scholarly journals Project SUCCESS: Results from a Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Karen S. Calabro ◽  
Salma Marani ◽  
Tracey Yost ◽  
Janice Segura ◽  
Mary Mullin Jones ◽  
...  

The present investigation tested whether an enhanced smoking cessation program produced higher cessation rates for participants than for controls. Participants in the enhanced intervention condition received in-person motivational counseling with health feedback, a tailored internet-based program, and nicotine patch. Participants in the control group received a smoking cessation self-help manual and nicotine patch. This randomized controlled trial was conducted at a 4-year university with a student body of 32,000. Five hundred-nine students who smoked ≥1 cigarette daily were individually randomized into the enhanced intervention and control groups. Over a 3-month period, participants in the enhanced intervention condition attended two personal sessions with smoking cessation counselors. Participants in both conditions were reassessed for smoking status 12 months post-baseline. Multivariate logistic regression techniques were used to analyze the data using the intent to treat approach. Results indicated that the odds of smoking cessation were 2 times larger for the enhanced intervention group than controls (odds ratio = 2.3, 95%, confidence interval = 1.3, 3.9, P<.01). This study begins to fill research gaps regarding college students and smoking cessation. Suggestions for future advancements in smoking cessation interventions for college students are provided.

10.2196/27162 ◽  
2021 ◽  
Vol 23 (9) ◽  
pp. e27162
Author(s):  
Philipp Schwaninger ◽  
Corina Berli ◽  
Urte Scholz ◽  
Janina Lüscher

Background Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7723-z


2020 ◽  
Author(s):  
Ivan Bindoff ◽  
Tristan R Ling ◽  
Peter Gee ◽  
Benjamin Geelan ◽  
Stuart G Ferguson ◽  
...  

BACKGROUND Numerous mobile health (mHealth) apps have been developed to support smokers attempting to quit smoking. Although these apps have been reported to be successful, only modest improvements in the quit rate have been measured. It has been proposed that efforts to improve user engagement and retention may improve the quit rate further. Owing to the high cost of smoking-related disease, it is considered worthwhile to pursue even small improvements. OBJECTIVE The aim of this study was to test a novel smartphone app that leverages premium currency strategies developed by the mobile games industry in an attempt to improve engagement and retention with a smoking cessation intervention. METHODS We designed and developed a smoking cessation app called “Quittr” in line with previously developed smoking cessation mHealth apps. In addition to this established framework, we added a stand-alone fully featured city-building clicker-style game called “Tappy Town,” and a premium virtual currency called “QuitCoins.” The user earns QuitCoins for using the app in a way that contributes positively toward their quit attempt, and they can redeem these coins in Tappy Town for bonuses. To establish whether these features improved engagement and retention, we ran a 5-month randomized controlled trial where the intervention group had the full app with the extra games features, while the control group had the standard app only. Recruitment was performed via web-based advertising. Participants (N=175) had no direct contact with the researchers or other support staff. RESULTS No significant differences in terms of engagement, retention, or smoking outcomes were found between the control and intervention groups. However, survey data indicated that the majority of the participants valued Tappy Town (10/17, 59%) and the QuitCoins rewards system (13/17, 77%). Usage data also suggested that Tappy Town was widely played and was generally appealing to users (mean total time spent in app, control group: 797 seconds vs intervention group: 3502 seconds, <i>P&lt;</i>.001). Analysis of the results suggests that users in the intervention group may have been negatively affected by the aspects of the chosen design, and some theories were explored to explain this unexpected outcome. CONCLUSIONS Although the novel features of the Quittr app failed to improve the key outcomes measured in this study, there were enough positive indications to warrant further exploration of the concept. Additional research will be required to identify and correct any design flaws that may have adversely affected our participants before a follow-up study can be completed. CLINICALTRIAL Australian and New Zealand Clinical Trials Register ACTRN12617000491369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372661&amp;isReview=true


2021 ◽  
Author(s):  
Philipp Schwaninger ◽  
Corina Berli ◽  
Urte Scholz ◽  
Janina Lüscher

BACKGROUND Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (<i>buddy</i>) in daily life. OBJECTIVE The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. METHODS A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. RESULTS A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. CONCLUSIONS Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. CLINICALTRIAL ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7723-z


2018 ◽  
Author(s):  
Francesc X Marin-Gomez ◽  
Rocio Garcia-Moreno Marchán ◽  
Anabel Mayos-Fernandez ◽  
Gemma Flores-Mateo ◽  
Esther Granado-Font ◽  
...  

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)


10.2196/23734 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e23734
Author(s):  
Ivan Bindoff ◽  
Tristan R Ling ◽  
Peter Gee ◽  
Benjamin Geelan ◽  
Stuart G Ferguson ◽  
...  

Background Numerous mobile health (mHealth) apps have been developed to support smokers attempting to quit smoking. Although these apps have been reported to be successful, only modest improvements in the quit rate have been measured. It has been proposed that efforts to improve user engagement and retention may improve the quit rate further. Owing to the high cost of smoking-related disease, it is considered worthwhile to pursue even small improvements. Objective The aim of this study was to test a novel smartphone app that leverages premium currency strategies developed by the mobile games industry in an attempt to improve engagement and retention with a smoking cessation intervention. Methods We designed and developed a smoking cessation app called “Quittr” in line with previously developed smoking cessation mHealth apps. In addition to this established framework, we added a stand-alone fully featured city-building clicker-style game called “Tappy Town,” and a premium virtual currency called “QuitCoins.” The user earns QuitCoins for using the app in a way that contributes positively toward their quit attempt, and they can redeem these coins in Tappy Town for bonuses. To establish whether these features improved engagement and retention, we ran a 5-month randomized controlled trial where the intervention group had the full app with the extra games features, while the control group had the standard app only. Recruitment was performed via web-based advertising. Participants (N=175) had no direct contact with the researchers or other support staff. Results No significant differences in terms of engagement, retention, or smoking outcomes were found between the control and intervention groups. However, survey data indicated that the majority of the participants valued Tappy Town (10/17, 59%) and the QuitCoins rewards system (13/17, 77%). Usage data also suggested that Tappy Town was widely played and was generally appealing to users (mean total time spent in app, control group: 797 seconds vs intervention group: 3502 seconds, P<.001). Analysis of the results suggests that users in the intervention group may have been negatively affected by the aspects of the chosen design, and some theories were explored to explain this unexpected outcome. Conclusions Although the novel features of the Quittr app failed to improve the key outcomes measured in this study, there were enough positive indications to warrant further exploration of the concept. Additional research will be required to identify and correct any design flaws that may have adversely affected our participants before a follow-up study can be completed. Trial Registration Australian and New Zealand Clinical Trials Register ACTRN12617000491369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372661&isReview=true


2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)


2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.


2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.


Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).


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