Telegram Messenger Support for Smoking Cessation After Heart Attack
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Telegram-based Smoking Cessation Support, Standard Care (in control arm).
- Кому может быть актуально
- Состояния в реестре: Myocardial Infarction (MI), Tobacco Use, Smoking Cessation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Россия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of a Behavioral Intervention Delivered Via Telegram Messenger on Smoking Cessation in Patients After Myocardial Infarction: The TELEGRAM-MI Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Telegram-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. - Другое Standard 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.
Первичные конечные точки
- 30-day point prevalence abstinence (PPA) [Срок оценки: 6 months]
Вторичные конечные точки (7)
- 7-day point prevalence abstinence (7-day PPA) [Срок оценки: 1 month and 3 months]
- Change in cigarette consumption [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
- Score on the Fagerström Test for Nicotine Dependence (FTND) [Срок оценки: Baseline and 6 months]
- Motivation to quit (Importance and Confidence Scales) [Срок оценки: Baseline and 6 months]
- Participant engagement with the Telegram bot [Срок оценки: 6 months]
- Intervention acceptability and satisfaction [Срок оценки: 6 months]
- Time to first relapse [Срок оценки: 6 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Россия · 1 центр
- Ulyanovsk Regional Clinical Hospital — Ulyanovsk
Публикации
- 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: 10.2196/342 PMID 35759328
- 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. PMID 39490766
- 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. PMID 38090104
- 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. PMID 20082928
- 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. PMID 35022490
- 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. PMID 10761958
Идентификаторы
NCT: NCT07230249 · TELEGRAM-MI