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Clinical Trials/NCT06187142
NCT06187142
Active, not recruiting
Not Applicable

Mobile Phone-Based Smoking-Cessation Intervention for Chronic Patients: a Sequential, Multiple Assignment, Randomized Trial (SMART)

Beijing Normal University1 site in 1 country130 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Beijing Normal University
Enrollment
130
Locations
1
Primary Endpoint
Participation rate of eligible smokers (Feasibility)
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.

Detailed Description

Noncommunicable diseases (NCDs) , also known as chronic diseases, affect of a large of number of people and cause 41 million death each year, equivalent to 74% of globally mortality. In China, NCDs have caused 86% of deaths in the past three decades. Tobacco use is a type of modifiable behavioural risk factor for the development of noncommunicable disease and death. It not only increases the risk of developing NCDs, but also exacerbates their severity and complications. Tobacco causes over 8 million deaths annually. China has the world's largest population of smokers, more than 300 million. Tobacco related deaths in China are 1 million per year. Smoking cessation is one of the most effective and cost-efficient measures for the prevention and control of NCDs. It can reduce the morbidity and mortality rates of NCDs and improve the health and quality of life of patients. Meanwhile, among current smokers in China, the prevalence of tobacco dependence was 49.7%, smoking cessation services are extremely limited in China, with only 366 clinics nationwide. For smokers with NCDs, hospitalization or outpatient treatment due to health problems can be a 'teachable moment' for quit smoking. Most physicians are unable to provide comprehensive cessation advice due to time and resource constraints, and chronic patients face many relapse triggers after leaving the hospital. Therefore, it is necessary to implement staged and personalized smoking cessation interventions for chronic patients. To facilitate smoking cessation among chronic patients, we propose to use a sequential multiple assignment randomized trial (SMART) design. This adaptive approach is a concept of stepped treatment that aims to address the unmet needs of chronic patients and enhance smoking cessation outcomes. The study aims to facilitate mobile phone-based cessation support for chronic patients using a sequential multiple assignment randomized trial (SMART) , and combines different effective treatments to enhance engagement and determine the most effective adaptive interventions.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Normal University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged 18 or above, reside in Zhuhai for next 6 months;
  • smoke at least 1 cigarette or use e-cigarettes daily;
  • having a smartphone and a WeChat account, being able to use WeChat skillfully;
  • having a diagnosis of at least one chronic disease related to smoking;
  • intent to quit / reduce smoking.

Exclusion Criteria

  • smokers who have communication barrier (either physically or cognitively)
  • having participation in other smoking cessation programmes or services

Outcomes

Primary Outcomes

Participation rate of eligible smokers (Feasibility)

Time Frame: Baseline

The percentage of eligible smokers who agree to participate in the intervention

Secondary Outcomes

  • Validated and self-reported abstinence of GCS-3 vs. GCS-2(3- and 6-month follow-up)
  • Engagement in PCS / GCS intervention(3- and 6-months follow-up)
  • Validated and self-reported abstinence of PCS-3 vs. GCS-2(3- and 6-month follow-up)
  • Validated and self-reported abstinence of PCS-3 vs. PCS-2(3- and 6-month follow-up)
  • Smoking reduction rate(3- and 6-months follow-up)
  • Validated and self-reported abstinence of PCS vs. GCS(3- and 6-month follow-up)
  • Validated and self-reported abstinence of PCS-1+2 vs. GCS-1+2(3- and 6-month follow-up)
  • Validated abstinence and self-reported of PCS-3 vs. GCS-3(3- and 6-months follow-up)

Study Sites (1)

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