Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)

NCT05508672 | Completed

• 1 other identifier: 22KDKUF016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Lifestyle, Healthy

Keywords

Smoking Cessation; Disease control and prevention; Health management; Effectiveness evaluation

Outcome Measures

Primary Outcomes (1)

• Biochemically verified continuous smoking abstinence at 3 month

  Investigators will use cotinine to measure the smoking abstinence. Cotinine is a good biomarker for nicotine with a longer half-life (16-18h), and lab test for saliva is highly sensitive, convenient, and cost-effective. measured by cotinine saliva tests (\<10ng•mL-1)

  3 month

Secondary Outcomes (10)

• Fagerstrom Test For Nicotine Dependence (FTND) Score

  Change from baseline to 3-month follow up

• Patient Health Questionnaire-9

  Change from baseline to 3-month follow up

• Self-reported 7-day point smoking status

  3-month follow up

• Self-reported continuous abstinence at 3 month

  3-month follow up

• Self-reported average number of cigarettes

  Change from baseline to 3-month follow up

Study Arms (2)

Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group

EXPERIMENTAL

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

Other: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI)

Traditional "smoking is harmful" education group

ACTIVE COMPARATOR

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

Other: Traditional "smoking is harmful" education

Interventions

Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) 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.

Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group

Traditional "smoking is harmful" education OTHER

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

Traditional "smoking is harmful" education group

Eligibility Criteria

• Age: 25 Years - 64 Years
• Gender Eligibility Details: The eligible participants are male smokers.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, current cigarette smokers who are willing to quit
• Citizens who currently reside in Qingpu District, Shanghai, China
• Age 25-64
• Smoking index greater than or equal to 100 (smoking index = average number of cigarettes smoked per day × years of smoking)
• Able to understand mandarin Chinese
• Willing to provide informed consent to participate in the study

You may not qualify if:

• 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
• Currently participating in other individual-based cessation program(s), such as psychological counseling, behavioral therapy etc.
• Currently under treatment of life-threatening medical conditions or critically ill
• Unable to make commitment of a consecutive 4-hour video viewing
• Plan to move out of the community in the next 3 month

Sponsors & Collaborators

• Duke Kunshan University: lead

Study Sites (1)

Shanghai Qingpu Patriotic Hygiene and Health Promotion Guidance Center

Shanghai, Shanghai Municipality, 201700, China

Location

Related Publications (12)

• GBD 2015 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1659-1724. doi: 10.1016/S0140-6736(16)31679-8.

  PMID: 27733284 BACKGROUND

• Wang L, Shen Y, Jiang Y, Yang Y. [Investigation and analysis on current status of smoking cessation clinics in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2015 Sep;36(9):917-20. Chinese.

  PMID: 26814853 BACKGROUND

• Wang J, Xie L, Jiang Y, Li Q. Conclusions and impacts of U.S. Surgeon General' s Reports on smoking and tobacco use. Chinese Journal of Health Education 2012;28(7):591-593+601. DOI: 10.16168/j.cnki.issn.1002-9982.2012.07.019.

  BACKGROUND

• Huang X, Fu W, Zhang H, Li H, Li X, Yang Y, Wang F, Gao J, Zheng P, Fu H, Chapman S, Ding D. Why are male Chinese smokers unwilling to quit? A multicentre cross-sectional study on smoking rationalisation and intention to quit. BMJ Open. 2019 Feb 19;9(2):e025285. doi: 10.1136/bmjopen-2018-025285.

  PMID: 30782929 BACKGROUND

• Fotuhi O, Fong GT, Zanna MP, Borland R, Yong HH, Cummings KM. Patterns of cognitive dissonance-reducing beliefs among smokers: a longitudinal analysis from the International Tobacco Control (ITC) Four Country Survey. Tob Control. 2013 Jan;22(1):52-8. doi: 10.1136/tobaccocontrol-2011-050139. Epub 2012 Jan 3.

  PMID: 22218426 BACKGROUND

• Huang X, Fu W, Zhang H, Li H, Li X, Yang Y, Wang F, Gao J, Zheng P, Fu H, Ding D, Chapman S. Development and validation of a smoking rationalization scale for male smokers in China. J Health Psychol. 2020 Mar;25(4):472-489. doi: 10.1177/1359105317720276. Epub 2017 Jul 20.

  PMID: 28810494 BACKGROUND

• Chen S, Gong E, Kazi DS, Gates AB, Bai R, Fu H, Peng W, De La Cruz G, Chen L, Liu X, Su Q, Girerd N, Karaye KM, Alhabib KF, Yan LL, Schwalm JD. Using Mobile Health Intervention to Improve Secondary Prevention of Coronary Heart Diseases in China: Mixed-Methods Feasibility Study. JMIR Mhealth Uhealth. 2018 Jan 25;6(1):e9. doi: 10.2196/mhealth.7849.

  PMID: 29371178 BACKGROUND

• Gong E, Gu W, Luo E, Tan L, Donovan J, Sun C, Yang Y, Zang L, Bao P, Yan LL. Development and Local Contextualization of Mobile Health Messages for Enhancing Disease Management Among Community-Dwelling Stroke Patients in Rural China: Multimethod Study. JMIR Mhealth Uhealth. 2019 Dec 17;7(12):e15758. doi: 10.2196/15758.

  PMID: 31845901 BACKGROUND

• Gong E, Sun L, Long Q, Xu H, Gu W, Bettger JP, Tan J, Ma J, Jafar TH, Oldenburg B, Yan LL. The Implementation of a Primary Care-Based Integrated Mobile Health Intervention for Stroke Management in Rural China: Mixed-Methods Process Evaluation. Front Public Health. 2021 Nov 17;9:774907. doi: 10.3389/fpubh.2021.774907. eCollection 2021.

  PMID: 34869187 BACKGROUND

• Ni Z, Liu C, Wu B, Yang Q, Douglas C, Shaw RJ. An mHealth intervention to improve medication adherence among patients with coronary heart disease in China: Development of an intervention. Int J Nurs Sci. 2018 Sep 8;5(4):322-330. doi: 10.1016/j.ijnss.2018.09.003. eCollection 2018 Oct 10.

  PMID: 31406843 BACKGROUND

• Yan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.

  PMID: 33909607 BACKGROUND

• Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.

  PMID: 26187183 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 19, 2022
• Study Start: March 13, 2023
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)