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临床试验/NCT03219541
NCT03219541已完成不适用

Feasibility and Acceptability of a Text Messaging Intervention to Increase Smoking Cessation in Vietnam

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2018年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
1
主要终点
Intervention Acceptability

研究概览

简要总结

The purpose of this study is to develop and then test the feasibility, acceptability, and preliminary effect of a bidirectional text message smoking cessation intervention among Vietnamese smokers in Hanoi, Vietnam. The specific aim are: 1) To develop a smoking cessation text message library among Vietnamese smokers; 2) To evaluate message preferences, and the feasibility and acceptability of the bidirectional text message smoking cessation intervention; and 3) To assess the preliminary effect of a bidirectional mobile phone text message intervention on biochemically validated smoking abstinence.

详细描述

For two-arm randomized control (RCT) pilot study (AIM 3), 100 current smokers will be observed to examine the preliminary effect of bidirectional SMS smoking cessation intervention. Subjects will be randomized into two groups (intervention vs. control), and compare the carbon monoxide (CO) validated 7-day point prevalence smoking abstinence rates at 4-week follow-up between intervention group (SMS smoking cessation treatment) and control group (assessment texts only).

Investigators will administer surveys at baseline, 4- and 12-weeks, and assess daily cigarette consumption using text message surveys. After the intervention, they will randomly select 10 participants from the intervention group to attend semi-structured interviews to obtain more in-depth understanding about the usefulness, usability, and acceptability of the intervention. Findings from the pilot RCT will be used to derive an estimate of the effect size, power, and sample size for a full-scale efficacy trial.

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 (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •smoke ≥10 cigarettes per day
  • •capability to read and communicate
  • •plan to quit in the next 30 days
  • •has a mobile phone
  • •has experience using mobile phone text messaging during the past 6 months.

排除标准

  • •Under smoking cessation treatment or is participating in other tobacco cessation intervention
  • •pregnant or breastfeeding.

研究组 & 干预措施

Interventional Automated mobile phone text

Active Comparator

Subjects will receive 2 messages per day in the pre-quit phase, 3 messages per day on the quit date and the first week in the post-quit phase, and 2 messages per day in the last 3 weeks of the intervention. During the intervention, participants will receive a text question at the end of every day asking you "How many cigarettes have you smoked today?"

干预措施: Interventional Automated mobile phone text (Behavioral)

Control Texts

Placebo Comparator

The intervention will consist of a 3-day pre-quit period and then a 4-week post-quit period. Participants will receive 2 text questions each week asking the number of smoking days in the past week and the average number of cigarette smoked per day.

干预措施: Control Automated mobile phone text (Behavioral)

结局指标

主要结局

Intervention Acceptability

时间窗: 12 Weeks

Measured by ranking the mean score of each message

次要结局

  • Number of quit attempts(12 Weeks)
  • Percentage of respondents who have made at least one quit attempt during the intervention period,(12 Weeks)
  • Percent decrease in cigarette consumption per day at 2- and 4-week follow-ups compared to baseline(4 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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