An interventional study of Telegram-based Smoking Cessation Support and Standard Care (in control arm) in Myocardial Infarction (MI), Tobacco Use and Smoking Cessation, sponsored by ITMO University. Recruiting at 2 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by ITMO University · Not applicable, Interventional, and Treatment
This randomized controlled trial will evaluate whether a 6-month behavioral intervention delivered via Telegram messenger increases smoking cessation rates in patients after myocardial infarction (MI).
Adult smokers hospitalized with acute MI who regularly use Telegram will be randomly assigned to either:
The primary outcome is 30-day point prevalence abstinence at 6 months, verified by blinded telephone interview with participant and corroborating report from a close relative. Secondary outcomes include changes in cigarette consumption, nicotine dependence, motivation, and intervention engagement metrics.
This study addresses the critical gap in smoking cessation support after hospital discharge and could provide evidence for a scalable digital health solution in cardiac secondary prevention.
The TELEGRAM-MI trial is a multicenter, randomized, controlled, assessor-blinded superiority study testing a digital behavioral intervention for smoking cessation in post-myocardial infarction patients.
BACKGROUND: Smoking cessation is the most effective modifiable risk factor for reducing mortality after MI, yet long-term abstinence remains challenging due to limited sustained support. Digital interventions using popular messaging platforms offer a scalable solution to bridge the post-discharge support gap.
OBJECTIVES:
Primary: To determine if a 6-month Telegram chatbot intervention increases 30-day point prevalence abstinence rates at 6 months compared to standard care alone.
Secondary: To examine associations between baseline characteristics (nicotine dependence, motivation), engagement metrics, and cessation success; and to assess intervention acceptability.
METHODS: Approximately 142 participants will be recruited from inpatient cardiology departments. After providing informed consent, participants will be randomized 1:1 via the chatbot to either the intervention group (standard care plus 6-month behavioral support) or control group (standard care plus data collection only). The intervention incorporates evidence-based techniques including motivational messaging, cognitive-behavioral strategies, and relapse prevention protocols.
OUTCOMES: The primary outcome is biochemically unverified 30-day point prevalence abstinence at 6 months, assessed via blinded telephone interview with participant and relative verification. Secondary outcomes include various smoking behavior metrics collected through the chatbot platform.
ANALYSIS: Primary analysis will follow intention-to-treat principles, with missing data imputed as smoking. Statistical analyses will include chi-square tests for primary outcome and regression models for secondary outcomes.
POTENTIAL IMPACT: If effective, this intervention represents a readily implementable, low-cost strategy to enhance secondary prevention in cardiac patients.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 142 is close to the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →ITMO University is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 9, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard care PLUS the 6-month behavioral intervention delivered via the Telegram chatbot.
Behavioral: Telegram-based Smoking Cessation Support
Participants receive standard care only. They are connected to the Telegram bot but only complete baseline and follow-up surveys without receiving any active smoking cessation content.
Other: Standard Care (in control arm)
A 6-month behavioral intervention delivered via a Telegram chatbot. The intervention includes personalized daily motivational messages, cognitive-behavioral techniques for craving management, access to an SOS/craving support button, weekly check-ins, and relapse prevention protocols. Content is tailored based on user responses to questionnaires (Fagerström Test, Importance/Confidence scales) and engagement metrics.
Routine physician advice to quit smoking provided upon hospital discharge. This represents the current standard of care in the participating clinical centers.
30-day point prevalence abstinence (PPA)
Proportion of participants who report abstinence from smoking for the past 30 days or more, verified by both participant self-report AND corroborating report from a close relative or cohabiting person during a telephone interview conducted by a blinded assessor. A positive outcome is recorded ONLY if both sources confirm abstinence. Participants with missing data (e.g., lost to follow-up) will be considered smokers in the primary analysis (intention-to-treat).
Time frame: 6 months
7-day point prevalence abstinence (7-day PPA)
Proportion of participants who report abstinence from smoking for the past 7 days. Assessed via the Telegram bot.
Time frame: 1 month and 3 months
Change in cigarette consumption
Change from baseline in the self-reported number of cigarettes smoked per day. Assessed via the Telegram bot.
Time frame: Baseline, 1 month, 3 months, and 6 months
Score on the Fagerström Test for Nicotine Dependence (FTND)
Change in nicotine dependence measured by the FTND questionnaire (score range 0-10, higher scores indicate greater dependence). Assessed via the Telegram bot.
Time frame: Baseline and 6 months
Motivation to quit (Importance and Confidence Scales)
Scores on self-rated scales (0-10) for the importance of quitting and confidence in the ability to quit. Assessed via the Telegram bot.
Time frame: Baseline and 6 months
Participant engagement with the Telegram bot
Composite measure of engagement (dose) including: proportion of completed weekly check-ins, proportion of opened messages, number of SOS/craving button uses, number of active weeks. Metrics are automatically logged by the bot.
Time frame: 6 months
Intervention acceptability and satisfaction
Total score on a custom acceptability and satisfaction questionnaire (5-12 items) completed by participants in the intervention group via the Telegram bot. Higher scores indicate higher satisfaction.
Time frame: 6 months
Time to first relapse
Number of days from randomization to the first self-reported relapse (lapse) event. Assessed via continuous monitoring through the bot's check-in system.
Time frame: 6 months
Plan to share: Yes — All individual participant data collected during the trial, after de-identification, will be shared. This includes demographic data, smoking history, questionnaire responses (Fagerström Test, Importance/Confidence scales), intervention engagement metrics, and primary/secondary outcome data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning 12 months after main results publication and ending 5 years after publication. Data will be available for this period.
Access criteria: Data will be available to researchers who provide a methodologically sound research proposal approved by an independent review committee. Proposals should be directed to the corresponding author. Requestors will need to sign a data access agreement specifying the purpose of analysis, commitment to secure data handling, and agreement not to attempt re-identification of participants.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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