Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)

NCT ID: NCT05508672

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2023-06-30

Brief Summary

Recent findings regarding why Chinese male smokers are reluctant to quit have offered insight for a possible new solution. Consistent with the Cognitive Dissonance Theory, "smoking rationalization beliefs" are a set of beliefs by smokers to rationalize their smoking behavior and avoid quitting. These beliefs have been well studied by global researchers, and a "smoking rationalization beliefs" scale was recently developed and validated for Chinese male smokers. The six dimensions of these beliefs are: smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs, and quitting is harmful beliefs. Studies on smoking rationalization in China have primarily been observational. Investigators propose to develop a Community-Centered eHealth Smoking Cessation Intervention (CCeSCI). The trinity of CCeSCI are the triangular unity of "smoking rationalization beliefs" framework, the non-physician community workers, and the eHealth technologies. The latter two were previously proven effective in interventional studies (including three conducted by the PI) but not yet widely used in smoking cessation. With the adoption of smoking rationalization beliefs framework aiming to address the cognitive causes of phycological addition to smoking and supported by the community-based behavioral interventions and the use of eHealth, CCeSCI is designed to overcome previous challenges with the principles of people-centeredness, convenience, and personalization.

Detailed Description

Investigators will firstly evaluate the feasibility of CCeSCI. Once CCeSCI is ready to deploy, investigators will recruit 60 smokers (male, 25-64 years old) in two communities in Qingpu to conduct a pilot non-blinded randomized controlled trial. They will be randomized in a 1:1 ratio into either the intervention group to receive CCeSCI or the control group to receive the traditional "smoking is harmful" education video. Investigators will also use qualitative research methods (one on one interviews) to conduct process evaluations at 4th, 8th, and 12th weeks according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. At the end of the 12th week after the participants joined the RCT, saliva samples will be collected by community workers and quitting outcomes will be biochemically verified by a third party lab.

Conditions

Smoking Cessation; Lifestyle, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group

The intervention group will receive Community-Centered eHealth Smoking Cessation Intervention(CCeSCI).

Group Type: EXPERIMENTAL

Community-Centered eHealth Smoking Cessation Intervention (CCeSCI)

Intervention Type: OTHER

We will equip CCeSCI with both core eHealth features and provider-side intervention. Patients assigned to the intervention group will receive a series of online interactive and personalization technologies, including an algorithm-based video curriculum with auto-texting, backstage monitoring system etc. Besides, the patients will also have the face-to-face meetings with community health workers. Provider-side intervention includes training for community workers, WeChat group discussion, and performance-based incentives. The training aims to provide essential skills for community workers so that they can provide face-to-face meetings with smokers during the first 3 months of quitting to prevent or revert relapse in a timely and proactive manner.

Traditional "smoking is harmful" education group

The control group to receive the traditional "smoking is harmful" education.

Group Type: ACTIVE_COMPARATOR

Traditional "smoking is harmful" education

Intervention Type: OTHER

In the control group, the participants will receive traditional "smoking is harmful" education video, which is recorded by the clinical physicians.

Interventions

Community-Centered eHealth Smoking Cessation Intervention (CCeSCI)

We will equip CCeSCI with both core eHealth features and provider-side intervention. Patients assigned to the intervention group will receive a series of online interactive and personalization technologies, including an algorithm-based video curriculum with auto-texting, backstage monitoring system etc. Besides, the patients will also have the face-to-face meetings with community health workers. Provider-side intervention includes training for community workers, WeChat group discussion, and performance-based incentives. The training aims to provide essential skills for community workers so that they can provide face-to-face meetings with smokers during the first 3 months of quitting to prevent or revert relapse in a timely and proactive manner.

Intervention Type: OTHER

Traditional "smoking is harmful" education

In the control group, the participants will receive traditional "smoking is harmful" education video, which is recorded by the clinical physicians.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male, current cigarette smokers who are willing to quit

2. Citizens who currently reside in Qingpu District, Shanghai, China

3. Age 25-64

4. Smoking index greater than or equal to 100 (smoking index = average number of cigarettes smoked per day × years of smoking)

5. Able to understand mandarin Chinese

6. Willing to provide informed consent to participate in the study

Exclusion Criteria

1. Ever or currently on pharmacologic treatments, including various forms of NRT formulations such as gum, transdermal patch, nasal spray, oral inhaler, lozenge, Bupropion, Varenicline and newly emerged precision medicine

2. Currently participating in other individual-based cessation program(s), such as psychological counseling, behavioral therapy etc.

3. Currently under treatment of life-threatening medical conditions or critically ill

4. Unable to make commitment of a consecutive 4-hour video viewing

5. Plan to move out of the community in the next 3 month

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke Kunshan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Qingpu Patriotic Hygiene and Health Promotion Guidance Center

Shanghai, Shanghai Municipality, China

Countries

China

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Other Identifiers

22KDKUF016

Identifier Type: -

Identifier Source: org_study_id