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

Impact of seasonality on recruitment, retention, adherence, and outcomes in a web-based smoking cessation intervention: randomized controlled trial.
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DOI:
10.2196/jmir.2880
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发表时间:
2013-11-07
影响因子:
7.4
通讯作者:
Mushro A
Mushro A
中科院分区:
医学2区
文献类型:
--
作者:
Graham AL;Cha S;Cobb NK;Fang Y;Niaura RS;Mushro A

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吸烟和戒烟行为的季节性变化已经被记录在案,许多吸烟者在新年开始时寻求戒烟帮助。目前尚不清楚的是,与在一年中的其他时间招募的吸烟者相比,在新年期间被招募参加戒烟治疗试验的吸烟者是否有同样的戒烟动机,或者是否同样有可能参加研究试验,遵守研究方案,并从戒烟干预中受益。这项研究的目的是确定在新年期间招募的吸烟者与在其他时间招募的吸烟者在戒烟动机和戒烟愿望、招募和保留率、网站使用率和短期戒烟结果方面是否存在差异。参与者是目前的吸烟者,他们已经注册了一个免费的基于网络的戒烟计划(BecomeAnEX.org),并被邀请参加一项临床试验。根据在该网站上注册的访问者比例的明显高峰和下降来定义新年期间,从2012年12月26日到2013年1月9日的15天期间。另外两个为期15天的招聘期在夏季(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)进行了比较。数据来自3个来源:(1)基于网络的临床试验管理系统,它自动完成招募和登记过程;(2)基线和3个月后的自我报告评估;以及(3)记录试验前3个月网站使用情况的在线跟踪软件。与夏季或秋季访问的吸烟者相比,新年期间访问BecomeAnEX的访问者更有可能在网站上注册(转换率分别为7.4%、4.6%、4.9%;P<.001),但研究接受率、同意率、随机化、3个月跟踪调查完成率或戒烟率在3个时期之间没有差异。与一年中其他时间招募的参与者相比,新年参与者年龄更大,受教育程度更高,更有可能从事全职工作,更有可能有伴侣,但在动机和戒烟愿望的衡量标准上没有差异。在新年期间访问基于网络的戒烟计划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,但与在一年中其他时间段访问该网站的参与者相比,他们在治疗参与度、保留率、随访和短期戒烟结果方面表现出相似的模式。这些结果缓解了科学上对在这一时间框架内招募参与者的担忧,并对进行基于网络的戒烟试验的研究人员来说是放心的。ClinicalTrials.gov ID:nct01544153;http://clinicaltrials.gov/ct2/show/NCT01544153(由网站http://www.webcitation.org/6KjhmAS9u).存档
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. 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. 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. 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. 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. ClinicalTrials.gov ID: NCT01544153; http://clinicaltrials.gov/ct2/show/NCT01544153 (Archived by WebCite at http://www.webcitation.org/6KjhmAS9u).
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