Effect of a Behavioral Intervention Delivered Via Telegram Messenger on Smoking Cessation in Patients After Myocardial Infarction: The TELEGRAM-MI Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- 30-day point prevalence abstinence (PPA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard Care (in control arm) (Other)
Telegram Bot Intervention Group
Participants receive standard care PLUS the 6-month behavioral intervention delivered via the Telegram chatbot.
干预措施: Telegram-based Smoking Cessation Support (Behavioral)
结局指标
主要结局
30-day point prevalence abstinence (PPA)
时间窗: 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).
次要结局
- 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)
- Intervention acceptability and satisfaction(6 months)
- Time to first relapse(6 months)
研究者
Mikhail Kuznetsov
Chief Investigator, Cardiologist
ITMO University