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基于网络的戒烟干预中季节性对招募、留存、依从性及结局的影响:随机对照试验

Impact of seasonality on recruitment, retention, adherence, and outcomes in a web-based smoking cessation intervention: randomized controlled trial.

作者信息

Graham Amanda L, Cha Sarah, Cobb Nathan K, Fang Ye, Niaura Raymond S, Mushro Aaron

机构信息

Schroeder Institute for Tobacco Research and Policy Studies, Legacy, Washington, DC, United States.

出版信息

J Med Internet Res. 2013 Nov 7;15(11):e249. doi: 10.2196/jmir.2880.

DOI:10.2196/jmir.2880
PMID:24201304
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3841362/
Abstract

BACKGROUND

Seasonal variations in smoking and quitting behaviors have been documented, with many smokers seeking cessation assistance around the start of the New Year. What remains unknown is whether smokers who are recruited to cessation treatment trials during the New Year are as motivated to quit, or as likely to enroll in a research trial, adhere to a research protocol, and benefit from a cessation intervention compared to those who are recruited during other times of the year.

OBJECTIVE

The objective of this study was to determine whether smokers recruited during the New Year period differ on measures of motivation and desire to quit, recruitment and retention rates, website utilization rates, and short-term cessation outcomes compared to smokers recruited at other times.

METHODS

Participants were current smokers who had registered on a free Web-based cessation program (BecomeAnEX.org) and were invited to participate in a clinical trial. The New Year period was defined according to a clear peak and drop in the proportion of visitors who registered on the site, spanning a 15-day period from December 26, 2012 to January 9, 2013. Two other 15-day recruitment periods during summer (July 18, 2012 to August 1, 2012) and fall (November 7, 2012 to November 21, 2012) were selected for comparison. Data were examined from 3 sources: (1) a Web-based clinical trials management system that automated the recruitment and enrollment process, (2) self-report assessments at baseline and 3 months postrandomization, and (3) online tracking software that recorded website utilization during the first 3 months of the trial.

RESULTS

Visitors to BecomeAnEX during the New Year period were more likely to register on the site than smokers who visited during summer or fall (conversion rates: 7.4%, 4.6%, 4.9%, respectively; P<.001), but there were no differences in rates of study acceptance, consent, randomization, 3-month follow-up survey completion, or cessation between the 3 periods. New Year participants were older, more educated, more likely to be employed full time, and more likely to have a relationship partner compared with participants recruited at other times during the year, but did not differ on measures of motivation and desire to quit.

CONCLUSIONS

Smokers visiting a Web-based cessation program during the New Year period were more likely to register for treatment and differ on several demographic variables, but showed similar patterns of treatment engagement, retention, follow-up, and short-term cessation outcomes compared with participants who visited the site during other periods of the year. These results allay scientific concerns about recruiting participants during this time frame and are reassuring for researchers conducting Web-based cessation trials.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0cf2/3841362/6f81624977f6/jmir_v15i11e249_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0cf2/3841362/6f81624977f6/jmir_v15i11e249_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0cf2/3841362/6f81624977f6/jmir_v15i11e249_fig1.jpg
摘要

背景

吸烟和戒烟行为存在季节性变化,许多吸烟者在新年伊始寻求戒烟帮助。尚不清楚在新年期间招募参加戒烟治疗试验的吸烟者与在一年中其他时间招募的吸烟者相比,在戒烟动机、参加研究试验的可能性、遵守研究方案以及从戒烟干预中获益方面是否相同。

目的

本研究的目的是确定与在其他时间招募的吸烟者相比,在新年期间招募的吸烟者在戒烟动机和意愿、招募和保留率、网站使用率以及短期戒烟结果方面是否存在差异。

方法

参与者为在一个免费的基于网络的戒烟项目(BecomeAnEX.org)上注册的当前吸烟者,并被邀请参加一项临床试验。新年期间根据在该网站注册的访问者比例的明显峰值和下降来定义,为期15天,从2012年12月26日至2013年1月9日。另外选择夏季(2012年7月18日至2012年8月1日)和秋季(2012年11月7日至2012年11月21日)的另外两个15天招募期进行比较。数据来自3个来源进行检查:(1)一个基于网络的临床试验管理系统,该系统使招募和入组过程自动化;(2)随机分组前基线和随机分组后3个月的自我报告评估;(3)在试验的前3个月记录网站使用情况的在线跟踪软件。

结果

与夏季或秋季访问该网站的吸烟者相比,新年期间访问BecomeAnEX的访问者在该网站注册的可能性更高(转化率分别为7.4%、4.6%、4.9%;P<0.001),但在3个时间段之间,研究接受率、同意率、随机化率、3个月随访调查完成率或戒烟率没有差异。与在一年中其他时间招募的参与者相比,新年期间的参与者年龄更大、受教育程度更高、更有可能全职工作且更有可能有恋爱伴侣,但在戒烟动机和意愿方面没有差异。

结论

与在一年中其他时间段访问该网站的参与者相比,新年期间访问基于网络的戒烟项目的吸烟者更有可能注册接受治疗,并且在几个人口统计学变量上存在差异,但在治疗参与、保留、随访和短期戒烟结果方面表现出相似的模式。这些结果消除了在此时间段招募参与者的科学担忧,并让进行基于网络的戒烟试验的研究人员放心。

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