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

NCT05374629 | Completed

• 1 other identifier: CGH-109078
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; Smoking Cessation; Psychological Dependence

Keywords

COPD; shared decision making; smoking cessation; Psychological Cigarette Dependence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The change of Fagerstrom Test for Nicotine Dependence (FTND)

  baseline, pre-intervention

• Disease severity

  baseline, pre-intervention

Study Arms (2)

The Intervention group had Shared Decision Making of smoking cessation.

EXPERIMENTAL

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

The control group received routine smoking cessation health education

NO INTERVENTION

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 .

Interventions

Use different methods of teaching BEHAVIORAL

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

The Intervention group had Shared Decision Making of smoking cessation.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cathay General Hospital: lead

Study Sites (1)

Cathay General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 29890766 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking Cessation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Yen-Ping Tsai

  Cathay General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 16, 2022
• Study Start: November 23, 2020
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)