Effectiveness of telephone-based follow-up support delivered in combination with a multi-component smoking cessation intervention in family practice: A cluster-randomized trial

2013 ◽  
Vol 56 (6) ◽  
pp. 390-397 ◽  
Author(s):  
Sophia Papadakis ◽  
Paul W. McDonald ◽  
Andrew L. Pipe ◽  
Scott T. Letherdale ◽  
Robert D. Reid ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomized Trial ◽  
Family Practice ◽  
Cluster Randomized Trial ◽  
Smoking Cessation Intervention ◽  
Cessation Intervention ◽  
Cluster Randomized

Implementing a Novel Workplace Smoking Cessation Intervention Targeting Hispanic/Latino Construction Workers: A Pilot Cluster Randomized Trial

2020 ◽  
pp. 109019812096039
Author(s):  
Taghrid Asfar ◽  
Kristopher L. Arheart ◽  
Laura A. McClure ◽  
Estefania C. Ruano-Herreria ◽  
Noella A. Dietz ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Smoking Cessation Intervention ◽  
Construction Workers ◽  
Retention Rates ◽  
Adherence To Treatment ◽  
Enrollment Rate ◽  
Cessation Intervention ◽  
Cluster Randomized

Background U.S. Hispanic/Latino construction workers constitute a large and historically underserved group in terms of smoking cessation services. Using formative research, we developed a worksite smoking cessation intervention tailored to the life/work circumstances of these workers. Aims This study aims to examine the feasibility, acceptability, and potential efficacy of the developed intervention “Enhanced Care” (EC; one group behavioral counseling session provided around the food truck + fax referral to tobacco quitline [QL] + 8-week nicotine replacement treatment [NRT]) compared with “Standard Care” (SC; fax referral to tobacco QL + 8-week NRT) in a pilot, two-arm, cluster randomized controlled trial. Method In collaboration with construction site safety managers, a sample of 17 construction sites (EC: nine sites/65 smokers; SC: eight sites/69 smokers) was enrolled. Participants received two follow-ups at 3 and 6 months after enrollment. Feasibility outcomes were enrollment rate, adherence to treatment, and 6-month retention rates. The primary efficacy outcome was 6 months prolonged abstinence verified by expired carbon monoxide <10 ppm. Results Enrollment rate was high (85.9%). Six-month follow-up rates were acceptable (EC = 76.9%, SC = 66.6%). Adherence to treatment was better in the EC group (received worksite intervention: EC = 93.8%, SC = 88.4%; contacted by QL: EC = 49.2%, SC = 40.6%). Abstinence rates were 27.7% for the EC and 20.3% for the SC ( p = .315). Discussion The developed intervention was feasible and acceptable, and it substantially improved abstinence among Hispanic/Latino workers. The involvement of safety managers was essential to the implementation of the intervention. Training safety managers to deliver the intervention has great potential to implement a sustainable smoking cessation service in the construction sector.

scholarly journals Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial

PLoS ONE ◽  
2016 ◽  
Vol 11 (2) ◽  
pp. e0146459 ◽  
Author(s):  
Arthur V. Peterson ◽  
Patrick M. Marek ◽  
Kathleen A. Kealey ◽  
Jonathan B. Bricker ◽  
Evette J. Ludman ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomized Trial ◽  
Young Adulthood ◽  
Adolescent Smoking ◽  
Smoking Cessation Intervention ◽  
Cessation Intervention ◽  
Group Randomized Trial

scholarly journals Assessing the efficacy and impact of a personalised smoking cessation intervention among type 2 diabetic smokers: study protocol for an open-label randomised controlled trial (DISCGO-RCT)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040117
Author(s):  
Carole Clair ◽  
Aurélie Augsburger ◽  
Priska Birrer ◽  
Isabella Locatelli ◽  
Joelle Schwarz ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Smoking Cessation ◽  
Smoking Cessation Intervention ◽  
Randomised Control Trial ◽  
Primary Study ◽  
Smoking Abstinence ◽  
Open Label ◽  
Cessation Intervention

IntroductionFew studies have assessed the efficacy of smoking cessation interventions in individuals with type 2 diabetes, but interventions adapted to the specific needs of this population are warranted. The aim of this study is to assess the efficacy of a smoking cessation intervention in a population of smokers with type 2 diabetes and to measure the metabolic impact of smoking cessation.Methods and analysisThe study is an open-label, randomised control trial. Participants recruited from a sanitary region of Switzerland will be randomly allocated to either the intervention or the control arm. The intervention group will have four individual counselling sessions over 12 weeks. Trained research nurses will conduct the behavioural intervention, using motivational interviews and addressing diabetes and gender specificities. The control group will have one short counselling session at baseline and will be given written information on smoking cessation. Both groups will have a follow-up visit at 26 and 52 weeks. Demographic and medical data will be collected at baseline and follow-up, along with blood and urine samples. The primary study outcome is continuous smoking abstinence validated by expired-air carbon monoxide from week 12 to week 52. Secondary study outcomes are continuous and 7-day point prevalence smoking abstinence at 12 and 26 weeks; change in motivation to quit and cigarette consumption; and change in glycosylated haemoglobin levels, body weight, waist circumference and renal function after smoking cessation. In a subsample of 80 participants, change in stool microbiota from baseline will be measured at 3, 8 and 26 weeks after smoking cessation.Ethics and disseminationEthical approval has been obtained by the competent ethics committee (Commission cantonale d’éthique de la recherche sur l’être humain, CER-VD 2017–00812). The results of the study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numbersClinicalTrials.gov NCT03426423 and SNCTP000002762; Pre-results.

scholarly journals Design and analysis of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria: Small sample considerations for cluster-randomized trials with count data

2021 ◽  
pp. 174077452110285
Author(s):  
Conner L Jackson ◽  
Kathryn Colborn ◽  
Dexiang Gao ◽  
Sangeeta Rao ◽  
Hannah C Slater ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Mixed Effects ◽  
Small Sample ◽  
Mixed Effects Models ◽  
Type I ◽  
Cluster Randomized ◽  
Cluster Level ◽  
Generalized Estimating

Background: Cluster-randomized trials allow for the evaluation of a community-level or group-/cluster-level intervention. For studies that require a cluster-randomized trial design to evaluate cluster-level interventions aimed at controlling vector-borne diseases, it may be difficult to assess a large number of clusters while performing the additional work needed to monitor participants, vectors, and environmental factors associated with the disease. One such example of a cluster-randomized trial with few clusters was the “efficacy and risk of harms of repeated ivermectin mass drug administrations for control of malaria” trial. Although previous work has provided recommendations for analyzing trials like repeated ivermectin mass drug administrations for control of malaria, additional evaluation of the multiple approaches for analysis is needed for study designs with count outcomes. Methods: Using a simulation study, we applied three analysis frameworks to three cluster-randomized trial designs (single-year, 2-year parallel, and 2-year crossover) in the context of a 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria. Mixed-effects models, generalized estimating equations, and cluster-level analyses were evaluated. Additional 2-year parallel designs with different numbers of clusters and different cluster correlations were also explored. Results: Mixed-effects models with a small sample correction and unweighted cluster-level summaries yielded both high power and control of the Type I error rate. Generalized estimating equation approaches that utilized small sample corrections controlled the Type I error rate but did not confer greater power when compared to a mixed model approach with small sample correction. The crossover design generally yielded higher power relative to the parallel equivalent. Differences in power between analysis methods became less pronounced as the number of clusters increased. The strength of within-cluster correlation impacted the relative differences in power. Conclusion: Regardless of study design, cluster-level analyses as well as individual-level analyses like mixed-effects models or generalized estimating equations with small sample size corrections can both provide reliable results in small cluster settings. For 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria, we recommend a mixed-effects model with a pseudo-likelihood approximation method and Kenward–Roger correction. Similarly designed studies with small sample sizes and count outcomes should consider adjustments for small sample sizes when using a mixed-effects model or generalized estimating equation for analysis. Although the 2-year parallel follow-up of repeated ivermectin mass drug administrations for control of malaria is already underway as a parallel trial, applying the simulation parameters to a crossover design yielded improved power, suggesting that crossover designs may be valuable in settings where the number of available clusters is limited. Finally, the sensitivity of the analysis approach to the strength of within-cluster correlation should be carefully considered when selecting the primary analysis for a cluster-randomized trial.

Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Karen L Margolis ◽  
Stephen E Asche ◽  
Anna R Bergdall ◽  
Steven P Dehmer ◽  
Beverly B Green ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Home Blood Pressure ◽  
Uncontrolled Hypertension ◽  
Routine Clinical Care ◽  
Differential Reduction ◽  
Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

scholarly journals Outcomes of a smoking cessation intervention at follow-up after 5 years among tuberculosis patients in China

2019 ◽  
Vol 17 (September) ◽  
Author(s):  
Yan Lin ◽  
Riitta Dlodlo ◽  
Qi Shu ◽  
Haoxiang Lin ◽  
Qin Huang ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Smoking Cessation Intervention ◽  
Tuberculosis Patients ◽  
Cessation Intervention

scholarly journals Dropout, response, and abstinence outcomes of a national text-messaging smoking cessation intervention for teens, SmokeFreeTeen

2020 ◽  
Author(s):  
Charmaine Chan ◽  
Kristyn Kamke ◽  
Freda Assuah ◽  
Sherine El-Toukhy
Keyword(s):  
Smoking Cessation ◽  
Text Messaging ◽  
Cox Regression ◽  
Smoking Status ◽  
Smoking Cessation Intervention ◽  
Cox Regression Analysis ◽  
Cessation Intervention ◽  
Quit Attempts ◽  
The Usa

Abstract Although text-messaging interventions are effective for smoking cessation, few target teens in the USA and little is known about their effectiveness. The purpose of this manuscript is to examine correlates of dropout, response to smoking status prompts, and abstinence rates among subscribers of SmokeFreeTeen, a free, publicly available text-messaging smoking cessation intervention sponsored by the National Cancer Institute’s SmokeFree.Gov initiative, on quit day through 1 month follow-up. In a sample of teens (N = 2,685), aged 13–19, we examined demographics, smoking frequency, cigarettes smoked per day, prequit intervention time (i.e., maximum of 14 days of prequit day preparation), and number of quit attempts as correlates of response and abstinence rates among program initiators (i.e., participants who reached quit day but dropped out on or before intervention end) and completers (i.e., participants who reached quit day and completed the intervention). We also conducted Cox regression analysis of time from quit day to dropout by daily and nondaily smoking status. Two-thirds (n = 1,733, 64.54%) dropped out before the intervention ended, with dropout rates peaking on quit day (n = 289, 13.10%). Response rate to smoking status prompts remained below 30% throughout the intervention. At intervention end and 1 month follow-up, abstinence was 2.63% and 2.55% among program initiators, whereas abstinence was 6.09% and 6.01% among program completers. Dropout, response, and abstinence rates did not consistently differ by subscriber characteristics. Prequit time was associated with decreased likelihood of dropping out (adjusted hazards ratio: 0.94, confidence interval [CI]: 0.93–0.95), responding to smoking status prompts (adjusted odds ratio [aOR]: 0.94, CI: 0.92–0.96), and being abstinent (aOR: 0.96, CI: 0.93–0.99) on quit day. Two or more quit attempts were associated with increased response (aOR: 1.61, CI: 1.16–2.23) and abstinence (aOR: 1.91, CI: 1.25–2.92) rates on Day 7. In a first assessment of SmokeFreeTeen outcomes, we document high dropouts and low response and abstinence rates. SmokeFreeTeen produced abstinence rates lower than comparable text-messaging interventions targeting teens and young adults. Improving SmokeFreeTeen’s reach, engagement, and effectiveness is needed.

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