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Smoking is a major public health concern. In Japan, a 12-week standard smoking cessation support program is available, however, its required face-to-face visits are a key obstacle in completing the program. Telemedicine is a useful way to provide medical treatment at a distance. Although telemedicine for smoking cessation using an internet-based video system has the potential for ensuring better clinical outcomes for patients with nicotine dependence, its efficacy is unclear.
The aim of this study is to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program among patients with nicotine dependence.
This study will be a randomized, controlled, open-label, multicenter trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program, whereas control participants will undergo a standard face-to-face program. We will use the
We will recruit 114 participants who are nicotine-dependent but otherwise healthy adults from March to July 2018 and follow up with them until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019.
This will be the first randomized controlled trial to evaluate the efficacy and feasibility of an internet-based (telemedicine) smoking cessation support program relative to a face-to-face program among patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program will not be clinically worse than the face-to-face program. If this trial demonstrates that telemedicine does not have clinically worse efficacy and feasibility than a conventional face-to-face program, physicians can begin to offer a more flexible smoking cessation program to patients who may otherwise give up on trying such programs.
University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975
DERR1-10.2196/12701
Smoking is a major public health concern responsible for a diverse range of diseases, such as cancers, heart disease, cerebrovascular disease, and chronic obstructive pulmonary disease [
A smoking cessation support program is widely available in Japan for patients with nicotine dependence. This program is agreed to be a standard program by related academic societies and reimbursed by national health insurance [
Recently, telemedicine—or the delivery of health care by remote health care providers via communication technologies—has come to be regarded as a useful method of providing medical care to patients. Telemedicine minimizes a patient’s burden of traveling to a health institution and waiting for consultations with their physicians. In addition, it can lead to improved clinical outcomes for patient quality of life [
Telemedicine might also be suitable for delivering a smoking cessation support program, as 71.7% of the patients with nicotine dependence in Japan are under 60 years of age and 66.7% of patients are men, both of who are demographics who are unwilling to spend half their day visiting a clinic for treatment [
The
Therefore, telemedicine might have the potential to enhance the smoking cessation success rate and other clinical outcomes among patients with nicotine dependence by helping them achieve easier access to smoking cessation programs. However, it remains unclear whether the smoking cessation program using an internet-based video system is effective and safe relative to a conventional face-to-face program.
This is a proof-of-concept study aiming to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program, both of which use the CASC, among patients with nicotine dependence.
This study will be a randomized, controlled, open-label, multicenter trial. The study will be conducted in 4 community clinics located in Tokyo, Japan: Tokyo-Eki Center-building Clinic, Shinjuku Research Park Clinic, Fukuwa Clinic and Miyazaki RC Clinic.
Participants in both arms will undergo the smoking cessation support program used in Japan. For the telemedicine arm, the entire program will be conducted remotely via an internet-based video system except for the first registration visit [
We will recruit nicotine-dependent but otherwise healthy adults from March to July 2018. We plan to follow them up until January 2019 (ie, for 24 weeks). We will include the participants who are diagnosed as nicotine dependent, have smoking history of Brinkman index (BI) >200, and have a determination to quit smoking immediately. Then, we will exclude those participants with severe mental illness and those with any smoking cessation aid, besides prescribed medication at clinics before or after enrollment, based on the subjective questionnaire on the enrollment visit (detail of the inclusion criteria is shown in
Scheme of this trial protocol. CASC: CureApp Smoking Cessation.
Assessment and evaluation schedule of the study.
Variables | Registration | Observation period | |||||
Assessments | Day 1 | Day 15 (2 weeks) | Day 29 (4 weeks) | Day 57 (8 weeks) | Day 85 (12 weeks) | Day 168 (24 weeks) | At withdrawal |
Patients’ profile | ✓a | —b | — | — | — | — | — |
Tobacco Dependence Screening Test | ✓ | — | — | — | — | — | — |
Brinkman Index | ✓ | — | — | — | — | — | — |
Fagerström test for nicotine dependence | ✓ | — | — | — | — | — | — |
12-item French version of the Tobacco Craving Questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | — |
Kano Test for Social Nicotine Dependence | ✓ | — | — | ✓ | ✓ | ✓ | — |
Mood and physical symptoms scale | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | — |
Nicotine dependence and cognition scale | ✓ | — | — | — | ✓ | ✓ | — |
Exhaled carbon oxide concentration | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Smoking status | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Device use status | — | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Adverse events | — | — | — | — | — | — | — |
aInformation collected.
bNot applicable.
As shown in the findings of a previous pilot study of the CASC, the difference in CAR from weeks 9 to 12 between using a CASC smartphone app group (78%) and historical control groups (not using the application; 54%) is 24% [
For randomization, we will use the block randomization method (with 4 blocks) with a 1:1 allocation ratio. Participants will be allocated in this way to either the intervention (telemedicine) or control (face-to-face) arm. The randomization will be performed at the time of participants’ registration by a staff member using a computer-generated random sequence for each participating clinic.
Participants randomized to the intervention (ie, telemedicine) arm will receive an internet-based support program for smoking cessation using the CASC. In contrast, participants randomized to the control (face-to-face) arm will receive the conventional face-to-face standard smoking cessation support program, also using the CASC.
The standard smoking cessation support program in Japan consists of 5 clinic visits over 12 weeks, including doctor consultation and exhaled CO check at a registered institution or clinic [
Patients in the telemedicine arm will undergo the standard smoking cessation support program with the CASC. However, instead of visiting the clinics, they will meet their physicians to receive counseling via a video-conference system and a standardized telemedicine platform app, in accordance with the guideline for telemedicine in Japan [
The CASC consists of the following: (1) a CASC smartphone app for patients with nicotine dependence, (2) a mobile CO checker for patients, and (3) a Web-based patient management software for health care providers [
The CASC will be delivered by the study sponsor, CureApp Inc, Tokyo, Japan, and will be carefully managed to avoid being used outside the current study at each institution or clinic. A prescription code specific to each practicing institution or clinic is required to activate the entire system issued by the sponsor, and the sponsor regularly (at least once a year) performs an inventory and confirms the devices are not used outside the research.
The primary endpoint of this study will be the CAR from weeks 9 to 12. We hypothesize that the telemedicine group will not show clinically worse CAR from weeks 9 to 12 than the control group (threshold of 15%). The CAR is defined as the percentage of individuals continuously not smoking during the specified period. We will also evaluate the following secondary endpoints: (1) smoking cessation success rate at the points of 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in the scores on the mood and physical symptoms scale (MPSS) [
The NDCS is a scale for measuring nicotine dependence and cognitive impairment among smokers. It consists of 8 items, each rated on a 4-point scale (ranging from 0 to 3). A higher total score (minimum=0, maximum=24) implies more severe dependency or cognitive impairment.
The follow-up schedule is shown in
We will compare all endpoints between the telemedicine and the face-to-face arms. Baseline characteristics will be described by means and standard deviations, or medians and interquartile ranges (for continuous variables), or proportions (for categorical variables). We will analyze the primary outcome using the full analysis set (excluding participants who violate the abovementioned inclusion or exclusion criteria). For all outcomes, summary statistics and group difference measures (eg, odds ratios and mean differences) will be presented with 95% CIs and
Participants in this study were not involved in the design, recruitment, conduct, or assessment of the study.
We will conduct this study in compliance with the Declaration of Helsinki, Medical Device Good Clinical Practice guidelines, and all other applicable laws and guidelines in Japan. This protocol and related documents of all the participating clinics were approved by the Tokyo-Eki Center-building clinic institutional review board. We will always use the latest version of the approved documents. We used the SPIRIT reporting guidelines for submitting this protocol to the journal [
As of November 2018, 115 participants with nicotine-dependency were already recruited and will be followed up until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019.
This will be the first randomized control trial to evaluate the efficacy and feasibility of an internet-based video-assisted smoking cessation support program compared with a face-to-face program in patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program (in terms of CAR from weeks 9 to 12) will not be clinically worse than the face-to-face program.
Recent advances in mobile technologies have dramatically changed nearly every aspect of our daily lives. Internet services and smartphone apps play a particularly key role because they help us directly communicate with each other even when apart. Nowadays, smartphone and internet-based video communication have been considered useful tools for improving accessibility to smoking cessation programs, thereby improving the outcomes of patients with nicotine dependence. Scott-Sheldon et al demonstrated in their meta-analysis that a mobile phone short messaging service intervention led to substantial benefits for smoking cessation [
Considering that the aim of this study is to compare different ways of delivering a standard 12-week smoking cessation program, a CAR for the last 4 weeks of the treatment period would be the ideal endpoint. It would also be appropriate to compare those 2 groups for CAR from weeks 9 to 12 because a previous phase III clinical trial on smoking cessation aid medications, such as varenicline, evaluated CAR for the same period to assess the efficacy [
In this study, we will use the CASC for both arms as it serves to complement the standard smoking cessation program. A previous single arm, prospective pilot study showed that the CASC, in addition to the standard program, led to significantly higher CAR from weeks 9 to 24 when compared with a historical control group [
This study has several limitations. First, this study will be conducted in multiple centers, but participants will be limited to residents in an urban area in Tokyo, Japan, which may limit the generalizability of the study findings. We might need to conduct further investigations to apply the study findings to other cohorts. Second, participants in both groups are going to use the CASC, but this system has not yet been cleared by the Pharmaceuticals and Medical Devices Agency. Therefore, the outcomes for each group must be carefully interpreted because they might be the result of mixed effects of the study intervention and the CASC on the standard smoking cessation program. Nevertheless, since the program in Japan requires evaluation of exhaled CO concentration at each visit, supplying participants with the CASC is the only realistic and validated solution to conduct this study at present. Third, the primary physicians can prescribe treatment drugs, either varenicline or nicotine patch, to support the patients in quitting smoking according to a physician’s discretion. Although the institution is an allocation factor for equal randomization, the baseline characteristics of the drug assignment might not be matched between the 2 arms, which could cause the biased results.
In conclusion, we will test whether an internet-based smoking cessation support program does not have clinically worse efficacy and feasibility than a face-to-face smoking cessation program among patients with nicotine dependence. If we obtain the expected findings, physicians can offer a more flexible standard smoking cessation program to patients who might otherwise give up on the idea of trying such programs. In addition, this study could be a milestone to expand the scope of the effective smoking cessation support program, which might contribute to an improvement of public health and reduction of medical expenses.
Inclusion criteria.
Exclusion criteria.
List of smoking cessation treatment lectures provided by the application.
Brinkman index
Continuous abstinence rate
CureApp Smoking Cessation
carbon monoxide
12-item French version of the Tobacco Craving Questionnaire
Kano Test for Social Nicotine Dependence
mood and physical symptoms scale
nicotine dependence and cognition scale
The authors express their gratitude to all the staff and participants regarding this study. They also thank Editage for English language editing. This study was funded by CureApp, Inc (Kodenma-Cho YS building 4th floor, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan).
TT, AN, MK, TM, and KS designed and conducted the study. EH provided statistical expertise in study design. All authors contributed to the refinement of the study protocol and approved the final paper.
TT and AN have received consulting fees from CureApp, Inc, Japan. MK and TM are employees of CureApp, Inc, Japan. KS is the founder and a shareholder of CureApp, Inc and patent holder of the CASC. EH has a consultation contract as a biostatistician with CureApp, Inc, Japan.