NCT05508672

Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)

Community-Centered eHealth Smoking Cessation Intervention Based on the "Smoking Rationalization Beliefs" Framework for Chinese Male Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Duke Kunshan University · Academic / Other
• Sex: Male
• Age: 25 Years – 64 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2023-03-13
• Primary completion: 2023-05-31
• Completion: 2023-06-30
• First posted: 2022-08-19
• Last updated: 2024-02-28

Locations

1 site across 1 country: China