Use of non-assigned smoking cessation programs among participants of a Web-based randomized controlled trial.

BACKGROUND: Concurrent with their enrollment in Web-based Randomized Controlled Trials (RCTs), participants can easily choose to use treatment programs that are not assigned in the study. The prevalence of using non-assigned treatments is largely unknown although it is likely to be related to the extent to which non-assigned treatments are: (a) easy to find and use, (b) low in cost, (c) well publicized, and (d) available from trusted sources. The impact of using other programs--both beneficial and detrimental--warrants additional research investigation. OBJECTIVE: The aim of this report is to explore the extent to which participants enrolled in a Web-based intervention for smoking cessation used treatment methods that were not explicitly assigned ("non-assigned treatment"). In addition to describing the relation between using non-assigned treatments and smoking cessation outcomes, we also explore the broader issue of non-assigned program use by RCT participants in Web-based behavioral interventions, generally. METHODS: We describe the use of other programs (as measured by self-report at the 3-month follow-up assessment) by 1028 participants who were randomized to the Web-based SHIP (Smokers' Health Improvement Program) RCT which compared the Quit Smoking Network (QSN) treatment program and the Active Lives control condition. We examine the extent to which pharmacotherapy products were used by participants in the QSN condition (which explicitly recommended their use) and the Active Lives condition (which purposefully omitted mention of the use of pharmacotherapy). We also test for any between-condition impact of using non-assigned treatments and pharmacotherapy products on smoking cessation outcomes. RESULTS: A total of 24.1% (248/1028) participants reported using one or more smoking cessation treatment programs that were not explicitly recommended or assigned in their treatment protocol. Types of non-assigned treatments used in this manner included individual counseling (1.7%), group counseling (2.3%), hypnotherapy/acupuncture (4.5%), pamphlets/books (12.6%), and other Web-based smoking cessation programs (9.0%). Participants who used non-assigned treatments were more likely to be female and have at least a high school education. Use of non-assigned Web programs was related to greater levels of self-reported smoking cessation measured at the 3-month assessment (OR = 2.63, CI = 1.67 - 4.14, P < .001) as well as the combined 3- and 6-month assessments (OR = 2.09, CI = 1.11 - 3.91, P = .022). In terms of reported medication use, there were no differences between conditions in the number of pharmacotherapy products used. However, more participants in the QSN condition used at least one pharmacotherapy product: 50.0% (262/524) vs 43.8% (221/504); chi(2)(1, N = 1028) = 3.90, P = .048. The use of pharmacotherapy and non-assigned treatment types showed a small but marginally significant correlation: r(1028) = .061, P = .05. CONCLUSIONS: A noteworthy proportion of individuals recruited via the Internet to participate in a Web-based intervention used treatment programs and tools not formally assigned as a part of their research protocol. We consider factors likely to influence using non-assigned treatments and suggest ways that future research can begin to study more fully this important phenomenon which is likely to be found in any type of research, but may be particularly pronounced in minimal contact, Web-based intervention trials.

Comparing two web-based smoking cessation programs: randomized controlled trial.

BACKGROUND: Smoking cessation remains a significant public health problem. Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change. To date, the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals. OBJECTIVE: We describe the 6-month follow-up results of a randomized controlled trial in which participants recruited online were randomly assigned to either a Web-based smoking cessation program (Quit Smoking Network; QSN) or a Web-based exercise enhancement program (Active Lives) adapted somewhat to encourage smoking cessation. METHODS: The study was a two-arm randomized controlled trial that compared two Web-based smoking cessation programs: (1) the QSN intervention condition presented cognitive-behavioral strategies, and (2) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting. The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting. The QSN condition was designed to be more engaging (eg, it included multimedia components) and to present much greater content than is typically found in smoking cessation programs. RESULTS: Contrary to our hypotheses, no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessments. While participants in the QSN intervention condition spent more time than controls visiting the online program, the median number of 1.0 visit in each condition and the substantial attrition (60.8% at the 6-month follow-up) indicate that participants were not as engaged as we had expected. CONCLUSIONS: Contrary to our hypothesis, our test of two Web-based smoking cessation conditions, an intervention and an attention placebo control, failed to show differences at 3- and 6-month assessments. We explored possible reasons for this finding, including limited engagement of participants and simplifying program content and architecture. Future research needs to address methods to improve participant engagement in online smoking cessation programs. Possible approaches in this regard can include new informed consent procedures that better explain the roles and responsibilities of being a research participant, new program designs that add more vitality (changing content from visit to visit), and new types of reminders pushed out to participants to encourage return visits. Simplifying program content through a combination of enhanced tailoring and information architecture also merits further research attention.

Measuring participant rurality in Web-based interventions.

BACKGROUND: Web-based health behavior change programs can reach large groups of disparate participants and thus they provide promise of becoming important public health tools. Data on participant rurality can complement other demographic measures to deepen our understanding of the success of these programs. Specifically, analysis of participant rurality can inform recruitment and social marketing efforts, and facilitate the targeting and tailoring of program content. Rurality analysis can also help evaluate the effectiveness of interventions across population groupings. METHODS: We describe how the RUCAs (Rural-Urban Commuting Area Codes) methodology can be used to examine results from two Randomized Controlled Trials of Web-based tobacco cessation programs: the ChewFree.com project for smokeless tobacco cessation and the Smokers' Health Improvement Program (SHIP) project for smoking cessation. RESULTS: Using RUCAs methodology helped to highlight the extent to which both Web-based interventions reached a substantial percentage of rural participants. The ChewFree program was found to have more rural participation which is consistent with the greater prevalence of smokeless tobacco use in rural settings as well as ChewFree's multifaceted recruitment program that specifically targeted rural settings. CONCLUSION: Researchers of Web-based health behavior change programs targeted to the US should routinely include RUCAs as a part of analyzing participant demographics. Researchers in other countries should examine rurality indices germane to their country.

The information architecture of behavior change websites.

The extraordinary growth in Internet use offers researchers important new opportunities to identify and test new ways to deliver effective behavior change programs. The information architecture (IA)-the structure of website information--is an important but often overlooked factor to consider when adapting behavioral strategies developed in office-based settings for Web delivery. Using examples and relevant perspectives from multiple disciplines, we describe a continuum of website IA designs ranging from a matrix design to the tunnel design. The free-form matrix IA design allows users free rein to use multiple hyperlinks to explore available content according to their idiosyncratic interests. The more directive tunnel IA design (commonly used in e-learning courses) guides users step-by-step through a series of Web pages that are arranged in a particular order to improve the chances of achieving a goal that is measurable and consistent. Other IA designs are also discussed, including hierarchical IA and hybrid IA designs. In the hierarchical IA design, program content is arranged in a top-down manner, which helps the user find content of interest. The more complex hybrid IA design incorporates some combination of components that use matrix, tunnel, and/or hierarchical IA designs. Each of these IA designs is discussed in terms of usability, participant engagement, and program tailoring, as well as how they might best be matched with different behavior change goals (using Web-based smoking cessation interventions as examples). Our presentation underscores the role of considering and clearly reporting the use of IA designs when creating effective Web-based interventions. We also encourage the adoption of a multidisciplinary perspective as we move towards a more mature view of Internet intervention research.

Bandwidth constraints to using video and other rich media in behavior change websites.

BACKGROUND: Web-based behavior change interventions often include rich media (eg, video, audio, and large graphics). The rationale for using rich media includes the need to reach users who are not inclined or able to use text-based website content, encouragement of program engagement, and following the precedent set by news and sports websites. OBJECTIVES: We describe the development of a bandwidth usage index, which seeks to provide a practical method to gauge the extent to which websites can successfully be used within different Internet access scenarios (eg, dial-up and broadband). METHODS: We conducted three studies to measure bandwidth consumption. In Study 1, we measured the bandwidth usage index for three video-rich websites (for smoking cessation, for caregivers, and for improving eldercare by family members). We then estimated the number of concurrent users that could be accommodated by each website under various Internet access scenarios. In Study 2, we sought to validate our estimated threshold number of concurrent users by testing the video-rich smoking cessation website with different numbers of concurrent users. In Study 3, we calculated the bandwidth usage index and threshold number of concurrent users for three versions of the smoking cessation website: the video-rich version (tested in Study 1), an audio-rich version, and a Web-enabled CD-ROM version in which all media-rich content was placed on a CD-ROM on the client computer. RESULTS: In Study 1, we found that the bandwidth usage index of the video-rich websites ranged from 144 Kbps to 93 Kbps. These results indicated that dial-up modem users would not achieve a "good user experience" with any of the three rich media websites. Results for Study 2 confirmed that usability was compromised when the estimated threshold number of concurrent users was exceeded. Results for Study 3 indicated that changing a website from video- to audio-rich content reduced the bandwidth requirement by almost 50%, but it remained too large to allow satisfactory use in dial-up modem scenarios. The Web-enabled CD-ROM reduced bandwidth requirements such that even a dial-up modem user could have a good user experience with the rich media content. CONCLUSIONS: We conclude that the bandwidth usage index represents a practical tool that can help developers and researchers to measure the bandwidth requirements of their websites as well as to evaluate the feasibility of certain website designs in terms of specific use cases. These findings are discussed in terms of reaching different groups of users as well accommodating the intended number of concurrent users. We also discuss the promising option of using Web-enabled CD-ROMs to deliver rich media content to users with dial-up Internet access. We introduce a number of researchable themes for improving our ability to develop Web-based behavior change interventions that can better deliver what they promise.

Harnessing the potential of the internet to promote chronic illness self-management: diabetes as an example of how well we are doing.

OBJECTIVES: Given the potential for the Internet to be used as a dynamic, interactive medium for providing information, changing attitudes and behaviour and enhancing social support, it is important to consider whether what is currently available online for chronic illness self-management adequately harnesses this potential. The objective of this paper was to review the content of diabetes self-management websites and to identify strengths and limitations of online diabetes self-management. METHODS: We reviewed and coded features of 87 publicly available diabetes websites hosted by governmental, health plan, commercial, pharmaceutical, and not-for-profit organizations. We assessed whether each website was using online opportunities in the areas of interactivity, theory-based interventions, social support, and evidence-based care. RESULTS: The majority of sites provided information, essentially using an electronic newspaper or pamphlet format. Few sites offered interactive assessments, social support or problem-solving assistance, although there were some significant differences in these characteristics across the types of site. DISCUSSION: Current diabetes websites fall short of their potential to help consumers. Suggestions are made for ways to improve the helpfulness and interactivity of these resources.

The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results.

BACKGROUND: A prerequisite to translating research findings into practice is information on consistency of implementation, maintenance of results, and generalization of effects. This follow-up report is one of the few experimental studies to provide such information on Internet-based health education. METHODS: We present follow-up data 10 months following randomization on the "Diabetes Network (D-Net)" Internet-based self-management project, a randomized trial evaluating the incremental effects of adding (1) tailored self-management training or (2) peer support components to a basic Internet-based, information-focused comparison intervention. Participants were 320 adult type 2 diabetes patients from participating primary care offices, mean age 59 (SD = 9.2), who were relatively novice Internet users. RESULTS: All intervention components were consistently implemented by staff, but participant website usage decreased over time. All conditions were significantly improved from baseline on behavioral, psychosocial, and some biological outcomes; and there were few differences between conditions. Results were robust across on-line coaches, patient characteristics, and participating clinics. CONCLUSIONS: The basic D-Net intervention was implemented well and improvements were observed across a variety of patients, interventionists, and clinics. There were, however, difficulties in maintaining usage over time and additions of tailored self-management and peer support components generally did not significantly improve results.

Evaluation of an Internet-based smoking cessation program: lessons learned from a pilot study.

The potential contribution of the Internet to smoking cessation seems huge, given that a majority of Americans now have both computers and telephones. Despite the proliferation of Web sites offering smoking cessation support, there is little empirical evidence regarding the efficacy of Internet-delivered cessation programs. We developed a cessation Web site and conducted a short-term evaluation of it, examining recruitment approaches, Web site use patterns, alternative retention incentives and re-contact modes, satisfaction, and cessation rate. The intervention included modules on social support and cognitive-behavioral coping skills configured to take advantage of the interactive and multimedia capabilities of the Internet. Cessation and satisfaction data were obtained from a subsample of 370 subjects followed for 3 months. The program was rated as easy to use, and the social support group component was used most frequently. The cessation rate (abstinence for the previous 7 days) at 3 months was 18%, with nonrespondents (n=161) considered smokers. Among a variety of traditional and Internet-based recruitment strategies, the most successful made use of Internet user groups and search engines. Methodological and procedural issues posed in conducting research on the Internet are discussed.

Do Internet-based support interventions change perceptions of social support?: An experimental trial of approaches for supporting diabetes self-management.

Internet-based support groups are a rapidly growing segment of mutual aid programs for individuals with chronic illnesses and other challenges. Previous studies have informed us about the content of online exchanges between support group members, but we know little about the ability of these interventions to change participants' perceptions of support. A randomized trial of 160 adult Type 2 diabetes patients provided novice Internet users with computers and Internet access to 1 of 4 conditions: (a) diabetes information only, (b) a personal self-management coach, (c) a social support intervention, or (d) a personal self-management coach and the support intervention. After 3 months, individuals in the 2 support conditions reported significant increases in support on a diabetes-specific support measure and a general support scale. Participants' age was significantly related to change in social support, but intervention effects were still significant after accounting for this relationship. This report is a critical first step in evaluating the long-term effects of Internet-based support for diabetes self-management. The discussion identifies directions for future research.