Clinical trial NCT05374629: Study on the Effect of Smoking Cessation in COPD Patients After Shared Decision Making Intervention
Official title: Exploring of the Effectiveness of the Shared-decision Making Education to the Patient With COPD: the Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Smoking Cessation
Psychological Dependence
Keywords: COPD
shared decision making
smoking cessation
Psychological Cigarette Dependence
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group had the shared decision-making of smoking cessation which was guided by the smoking cessation health educator. The control group received routine smoking cessation health education by another smoking cessation health educator. Both groups will receive a post-test three months after the intervention.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Smoking cessation success
timeFrame: 12weeks
measure: Smoking cessation psychological dependence
timeFrame: 12weeks
Secondary outcomes:
measure: The change of Fagerstrom Test for Nicotine Dependence (FTND)
timeFrame: baseline, pre-intervention
measure: Disease severity
timeFrame: baseline, pre-intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: Cathay General Hospital
name: Yen-Ping Tsai
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.