Coffee Zhanette, Hsu Chiu-Hsieh, Vanderah Todd W, Gordon Judith S
College of Nursing, University of Arizona, Tucson, AZ, USA.
Comprehensive Center for Pain and Addiction, University of Arizona, Tucson, AZ, USA.
Tob Use Insights. 2024 Dec 12;17:1179173X241308136. doi: 10.1177/1179173X241308136. eCollection 2024.
New therapeutic cessation approaches are being tested in clinical trials to engage and retain people who smoke. Our team is conducting a pragmatic randomized clinical trial (RCT) to evaluate a new treatment for tobacco dependence, but enrolling participants and ensuring adherence has been more challenging than in previous trials.
To determine the predictors of enrollment and adherence in the RCT.
A secondary analysis of data from a tobacco cessation RCT.
Data was collected during a two-group RCT testing the efficacy of an integrative guided imagery vs behavioral treatment, with both conditions involving six weekly, hour-long sessions over 9 weeks.
Of the 1074 randomized participants, 803 (74.8%) enrolled (completed the first session), and 631 (78.6%) of those were adherent (attended all scheduled sessions). Variables associated with enrollment included age (adjusted odds ratio [AOR], 1.01; 95% CI, 1.0003-1.02; = 0.04) and state of residence (West Virginia vs New York (NY), AOR, 0.66; 95% CI, 0.46-0.94; = 0.02), with older participants and those from NY more likely to enroll. Variables associated with adherence included race (Black vs White) (AOR, 2.09; 95% CI, 1.05-4.16; = 0.04), higher education (at least some college vs high school or less) (AOR, 2.27; 95% CI, 1.58-3.26; < 0.0001), marital status (all others vs single/never married) (AOR, 1.66; 95% CI, 1.11-2.48; = 0.01), and state of residence (Arizona vs NY) (AOR, 0.52; 95% CI, 0.34-0.78; = 0.002). Within Arizona, older age increased enrollment, while higher education and marriage improved adherence. Within NY, higher education was associated with both increased enrollment and adherence, while higher number of household smokers, and not reporting substance use were associated with increased adherence.
Enrolling and retaining people who smoke in cessation trials requires novel strategies. Identifying predictors of enrollment and adherence offers valuable insights for overcoming barriers in future tobacco cessation RCTs.
新的戒烟治疗方法正在临床试验中进行测试，以吸引并留住吸烟者。我们的团队正在开展一项实用的随机临床试验（RCT），以评估一种新的烟草依赖治疗方法，但招募参与者并确保其依从性比以往的试验更具挑战性。
确定随机临床试验中招募和依从性的预测因素。
对一项戒烟随机临床试验的数据进行二次分析。
在一项两组随机临床试验中收集数据，该试验测试综合引导式意象疗法与行为疗法的疗效，两种疗法均包括在9周内每周进行6次、每次时长1小时的治疗。
在1074名随机分组的参与者中，803人（74.8%）登记入组（完成了第一阶段治疗），其中631人（78.6%）坚持治疗（参加了所有预定的治疗）。与登记入组相关的变量包括年龄（调整后的优势比[AOR]，1.01；95%置信区间，1.0003 - 1.02；P = 0.04）和居住州（西弗吉尼亚州与纽约州[NY]相比，AOR，0.66；95%置信区间，0.46 - 0.94；P = 0.02），年龄较大的参与者和来自纽约州的参与者更有可能登记入组。与依从性相关的变量包括种族（黑人与白人）（AOR，2.09；95%置信区间，1.05 - 4.16；P = 0.04）、高等教育程度（至少上过一些大学与高中或以下学历相比）（AOR，2.27；95%置信区间，1.58 - 3.26；P < 0.000１）、婚姻状况（其他所有情况与单身/从未结婚相比）（AOR，1.66；95%置信区间，1.11 - 2.48；P = 0.01）和居住州（亚利桑那州与纽约州相比）（AOR，0.52；95%置信区间，0.34 - 0.78；P = 0.002）。在亚利桑那州，年龄较大增加了登记入组率，而高等教育程度和婚姻状况改善了依从性。在纽约州，高等教育程度与登记入组率和依从性的提高均相关，而家庭吸烟者数量较多以及未报告物质使用情况与依从性的提高相关。
在戒烟试验中招募并留住吸烟者需要新的策略。识别登记入组和依从性的预测因素为克服未来戒烟随机临床试验中的障碍提供了有价值的见解。
