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Tobacco is a major public health concern. A 12-week standard smoking cessation program is available in Japan; however, it requires face-to-face clinic visits, which has been one of the key obstacles to completing the program, leading to a low smoking cessation success rate. Telemedicine using internet-based video counseling instead of regular clinic visits could address this obstacle.
This study aimed to evaluate the efficacy and feasibility of an internet-based remote smoking cessation support program compared with the standard face-to-face clinical visit program among patients with nicotine dependence.
This study was a randomized, controlled, open-label, multicenter, noninferiority trial. We recruited nicotine-dependent adults from March to June 2018. Participants randomized to the telemedicine arm received internet-based video counseling, whereas control participants received standard face-to-face clinic visits at each time point in the smoking cessation program. Both arms received a CureApp Smoking Cessation smartphone app with a mobile exhaled carbon monoxide checker. The primary outcome was a continuous abstinence rate (CAR) from weeks 9 to 12. Full analysis set was used for data analysis.
We randomized 115 participants with nicotine dependence: 58 were allocated to the telemedicine (internet-based video counseling) arm and 57, to the control (standard face-to-face clinical visit) arm. We analyzed all 115 participants for the primary outcome. Both telemedicine and control groups had similar CARs from weeks 9 to 12 (81.0% vs 78.9%; absolute difference, 2.1%; 95% CI –12.8 to 17.0), and the lower limit of the difference between groups (–12.8%) was greater than the prespecified limit (–15%).
The application of telemedicine using internet-based video counseling as a smoking cessation program had a similar CAR from weeks 9 to 12 as that of the standard face-to-face clinical visit program. The efficacy of the telemedicine-based smoking cessation program was not inferior to that of the standard visit–based smoking cessation program.
University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975.
Tobacco is a major public health concern and the biggest preventable cause of a variety of disorders such as cerebro- and cardiovascular diseases, malignant tumors, and chronic obstructive pulmonary disease [
To help quit smoking, Japan provides a smoking cessation program for patients with nicotine dependence. This 12-week program mainly consists of face-to-face clinic visits, involving counseling with a primary physician, checking exhaled carbon monoxide (CO) concentration, and prescribing smoking cessation medications [
Recently, telemedicine, defined as remote delivery of health care via the internet, was considered one of the useful methods for providing medical care to patients [
In this study, we tested the clinical efficacy and feasibility of telemedicine using internet-based Web counseling compared to a standard face-to-face clinical visit in the smoking cessation program among patients with nicotine dependence.
This trial was a randomized, controlled, open-label, multicenter, noninferiority trial. Details of the trial protocol have been described elsewhere [
We recruited individuals with nicotine dependence from March to June 2018. We conducted follow-up for 24 weeks. Only the participants who met all the inclusion criteria were included; those who met any of the exclusion criteria were excluded [
Primary physicians at each clinic obtained written informed consent from all trial participants. We confirmed that clinics participating in this trial could provide the standard smoking cessation support program and had the necessary equipment to provide Web-based telemedicine (eg, WiFi access in the facility). We conducted this trial in compliance with the Declaration of Helsinki, Medical Device Good Clinical Practice guidelines, and all other applicable laws and guidelines in Japan. The trial protocol was approved by the Tokyo-Eki Center-Building Clinic institutional review board. We reported the trial according to CONSORT-EHEALTH (V 1.6.1). This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN000031620).
We used the stratified-block randomization (four blocks) method with a 1:1 allocation ratio to achieve equal assignment to two arms with stratification of the trial sites. Participants were allocated to either the telemedicine arm or the control arm. The randomization was performed by the staff at each participating clinic at the time of participants’ registration, using a computer-generated random sequence.
Participants allocated to the telemedicine arm received internet-based Web counseling for the smoking cessation program. Participants assigned to the control arm received the conventional face-to-face clinic visits for the smoking cessation program. Both arms also received the CASC smartphone app and a mobile exhaled CO checker during the trial period (24 weeks).
The standard smoking cessation program in Japan consists of five face-to-face clinic visits lasting for 12 weeks, including doctor consultations and exhaled CO checks at a registered institution or clinic [
Following the first visit, telemedicine participants were supposed to receive counseling via the internet-based video counseling system with a standardized telemedicine platform application [
The CASC system was developed by CureApp, Inc. (Tokyo, Japan). Details of the system have been demonstrated elsewhere [
The primary outcome was the biochemically validated CAR from weeks 9-12, which was consistent with the previous clinical trial of varenicline in Japan [
From previous pilot studies of a CASC smartphone app, the difference in CAR from 9-12 weeks between the CASC smartphone app group (78%) and historical control groups (not using the app; 54%) is 24% [
We compared all endpoints between the telemedicine and control groups. Baseline characteristics were described by means and SDs, medians and interquartile ranges (for continuous variables), or proportions (for categorical variables). We analyzed the primary outcome using the full analysis set (excluding participants who violated the inclusion or exclusion criteria). In case a patient discontinued an allocated treatment, the case was considered as smoking cessation failure. We compared CARs between telemedicine and the control groups using a logistic regression model with crude odds ratios (ORs). For all outcomes, summary statistics and group difference measures (eg, ORs by logistic regression or mean differences) were presented with 95% CIs. We also tested if the CAR from 9-12 weeks of telemedicine and the control condition varied by subgroups. We assessed interactions of CAR from 9-12 weeks with each variable (greater than vs less than the median for continuous variables) and calculated ORs with 95% CIs in each subgroup. We used the Wilcoxon signed-rank test for comparing the scores regarding nicotine dependence between baseline and at weeks 12 and 24 in each group. R version 3.4.1 (R Foundation for Statistical Computing, Vienna, Austria) was used for all the analyses.
We randomized 115 participants to the telemedicine arm or control arm (
Biochemically validated CARs from weeks 9-12 were 81.0% (95% CI 71-91) in the telemedicine group and 78.9% (95% CI 68-89) in the control group (
Next, we demonstrated the efficacy of the telemedicine on CAR from weeks 9-12 by subgroup. Although the KTSND had a moderate interaction with the outcome, we found little evidence of significant interactions for any of the subgroup analyses (
We also assessed the evolution of scores by MPSS, FTCQ-12, KTSND, and NDCS (
Trial flowchart. CASC: CureApp Smoking Cessation; SC: smoking cessation.
Baseline characteristics of the trial participants.
Characteristic | Total (N=115) | Telemedicine (N=58) | Standard care (N=57) | |
Age (years), mean (SD) | 55 (11) | 55 (12) | 53 (10) | |
Male sex, n (%) | 93 (81) | 45 (78) | 48 (84%) | |
Body mass index (kg/m2), median (interquartile range) | 23 (21-26) | 23 (21-26) | 23 (21-25) | |
Cigarettes per day | 15 (13-20) | 16 (15-20) | 15 (12-20) | |
Years of smoking | 34 (27-40) | 35 (29-41) | 33 (26-38) | |
Number of attempts of smoking cessation before the trial, median (interquartile range) | 1 (0-2) | 1 (0-2) | 0 (0-2) | |
TDSa score, median (interquartile range) | 7 (6-8) | 7 (6-8) | 7 (6-8) | |
FTNDb score, median (interquartile range) | 5 (3-7) | 5 (4-7) | 5 (3-6) | |
KTSNDc score, median (interquartile range) | 17 (16-20) | 17 (16-20) | 18 (15-21) | |
Hypertension | 33 (29) | 16 (28) | 17 (30) | |
Diabetes mellitus | 9 (8) | 5 (9) | 4 (7) | |
Dyslipidemia | 42 (37) | 23 (40) | 19 (33) | |
Varenicline | 63 (55) | 29 (50) | 34 (60) | |
Nicotine patch | 52 (45) | 29 (50) | 23 (40) |
aTDS: Tobacco Dependence Screener.
bFTND: Fagerström Test for Nicotine Dependence.
cKTSND: Kano Test for Social Nicotine Dependence.
Continuous abstinence rates in percentages from weeks 9-12 (primary outcome) and weeks 9-24 (secondary outcome).
Continuous abstinence rate | Telemedicine, mean (SE) | Control, mean (SE) | Difference (95% CI) | Odds ratio (95% CI) |
Weeks 9-12 | 81.0 (5.1) | 78.9 (5.4) | 2.1 (–12.8 to 17.0) | 1.14 (0.45-2.88) |
Weeks 9-24 | 74.1 (5.7) | 71.9 (6.0) | 2.2 (–14.0 to 18.4) | 1.12 (0.49-2.57) |
In this randomized trial, we assessed the efficacy and feasibility of an internet-based remote smoking cessation program compared to the standard face-to-face clinical visit program among patients with nicotine dependence. We found that (1) CARs from weeks 9-12 were relatively high in both groups (81.0% in the telemedicine and 78.9% in the face-to-face control groups) and (2) the clinical efficacy of the telemedicine group was not significantly greater than that of the face-to-face control group in terms of CAR from weeks 9-12.
This trial has several important findings. First, CARs from weeks 9-12 were relatively high. CARs from weeks 9-24 also reached favorable results in both groups (74.1% in telemedicine and 71.9% in control). Compared to other countries [
Second, the dropout rates of the smoking cessation program were low even at week 24 in both groups, indicating potential improvement in the overall smoking cessation success rates. The Japanese national survey on the efficacy of nicotine-dependence treatment showed a linear relationship between the number of patient visits to outpatient clinics and the treatment success rate [
Third, most of the scores for nicotine dependence in the trial were significantly decreased in both groups. This result indicated that the telemedicine-based and face-to-face smoking cessation programs with the CASC system were effective in improving the status of nicotine dependence and ameliorating craving for smoking over time in the smoking cessation program. However, mood symptoms (depressed, irritable in control, restless, hungry, and poor concentration) of the MPSS did not change during the trial. This outcome may be because the baseline median scores of these symptoms were already low (1=Not at all or 2=Slightly) and continuously stabilized during the trial period.
The strength of this trial was that it was the first randomized controlled trial to test the efficacy and feasibility of telemedicine using internet-based video counseling directly compared with face-to-face clinical visit in patients with nicotine dependence. This trial had a few limitations. First, the prespecified limit value of 15% might not be conservative. However, CARs from weeks 9-12 in both groups were almost what we expected (both around 80%), and we considered 65% of CAR from weeks 9-12 to be a reasonable threshold for checking the clinical relevance of the telemedicine program compared with the face-to-face clinic visit program in accordance with previous reports [
Telemedicine using internet-based video counseling for the smoking cessation program had a similar CAR from weeks 9-12 as that of the standard face-to-face clinic visit program. The efficacy of the telemedicine-based smoking cessation program was noninferior to that of the standard clinic visit–based smoking cessation program. The results of this trial demonstrated that internet-based counselling might be a viable alternative to standard clinic visits for smoking cessation.
Supplemental figures and tables.
CONSORT-EHEALTH checklist (V 1.6.1).
continuous abstinence rate
carbon monoxide
12-item French version of the Tobacco Craving Questionnaire
Kano Test for Social Nicotine Dependence
Mood and Physical Symptoms Scale
Nicotine Dependence Cognition Scale
odds ratio
We thank all the staff and participants involved in this trial. We would also like to express our gratitude to Ayaka Kato for her productive comments on our draft manuscript and Yoshihiko Raita and Masaaki Yamada for their support in conducting the statistical analyses. In addition, we thank Tatsue Takami, Satomi Ono, Naomi Suzuki, Masaru Tukahara and all other administrative and engineering team members in CureApp Inc for their dedicated work for this study.
This trial was supported by CureApp, Inc. AN received consulting fees from CureApp, Inc. TT and TM are employees of CureApp, Inc. KS is the founder and a shareholder of CureApp, Inc, and patent holder of the CASC system. EH has a consultation contract as a biostatistician with CureApp, Inc. TO, YF, AK and MM received research support fees from CureApp, Inc.