An Online Pilot Study of Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ease-of-use and Helpfulness of the App
研究概览
简要总结
The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a smartphone app investigators designed to support smoking cessation, and to test if within-person theorized mechanisms of change are occurring as participants undergo the app-assisted quit attempt. Data sources will be passively collected smartphone app usage data, surveys and, in a sub-sample (n=20), online video-conference user feedback sessions. Results will be used to guide the design of Version 3.0 of the "Smiling Instead of Smoking" (SiS) smartphone app. Specifically, the aims of this study are to:
- Assess ease-of-use and helpfulness of the app, as rated by app users 6 weeks after their chosen smoking cessation date
- Test if within-person changes occur in theorized mechanisms of behavior change as nondaily smokers undergo a SiS app assisted quit attempt
- Identify app features in need of improvement, as identified by passively recorded app usage patterns, REDCap open-ended survey items, and, in a sub-sample, user feedback sessions (n=20)
详细描述
An estimated 90 participants will participate in this study based on the following eligibility criteria: (a) 18+ years of age, (b) smartphone ownership (c) current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days (i.e., 71% of nondaily smokers), and (d) has current quit intention (i.e., 65-74% of nondaily smokers). Investigators will stop enrollment when n=90 participants have completed the primary endpoint of the study, which is the 6-week follow-up. This study will be conducted entirely remotely and will require a screening process prior to enrolling participants on the app.
Study participation will last 6 months, where surveys will be administered prior to the quit day (online, as part of a screening test), and at 2-week, 6-week, 3-month, and 6-month follow-ups of the participant's chosen quit day. Participants will use the app for a strongly encouraged period of 7 weeks (1 week before, 6 weeks following the quit attempt), and optional continued use thereafter.
Participants will complete two types of assessment: (1) surveys, and (2) (in a sub-sample) user feedback sessions conducted via phone and/or video-conference call. Potential participants will click-through to the study website. This website will explain that participants must call study staff in order to be phone-screened and to participate in the study. During the phone-screen, participants will be directed to complete an online survey via REDCap. If participants complete the survey and pass the screening test (e.g., correctly responding to reading-check items in the online survey), they choose a smoking cessation quit day, and schedule a phone call with study staff to enroll in the study. This enrollment phone call occurs 1 week prior to the chosen quit day. During this call, study staff will provide the link to download the app, and provide participants with an app-walkthrough. Thereafter, participants will receive survey links for 2-week, 6-week, 3-month and 6-month follow-ups via an emailed link.
Participation in the user feedback session is optional. Within the baseline survey, participants will be asked if they would be willing to participate in an online video-conference user feedback session after they have used the app for seven weeks (1 week pre, 6 weeks post their chosen smoking quit day). If selected for the online user feedback sessions (selected at random from interested participants, with stratification based on gender, age, and race/ethnicity), participants will receive an email and/or phone call upon completing their 6-week survey to set up the user feedback session.
The online user feedback sessions (n=20) will consist of the participants, and 1-2 members of the study staff. Relatively little guidance will be provided in this setting. Instead, 4 open-ended questions will be posed (i.e., did the app help you in your quit attempt? What did you like? What did you dislike? How could the app be improved?). All conference calls will be recorded for later analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Owns a smartphone
- •Is a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days
- •Has a current intention to quit smoking
- •Interested in using a smartphone app to quit smoking
排除标准
- •Under 18 years of age
- •Does not own a smartphone
- •Is not a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days
- •Does not have a current intention to quit smoking
- •Is not interested in using a smartphone app to quit smoking
结局指标
主要结局
Ease-of-use and Helpfulness of the App
时间窗: 6 weeks after chosen smoking cessation date
As rated by app users 6 weeks after their chosen smoking cessation date via open-ended REDCap survey. This survey asks questions concerning feasibility, usefulness, and overall opinions of specific app features. Responses were rated on 4-point Likert-scales with ease-of-use rated with the options 0 = Not easy at all \| 1 = Somewhat easy to use \| 2 = Easy to use \| 3 = Very easy to use, and usefulness rated with the options 0 = Not at all useful \| 1 = Somewhat useful \| 2 = Useful \| 3 = Very useful. For both ease-of-use and usefulness items, scores range from 0 to 3 with higher scores indicating a better opinion of the app features.
次要结局
- Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit Measure(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges Measure(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness Measures(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy Measure(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking Measures(Baseline, 2-weeks, and 6-weeks post-quit)
- Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)(Baseline, 2-weeks, and 6-weeks post-quit)
研究者
Bettina B. Hoeppner
Associate Professor
Massachusetts General Hospital