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

Exploring of the Effectiveness of the Shared-decision Making Education to the Patient With COPD: the Randomized-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Copd; Psychological Dependence
• Intervention / Treatment: Behavioral: Use different methods of teaching

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).

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Cathay General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Use different methods of teaching; Both groups will receive a smoking cessation education guideline and post-test three months after the intervention.
No 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation success	Ask smoking cessation behavior, answer success or failure by self.	12weeks
Smoking cessation psychological dependence	The smoking psychological dependence adopted the smoking psychological dependence scale proposed by ZL Huang and has obtained the authorization of the original author. It has a total of 37 questions, scale title including life connection and health concern, 1 point for strongly disagree, 2 points for disagree, 3 points for moderate, 4 points for agree, 5 points for strongly agree, plus total points. The minimum values is 37, maximum values is 185, the higher the score the more dependent it is. This scale has the internal consistency (Cronbach's alpha) of 0.94, and the two-week test-retest reliability was 0.77.	12weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Fagerstrom Test for Nicotine Dependence (FTND)	Used the "Fagerstrom Test for Nicotine Dependence" (FTND) translated by Health Promotion Administration, Ministry of Health and Welfare. The content of the scale includes six questions. The total score is from 0 to 10, the higher the score, the higher the nicotine addiction, and it was divided into three categories: low addiction (0-3 points), moderate addiction (4-6 points), and high addiction (7-10 points).	baseline, pre-intervention
Disease severity	Follow COPD treatment guidelines：The severity of expiratory airflow obstruction by the Forced expiratory volume in 1 second (FEV1) value, Mild ( FEV1 ≥ 80%), Moderate ( 50% ≤ FEV1 < 80%), Severe (30% ≤ FEV1 < 50%) and Extremely severe (FEV1 < 30%).	baseline, pre-intervention

Collaborators and Investigators

• Sponsor: Cathay General Hospital
• Investigators: Principal Investigator: Yen-Ping Tsai, Cathay General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: COPD; smoking cessation; shared decision making; Psychological Cigarette Dependence
• Other Study ID Numbers: CGH-109078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No