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Completed

NCT Number: NCT05374629

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cathay General Hospital

Taipei, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use different methods of teaching

Behavioral

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

Primary outcomes

  1. Smoking cessation success

    Time frame: 12weeks

    Ask smoking cessation behavior, answer success or failure by self.

  2. Smoking cessation psychological dependence

    Time frame: 12weeks

    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.

Secondary outcomes

  1. The change of Fagerstrom Test for Nicotine Dependence (FTND)

    Time frame: baseline, pre-intervention

    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).

  2. Disease severity

    Time frame: baseline, pre-intervention

    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%).

Sponsors and collaborators

Lead sponsor

Cathay General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 16, 2022
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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