NCT07230249

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 13, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

TelegramChatbotDigital HealthBehavioral InterventionSecondary PreventionRandomized Controlled TrialCardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (7)

  • 7-day point prevalence abstinence (7-day PPA)

    1 month and 3 months

  • Change in cigarette consumption

    Baseline, 1 month, 3 months, and 6 months

  • Score on the Fagerström Test for Nicotine Dependence (FTND)

    Baseline and 6 months

  • Motivation to quit (Importance and Confidence Scales)

    Baseline and 6 months

  • Participant engagement with the Telegram bot

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Telegram Bot Intervention Group

EXPERIMENTAL

Participants receive standard care PLUS the 6-month behavioral intervention delivered via the Telegram chatbot.

Behavioral: Telegram-based Smoking Cessation Support

Standard Care Control Group

OTHER

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)

Interventions

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.

Telegram Bot Intervention Group

Routine physician advice to quit smoking provided upon hospital discharge. This represents the current standard of care in the participating clinical centers.

Standard Care Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, 432000, Russia

Location

Related Publications (6)

  • 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.

MeSH Terms

Conditions

Myocardial InfarctionTobacco UseSmoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mikhail Kuznetsov, MD

    Ulyanovsk Regional Clinical Hospital

    PRINCIPAL INVESTIGATOR
  • Dmitry Sergeev, PhD

    ITMO University

    STUDY DIRECTOR
  • Artemiy Okhotin, MPH

    ITMO University

    STUDY DIRECTOR

Central Study Contacts

Mikhail A. Kuznetsov, MD

CONTACT

Dmitry V. Sergeev, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor conducting the 6-month telephone interview to ascertain smoking status is blinded to the participant's group assignment. The assessor has no access to the allocation data or the participant's interaction history with the Telegram bot. Participants are not explicitly informed of their group strategy but cannot be fully blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a pragmatic, randomized, controlled, superiority trial with two parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator, Cardiologist

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations