Mehring Michael, Haag Max, Linde Klaus, Wagenpfeil Stefan, Schneider Antonius
Institute of General Practice, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
J Med Internet Res. 2014 Sep 24;16(9):e218. doi: 10.2196/jmir.3536.
Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners.
Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting.
The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks.
We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080).
This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study's ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome.
German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).
初步研究结果表明，基于网络的干预措施可能在实现显著戒烟方面有效。迄今为止，针对初级保健患者的研究结果非常少，尤其是关于全科医生参与的研究。
我们的目标是在初级保健环境中，研究一个全自动的基于网络的辅导项目结合电话咨询在戒烟方面的短期效果。
该研究是一项非盲群随机试验，观察期为12周。由全科医生招募并随机分配到干预组的个体，参与一个基于教育、动机激发、运动指导、每日短信提醒、每周网络反馈以及全科医生积极监测的网络辅导项目。该项目的所有组成部分都是全自动的。对照组的参与者接受其医生提供的常规护理和建议，不参与基于网络的辅导项目。主要结局是12周后经生化确认的吸烟状态。
我们招募了168名参与者（86名干预组，82名对照组）进入研究。干预组的51名参与者和对照组的70名参与者在基线和12周时均有随访数据。干预组中极少患者（9.8%，5/51）和对照组中极少患者（8.6%，6/70）成功戒烟（比值比0.86，95%置信区间0.25 - 3.0；P = 0.816）。在意向性分析中也发现了类似结果：干预组的5.8%（5/86）和对照组的7.3%（6/82）（比值比1.28，95%置信区间0.38 - 4.36；P = 0.694）。干预组每天吸烟量平均减少9.3支，对照组减少6.6支（平均差值2.7；95%置信区间 - 5.33至 - 0.58；P = 0.045）。在对基线值、年龄、性别和身高进行调整后，这种显著性降低（平均差值2.2；95%置信区间 - 4.7至0.3；P = 0.080）。
与常规护理相比，该试验未表明所测试的基于网络的干预措施在实现戒烟方面有效。有限的统计效力和高失访率可能降低了该研究检测组间显著差异的能力。需要在更大规模人群中进行进一步的随机对照试验，并研究长期结局。
德国临床试验注册中心，注册号DRKS00003067；http://drks - neu.uniklinik - freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067（由WebCite存档于http://www.webcitation.org/6Sff1YZpx）
