Contemporary Clinical Trials Communications最新文献

{"title":"DISYNCRO: Perceived roles of clinical study coordinators and data managers: results from a web-based survey of professionals from contract research organizations","authors":"Susanna Yedro ,&nbsp;Elena Tinari ,&nbsp;Daniele Napolitano ,&nbsp;Giulia Wlderk ,&nbsp;Eleonora Ribaudi ,&nbsp;Luciana Giannone ,&nbsp;Gianluca Ianiro ,&nbsp;Mattia Bozzetti ,&nbsp;Antonio Gasbarrini ,&nbsp;Vincenzina Mora","doi":"10.1016/j.conctc.2025.101533","DOIUrl":"10.1016/j.conctc.2025.101533","url":null,"abstract":"<div><h3>Introduction</h3><div>The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency.</div></div><div><h3>Methods</h3><div>An online survey instrument was used to gather data from CRO professionals through an internet-based questionnaire. The survey gathered sociodemographic data and included a knowledge assessment of 18 items and a 9-item role responsibilities section. Participants were stratified into three ability groups using Item Response Theory (IRT) analysis based on a Rasch model. McNemar's tests and non-parametric tests analyzed knowledge discrepancies and perceptual contradictions.</div></div><div><h3>Results</h3><div>A total of 122 participants completed the survey. Most partecipants (98.4 %) identified the CSC as the primary figure within a research center, and 77.9 % considered the CSC essential for clinical trial execution. Regarding functional overlap, 57.4 % of respondents believed that the CSC could perform the duties of a DM, whereas only 42.6 % thought the DM could assume the CSC's responsibilities. Participants with lower levels of knowledge demonstrated a higher rate of contradictory responses, indicating greater difficulty distinguishing between the two roles.</div></div><div><h3>Conclusion</h3><div>Study findings demonstrate an overwhelming preference for CSCs, who play a key versatile role in managing clinical trials. The insufficient theoretical understanding of the different duties of CSCs and DMs hampers operational efficiency. Establishing standard training programs combined with harmonization is essential to defining roles, enhancing teamwork, and providing quality clinical research practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101533"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144810179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-centered medical tools for sustained motivation in cardiac rehabilitation of patients with heart failure: protocol of a multicenter randomized controlled trial (EXERCISE-HF trial)","authors":"Koki Yamaoka ,&nbsp;Yoshinori Katsumata ,&nbsp;Shun Kohsaka ,&nbsp;Yasuyuki Shiraishi ,&nbsp;Masahiro Kondo ,&nbsp;Kengo Nagashima ,&nbsp;Takeshi Onoue ,&nbsp;Masaharu Kataoka ,&nbsp;Takatomo Watanabe ,&nbsp;Daisuke Nakashima ,&nbsp;Yuki Muramoto ,&nbsp;Yasunori Sato ,&nbsp;Kazuki Sato ,&nbsp;Masaya Nakamura ,&nbsp;Masaki Ieda","doi":"10.1016/j.conctc.2025.101522","DOIUrl":"10.1016/j.conctc.2025.101522","url":null,"abstract":"<div><h3>Introduction</h3><div>Heart failure substantially affects the quality of life of patients and imposes notable social and economic burdens. Despite the beneficial effects of cardiac rehabilitation, global participation rates remain low. Recent advances in wearable biometric technologies may improve patient adherence through real-time monitoring and personalized feedback. This study aimed to develop and evaluate an exercise-support program that integrates wearable devices to enhance rehabilitation outcomes in patients with heart failure.</div></div><div><h3>Methods</h3><div>An innovative and practical cardiac rehabilitation program combined with a wearable device was developed based on patients and physicians’ feedback. A multicenter randomized controlled clinical trial was designed to evaluate the safety and effectiveness of the application in patients with heart failure in Japan from October 2022 to January 2025. Compared with traditional exercise-monitoring applications, the developed application offers an array of features that are designed to foster patient engagement and promote long-term adherence. These features include (1) individualized goal setting, (2) direct communication with healthcare providers, (3) education on heart failure through instructional videos, (4) automated motivational feedback, and (5) a curated library of research summaries on cardiac rehabilitation and self-care. Patients who meet the inclusion criteria (including those aged ≥18 years with a clinical diagnosis of heart failure) will be randomly assigned to one of two groups as follows: the integrated exercise-support app group or the standard care group, in which only a wearable device was implemented. The change in peak VO₂ at 12 weeks, adjusted for baseline and allocation factors, will be analyzed as the primary endpoint. The secondary outcomes include quality-of-life measures and re-hospitalization rates. Data analysis will follow the intention-to-treat principle, with results reported as two-tailed 95 % confidence intervals and corresponding <em>p</em>-values.</div><div>This study was approved by the relevant institutional ethics committee (approval number: DB23-001; iRCT: 2032230388). Informed consent will be obtained from all participants before study participation. The results of the study will be disseminated through peer-reviewed publications and presented at relevant scientific meetings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101522"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tele Tai Chi for people aging with mobility disabilities: Novel methodology and structured adaptation approach","authors":"Elena T. Remillard ,&nbsp;Tracy L. Mitzner ,&nbsp;Kara T. Mumma","doi":"10.1016/j.conctc.2025.101543","DOIUrl":"10.1016/j.conctc.2025.101543","url":null,"abstract":"<div><div>Many people aging with mobility disabilities experience barriers engaging in exercise programs and social events in-person and could benefit from virtual programs that make participation more accessible. The Tele Tai Chi clinical trial is assessing the acceptability and effectiveness of an evidence-based in-person Tai Chi program for older adults, Tai Chi for Arthritis and Fall Prevention (seated version), when adapted to be an online group intervention (via videoconferencing) with moderated social time for individuals aging with mobility disabilities. Specifically, we are examining the intervention efficacy for the target population for increasing physical activity and social connectedness, which are the primary outcome measures. Secondary outcome measures include exercise self-efficacy, falls efficacy, depression, quality of life, and pain. The participant sample (N = 60) includes community-dwelling adults (60–77 years of age) with a self-identified mobility disability (i.e., using a mobility aid or having serious difficulty walking or climbing stairs) for at least 10 years. Follow-up assessments occurred at the end of the 8-week intervention and 1 month thereafter. This methods-focused paper highlights our novel, user-centered, technology-mediated approach to adapting an in-person intervention for individuals aging with mobility disabilities, which can be used as a roadmap for researchers and practitioners launching similar trials or programs.</div></div><div><h3>ClinicalTrials.gov no</h3><div>NCT04696887.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101543"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144931927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Project Safe Guard–Trauma (PSG-T): Protocol for a randomized controlled trial of lethal means safety counseling to promote secure firearm storage among individuals with PTSD","authors":"Ian H. Stanley ,&nbsp;Julia Finn ,&nbsp;Kathleen M. Flarity ,&nbsp;Mengli Xiao ,&nbsp;Rachel L. Johnson ,&nbsp;Jaclyn C. Kearns ,&nbsp;Natalie L. Wilver ,&nbsp;Steven J. Berkowitz ,&nbsp;Michael D. Anestis ,&nbsp;Marian E. Betz ,&nbsp;Joseph A. Simonetti","doi":"10.1016/j.conctc.2025.101549","DOIUrl":"10.1016/j.conctc.2025.101549","url":null,"abstract":"<div><div>Firearm injury is the most common suicide method. When firearms are stored in a non-secure manner (e.g., unlocked, loaded), risk for suicide may be elevated. Accordingly, clinical, public health, and firearm industry stakeholders recommend efforts to promote secure firearm storage, such as lethal means safety counseling (LMSC). One LMSC intervention, Project Safe Guard (PSG), has demonstrated efficacy in prompting use of firearm locking devices in a sample of military service members; however, subsequent analyses show that PSG has diminished efficacy for individuals with elevated symptoms of posttraumatic stress disorder (PTSD). PTSD, characterized in part by hypervigilance to threat, is associated with elevated suicide risk as well as a greater likelihood of storing firearms using less secure methods. In response, our group developed an adaptation of PSG, termed Project Safe Guard-Trauma (PSG-T). This paper describes the design, methodology, and protocol of a randomized controlled trial comparing PSG-T to PSG among adults who screen positive for PTSD related to a victimization trauma (e.g., physical assault, sexual assault, combat) and who do not currently store all their personally owned firearms in a secure manner. PSG and PSG-T will be delivered by licensed clinical psychologists. Assessments will occur at pre-intervention, post-intervention, and 1-, 3-, and 6-month follow-up. The primary objective is to determine the efficacy of PSG-T in prompting greater beliefs and practices regarding secure storage of personal firearms.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101549"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145048841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials","authors":"Luigi Taranto-Montemurro ,&nbsp;Sanjay R. Patel ,&nbsp;Patrick J. Strollo Jr. ,&nbsp;John Cronin ,&nbsp;John Yee ,&nbsp;Huy Pho ,&nbsp;Andrea Werner ,&nbsp;Ron Farkas","doi":"10.1016/j.conctc.2025.101538","DOIUrl":"10.1016/j.conctc.2025.101538","url":null,"abstract":"<div><h3>Introduction</h3><div>Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA.</div></div><div><h3>Methods</h3><div>AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI₄) &gt;5 who either refuse or fail to tolerate positive airway pressure. Participants (LunAIRo: N = 660; SynAIRgy: N = 646) were randomized 1:1 to receive AD109 or placebo. We hypothesize that AD109 will significantly reduce AHI₄ and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is the change from baseline to Week 26 in AHI₄ in the AD109 arm versus placebo. Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI₄ at Week 26.</div></div><div><h3>Discussion</h3><div>LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101538"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144895000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials","authors":"Lauren Rogak ,&nbsp;Jamie K. Forschmiedt ,&nbsp;Ethan Basch ,&nbsp;Gina L. Mazza ,&nbsp;Minji K. Lee ,&nbsp;Eric A. Meek ,&nbsp;Brenda Ginos ,&nbsp;Blake T. Langlais ,&nbsp;Brie N. Noble ,&nbsp;Allison M. Deal ,&nbsp;Claire Yee ,&nbsp;Gita Thanarajasingam ,&nbsp;Amylou C. Dueck","doi":"10.1016/j.conctc.2025.101547","DOIUrl":"10.1016/j.conctc.2025.101547","url":null,"abstract":"<div><div>The Patient-Reported Outcomes version of the Common Terminology for Adverse Events® (PRO-CTCAE®) item library enables patient self-reporting of symptoms in cancer clinical trials. It was developed as a companion to CTCAE v4.0. The aim of this analysis is to understand how PRO-CTCAE has been used since its release. Trials using PRO-CTCAE were identified on clinicaltrials.gov. Trial characteristics were descriptively analyzed. Number of trials by year posted on clinicaltrials.gov was tested for increasing trend using Poisson regression. Among 327 identified trials, 318 (97 %) were in oncology, 269 (82 %) were interventional, and 170 (52 %) were randomized. Number of trials significantly increased over time (<em>P</em> &lt; .001). PRO-CTCAE has had substantial and growing use in oncology trials since its release.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101547"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145004165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized controlled trial protocol for evaluating the feasibility, acceptability, and work outcomes of individualized placement and support adapted for autistic adults in the community","authors":"Marjorie Solomon ,&nbsp;Jo A. Yon-Hernández ,&nbsp;Steve Ruder ,&nbsp;Susan R. McGurk ,&nbsp;Daniel Tancredi ,&nbsp;Yukari Takarae ,&nbsp;Aubyn C. Stahmer","doi":"10.1016/j.conctc.2025.101536","DOIUrl":"10.1016/j.conctc.2025.101536","url":null,"abstract":"<div><div>Relatively few autistic adults, including those with average intellectual abilities, are competitively employed, meaning that they hold jobs together with non-disabled workers and receive comparable wages and benefits. In California, for example, most autistic individuals served by the state are placed in programs where they participate in skill-building and socialization but not in actual competitive jobs. Failure to participate in the labor force can diminish autistic workers’ sense of purpose, well-being, and ability to earn a living wage.</div><div>Available research suggests that supported employment that assists autistic adults in finding and keeping jobs, produces the highest sustained competitive employment rates. Thus, our team has been investigating the Individualized Placement and Support (IPS) model, which has an extensive evidence base for increasing competitive employment rates in individuals with chronic mental illnesses. In a California Department of Developmental Services Employment Grant investigating adults with autism and intellectual disabilities, we demonstrated a competitive employment placement rate of 52 % using IPS. Components of IPS were appropriate for this population, however there were implementation challenges related to IPS model fit with the vocational support agencies.</div><div>Based on focus groups and stakeholder input, we have adapted IPS to provide intensive agency training, leadership education, and record keeping support. Herein, we detail a protocol for a randomized controlled trial of the adapted model (IPS-AUT) to evaluate feasibility, acceptability, and work outcomes. We also investigate potential moderators and mediators of treatment effectiveness to provide a foundation for a larger more adequately powered randomized clinical trial.</div><div>This protocol is registered at ClinicalTrials.gov: NCT 06829264.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101536"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol","authors":"Jaimee R. Rich ,&nbsp;Michael Dymock ,&nbsp;Elke J. Seppanen ,&nbsp;Elena Montgomery ,&nbsp;Tanisha Cayley ,&nbsp;Tamara Veselinović ,&nbsp;Greta Bernabei ,&nbsp;Anri Lester ,&nbsp;Amy Hannigan ,&nbsp;Nicole Irvine ,&nbsp;Kerryn Gidgup ,&nbsp;Edna Ninyette ,&nbsp;Steph Bray ,&nbsp;Tu Trang Tran ,&nbsp;Valerie M. Swift ,&nbsp;Melinda Edmunds ,&nbsp;Natalie Strobel ,&nbsp;Daniel McAullay ,&nbsp;Julie Marsh ,&nbsp;Evelyn Tay ,&nbsp;Christopher G. Brennan-Jones","doi":"10.1016/j.conctc.2025.101531","DOIUrl":"10.1016/j.conctc.2025.101531","url":null,"abstract":"<div><h3>Introduction</h3><div>Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years.</div></div><div><h3>Methods</h3><div>This parallel-group, 1:1, outcome assessor-blinded, individual adaptive RCT investigates whether completing the BBC intervention plus hand hygiene twice-daily at home increases OME resolution after 4-to-6 weeks in children with OME, compared to hand hygiene alone. Families (n = 250) perform their individually randomized program (BBC plus hand hygiene, or hand hygiene only) at home. The primary outcome is the difference in OME resolution rates between trial arms, assessed using tympanometry (type B to A or C₁ transition) and otoscopy. Secondary outcomes include natural OME resolution, discharges from tertiary care, family satisfaction, hearing thresholds, QoL, bacterial load in the nasopharynx and on hands, cost comparison within the RCT versus standard care, and adverse events. All outcomes are measured by blinded researchers. An intention-to-treat analysis will be performed on all randomized participants. Guided by an Aboriginal Community Advisory Group, the RCT ensures culturally appropriate research whilst addressing community priorities in managing childhood ear disease.</div></div><div><h3>Discussion</h3><div>If efficacious, BBC could reform OME treatment, reduce costs, and improve long-term hearing, speech, and QoL outcomes in some children. Its accessibility offers a globally scalable solution.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101531"},"PeriodicalIF":1.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144827306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trialing addiction neurocircuitry targets and directionality of brain stimulation effects: A deep TMS/fMRI trial in people with alcohol use disorder","authors":"Daniel J. Fehring ,&nbsp;Jordan Morrison-Ham ,&nbsp;Annalee L. Cobden ,&nbsp;Justin Mahlberg ,&nbsp;Mengxia Gao ,&nbsp;Claire E. Kelly ,&nbsp;Arshiya Sangchooli ,&nbsp;Devon Stoliker ,&nbsp;Emily Giddens ,&nbsp;Brody Quinn ,&nbsp;Antonia Cholewick ,&nbsp;Luiza Bonfim Pacheco ,&nbsp;Adeel Razi ,&nbsp;Natalia Albein-Urios ,&nbsp;Antonio Verdejo-Garcia","doi":"10.1016/j.conctc.2025.101515","DOIUrl":"10.1016/j.conctc.2025.101515","url":null,"abstract":"<div><h3>Background</h3><div>Excessive alcohol consumption is a global health concern, with an estimated 400 million people living with alcohol use disorder (AUD). Current treatments for AUD have limited efficacy and fail to address its diverse neurobiological underpinnings. There are at least two cortico-striatal circuits relevant to AUD neurobiology: a weakened dorsolateral prefrontal cortex (dlPFC) pathway, and a heightened ventromedial prefrontal cortex (vmPFC) pathway.</div></div><div><h3>Purpose</h3><div>This trial aims to examine whether deep transcranial magnetic stimulation (dTMS) can recalibrate the neurocircuitry disrupted in AUD as a proof-of-concept for its therapeutic potential. We will assess the capacity of two theta-burst stimulation protocols to modify neuroimaging and behavioral indices of AUD-related neurocircuitry alterations.</div></div><div><h3>Methods</h3><div>We will conduct a randomized, single-blind, sham-controlled crossover trial with 30 adults with moderate to severe AUD (aged 18–49). Participants will receive two doses of active or sham dTMS (for 2 sessions; 7 days apart; order counterbalanced) targeting the dlPFC or vmPFC with intermittent or continuous theta-burst stimulation, respectively.</div></div><div><h3>Results</h3><div>Primary, secondary, and exploratory outcomes (i.e., stimulation-induced changes in neural circuit connectivity, executive control/decision-making, and craving-related emotions, respectively) will be collected before and after each dTMS dose. Additional exploratory outcomes (daily craving experiences and weekly alcohol consumption) will be collected across a 90-day period from the first session.</div></div><div><h3>Discussion</h3><div>This trial innovates by utilizing distinct dTMS approaches to specifically target two functionally segregated neurocircuitries disrupted in AUD. Results will inform the development of a larger-scale trial by establishing optimal therapeutic approaches for AUD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101515"},"PeriodicalIF":1.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH)","authors":"Kristin Mayes ,&nbsp;Victor B. Talisa ,&nbsp;Adelina Malito ,&nbsp;Florian B. Mayr ,&nbsp;Kelly Williams ,&nbsp;Kalpana Char ,&nbsp;Richard Wadas ,&nbsp;Elizabeth Lorenzi ,&nbsp;Kert Viele ,&nbsp;Rana Awdish ,&nbsp;Derek C. Angus ,&nbsp;Chung-Chou Ho Chang ,&nbsp;Sachin Yende","doi":"10.1016/j.conctc.2025.101504","DOIUrl":"10.1016/j.conctc.2025.101504","url":null,"abstract":"<div><h3>Background</h3><div>The months following hospitalization for sepsis and lower respiratory tract infection can often be very difficult for patients. Many will have subsequent clinical deterioration, which for some requires hospital readmission while, for others, transition to hospice care may be more appropriate. Unfortunately, there is a lack of high-quality evidence regarding how best to support patients in this period. Remote patient monitoring (RPM) technology can allow patients to remain at home yet be monitored for early signs of clinical deterioration. However, what should be monitored, and how any response should be coordinated, is unclear. We designed a pragmatic adaptive randomized clinical trial to determine the effect of four post-discharge RPM strategies comprising low vs. high intensity monitoring and standard versus enhanced care team response on 90-day hospital readmission rates.</div></div><div><h3>Methods</h3><div>Adults admitted to the hospital with sepsis or lower respiratory tract infection (index admission) are recruited and randomized to usual care (structured telephonic support [STS]) or one of four post-discharge RPM care models in addition to STS. The primary outcome is home days, a composite endpoint of 90-day mortality and the number of days a patient spends at home within 90 days after discharge to home from the index admission. Hospital readmissions will be measured primarily by health insurance claims data. Secondary endpoints, such as functional status and health-related quality of life, will be measured at baseline and 90 days. An adaptive randomization process is run quarterly, improving patients' chances to be randomized to the highest-performing intervention arms.</div></div><div><h3>Discussion</h3><div>The study evaluates different post-discharge monitoring and workforce strategies to increase home days. With a large, representative sample and pragmatic adaptive study design, this research aims to deliver key insights into effective remote discharge monitoring technology and workforce deployment, benefiting patients, providers, and payers.</div></div><div><h3>Trial registration</h3><div>This trial is registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (NCT04829188). <span><span>https://clinicaltrials.gov/study/NCT04829188</span><svg><path></path></svg></span>. Date of registration: January 4, 2021.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101504"},"PeriodicalIF":1.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144366916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}