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临床试验/NCT03839043
NCT03839043已完成不适用

Perioperative Smoking Cessation in Surgical Patients Using Short Messaging Service Program.

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
100
试验地点
2
主要终点
Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30

研究概览

简要总结

Smoking can increase the risk of complications around the time of surgery. Researchers are trying to see if a text messaging program can help smokers stay off cigarettes around the time of surgery.

详细描述

The long-term goal of the project is to increase the reach and effectiveness of tobacco use interventions in healthcare settings. The main objective of this project is to determine whether an innovative tobacco use intervention targeting abstinence from the morning of surgery until one week after surgery ("quit for a bit") can increase sustained engagement of surgical patients in treatment compared with a standard tobacco use intervention that specifically targets long-term abstinence ("quit for good").

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

A randomization schedule for each strata will be generated by the biostatistician using variable length blocks of size 2 or 4 to ensure that the number of subjects assigned to each of the 2 intervention groups remains balanced within each strata. Using these randomization schedules, a computer application program will be used that allows the study personnel to enroll a patient into the trial and obtain the appropriate treatment assignment. The computer application will assign this patient the next sequential treatment assignment for the admission status, and update the randomization dataset accordingly.Once treatment assignment is determined, study personnel will deliver the assigned intervention. The patient will be blinded to treatment assignment to the extent of not knowing the goal of the intervention a priori.

入排标准

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

入选标准

  • Age 18 years or older
  • Greater than 100 cigarettes lifetime consumption and history of smoking cigarettes every day or most days within the week prior to enrollment
  • Willingness to either "quit for a bit" or "quit for good" in the perioperative period, and;
  • Owning a device with access to SMS with an unlimited text plan

排除标准

  • Surgery on the day of POE evaluation
  • Any active psychiatric condition

结局指标

主要结局

Proportion of subjects who elect to continue participating in the SMS service after postoperative day 30

时间窗: 30 days Post Op

Provides one measure of subject engagement in treatment - how many are willing to continue using the text messaging service after 30 days.

The rate at which subjects respond to any requests for subject response delivered via SMS and/or use of "keywords" sent via SMS by the subjects

时间窗: Cumulative from Day 1 to Day 30 Post Op

Another measure of treatment engagement, describing willingness of the subjects to interact with the SMS service

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Warner

Principal Investigator

Mayo Clinic

研究点 (2)

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