TY - JOUR
T1 - Improving adherence to web-based cessation programs
T2 - a randomized controlled trial study protocol.
AU - Graham, Amanda L.
AU - Cha, Sarah
AU - Papandonatos, George D.
AU - Cobb, Nathan K.
AU - Mushro, Aaron
AU - Fang, Y.
AU - Niaura, Raymond S.
AU - Abrams, David B.
N1 - Funding Information:
Primary funding for this work was from the National Cancer Institute at the National Institutes of Health (1R01CA155489-01A1 to ALG). The funding agency had no involvement in the conduct of the study or preparation of this manuscript. We also acknowledge the contributions of GlaxoSmithKline Consumer Healthcare, L.P. and Innotrac Corporation for their role in delivering nicotine replacement products in this study, and Perceptive Market Research for their work in collecting follow-up data. Finally, we are indebted to Larry An, MD, for his thoughtful guidance and input during the planning stages of the project.
Funding Information:
This study is a randomized controlled trial that uses a 2 (SN, no SN) x 2 (NRT, no NRT) factorial design to compare four treatment conditions in a repeated measures design: WEB, WEB + SN, WEB + NRT, and WEB + SN + NRT. Assessments occur at baseline, at 3 months, and at 9 months, with 30-day self-reported point prevalence abstinence at 9 months as the primary outcome. Self-reported smoking status is a commonly accepted outcome measure in web-based cessation trials [14,16,18,19,22,23,70]. Biochemical verification of abstinence is not feasible on a national sample enrolled through the internet. Furthermore, misreporting of abstinence is expected to be low for several reasons: low demand characteristics of the interventions, the use of a proactive recruitment strategy to recruit a representative sample of smokers that do not have special consideration that might elicit misreporting, the fact that participation is completely under the control of the participants, and the use of an extended, 9-month follow-up period [71-74]. We will verify smoking status among a random sample of 10% of self-reported quitters with an established protocol for verification by a significant other. Study procedures from enrollment through follow-up data collection are depicted in Figure 2. The study is funded by the National Cancer Institute of the U.S. National Institutes of Health (R01 CA155489-01A1).
PY - 2013
Y1 - 2013
N2 - Reducing smoking prevalence is a public health priority that can save more lives and money than almost any other known preventive intervention. Internet interventions have the potential for enormous public health impact given their broad reach and effectiveness. However, most users engage only minimally with even the best designed websites, diminishing their impact due to an insufficient 'dose'. Two approaches to improve adherence to Internet cessation programs are integrating smokers into an online social network and providing free nicotine replacement therapy (NRT). Active participation in online communities is associated with higher rates of cessation. Integrating smokers into an online social network can increase support and may also increase utilization of cessation tools and NRT. Removing barriers to NRT may increase uptake and adherence, and may also increase use of online cessation tools as smokers look for information and support while quitting. The combination of both strategies may exert the most powerful effects on adherence compared to either strategy alone. This study compares the efficacy of a smoking cessation website (WEB) alone and in conjunction with free NRT and a social network (SN) protocol designed to integrate participants into the online community. Using a 2 (SN, no SN) x 2 (NRT, no NRT) randomized, controlled factorial design with repeated measures at baseline, 3 months, and 9 months, this study will recruit N = 4,000 new members of an internet cessation program and randomize them to: 1) WEB, 2) WEB + SN, 3) WEB + NRT, or 4) WEB + SN + NRT. Hypotheses are that all interventions will outperform WEB and that WEB + SN + NRT will outperform WEB + NRT and WEB + SN on 30-day point prevalence abstinence at 9 months. Exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of outcome. Addressing adherence in internet cessation programs is critical and timely to leverage their potential public health impact. This study is innovative in its use of a social network approach to improve behavioral and pharmacological treatment utilization to improve cessation. This approach is significant for reducing tobacco's devastating disease burden and for optimizing behavior change in other arenas where adherence is just as critical. ISRCTN:ISRCTN45127327.
AB - Reducing smoking prevalence is a public health priority that can save more lives and money than almost any other known preventive intervention. Internet interventions have the potential for enormous public health impact given their broad reach and effectiveness. However, most users engage only minimally with even the best designed websites, diminishing their impact due to an insufficient 'dose'. Two approaches to improve adherence to Internet cessation programs are integrating smokers into an online social network and providing free nicotine replacement therapy (NRT). Active participation in online communities is associated with higher rates of cessation. Integrating smokers into an online social network can increase support and may also increase utilization of cessation tools and NRT. Removing barriers to NRT may increase uptake and adherence, and may also increase use of online cessation tools as smokers look for information and support while quitting. The combination of both strategies may exert the most powerful effects on adherence compared to either strategy alone. This study compares the efficacy of a smoking cessation website (WEB) alone and in conjunction with free NRT and a social network (SN) protocol designed to integrate participants into the online community. Using a 2 (SN, no SN) x 2 (NRT, no NRT) randomized, controlled factorial design with repeated measures at baseline, 3 months, and 9 months, this study will recruit N = 4,000 new members of an internet cessation program and randomize them to: 1) WEB, 2) WEB + SN, 3) WEB + NRT, or 4) WEB + SN + NRT. Hypotheses are that all interventions will outperform WEB and that WEB + SN + NRT will outperform WEB + NRT and WEB + SN on 30-day point prevalence abstinence at 9 months. Exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of outcome. Addressing adherence in internet cessation programs is critical and timely to leverage their potential public health impact. This study is innovative in its use of a social network approach to improve behavioral and pharmacological treatment utilization to improve cessation. This approach is significant for reducing tobacco's devastating disease burden and for optimizing behavior change in other arenas where adherence is just as critical. ISRCTN:ISRCTN45127327.
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U2 - 10.1186/1745-6215-14-48
DO - 10.1186/1745-6215-14-48
M3 - Article
C2 - 23414086
AN - SCOPUS:84873718900
SN - 0304-3975
VL - 14
JO - Unknown Journal
JF - Unknown Journal
ER -