Clinical trial

A Joint Real-World Study of Digital Smoking Cessation Interventions

Name
K4011
Description
According to the "China Smoking Health Hazard Report 2020", the total number of smokers in China is estimated to be 350 million, of which 180 million are already addicted. In addition, more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking victims, among which the family is one of the main places of secondhand smoke exposure, and mothers and children are the most affected group. Passive smoking is a risk factor for spontaneous abortion in pregnant women and an important risk factor for the occurrence of gestational hypertension syndrome and pregnancy complications, and it also affects embryonic development with adverse pregnancy outcomes such as miscarriage, stillbirth, intrauterine growth retardation, preterm birth, immune deficiency, birth defects, and mental retardation. Helping smokers quit is the fundamental solution to reducing secondhand smoke exposure. The accessibility and effectiveness of traditional offline smoking cessation intervention services do not meet the needs of society. With the development of mobile communication technology, digital cessation such as SMS cessation, WeChat cessation, and APP cessation have emerged, which combine clinical cessation guidelines with software technology and present rich product features and interactive design, providing a new solution to expand the accessibility of clinical cessation interventions and address the problem of secondhand smoke exposure.We hope to explore the impact of different digital cessation tools and their combinations on reducing smoking prevalence and maternal tobacco exposure.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Not yet recruiting
Treatment
Digital Smoking Cessation
The core technology of the study is a smoking cessation assistance practice service driven by a machine learning algorithm. The small programs used by the intervention group in this study included smoking cessation service packages based on cognitive behavioral therapy and online guidance from medical staff on staff, and more digital smoking cessation tools.
Arms:
Intervention group
Size
2214
Primary endpoint
Biologically validated subject withdrawal rate
through study completion, an average of 4 months
Biologically validated maternal environmental tobacco exposure rate
through study completion, an average of 4 months
Eligibility criteria
Inclusion Criteria: 1. Pregnant women's inclusion criteria A. Adult females during gestation and within 42 days after delivery B. I do not smoke, but I self-reported secondhand smoke exposure problems 2. Inclusion criteria for smoking quitters A. Adults over the age of 18 who smoke every day; B. I have a clear intention to quit smoking; Exclusion Criteria: 1. Maternal maternal exclusion criteria A. I am a smoker (pregnant women who are willing to quit smoking can join the smoking cessation group) B. Self-report had no risk of secondhand smoke exposure 2. Exclusion criteria for smoking quitters A. Receiving other smoking cessation interventions; B. having a severe mental illness or psychological disorder C. No smart phone or not skilled to use WeChat mini program
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2214, 'type': 'ESTIMATED'}}
Updated at
2023-08-16

1 organization

1 product

2 indications