Contemporary clinical trials最新文献

{"title":"Commentary on Chen et al. (2022): The need for continued methodological research on leveraging information in secondary endpoints for more efficient RCTs","authors":"","doi":"10.1016/j.cct.2024.107664","DOIUrl":"10.1016/j.cct.2024.107664","url":null,"abstract":"<div><p>Chen et al. (2022) recently proposed a set of estimating equations that incorporate data from secondary endpoints to improve precision in parameter estimates related to a primary endpoint. We were motivated to translate their methodology to the context of randomized controlled trials to gain precision in treatment effect estimation using data from secondary endpoints. Our results suggest that this estimator cannot gain efficiency in this context because of random treatment assignment, especially when there is a treatment effect on secondary endpoints, and that further methodological work in this area is needed.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A mobile health intervention for emerging adults with regular cannabis use: A micro-randomized pilot trial design protocol","authors":"","doi":"10.1016/j.cct.2024.107667","DOIUrl":"10.1016/j.cct.2024.107667","url":null,"abstract":"<div><h3>Background</h3><p>Emerging adult (EA) cannabis use is associated with increased risk for health consequences. Just-in-time adaptive interventions (JITAIs) provide potential for preventing the escalation and consequences of cannabis use. Powered by mobile devices, JITAIs use decision rules that take the person's state and context as input, and output a recommended intervention (e.g., alternative activities, coping strategies). The mHealth literature on JITAIs is nascent, with additional research needed to identify what intervention content to deliver when and to whom.</p></div><div><h3>Methods</h3><p>Herein we describe the protocol for a pilot study testing the feasibility and acceptability of a micro-randomized trial for optimizing MiWaves mobile intervention app for EAs (ages 18–25; target <em>N</em> = 120) with regular cannabis use (≥3 times per week). Micro-randomizations will be determined by a reinforcement learning algorithm that continually learns and improves the decision rules as participants experience the intervention. MiWaves will prompt participants to complete an in-app twice-daily survey over 30 days and participants will be micro-randomized twice daily to either: no message or a message [1 of 6 types varying in length (short, long) and interaction type (acknowledge message, acknowledge message + click additional resources, acknowledge message + fill in the blank/select an option)]. Participants recruited via social media will download the MiWaves app, and complete screening, baseline, weekly, post-intervention, and 2-month follow-up assessments. Primary outcomes include feasibility and acceptability, with additional exploratory behavioral outcomes.</p></div><div><h3>Conclusion</h3><p>This study represents a critical first step in developing an effective mHealth intervention for reducing cannabis use and associated harms in EAs.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the Move in the community: Protocol for a hybrid 1 trial examining effectiveness and fidelity of a community-based group exercise program for older adults","authors":"","doi":"10.1016/j.cct.2024.107666","DOIUrl":"10.1016/j.cct.2024.107666","url":null,"abstract":"<div><h3>Background</h3><p>On the Move (OTM), a group exercise program to improve mobility in older adults, is efficacious when delivered by research staff. The next step in the development of OTM as a fully implementable intervention is to conduct an effectiveness study in which the intervention is delivered in community settings by community providers.</p></div><div><h3>Methods</h3><p>We describe the methods of a hybrid 1 cluster randomized, single-blind, intervention trial to compare the effectiveness of OTM to a delayed intervention control in 502 community-dwelling older adults across 44 sites. OTM classes are taught by certified instructors in the community twice a week for 12 weeks. Control centers receive no intervention for the first 12 weeks followed by 12-weeks of OTM classes. Participants are assessed at baseline, 12 and 24 weeks. The primary outcome is gait speed. Intervention fidelity, measured by adherence and competence in intervention delivery, is assessed by review of instructor intervention diaries and observation. Organizational, instructor, and participant-level factors which may impact fidelity are assessed using questionnaires, focus groups, and structured interviews.</p></div><div><h3>Conclusion</h3><p>The findings of this trial will 1) establish the effectiveness of OTM on improvements in walking and post-intervention persistence of benefits, 2) assess intervention fidelity and identify the impact of organizational, instructor, and participant level factors on fidelity, and 3) determine the extent to which fidelity moderates the effectiveness of OTM. The information derived from this project will provide valuable insight into the real-world effectiveness of OTM as a health promotion program for improving mobility in older adults.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002490/pdfft?md5=06c46f22bb656e23a5b2dbe0973ef37e&pid=1-s2.0-S1551714424002490-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142003794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a randomized controlled trial of moderate intensity interval training in individuals with chronic obstructive pulmonary disease and obstructive sleep apnea overlap syndrome who have excessive daytime sleepiness","authors":"","doi":"10.1016/j.cct.2024.107663","DOIUrl":"10.1016/j.cct.2024.107663","url":null,"abstract":"<div><h3>Background</h3><p>The term “Overlap Syndrome” (OS) describes the presence of both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in a single individual. Excessive daytime sleepiness (EDS) is a common symptom of OS shown to be associated with an increased risk of cardiovascular disease (CVD) that could be reduced through exercise. Thus, we propose to investigate a novel exercise intervention in individuals with the EDS-OS phenotype as they are at highest risk of CVD yet have the greatest barriers to exercise.</p></div><div><h3>Methods</h3><p>We will conduct a single-site, randomized, two-arm, parallel group-controlled exercise trial in individuals with EDS-OS. The Epworth Sleepiness Scale (ESS) will be assessed at baseline. Individuals with OS and the EDS-OS phenotype (ESS &gt;10) (<em>n</em> = 46) will be randomized to a moderate intensity interval training (MIIT, i.e. intervals of 5 min at 50% VO2peak followed by 3 min of active recovery at 10% VO2peak) or a control group of standard of care. We will investigate if MIIT intervention decreases the risk of CVD in EDS-OS, which will be assessed by: 1) quality of life, measured by the 36-Item Short Form Health Survey; 2) physical activity, measured by daily step counts; and 3) cardiovascular health, assessed as VO2peak, flow-mediated dilation and serum high sensitivity C-reactive protein, lipids, and glucose.</p></div><div><h3>Conclusion</h3><p>Our findings will guide future development and implementation of exercise interventions that could reduce the risk of CVD in the understudied EDS-OS phenotype.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction","authors":"","doi":"10.1016/j.cct.2024.107662","DOIUrl":"10.1016/j.cct.2024.107662","url":null,"abstract":"<div><h3>Background</h3><p>Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention period.</p></div><div><h3>Methods</h3><p>Participants (<em>N</em> = 520) who smoked ≥10 cigarettes per day [CPD] for ≥1 year and reported interest in reducing but not quitting were randomized to 1 of 4 conditions: an ENDS containing 0, 8, or 36 mg/ml liquid nicotine (administered double-blind) or a cigarette-shaped plastic tube. Cox proportional hazards regression models were fit to examine attrition over time and predictors of attrition including baseline characteristics and condition. A stepwise approach was used to determine the final model; alpha was set at 0.05.</p></div><div><h3>Results</h3><p>Attrition did not differ significantly by condition (223/520), and most (69%) were lost-to-follow-up. Only age, education level, and household income were significantly predictive of attrition. For every additional year of age, attrition risk fell by 3%. Holding a bachelor's degree or higher was associated with reduced attrition risk. Those with the lowest income (&lt;$10 K) were more likely to be withdrawn compared to those earning $10 K–39 K, and those with the highest income ($100 K+) were more likely to be withdrawn compared with the latter bracket and those earning $70-99 K.</p></div><div><h3>Conclusion</h3><p>ENDS nicotine content did not drive differential attrition in this trial, and targeted retention efforts are needed for specific subgroups.</p><p>Trial Registration #: <span><span>NCT02342795</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Linking inter-professional newborn and contraception care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine well-baby visits","authors":"","doi":"10.1016/j.cct.2024.107659","DOIUrl":"10.1016/j.cct.2024.107659","url":null,"abstract":"<div><h3>Background</h3><p>Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes. Despite this, nearly one third of U.S. women experience a short IPI.</p></div><div><h3>Objective</h3><p>To address the gap in the current model of postpartum (PP) contraception care by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care to improve access to timely PP contraception.</p></div><div><h3>Methods</h3><p>The LINCC Trial will take place in seven clinical locations across five community health centers within the U.S. PP patients (planned <em>n</em> = 3150) who are attending a Well-Baby Visit between 0 and 6 months will be enrolled. The LINCC Trial aims to leverage the Electronic Health Record to prompt providers to ask PP patients attending a Well-Baby Visit about their PP contraception needs and facilitate co-scheduling of PP contraception care with routine newborn care visits. The study includes a cluster randomized, cross-sectional stepped wedge design to roll out the intervention across the seven sites. The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies. Implementation outcomes will be assessed at baseline and 6 months after site enters intervention period.</p></div><div><h3>Conclusions</h3><p>The LINCC Trial seeks to evaluate the effectiveness and feasibility of a linked care model in comparison to usual care.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A compassion microintervention targeting stress reactivity among sexual minority women and transgender/nonbinary people: Study protocol for a randomized controlled trial","authors":"","doi":"10.1016/j.cct.2024.107660","DOIUrl":"10.1016/j.cct.2024.107660","url":null,"abstract":"<div><h3>Objective</h3><p>Sexual minority women (SMW) and transgender and/or nonbinary (TNB) people report more adverse health outcomes (e.g., depression, anxiety, posttraumatic stress, substance use) relative to heterosexual, cisgender people, often due to the additional stress burden from experiencing stigma. Physiological and emotional stress reactivity are mechanisms through which high cumulative stress contributes to adverse health outcomes. The randomized controlled trial (RCT) described in this study protocol examines whether a single-session compassion microintervention may attenuate physiological and emotional stress reactivity to the minority stress Trier Social Stress Test (MS-TSST) among SMW/TNB people. This study will also examine whether the compassion microintervention reduces depression, anxiety, posttraumatic stress symptoms, and substance use from baseline to one-month follow-up, and assess microintervention acceptability.</p></div><div><h3>Methods</h3><p>This protocol describes a two-arm parallel RCT. Participants are recruited online and at in-person events (e.g., Pride events). Participants complete baseline measures online (e.g., demographics, anxiety symptoms) and then complete an in-person lab visit that includes the compassion microintervention (or no training control). Immediately after the intervention period, participants complete the MS-TSST. Measures of physiological (i.e., blood pressure, cortisol) and emotional (i.e., negative affect, state anxiety) reactivity are collected throughout the lab visit. Participants also complete a one-month follow-up survey. Participants randomized to the microintervention are invited to complete a semi-structured virtual interview about their experiences to assess acceptability.</p></div><div><h3>Conclusion</h3><p>Findings from this study could provide initial evidence that compassion microinterventions show promise in addressing stigma-related stress reactivity among SMW/TNB people.</p><p><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span><strong>registration:</strong><span><span>NCT05949060</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A real-world longitudinal study implementing digital screening and treatment for distress in inflammatory bowel disease (IBD): The COMPASS-IBD study protocol","authors":"","doi":"10.1016/j.cct.2024.107658","DOIUrl":"10.1016/j.cct.2024.107658","url":null,"abstract":"<div><h3>Introduction</h3><p>Co-morbid anxiety and depression (distress) in inflammatory bowel disease (IBD) results in poorer outcomes and increased healthcare burden. IBD services require scalable treatment pathways for distress to meet this need. This real-world longitudinal study evaluates the implementation of a new integrated care pathway for distress including: 1) routine mental health screening and 2) therapist-guided, digital CBT tailored to the challenges of living with IBD (compass with adaptations for IBD: COMPASS-IBD) in a UK National Health Service (NHS) large gastroenterology service (∼ 5000 patients).</p></div><div><h3>Methods</h3><p>We describe a mixed-methods, observational, real-world longitudinal study. Routine mental health screening in the IBD service will identify patients with distress (using pre-defined clinical cut-offs), who will be triaged to determine appropriate treatment pathways (including participation in the COMPASS-IBD study). Participants will receive COMPASS-IBD online for ∼12 weeks (including 6 × 30-min therapist sessions). Key implementation outcomes will assess reach and adoption of the new pathway using aggregate data on uptake of mental health screening, eligibility, and consent rates for COMPASS-IBD, and number of COMPASS-IBD sessions completed. Interviews with patients and healthcare providers will primarily assess acceptability of the new pathway. Potential effectiveness will be assessed using participant questionnaires at pre-intervention, 12-weeks (post-intervention), and 6-month follow-up. The primary effectiveness outcome will be pre-post changes in distress (PHQ-ADS scores). Quantitative data will be summarised using descriptive statistics and qualitative data analysed using reflexive thematic analysis.</p></div><div><h3>Conclusion</h3><p>Study findings will inform treatment pathways for co-morbid distress in IBD, and highlight adaptations required to increase future scalability and effectiveness.</p><p><strong>Trial registration number:</strong> <span><span>NCT05330299</span><svg><path></path></svg></span> (<span><span>clinicaltrials.gov</span><svg><path></path></svg></span>).</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002416/pdfft?md5=90a31748b58e58fd29ffe8b4c355785f&pid=1-s2.0-S1551714424002416-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a randomized controlled trial comparing phone-based prenatal mindfulness training to usual care for pregnant people at risk for hypertensive disorders of pregnancy","authors":"","doi":"10.1016/j.cct.2024.107661","DOIUrl":"10.1016/j.cct.2024.107661","url":null,"abstract":"<div><p>Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. There are few interventions available to prevent HDP, and those currently available do not target underlying mechanisms of disease. Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective at blood pressure reduction than other stress management interventions. MT thus holds great promise as a mind-body intervention to prevent HDP. This randomized trial will harness subjective and objective ecological momentary assessment methodology combined with wearable biosensor technology to capture psychological, physiological, and interpersonal processes through which MT may lead to improved maternal cardiovascular parameters. Pregnant women at risk for HDP will be randomized to an 8-week phone-delivered MT intervention or usual care. Through these methods, we will evaluate psychological, physiological, and interpersonal responses to daily experiences linking MT to cardiovascular parameters among women at risk for HDP.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial","authors":"","doi":"10.1016/j.cct.2024.107655","DOIUrl":"10.1016/j.cct.2024.107655","url":null,"abstract":"<div><h3>Background</h3><p>Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management strategies are needed to improve food security in real-world health system settings. We seek to test the effect of a prescription produce program, ‘Eat Well’ on cardiometabolic health and healthcare utilization. We will also assess the implementation of an automated, affirmative outreach strategy.</p></div><div><h3>Methods</h3><p>We will recruit approximately 2400 patients from an integrated academic health system in the southeastern United States as part of a two-arm parallel hybrid type 1 pragmatic randomized controlled trial. Patients with diabetes, at risk for food insecurity, and a recent hemoglobin A1c reading will be eligible to participate. The intervention arm receives, ‘Eat Well’, which provides a debit card with $80 (added monthly) for 12 months valid for fresh, frozen, or canned fruits and vegetables across grocery retailers. The control arm does not. Both arms receive educational resources with diabetes nutrition and self-management materials, and information on existing care management resources. Using an intent-to-treat analysis, primary outcomes include hemoglobin A1C levels and emergency department visits in the 12 months following enrollment. Reach and fidelity data will be collected to assess implementation.</p></div><div><h3>Discussion</h3><p>Addressing food insecurity, particularly among those at heightened cardiometabolic risk, is critical to equitable and effective population health management. Pragmatic trials provide important insights into the effectiveness and implementation of ‘Eat Well’ and approaches like it in real-world settings.</p></div><div><h3>Registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT05896644</span><svg><path></path></svg></span>; Clinical Trial Registration Date: 2023-06-09.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}