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CopdNCT05374629

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

A study testing Use different methods of teaching in people with Copd and Smoking Cessation, run by Cathay General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Copd, Smoking Cessation, Psychological Dependence
What is being tested?
Use different methods of teaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteTaiwan
Study dates
23 Nov 2020to 10 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Cathay General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read the 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).

Being tested
Use different methods of teaching
Keywords
COPD, shared decision making, smoking cessation, Psychological Cigarette Dependence
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use different methods of teachingBehavioural

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

Study groups in NCT05374629
Study groupRoleWhat they receive
The Intervention group had Shared Decision Making of smoking cessation.ExperimentalThe 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.
Receives: Behavioral: Use different methods of teaching
The control group received routine smoking cessation health educationNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking cessation success

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

    Measured: 12weeks

  2. 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.

    Measured: 12weeks

Secondary outcomes (2)

  1. 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).

    Measured: baseline, pre-intervention

  2. 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%).

    Measured: baseline, pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start23 Nov 2020
  3. Primary completion10 Feb 2022
  4. Study completion10 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374629
Sponsor's protocol ID
CGH-109078
Status last verified
Apr 2022
First submitted
27 Apr 2022
Last updated
16 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 29890766

Questions about this trial

What is this clinical trial studying?

A study testing Use different methods of teaching in people with Copd and Smoking Cessation, run by Cathay General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking cessation success (time frame: 12weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374629, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.

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