General Hospital

Locations

Cathay General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Huang WH, Hsu HY, Chang BC, Chang FC. Factors Correlated with Success Rate of Outpatient Smoking Cessation Services in Taiwan. Int J Environ Res Public Health. 2018 Jun 10;15(6):1218. doi: 10.3390/ijerph15061218.

Reference Type: RESULT

PMID: 29890766 (View on PubMed)

Other Identifiers

CGH-109078

Identifier Type: -

Identifier Source: org_study_id