Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial (Preprint)

BACKGROUND 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. OBJECTIVE 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. METHODS 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. RESULTS 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%). CONCLUSIONS 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. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975.

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Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial

Journal of Medical Internet Research ◽

10.2196/13520 ◽

2019 ◽

Vol 21 (4) ◽

pp. e13520 ◽

Cited By ~ 8

Author(s):

Akihiro Nomura ◽

Tomoyuki Tanigawa ◽

Tomoyasu Muto ◽

Takafumi Oga ◽

Yasushi Fukushima ◽

...

Keyword(s):

Smoking Cessation ◽

Clinical Efficacy ◽

Open Label ◽

Face To Face ◽

Randomized Controlled ◽

Noninferiority Trial ◽

Clinic Visits

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Comparing Telemedicine and Face-to-Face Consultation Based on the Standard Smoking Cessation Program for Nicotine Dependence: Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/12701 ◽

2019 ◽

Vol 8 (7) ◽

pp. e12701 ◽

Cited By ~ 1

Author(s):

Tomoyuki Tanigawa ◽

Akihiro Nomura ◽

Maki Kuroda ◽

Tomoyasu Muto ◽

Eisuke Hida ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Nicotine Dependence ◽

Controlled Trial ◽

Smoking Cessation Program ◽

Face To Face ◽

Randomized Controlled

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Comparing Telemedicine and Face-to-Face Consultation Based on the Standard Smoking Cessation Program for Nicotine Dependence: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.12701 ◽

2018 ◽

Cited By ~ 2

Author(s):

Tomoyuki Tanigawa ◽

Akihiro Nomura ◽

Maki Kuroda ◽

Tomoyasu Muto ◽

Eisuke Hida ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Smoking Cessation ◽

Nicotine Dependence ◽

Controlled Trial ◽

Smoking Cessation Program ◽

Support Program ◽

Health Concern ◽

Video System ◽

Face To Face ◽

Randomized Controlled

BACKGROUND 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. OBJECTIVE 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. METHODS 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 CureApp Smoking Cessation (CASC) for both arms, which consists of the CASC smartphone app for patients and a Web-based patient information management system for clinicians with a mobile carbon monoxide checking device. The primary endpoint will be the continuous abstinence rate (CAR) from weeks 9 to 12. Secondary endpoints will be: (1) the smoking cessation success rate at 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in scores on the mood and physical symptoms scale and 12-Item French Version Of The Tobacco Craving Questionnaire; (4) Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; (5) time to first lapse after the first visit; (6) nicotine dependence and cognition scale scores at 12 and 24 weeks; (7) usage rate of the CASC; (8) qualitative questionnaire about the usability and acceptability of telemedicine; and (9) presence of product problems or adverse events. RESULTS 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. CONCLUSIONS 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. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12701

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Evaluation of a Pharmacist and Nurse Practitioner Smoking Cessation Program

Journal of Pharmacy Practice ◽

10.1177/0897190016659221 ◽

2016 ◽

Vol 30 (4) ◽

pp. 406-411 ◽

Cited By ~ 5

Author(s):

Zubair Afzal ◽

Elizabeth Pogge ◽

Virginia Boomershine

Keyword(s):

Smoking Cessation ◽

Medication Adherence ◽

Nicotine Dependence ◽

Nurse Practitioner ◽

Point Prevalence ◽

Smoking Cessation Program ◽

Prevalence Rates ◽

Smoking Cessation Counseling ◽

Face To Face ◽

Study Completion

Purpose: To evaluate the efficacy of a smoking cessation program led by a pharmacist and a nurse practitioner. Methods: During a 6-month period, patients attended 7 one-on-one face-to-face smoking cessation counseling sessions with a pharmacist and 1 to 2 one-on-one face-to-face smoking cessation counseling sessions with a nurse practitioner. The primary outcome was smoking cessation point prevalence rates at months 1, 3, and 5 post-quit date. Secondary outcomes included medication adherence rates at months 1, 3, and 5 post-quit date, nicotine dependence at baseline versus program end, and patient satisfaction. Results: Nine (47%) of 19 total participants completed the program. Seven of the 9 patients who completed the program were smoke-free upon study completion. Point prevalence rates at months 1, 3, and 5 post-quit date were 66%, 77%, and 77%, respectively, based on patients who completed the program. Medication adherence rates were 88.6%, 54.6%, and 75% at months 1, 3, and 5 post-quit date, respectively. Based on the Fagerstrom test, nicotine dependence decreased from baseline to the end of the study, 4.89 to 0.33 ( P < .001). Overall, participants rated the program highly. Conclusion: A joint pharmacist and nurse practitioner smoking cessation program can assist patients in becoming smoke-free.

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Early Use of Sarilumab in Patients Hospitalised with COVID-19 Pneumonia and Features of Systemic Inflammation.

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.02107-21 ◽

2021 ◽

Author(s):

Nicolás Merchante ◽

Sheila Cárcel ◽

José Carlos Garrido-Gracia ◽

Marta Trigo-Rodríguez ◽

María Ángeles Esteban Moreno ◽

...

Keyword(s):

Mechanical Ventilation ◽

Systemic Inflammation ◽

Primary Outcome ◽

Invasive Mechanical Ventilation ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled ◽

Subcutaneous Dose ◽

Early Use

In this phase II, open-label, randomized, controlled clinical trial of 115 patients hospitalized with COVID-19 and systemic inflammation, early use of sarilumab was associated with a low risk of acute respiratory distress syndrome requiring high-flow devices or mechanical ventilation. Objective: To investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalised adults with COVID-19. Methods: Phase II, open-label, randomized, controlled clinical trial of hospitalised patients with COVID-19 pneumonia and interleukin (IL)-6 levels ≥ 40 pg/mL and/or D-dimer > 1500 ng/mL. Participants were randomized (1:1:1) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (Sarilumab-200) or SOC plus a single subcutaneous dose of sarilumab 400 mg (Sarilumab-400). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. Results: One-hundred and fifteen participants (control group, n = 39; Sarilumab-200, n = 37; Sarilumab-400, n = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, ten (27%) in Sarilumab-200 and five (13%) in Sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of Sarilumab-400 vs control group: 0.41 [0.14-1.18]; p=0.09). Seven (6%) patients died: three in the control group and four in Sarilumab-200. There were no deaths in Sarilumab-400 (p = 0.079, log-rank test for comparisons with the control group). Conclusion: In patients recently hospitalised with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes.

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