Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)

February 25, 2024 updated by: Duke Kunshan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201700
        • Shanghai Qingpu Patriotic Hygiene and Health Promotion Guidance Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group
The intervention group will receive Community-Centered eHealth Smoking Cessation Intervention(CCeSCI).
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.
Active Comparator: Traditional "smoking is harmful" education group
The control group to receive the traditional "smoking is harmful" education.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biochemically verified continuous smoking abstinence at 3 month
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fagerstrom Test For Nicotine Dependence (FTND) Score
Time Frame: Change from baseline to 3-month follow up
Investigators will use the Fagerström Test for Nicotine Dependence as a standard instrument for assessing the intensity of physical addiction to nicotine. In scoring the Fagerstrom Test for Nicotine Dependence, the three yes/no items are scored 0 (no) and 1 (yes). The three multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. A higher score means more dependence on nicotine.
Change from baseline to 3-month follow up
Patient Health Questionnaire-9
Time Frame: Change from baseline to 3-month follow up
Investigators will use PHQ-9 as a 9-question instrument to screen for depression. The scale ranges from 0 to 27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Higher score indicates severe depression
Change from baseline to 3-month follow up
Self-reported 7-day point smoking status
Time Frame: 3-month follow up
self-reported 7-day point prevalence of abstinence (not even a puff of smoke, for the last 7 days) at 3 months
3-month follow up
Self-reported continuous abstinence at 3 month
Time Frame: 3-month follow up
not even a puff of smoke, for the last 3 months
3-month follow up
Self-reported average number of cigarettes
Time Frame: Change from baseline to 3-month follow up
Investigators will count the number of cigarettes at 3 month
Change from baseline to 3-month follow up
Smoking Rationalization Scale
Time Frame: Change from baseline to 3-month follow up
Investigators will use Smoking Rationalization Scale to measure smokers' thoughts about smoking. The scale comprised 26 items (e.g., "Smoking is good for inspiration and active thinking.") and was divided into 6 dimensions including smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs and quitting is harmful beliefs. Participants responded on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Higher scores indicated a higher level of smoking rationalization beliefs.
Change from baseline to 3-month follow up
Questionnaire about community health workers' Knowledge, Attitude and Practices (KAP)
Time Frame: 3-month follow up
The knowledge, attitude, and practices (KAPs) survey provides a design to evaluate existing programs and to identify effective strategies for behavior change in society. The first section was related to knowledge, and this section had some questions where 1 point was assigned to the correct answer and 0 points were assigned to the wrong answer. A higher score demonstrated good knowledge. The second section was on attitude and had some questions on a 5-point Likert scale as strongly disagree = 1, disagree = 2, uncertain = 3, agree = 4, and strongly agree = 5. A higher score demonstrated a good attitude. The last part of the questionnaire was composed of questions related to the practice, and each question was scored as "yes" (1-point), "no" (0-point), and "sometimes" (0-point). A higher score indicated good practice.
3-month follow up
Weight in kilograms
Time Frame: Change from baseline to 3-month follow up
Investigators will measure the participants' heights
Change from baseline to 3-month follow up
Blood Pressure
Time Frame: Change from baseline to 3-month follow up
Investigators will measure the participants' both systolic and diastolic blood pressure
Change from baseline to 3-month follow up
Waist Circumference
Time Frame: Change from baseline to 3-month follow up
Investigators will measure the waist circumference of the participants
Change from baseline to 3-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke Kunshan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22KDKUF016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not share the individual participant data. But de-identified data is available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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