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

ABSTRACT: 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.

SUBMITTER: Graham AL

PROVIDER: S-EPMC3841362 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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

Graham Amanda L AL Cha Sarah S Cobb Nathan K NK Fang Ye Y Niaura Raymond S RS Mushro Aaron A

Journal of medical Internet research 20131107 11

<h4>Background</h4>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.<h4>Ob ...[more]

PMID: 24201304

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Project description:Web-based smoking cessation interventions can deliver evidence-based treatments to a wide swath of the population, but effectiveness is often limited by insufficient adherence to proven treatment components. This study evaluated the impact of a social network (SN) intervention and free nicotine replacement therapy (NRT) on adherence to evidence-based components of smoking cessation treatment in the context of a Web-based intervention.A sample of adult U.S. smokers (N = 5290) was recruited via BecomeAnEX.org, a free smoking cessation Web site. Smokers were randomized to one of four arms: (1) an interactive, evidence-based smoking cessation Web site (WEB) alone; (2) WEB in conjunction with an SN intervention designed to integrate participants into the online community (WEB+SN); (3) WEB plus free NRT (WEB+NRT); and (4) the combination of all treatments (WEB+SN+NRT). Adherence outcomes assessed at 3-month follow-up were as follows: Web site utilization metrics, use of skills training components, intratreatment social support, and pharmacotherapy use.WEB+SN+NRT outperformed all others on Web site utilization metrics, use of practical counseling tools, intratreatment social support, and NRT use. It was the only intervention to promote the sending of private messages and the viewing of community pages over WEB alone. Both social network arms outperformed WEB on most metrics of online community engagement. Both NRT arms showed higher medication use compared to WEB alone.This study demonstrated the effectiveness of two approaches for improving adherence to evidence-based components of smoking cessation treatment. Integrated approaches to medication provision and social network engagement can enhance adherence to components known to improve cessation.This study demonstrated that an integrated approach to medication provision and social network integration, when delivered through an online program, can enhance adherence across all three recommended components of an evidence-based smoking cessation program (skills training, social support, and pharmacotherapy use). Nicotine replacement therapy-when provided as part of an integrated program-increases adherence to other program elements, which in turn augment its own therapeutic effects. An explicit focus on approaches to improve treatment adherence is an important first step to identifying leverage points for optimizing intervention effectiveness.

Project description:Background and aimsVarenicline effectiveness may be related to the level of adherence, which might be reduced by adverse effects such as nausea. The aim of the study was to test a possible effect of nausea on smoking cessation outcomes mediated by adherence.DesignMediation path analysis.SettingMultiple sites within Canada and the United States.ParticipantsTreatment-seeking smokers receiving varenicline from two smoking cessation clinical trials: Quit2Live (NCT01836276; n = 449) and Pharmacogenetics of Nicotine Addiction Treatment (PNAT) (NCT01314001; n = 421).MeasurementsNausea severity was collected through self-report and adherence was biologically assessed using varenicline concentrations (Quit2Live, plasma sample at week 4; PNAT, saliva sample at week 2). In Quit2Live, the end-points were cotinine-verified abstinence at weeks 4, 12 and 26. In PNAT, the end-points were carbon monoxide-verified abstinence at weeks 2, 12 and 26.FindingsEarly nausea was not directly associated with abstinence [odds ratio (OR) ranging from 0.73-1.28; P ? 0.26]. However early nausea was indirectly associated with lower cessation rates at multiple timepoints (ORs ranging from 0.92-0.94; 95% CI between 0.83-0.99) in a relationship mediated by reduced varenicline adherence (assessed by plasma varenicline concentrations) in the primary trial (Quit2Live). This relationship between nausea, adherence and cessation was similar in direction but weaker in effect size (ORs ranging from 0.98-0.99; 95% CI between 0.90-1.03) in a secondary trial (PNAT), where adherence was assessed using salivary varenicline concentrations.ConclusionsThese data suggest that early nausea during varenicline treatment may be indirectly associated with lower likelihood of smoking cessation through reducing varenicline adherence. Differences in robustness between the trials may be due to the different biological matrices (plasma vs. saliva) and/or timing used to assess varenicline adherence. The results of the first study suggest that improved management of early nausea during varenicline treatment may positively impact smoking cessation success through increasing varenicline adherence.

Project description:BackgroundMobile health tools such as text messaging programs can support smoking cessation. However, high rates of disengagement from these tools decrease their effectiveness.ObjectiveThe purpose of this study was to identify user characteristics associated with retention in an adult text messaging smoking cessation intervention.MethodsAdults initiating a quit attempt using the publicly available program SmokefreeTXT between March 6 and June 21, 2016 (n=6215), were included. Data were collected to assess nicotine dependence, frequency of being around other smokers, time of the day for cigarette cravings, extrinsic and intrinsic motivation to quit smoking, confidence in quitting, and long-term intention to be smoke free. Multivariable survival analysis modeling for time to opt out was conducted to identify characteristics associated with opting out over the course of the intervention, adjusting for age, sex, and smoking frequency, reset of the quit date by the user, and the number of days enrolled before initiating the quit attempt. Among those who opted out, multivariable multinomial logistic regression analysis was used to identify predictors of opting out early (within 3 days and between 4 and 7 days into the quit attempt) compared to opting out late (more than 7 days into the quit attempt), adjusting for the same confounders.ResultsSurvival analyses indicated that younger age, female sex, higher levels of nicotine dependence, lower intention to be smoke free, and enrolling in SmokefreeTXT ≤1 week before initiating the quit attempt were associated with an increased risk of opting out. For example, users who smoked within 5 minutes of waking up were 1.17 times more likely to opt out than those who smoked more than 5 minutes after waking up (95% CI 1.01-1.35). Among users who opted out from SmokefreeTXT, logistic regression modeling indicated that compared to users who were never or rarely around other smokers, those who were sometimes around other smokers had 1.96 times more likely to opt out within the first 3 days of the quit attempt (95% CI 1.18-3.25). In addition, compared to users with high levels of long-term quit intention, users with lower levels of intention had 1.80 times the odds of opting out between 4 and 7 days into the quit attempt (95% CI 1.02-3.18). Users who reset their quit date after initiating a quit attempt were less likely to opt out at either time point compared with those who did not reset their quit date.ConclusionsSeveral user characteristics are associated with retention in an adult text messaging smoking cessation program. These results provide guidance on potential characteristics that should be addressed in future text messaging smoking cessation programs. Providing additional support to users with these characteristics may increase retention in text messaging programs and ultimately lead to smoking cessation.

Project description:Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components.We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome.This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses.NCT02585206.

Project description:BackgroundDespite having many advantages, online eHealth trials are not without challenges-notably, participant recruitment, and outcome data retention. Moreover, publications from these trials rarely provide detailed information on the methods used for recruitment and retention or discuss implications of the methods for future studies.ObjectiveTo address this need for empirical guidance regarding recruitment and outcome data retention planning, we aim to describe the methods and lessons learned from the recruitment and retention procedures used in a large randomized trial of 2 Web-based smoking cessation interventions.MethodsTo ensure a demographically and geographically diverse participant sample, we used the recruitment strategies (1) traditional, (2) Web-based, and (3) online survey panel methods and adaptively modified each in response to recruitment success. At baseline, participants indicated how they heard about the study and answered demographic questions. To maximize trial retention at each of the 3-, 6-, and 12-month assessment points, 4 survey modalities (first Web, followed by phone, mail, and postcard) were sequentially timed over a 30-day period. Participants received US $25 for submitting their responses, regardless of modality, and received an additional US $10 bonus for completing the Web survey within 24h of electronic notification.ResultsWe randomized 2637 smokers in 16 months and achieved 88% retention at 12-months. Participants (79.26% female, 72.60% Caucasian) were recruited from all 50 states. The majority of participants were recruited through Facebook (49.43%), followed by the survey panel (20.85%), free internet sources (14.54%), traditional media (11.34%), and Google ads (3.84%). Descriptively, participant demographics varied by recruitment source. Of the completed follow-up surveys, most were completed by Web (92%). Retention rates did not vary by recruitment source.ConclusionsContinuous monitoring and refinement of multiple recruitment methods, particularly of online advertising campaigns, allowed us to maximize the effectiveness of recruitment strategies in recruiting a large, diverse sample of smokers. Likewise, offering multiple follow-up survey modalities in sequential order along with time-dependent bonus incentives enabled us to obtain outcome data from a very high level of enrolled participants for the duration of the trial protocol. These strategies may be similarly useful in other trials.Trial registrationClinicalTrials.gov NCT01812278; https://clinicaltrials.gov/ct2/show/NCT01812278 (Archived by WebCite at http://www.webcitation.org/71gy5GLvO).

Dataset Information

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

Publications

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

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