- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07230249
Telegram Messenger Support for Smoking Cessation After Heart Attack (TELEGRAM-MI)
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
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mikhail A. Kuznetsov, MD
- Phone Number: +79170610352
- Email: mihkuzn@gmail.com
Study Contact Backup
- Name: Dmitry V. Sergeev, PhD
- Phone Number: +79802128785
- Email: ser.dmitry.v@gmail.com
Study Locations
-
-
Ulyanovsk Oblast
-
Ulyanovsk, Ulyanovsk Oblast, Russia, 432000
- Ulyanovsk Regional Clinical Hospital
-
Contact:
- Mikhail A. Kuznetsov, MD
- Phone Number: +79170610352
- Email: mihkuzn@gmail.com
-
Contact:
- Dmitry V. Sergeev, PhD
- Phone Number: +79802128785
- Email: ser.dmitry.v@gmail.com
-
Principal Investigator:
- Mikhail A. Kuznetsov, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
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
General Publications
- Olano-Espinosa E, Avila-Tomas JF, Minue-Lorenzo C, Matilla-Pardo B, Serrano Serrano ME, Martinez-Suberviola FJ, Gil-Conesa M, Del Cura-Gonzalez I; Dejal@ Group. Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care. JMIR Mhealth Uhealth. 2022 Jun 27;10(6):e34273. doi: 10.2196/34273.
- Bricker JB, Sullivan BM, Mull KE, Lavista-Ferres J, Santiago-Torres M. Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial. Contemp Clin Trials. 2024 Dec;147:107727. doi: 10.1016/j.cct.2024.107727. Epub 2024 Oct 28.
- Hayrumyan V, Harutyunyan A, Harutyunyan T. Smoking cessation after myocardial infarction: Findings from a cross-sectional survey in Armenia. Tob Prev Cessat. 2023 Dec 11;9:36. doi: 10.18332/tpc/174359. eCollection 2023.
- Gerber Y, Rosen LJ, Goldbourt U, Benyamini Y, Drory Y; Israel Study Group on First Acute Myocardial Infarction. Smoking status and long-term survival after first acute myocardial infarction a population-based cohort study. J Am Coll Cardiol. 2009 Dec 15;54(25):2382-7. doi: 10.1016/j.jacc.2009.09.020.
- Leosdottir M, Warjerstam S, Michelsen HO, Schlyter M, Hag E, Wallert J, Larsson M. Improving smoking cessation after myocardial infarction by systematically implementing evidence-based treatment methods. Sci Rep. 2022 Jan 12;12(1):642. doi: 10.1038/s41598-021-04634-5.
- Wilson K, Gibson N, Willan A, Cook D. Effect of smoking cessation on mortality after myocardial infarction: meta-analysis of cohort studies. Arch Intern Med. 2000 Apr 10;160(7):939-44. doi: 10.1001/archinte.160.7.939.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Infarction
- Necrosis
- Myocardial Ischemia
- Ischemia
- Pathological Conditions, Signs and Symptoms
- Behavior
- Health Behavior
- Myocardial Infarction
- Smoking Cessation
- Tobacco Use
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- TELEGRAM-MI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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