scholarly journals A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial

10.2196/16907 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e16907 ◽  
Author(s):  
Emily T Hébert ◽  
Chaelin K Ra ◽  
Adam C Alexander ◽  
Angela Helt ◽  
Rachel Moisiuc ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Usual Care ◽  
Controlled Trial ◽  
Care Group ◽  
Just In Time ◽  
Smartphone Apps ◽  
Adaptive Intervention ◽  
Randomized Controlled ◽  
Pilot Rct

Background Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. Objective This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute’s free smoking cessation app, QuitGuide. Methods Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. Results Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. Conclusions Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. Trial Registration ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200

scholarly journals Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zeenat Fatima Chatha ◽  
Usman Rashid ◽  
Sharon Olsen ◽  
Fakhar ud Din ◽  
Amjad Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
People Living With Hiv ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cell Counts ◽  
Cd4 Cell

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

Randomized controlled trial of OnTrack, a just-in-time adaptive intervention designed to enhance weight loss

2019 ◽  
Vol 9 (6) ◽  
pp. 989-1001 ◽  
Author(s):  
Evan M Forman ◽  
Stephanie P Goldstein ◽  
Rebecca J Crochiere ◽  
Meghan L Butryn ◽  
Adrienne S Juarascio ◽  
...  
Keyword(s):  
Machine Learning ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Weight Loss Program ◽  
Just In Time ◽  
Adaptive Intervention ◽  
Randomized Controlled

This randomized trial demonstrated qualified support for the ability of a machine learning-powered, smartphone-based just-in-time, adaptive intervention to enhance weight loss over and above a commercial weight loss program.

scholarly journals Efficacy of a Tailored Moisturizer for Reducing Chemotherapy-Induced Skin Dryness in Breast Cancer Patients: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Danbee Kang ◽  
Nayeon Kim ◽  
Young Hyuck Im ◽  
Yeon Hee Park ◽  
Ji Yeon Kim ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Care Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled

Abstract Introduction: While up to 60% of breast cancer patients undergoing chemotherapy experience skin side effects reducing quality of life, it was unclear which individual product was beneficial. To evaluate the effectiveness of a tailored moisturizer with a high content (1.5%) of pseudo-ceramides on skin dryness due to chemotherapy in breast cancer patients. Methods: Randomized controlled trial conducted from February 2015 to October 2018. 204 breast cancer patients experiencing skin dryness after 1 cycle of chemotherapy were randomly assigned to 3 groups (tailored moisturizer with high pseudo-ceramide content; general moisturizer; and usual care). Skin dryness, dullness, quality of life, and changes in sebum level were assessed at baseline, 3 weeks, and 1 month after completion of chemotherapy. The primary objective of the trial was to compare the tailored moisturizer group to usual care.Results: At 1 month after completion of chemotherapy, the tailored moisturizer group was significantly less likely to report severe skin dryness compared to the usual care group (8.5 vs. 27.9%, respectively, P < 0.01). The tailored moisturizer group reported significantly lower levels of skin dullness and lower levels of impairment of dermatological quality of life compared with the other two groups. Conclusions: A tailored moisturizer with a high content of pseudo-ceramides improved skin dryness, dullness and dermatological quality of life compared to usual care in breast cancer patients undergoing chemotherapy.

scholarly journals Adjunctive sepsis therapy with aminophylline (STAP): a randomized controlled trial

2021 ◽  
Author(s):  
Ruifang Zhang ◽  
Huan Liu ◽  
Dongmei Dai ◽  
Xianfei Ding ◽  
Dong Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Usual Care ◽  
Survival Time ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Oxygenation Index ◽  
Care Group ◽  
Risk Of Death ◽  
Randomized Controlled

Abstract BackgroundSepsis is a serious disease that is often caused by infection. Aminophylline has anti-asthma and anti-inflammatory effects. We aimed to explore the safety and effect of aminophylline in sepsis.MethodsWe conducted a clinical randomized controlled trial involving 100 patients diagnosed with sepsis within 48 hours after ICU (intensive care unit) admission in two sites (First Affiliated Hospital of Zhengzhou University and First Affiliated Hospital of Kunming Medical University). All patients were randomized in a 1:1 ratio to receive standard therapy with or without aminophylline. The primary clinical outcome was all-cause mortality at 28 days.ResultsFrom 27 September 2018 to 12 February 2020, we screened 277 septic patients and eventually enrolled 100 patients, with 50 assigned to the aminophylline group and 50 to the usual-care group. At 28 days, 7 of 50 patients (14.0%) in the aminophylline group had died, compared with 16 of 50 (32.0%) in the usual-care group (P = 0.032). Cox regression showed that the aminophylline group had a lower risk of death (HR = 0.312, 95%CI: 0.129–0.753). Compared with the usual-care group, patients in the aminophylline group had a longer survival time (P = 0.039 by the log-rank test). With the extension of the treatment time, the effect of aminophylline on the doses of vasopressors, oxygenation index, and SOFA score increased. There were no significant differences in total hospitalization days, ICU hospitalization days, and rates of serious adverse events (all P > 0.05). No adverse events were observed in the trial.ConclusionsAminophylline as an adjunct therapy could significantly reduce the risk of death and prolong the survival time of patients with sepsis.Trial registrationThe trial was registered at the Chinese clinical trial registry (ChiCTR1800019173), 29 October 2018 - retrospectively registered, http://www.chictr.org.cn/index.aspx

scholarly journals Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Joanna Proctor ◽  
Felix Naughton ◽  
Melanie Sloan ◽  
Sarah Hopewell ◽  
James Brimicombe ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Success Rates ◽  
Behavioral Support ◽  
Randomized Controlled ◽  
The Impact

BACKGROUND The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)—the control—with usual care plus iQuit—the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17160

scholarly journals Smoking cessation with smartphone applications (SWAPP): study protocol for a randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Janina Lüscher ◽  
Corina Berli ◽  
Philipp Schwaninger ◽  
Urte Scholz
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Smoking Abstinence ◽  
Smartphone Apps ◽  
Randomized Controlled ◽  
Quit Smoking

Abstract Background Tobacco smoking remains one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real-time. The social context of smokers has, however, been neglected in smartphone apps promoting smoking cessation. This randomized controlled trial investigates the effectiveness of a smartphone app in which smokers quit smoking with the help of a social network member. Methods This protocol describes the design of a single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Participants of this study are adult smokers who smoke at least one cigarette per day and intend to quit smoking at a self-set quit date. Blocking as means of group-balanced randomization is used to allocate participants to intervention or control conditions. Both intervention and control group use a smartphone-compatible device for measuring their daily smoking behavior objectively via exhaled carbon monoxide. In addition, the intervention group is instructed to use the SmokeFree Buddy app, a multicomponent app that also facilitates smoking-cessation specific social support from a buddy over a smartphone application. All participants fill out a baseline diary for three consecutive days and are invited to the lab for a background assessment. They subsequently participate in an end-of-day diary phase from 7 days before and until 20 days after a self-set quit date. Six months after the self-set quit date a follow-up diary for three consecutive days takes place. The primary outcome measures are daily self-reported and objectively-assessed smoking abstinence and secondary outcome measures are daily self-reported number of cigarettes smoked. Discussion This is the first study examining the effectiveness of a smoking cessation mobile intervention using the SmokeFree Buddy app compared to a control group in a real-life setting around a self-set quit date using a portable objective measure to assess smoking abstinence. Opportunities and challenges with running studies with smoking participants and certain design-related decisions are discussed. Trial registration This trial was prospectively registered on 04/04/2018 at ISRCTNregistry: ISRCTN11154315.

scholarly journals Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial

2019 ◽  
Vol 35 (4) ◽  
pp. 676-686
Author(s):  
Ying Xu ◽  
Yuhui Zhang ◽  
Bin Yang ◽  
Suping Luo ◽  
Zhikai Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Usual Care ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Care Group ◽  
Randomized Controlled ◽  
Education Group ◽  
Peking University ◽  
To Receive

Abstract Background There has been little research on strategies for prevention of peritoneal dialysis (PD)-related peritonitis. We explored whether regular retraining on bag exchanges (via two methods: technique inspection and oral education) every other month could help reduce the risk of peritonitis in PD patients through a randomized controlled trial (RCT). Method This is an RCT conducted at Peking University First Hospital. A total of 150 incident patients receiving PD at our centre were included between December 2010 and June 2016 and followed up until June 2018. Patients were randomly assigned 1:1:1 to receive retraining on bag exchange via technique inspection, oral education or usual care. The primary outcome was time to the first peritonitis episode. Secondary outcomes were time to organism-specific peritonitis, transfer to haemodialysis and all-cause death. Results Patients in the technique inspection group, oral education group and usual care group (n = 50 for each group) were followed up for 47.5 ± 22.9 months. Time to first peritonitis was comparable between the groups. The technique inspection group showed a lower risk of first non-enteric peritonitis than the usual care group, while the oral education group did not show a significant benefit. The incidence of first non-enteric peritonitis in the usual care group (0.07/patient-year) was significantly higher than that in the technique inspection group (0.02/patient-year; P &lt; 0.01) but was comparable with that in the oral education group (0.06/patient-year). Transfer to haemodialysis and all-cause mortality were not significantly different between the groups. Conclusions Neither technique inspection nor oral education significantly altered the risk of all-cause peritonitis compared with usual care, despite technique inspection showing a trend towards reducing the risk of non-enteric PD-related peritonitis. Trial registration ClinicalTrials.gov (NCT01621997).

scholarly journals Randomised controlled trial of a just-in-time adaptive intervention (JITAI) smoking cessation smartphone app: the Quit Sense feasibility trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e048204
Author(s):  
Felix Naughton ◽  
Chloë Brown ◽  
Juliet High ◽  
Caitlin Notley ◽  
Cecilia Mascolo ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Just In Time ◽  
Smartphone App ◽  
Potential Cost ◽  
Adaptive Intervention ◽  
Randomised Controlled

IntroductionA lapse (any smoking) early in a smoking cessation attempt is strongly associated with reduced success. A substantial proportion of lapses are due to urges to smoke triggered by situational cues. Currently, no available interventions proactively respond to such cues in real time. Quit Sense is a theory-guided just-in-time adaptive intervention smartphone app that uses a learning tool and smartphone sensing to provide in-the-moment tailored support to help smokers manage cue-induced urges to smoke. The primary aim of this randomised controlled trial (RCT) is to assess the feasibility of delivering a definitive online efficacy trial of Quit Sense.Methods and analysesA two-arm parallel-group RCT allocating smokers willing to make a quit attempt, recruited via online adverts, to usual care (referral to the NHS SmokeFree website) or usual care plus Quit Sense. Randomisation will be stratified by smoking rate (<16 vs ≥16 cigarettes/day) and socioeconomic status (low vs high). Recruitment, enrolment, baseline data collection, allocation and intervention delivery will be automated through the study website. Outcomes will be collected at 6 weeks and 6 months follow-up via the study website or telephone, and during app usage. The study aims to recruit 200 smokers to estimate key feasibility outcomes, the preliminary impact of Quit Sense and potential cost-effectiveness, in addition to gaining insights on user views of the app through qualitative interviews.Ethics and disseminationEthics approval has been granted by the Wales NHS Research Ethics Committee 7 (19/WA/0361). The findings will be disseminated to the public, the funders, relevant practice and policy representatives and other researchers.Trial registration numberISRCTN12326962.

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