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

10.2196/13520 ◽  
2019 ◽  
Vol 21 (4) ◽  
pp. e13520 ◽  
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

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

2019 ◽  
Author(s):  
Akihiro Nomura ◽  
Tomoyuki Tanigawa ◽  
Tomoyasu Muto ◽  
Takafumi Oga ◽  
Yasushi Fukushima ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Nicotine Dependence ◽  
Primary Outcome ◽  
Smoking Cessation Program ◽  
Open Label ◽  
Face To Face ◽  
Randomized Controlled ◽  
Clinical Visit ◽  
Noninferiority Trial ◽  
Clinic Visits

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.

Clinical efficacy of a herbo-mineral Unani formulation in scabies: an open-label randomized controlled study

2015 ◽  
Vol 15 (3) ◽  
pp. 173-181 ◽  
Author(s):  
Jameelur Rahman ◽  
Akhtar H. Farooqi ◽  
Arshiya Sultana ◽  
Khaleequr Rahman ◽  
Ateequr Rahman
Keyword(s):  
Clinical Efficacy ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Open Label ◽  
Randomized Controlled

scholarly journals Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Laurie Zawertailo ◽  
Tara Mansoursadeghi-Gilan ◽  
Helena Zhang ◽  
Sarwar Hussain ◽  
Bernard Le Foll ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Real World ◽  
Smoking Status ◽  
Controlled Trial ◽  
Health Study ◽  
Open Label ◽  
Randomized Controlled

BACKGROUND Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. OBJECTIVE The primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation. METHODS This is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales. RESULTS The project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway. CONCLUSIONS To the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials. CLINICALTRIAL ClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ) REGISTERED REPORT IDENTIFIER RR1-10.2196/10826

Clinical Efficacy of Azithromycin in Patients With Severe Sepsis: Open Label Pilot Randomized Controlled Trial

CHEST Journal ◽  
2014 ◽  
Vol 145 (3) ◽  
pp. 151A
Author(s):  
Marcos Restrepo ◽  
Paola Faverio ◽  
Alejandro Arango ◽  
Oriol Sibila ◽  
Eric Mortensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Severe Sepsis ◽  
Clinical Efficacy ◽  
Controlled Trial ◽  
Open Label ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

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

2018 ◽  
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

scholarly journals Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Elizabeth R. Stevens ◽  
Lei Lei ◽  
Charles M. Cleland ◽  
Mahathi Vojjala ◽  
Omar El-Shahawy ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Pilot Study ◽  
Harm Reduction ◽  
Electronic Cigarettes ◽  
Pilot Trial ◽  
Unmet Need ◽  
Open Label ◽  
Reduction Strategy ◽  
Randomized Controlled ◽  
Harm Reduction Strategy

Abstract Background Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD. Methods In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms. Discussion Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke. Trial Registration ClinicalTrials.gov Identifier: NCT04465318.

Sign in / Sign up

Export Citation Format

Share Document