Smoking CessationNCT05508672

Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)

A study testing Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) and Traditional "smoking is harmful" education in people with Smoking Cessation and Lifestyle, Healthy, run by Duke Kunshan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for: Smoking Cessation, Lifestyle, Healthy
What is being tested?: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) and Traditional "smoking is harmful" education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 13 Mar 2023to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 64 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Qingpu Patriotic Hygiene and Health Promotion Guidance Center
Shanghai, Shanghai Municipality, 201700

Other trials in China

About this study

Official title: 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.

Read the 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
Being tested: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI), Traditional "smoking is harmful" education
Keywords: Smoking Cessation, Disease control and prevention, Health management, Effectiveness evaluation
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05508672
Study group	Role	What they receive
Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group	Experimental	The intervention group will receive Community-Centered eHealth Smoking Cessation Intervention(CCeSCI). Receives: 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. Receives: Other: Traditional "smoking is harmful" education

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 3 month

Secondary outcomes (10)

Fagerstrom Test For Nicotine Dependence (FTND) Score
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.
Measured: Change from baseline to 3-month follow up
Patient Health Questionnaire-9
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
Measured: Change from baseline to 3-month follow up
Self-reported 7-day point smoking status
self-reported 7-day point prevalence of abstinence (not even a puff of smoke, for the last 7 days) at 3 months
Measured: 3-month follow up
Self-reported continuous abstinence at 3 month
not even a puff of smoke, for the last 3 months
Measured: 3-month follow up
Self-reported average number of cigarettes
Investigators will count the number of cigarettes at 3 month
Measured: Change from baseline to 3-month follow up
Smoking Rationalization Scale
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.
Measured: Change from baseline to 3-month follow up
Questionnaire about community health workers' Knowledge, Attitude and Practices (KAP)
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.
Measured: 3-month follow up
Weight in kilograms
Investigators will measure the participants' heights
Measured: Change from baseline to 3-month follow up
Blood Pressure
Investigators will measure the participants' both systolic and diastolic blood pressure
Measured: Change from baseline to 3-month follow up
Waist Circumference
Investigators will measure the waist circumference of the participants
Measured: Change from baseline to 3-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202330 Jun 2023

First posted19 Aug 2022
Study start13 Mar 2023
Primary completion31 May 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05508672
Sponsor's protocol ID: 22KDKUF016
Status last verified: Feb 2024
First submitted: 15 Aug 2022
Last updated: 28 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The investigators will not share the individual participant data. But de-identified data is available upon request.

Publications

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.
PubMed 27733284
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.
PubMed 26814853
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.
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.
PubMed 30782929
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.
PubMed 22218426
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.
PubMed 28810494
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.
PubMed 29371178
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.
PubMed 31845901
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.
PubMed 34869187
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.
PubMed 31406843
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.
PubMed 33909607
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.
PubMed 26187183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community-Centered eHealth Smoking Cessation Intervention Based on the "Smoking Rationalization Beliefs" Framework for Chinese Male Smokers
ClinicalTrials.gov ID: NCT05508672
Acronym / sponsor ID: 22KDKUF016
Conditions: Smoking Cessation, Lifestyle, Healthy
Keywords: Smoking Cessation, Disease control and prevention, Health management, Effectiveness evaluation
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Duke Kunshan UniversityUniversity, hospital or other
Study start: 13 Mar 2023 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 19 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group	Experimental	Other: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI)The intervention group will receive Community-Centered eHealth Smoking Cessation Intervention(CCeSCI).
Traditional "smoking is harmful" education group	Active comparator	Other: Traditional "smoking is harmful" educationThe control group to receive the traditional "smoking is harmful" education.

Who may qualify

Ages: 25 to 64 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group
Traditional "smoking is harmful" educationIn the control group, the participants will receive traditional "smoking is harmful" education video, which is recorded by the clinical physicians.	Other	Traditional "smoking is harmful" education group

Primary outcome

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)

10 secondary outcomes

Fagerstrom Test For Nicotine Dependence (FTND) Score
Time frame: Change from baseline to 3-month follow up
Patient Health Questionnaire-9
Time frame: Change from baseline to 3-month follow up
Self-reported 7-day point smoking status
Time frame: 3-month follow up
Self-reported continuous abstinence at 3 month
Time frame: 3-month follow up
Self-reported average number of cigarettes
Time frame: Change from baseline to 3-month follow up
Smoking Rationalization Scale
Time frame: Change from baseline to 3-month follow up
Questionnaire about community health workers' Knowledge, Attitude and Practices (KAP)
Time frame: 3-month follow up
Weight in kilograms
Time frame: Change from baseline to 3-month follow up
Blood Pressure
Time frame: Change from baseline to 3-month follow up
Waist Circumference
Time frame: Change from baseline to 3-month follow up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Background: PubMed 27733284GBD 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.
Background: PubMed 26814853Wang 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.
BackgroundWang 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: PubMed 30782929Huang 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.
Background: PubMed 22218426Fotuhi 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.
Background: PubMed 28810494Huang 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.
Background: PubMed 29371178Chen 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.
Background: PubMed 31845901Gong 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.
Background: PubMed 34869187Gong 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.
Background: PubMed 31406843Ni 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.
Background: PubMed 33909607Yan 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.
Background: PubMed 26187183Tian 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.
Individual participant dataSharing planned: No. The investigators will not share the individual participant data. But de-identified data is available upon request.

Related trials for Smoking Cessation

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically verified continuous smoking abstinence at 3 month (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508672, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.