Telegram Messenger Support for Smoking Cessation After Heart Attack (TELEGRAM-MI)

April 2, 2026 updated by: Mikhail Kuznetsov, ITMO University

Effect of a Behavioral Intervention Delivered Via Telegram Messenger on Smoking Cessation in Patients After Myocardial Infarction: The TELEGRAM-MI Randomized Controlled Trial

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:

  • INTERVENTION GROUP: Standard care plus a 6-month Telegram chatbot program providing personalized motivational messages, cognitive-behavioral techniques for craving management, and relapse prevention support.
  • CONTROL GROUP: Standard care (routine physician advice to quit smoking) plus basic surveys via Telegram without therapeutic content.

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • 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 Backup

Study Locations

    • Ulyanovsk Oblast
      • Ulyanovsk, Ulyanovsk Oblast, Russia, 432000
        • Ulyanovsk Regional Clinical Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mikhail A. Kuznetsov, MD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Age 18 years or older.
  • Hospitalization with a confirmed diagnosis of acute myocardial infarction (MI), including both ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI).
  • Current smoker at the time of index MI: self-reported smoking of at least one cigarette per day in the month prior to hospitalization.
  • Regular user of the Telegram messenger application (app installed on a personal smartphone).
  • Possession of a smartphone with internet access and a valid phone number.
  • Ability and willingness to provide contact information for a close relative or cohabiting person who can verify smoking status at follow-up.

Exclusion Criteria:

  • Smoking cessation more than 1 month prior to the index MI hospitalization.
  • Physical or cognitive impairment that prevents the use of a smartphone (e.g., severe visual/hearing impairment, inability to read or respond to messages).
  • Inability to read and understand the Russian language fluently.
  • Comorbid condition with a life expectancy of less than 1 year.
  • Active severe mental illness (e.g., psychosis, severe untreated depression) that would impede understanding of the protocol or adherence.
  • Unwillingness or inability to provide contact details for a close relative for outcome verification.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telegram Bot Intervention Group
Participants receive standard care PLUS the 6-month behavioral intervention delivered via the Telegram chatbot.
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.
Other: Standard Care Control Group
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.
Routine physician advice to quit smoking provided upon hospital discharge. This represents the current standard of care in the participating clinical centers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day point prevalence abstinence (PPA)
Time Frame: 6 months
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day point prevalence abstinence (7-day PPA)
Time Frame: 1 month and 3 months
Proportion of participants who report abstinence from smoking for the past 7 days. Assessed via the Telegram bot.
1 month and 3 months
Change in cigarette consumption
Time Frame: Baseline, 1 month, 3 months, and 6 months
Change from baseline in the self-reported number of cigarettes smoked per day. Assessed via the Telegram bot.
Baseline, 1 month, 3 months, and 6 months
Score on the Fagerström Test for Nicotine Dependence (FTND)
Time Frame: Baseline and 6 months
Change in nicotine dependence measured by the FTND questionnaire (score range 0-10, higher scores indicate greater dependence). Assessed via the Telegram bot.
Baseline and 6 months
Motivation to quit (Importance and Confidence Scales)
Time Frame: Baseline and 6 months
Scores on self-rated scales (0-10) for the importance of quitting and confidence in the ability to quit. Assessed via the Telegram bot.
Baseline and 6 months
Participant engagement with the Telegram bot
Time Frame: 6 months
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.
6 months
Intervention acceptability and satisfaction
Time Frame: 6 months
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.
6 months
Time to first relapse
Time Frame: 6 months
Number of days from randomization to the first self-reported relapse (lapse) event. Assessed via continuous monitoring through the bot's check-in system.
6 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Mikhail Kuznetsov, MD, Ulyanovsk Regional Clinical Hospital
  • Study Director: Dmitry Sergeev, PhD, ITMO University
  • Study Director: Artemiy Okhotin, MPH, ITMO 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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 12 months after main results publication and ending 5 years after publication. Data will be available for this period.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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