Myocardial Infarction (MI), Smoking Cessation, Tobacco Use
Conditions
Keywords
Telegram, Chatbot, Digital Health, Behavioral Intervention, Secondary Prevention, Randomized Controlled Trial, Cardiac Rehabilitation
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.
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.
Interventions
BEHAVIORALTelegram-based Smoking Cessation Support
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.
OTHERStandard Care (in control arm)
Routine physician advice to quit smoking provided upon hospital discharge. This represents the current standard of care in the participating clinical centers.
Sponsors
ITMO University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
This is a pragmatic, randomized, controlled, superiority trial with two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day point prevalence abstinence (PPA) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence (7-day PPA) | 1 month and 3 months | Proportion of participants who report abstinence from smoking for the past 7 days. Assessed via the Telegram bot. |
| Change in cigarette consumption | 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. |
| Score on the Fagerström Test for Nicotine Dependence (FTND) | 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. |
| Motivation to quit (Importance and Confidence Scales) | 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. |
| Participant engagement with the Telegram bot | 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. |
| Intervention acceptability and satisfaction | 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. |
| Time to first relapse | 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. |
Countries
Russia
Contacts
CONTACTMikhail A. Kuznetsov, MD
CONTACTDmitry V. Sergeev, PhD
PRINCIPAL_INVESTIGATORMikhail Kuznetsov, MD
Ulyanovsk Regional Clinical Hospital
STUDY_DIRECTORDmitry Sergeev, PhD
ITMO University
STUDY_DIRECTORArtemiy Okhotin, MPH
ITMO University
Outcome results
None listed