Contemporary clinical trials最新文献

{"title":"The pregnant body project pilot RCT protocol: Preventing disordered eating behaviors in high-risk pregnant individuals.","authors":"Rachel Vanderkruik, Caroline M Frisch, Emily C Woodworth, Sophie Scharner, Stephen J Bartels, Marlene P Freeman, Lee S Cohen, Eric Stice","doi":"10.1016/j.cct.2025.108039","DOIUrl":"10.1016/j.cct.2025.108039","url":null,"abstract":"<p><strong>Introduction: </strong>Pregnancy and the postpartum (i.e., the perinatal period) can be a trigger for body dissatisfaction and disordered eating. Little is known about effective approaches to mitigate this increased risk and reduce the potential negative impact on perinatal individuals and their offspring. To begin addressing this need, we are testing the feasibility of an adapted evidence-based eating disorder prevention program for pregnant individuals with a history of disordered eating. The purpose of this paper is to describe the protocol of a unique pilot randomized controlled trial (RCT).</p><p><strong>Methods: </strong>We are conducting a single-blind feasibility RCT of a group-based, peer-delivered eating disorder prevention program (Pregnancy Body Project; PBP) compared to a dose- and time-matched educational control. The study will assess the experiences of participants in the treatment and control conditions as well as the peer-facilitators leading the PBP program. Participants will complete quantitative and qualitative assessments to measure feasibility, acceptability, adherence to the intervention, eating disorder symptomology, body dissatisfaction, and mental health.</p><p><strong>Project status and discussion: </strong>Data collection is in process as of March 2025 and we aim to recruit N = 60 total. A program to mitigate the increased risk of disordered eating behaviors and body dissatisfaction during pregnancy and postpartum is needed to address a critical public health issue. If the PBP program and control condition meet feasibility and acceptability benchmarks, we will pursue a subsequent, fully powered effectiveness trial of the PBP program vs the health education control. Clinical Trials NCT06659354.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108039"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768441","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":"Association of study visit interval length with follow-up completeness and adherence to assigned study drug dose: A randomized comparison of participants in the ADAPTABLE trial.","authors":"Dennis I Narcisse, Jeff Whittle, Grace M Rhodes, Amanda L Stebbins, Lisa M Wruck, Hillary Mulder, Sunil Kripalani, Daniel Muñoz, Mark B Effron, Kamal Gupta, Eileen M Handberg, Saket Girotra, Rachel Hess, Catherine P Benziger, Peter Farrehi, Jeffrey J VanWormer, Kirk U Knowlton, Tamar S Polonsky, Steven M Bradley, Holly R Robertson, Bradley G Hammill, Russell L Rothman, Robert A Harrington, W Schuyler Jones, Adrian F Hernandez","doi":"10.1016/j.cct.2025.108030","DOIUrl":"10.1016/j.cct.2025.108030","url":null,"abstract":"<p><strong>Background: </strong>Little is known of the frequency of follow-up visits impact on completion of scheduled study visits, adherence to randomized treatment assignment, and completion of the study.</p><p><strong>Methods: </strong>In ADAPTABLE, participants with ASCVD were randomized to 81 mg or 325 mg of aspirin and to follow-up at 3- or 6-month intervals. At follow-up, participants answered questions about aspirin dose, adherence, and outcome measures via internet patient portal or telephone. Differences in visit adherence and study completion were compared using logistic regression. Proportional hazard models were used to compare time to study drop out, stopping aspirin, or changing aspirin dose between the 3-and 6-month groups.</p><p><strong>Results: </strong>When compared with 6-month follow-up, participants assigned to 3-month follow-up were less likely to attend any study visit (OR 0.69, 95 % CI 0.65-0.73), but 3-month follow-up had more total visits (8 vs 5, p < 0.0001). The likelihood of completing the end-of-study visit were similar (OR 0.94, 95 % CI 0.87-1.03). Assignment to 3- vs 6-month follow-up was not associated with rates of aspirin dose switching (HR 1.02, 95 % CI = 0.94-1.09), aspirin discontinuation (HR 1.00, 95 % CI 0.88-1.14), or study drop out (HR 0.95, 95 % CI 0.88-1.03).</p><p><strong>Conclusions: </strong>More frequent study visits led to higher total visits but lower visit adherence. There were no significant differences in visit and medication adherence between 3 v. 6 months follow up. As we continue to refine approaches to designing pragmatic clinical trials, more work is needed to understand the factors that may impact adherence to randomized assignments.</p><p><strong>Clinicaltrials: </strong>govIdentifier:NCT02697916.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108030"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728466","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":"Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis","authors":"Jennifer E. Flythe ,&nbsp;Cassandra B. Picataggio ,&nbsp;Leah Bernardo ,&nbsp;Lorien S. Dalrymple ,&nbsp;Robert J. Kossmann ,&nbsp;Darren A. DeWalt ,&nbsp;Laura C. Hanson ,&nbsp;Virginia Wang ,&nbsp;Mark L. Unruh ,&nbsp;Jesse Y. Hsu ,&nbsp;Laura M. Dember","doi":"10.1016/j.cct.2025.108058","DOIUrl":"10.1016/j.cct.2025.108058","url":null,"abstract":"<div><div>Individuals with hemodialysis-dependent kidney failure often suffer from numerous symptoms that contribute to poor patient outcomes. The Symptom Monitoring in Renal Replacement Therapy-Hemodialysis (SMaRRT-HD) Study is a pragmatic randomized trial of monitoring and follow-up of symptoms for individuals receiving maintenance hemodialysis. The trial uses an effectiveness-implementation hybrid design with randomization at the clinic level to compare the effectiveness of once monthly symptom monitoring with supported clinician follow-up via an electronic patient-reported outcome measure (ePROM) system called SMaRRT-HD compared to routine symptom monitoring without supported follow-up (Usual Care) to improve patient-reported and biomedical outcomes over a 12-month intervention period. This manuscript describes the design of the trial with a focus on the effectiveness evaluation component. The primary outcome is symptom severity ascertained with the Dialysis Symptom Index at 6 and 12 months. Secondary outcomes are additional patient-reported outcomes (PROs) including health-related quality of life, fatigue, pain, hemodialysis recovery time, depression, anxiety, and healthcare engagement and biomedical outcomes including hospitalizations, missed hemodialysis treatments, and shortened hemodialysis treatments. Exploratory outcomes include death and quality of communication between patients and clinicians. The trial will include up to 36 hemodialysis clinics located across the United States. The enrollment targets are 2400 participants for the Full Cohort from which the biomedical outcomes will be ascertained, and 1200 participants for the PRO Subset from which PROs will be ascertained. The findings of the trial will inform approaches to symptom monitoring and follow-up for people with hemodialysis-dependent kidney failure.</div><div>Clinical Trials Registration Number: <span><span>NCT05738330</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108058"},"PeriodicalIF":1.9,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945574","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 randomization strategy for a cluster-randomized controlled trial with variable operating room availability","authors":"Sheau-Chiann Chen ,&nbsp;Heidi Chen ,&nbsp;Rafael Paez ,&nbsp;Cheryl L. Gatto ,&nbsp;Robert James Lentz ,&nbsp;Fabien Maldonado","doi":"10.1016/j.cct.2025.108057","DOIUrl":"10.1016/j.cct.2025.108057","url":null,"abstract":"<div><div>A single-center, open-label, pragmatic, non-inferiority, cluster randomized controlled trial was conducted to compare the clinical outcomes of two diagnostic bronchoscopy approaches, Platform A and Platform B. A cluster was defined as an operating room (OR) day. The expected allocation ratio at the cluster level was 1:1 between Platform A and Platform B. The resources available for this trial included one Platform A, one Platform B, two ORs available for two days a week, and one OR available for the other three days. When one platform was randomly assigned to one OR, the other platform was placed in the other OR.</div><div>Due to limitations in OR and bronchoscopy platform availability precluding individual patient randomization, a stratification strategy was proposed to randomize ORs to a given platform. A simulation with 1000 replicates was performed to assess balance of assignments, using imbalance (defined as the difference/imbalance in the number of patients enrolled between Platform A and Platform B) and its standard deviation as evaluation metrics.</div><div>At day 150 (210 assignments), a permuted-block randomization method, incorporating stratification by weekdays, reduced both imbalance and variation (mean = 0.044, standard deviation (SD) = 1.110, median = 0, range = (−4, 4)), compared to a permuted-block randomization method (mean = −0.238, SD = 7.064, median = 0, range = (−24, 22)). We further explored an alternative strategy: stratification by OR availability. This evaluation analysis revealed a greater reduction in imbalance, with a range of −2 and 2 (mean = −0.006, SD = 0.690, median = 0).</div><div>Our innovative study designs, incorporating a permuted-block randomization method stratified by OR availability, effectively reduced the imbalance assignments and optimized allocation of resources.</div><div><strong>Trial registration</strong></div><div>ClinicalTrials.gov registration (NCT05705544) for RELIANT on January 30, 2023.</div><div>ClinicalTrials.gov registration (NCT06654271) for RELIANT 2 on January 12, 2024.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108057"},"PeriodicalIF":1.9,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144932383","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":"Study protocol of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation","authors":"Siiri-Liisi Kraav ,&nbsp;Eric Schoenmakers ,&nbsp;Ismo Linnosmaa ,&nbsp;Samu Sorola ,&nbsp;Tommi Tolmunen","doi":"10.1016/j.cct.2025.108060","DOIUrl":"10.1016/j.cct.2025.108060","url":null,"abstract":"<div><h3>Background</h3><div>Dissatisfaction with interpersonal relationships in the workplace negatively impacts well-being and work performance. Almost 30 % of people of working age in Finland experience loneliness all or most of the time. Cost-effective methods are needed to improve the social well-being of the general working-age population. This cluster randomized trial aims to investigate whether a mobile application can improve employees' well-being and work-life relationships and reduce their experience of loneliness.</div></div><div><h3>Methods</h3><div>The current study aims to evaluate the effectiveness of the Frendie PRO mobile application on employees' social well-being measured by loneliness, workplace loneliness, work belongingness, and depressive symptoms as primary outcomes. A cluster randomized trial will be performed in workplaces. The intervention group will be given access to and is encouraged to use the Frendie PRO mobile application. The control group will have access to the application after the follow-up period. Data will be collected at three timepoints: baseline (before using the application), 3-month, and 6-month follow-up. The effectiveness and cost-effectiveness of the application will be analyzed.</div></div><div><h3>Discussion</h3><div>The intervention is hypothesized to reduce loneliness and workplace loneliness and increase the sense of work belongingness among employees. The study results may be used to develop the Frendie PRO mobile application further and develop other similar digital loneliness interventions for adults in the general population.</div><div><strong>Trial registration:</strong> The trial has been registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, registration number NCT06495801, date of registration 11. July 2024.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108060"},"PeriodicalIF":1.9,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945491","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":"Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial","authors":"Nicola Guess ,&nbsp;Sarah Wane ,&nbsp;Charlotte Albury ,&nbsp;Penny Breeze ,&nbsp;Alan Brennan ,&nbsp;Jack B. Joyce ,&nbsp;Ushma Galal ,&nbsp;Elizabeth Morris ,&nbsp;Carolyn Newbert ,&nbsp;Caroline Mitchell ,&nbsp;Ly-Mee Yu ,&nbsp;Paul Aveyard ,&nbsp;Susan A. Jebb","doi":"10.1016/j.cct.2025.108050","DOIUrl":"10.1016/j.cct.2025.108050","url":null,"abstract":"<div><h3>Background</h3><div>The NHS Path to Remission (PtR) offers a total diet replacement (TDR) programme to help people newly-diagnosed with type 2 diabetes (T2D) lose weight. It is very effective for people who participate, but most eligible people do not take part.</div></div><div><h3>Aim</h3><div>To assess whether offering a range of weight loss programmes can increase uptake of, and persistence with, weight loss and lead to a higher proportion of the population achieving remission of T2D compared with offering PtR only.</div></div><div><h3>Method</h3><div>1788 people diagnosed with T2D in the last six years, who are willing to try to lose weight to achieve remission, will be recruited via GP practices and randomised to the NewDAWN service or PtR. Outcomes (weight, height, HbA1c, medications, BP, CVD risk score, PAID, EQ-5D, healthcare resource use) will be assessed at baseline and 12 months, with diabetes remission at 12 months as the primary outcome. An internal pilot assessment will follow 150 participants for 16 weeks to determine whether to progress using pre-specified criteria based on fidelity of programme delivery, adherence to the programme and change in weight. The decision will be reviewed by an external programme steering committee who will also advise on any other considerations they deem material to the likely successful completion of the full trial. A process evaluation will assess fidelity of delivery and collect both staff and participant feedback on the NewDAWN service to improve the effectiveness of implementation. The costs of NewDAWN and lifetime cost-effectiveness of the service will also be determined.</div><div>ISRCTN Registration: 11090437</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108050"},"PeriodicalIF":1.9,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144913597","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":"Multi-hospital electronic decision support for drug-associated acute kidney injury (MEnD-AKI): Study protocol for a randomized clinical trial","authors":"Britney A. Stottlemyer ,&nbsp;John A. Kellum ,&nbsp;Azra Bihorac ,&nbsp;Tezcan Ozrazgat-Baslanti ,&nbsp;Raghavan Murugan ,&nbsp;Chung-Chou Ho Chang ,&nbsp;Nabihah Amatullah ,&nbsp;Tiffany L. Tran ,&nbsp;Caiden J. Lukan ,&nbsp;Michele M. Elder ,&nbsp;Esra Adiyeke ,&nbsp;Yuanfang Ren ,&nbsp;Dan Ricketts ,&nbsp;Beth Emanuele ,&nbsp;Parisa Rashidi ,&nbsp;Sandra L. Kane-Gill","doi":"10.1016/j.cct.2025.108055","DOIUrl":"10.1016/j.cct.2025.108055","url":null,"abstract":"<div><h3>Background and objectives</h3><div>Tools to assist with drug management for both nephrotoxic medications and renally eliminated drugs are urgently needed. “Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury” (MEnD-AKI) aims to examine the effect of a pharmacist-led intervention augmented with predictive analytics in the form of electronic alerts delivered to pharmacists followed by drug management recommendations provided to physicians via telemedicine for the early management of patients at risk of developing AKI or progressing to higher AKI stages.</div></div><div><h3>Design</h3><div>Prospective, multi-site, cluster-randomized clinical trial.</div></div><div><h3>Setting</h3><div>Eight hospitals within the UPMC health system.</div></div><div><h3>Patients</h3><div>Attending physicians belonging to primary services other than intensive care or organ transplant will be eligible for participation in the study. The unit of randomization is physician hospital services (clusters), and outcomes will be assessed for patients cared for by these physicians.</div></div><div><h3>Interventions</h3><div>Researchers will randomize 38 hospital service clusters to receive: 1) electronic medical record (EMR)-based AKI passive alert, which is standard of care at UPMC; this alert provides the diagnosis and staging of AKI but without recommendations for management; or 2) protocolized, tiered pharmacist-led intervention augmented with near-realtime predictive analytics in the form of automated alerts incorporated into a web application delivered to pharmacists followed by drug management recommendations provided to physicians via telemedicine for consideration and approval.</div></div><div><h3>Outcomes</h3><div>The primary outcome is major adverse kidney events (MAKE) measured within 30 days of admission. Secondary outcomes include progression of AKI, AKI duration, and nephrotoxic burden.</div></div><div><h3>Clinical trials registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06264752</span><svg><path></path></svg></span> (v2).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108055"},"PeriodicalIF":1.9,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144902527","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":"Introducing the Adherence Promotion with Person-centered Technology (APPT) trial: Rationale, methods, and baseline characteristics","authors":"Shenghao Zhang ,&nbsp;Michael Dieciuc ,&nbsp;Andrew Dilanchian ,&nbsp;Mia Liza A. Lustria ,&nbsp;Dawn C. Carr ,&nbsp;Antonio Terracciano ,&nbsp;Zhe He ,&nbsp;Shayok Chakraborty ,&nbsp;Neil Charness ,&nbsp;Walter R. Boot","doi":"10.1016/j.cct.2025.108056","DOIUrl":"10.1016/j.cct.2025.108056","url":null,"abstract":"<div><div>Home-based cognitive training programs delivered via computers and tablets hold promise as cost-effective, population-level interventions to prevent or mitigate age-related cognitive decline. However, adherence to such programs is often low. Using message-tailoring techniques and an adaptive algorithm, we developed a person-centered reminder smart system that delivers motivational messages at times when participants are predicted to be available for training activities. This paper presents the background, study design, methodology, and baseline data for a randomized controlled trial examining the system's efficacy in supporting adherence to cognitive training. A total of 199 cognitively normal, community-dwelling older adults aged 62 to 88 were randomly assigned (1:1) to either the smart reminder or the control condition. Participants were instructed to engage in training activities for 30 min per day, five days per week, for 18 consecutive weeks. Those in the smart reminder condition received personalized messages, delivered at optimized times, and with targeted content, while those in the control condition received generic messages at a fixed time. Adherence rate will be the primary outcome measure, calculated and compared across conditions. Findings from this study will have implications not only for adherence support in cognitive training but also for broader applications of technology-mediated smart reminder systems, including physical exercise, nutrition, medication management, telehealth, and social connectivity. By enhancing intervention engagement, these systems have the potential to improve the health and well-being of older adults on a large scale.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108056"},"PeriodicalIF":1.9,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144902526","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":"Community-clinic partnership to address social needs and improve colorectal cancer screening outcomes: The PRIME stepped-wedge study","authors":"Gloria D. Coronado ,&nbsp;John F. Dickerson ,&nbsp;Amanda F. Petrik ,&nbsp;Elva M Arredondo ,&nbsp;Ming-Hsiang Tsou ,&nbsp;Lourdes S. Martinez ,&nbsp;Charisma L. Jenkins ,&nbsp;Ana G. Rosales ,&nbsp;Namrata Shivaprakash ,&nbsp;Elizabeth Shuster ,&nbsp;Jennifer L. Schneider ,&nbsp;Jennifer S. Rivelli ,&nbsp;Joanna G. Garcia ,&nbsp;Juan A. Rodriguez ,&nbsp;Katherine Mendoza ,&nbsp;Jamie H. Thompson ,&nbsp;Anne L. Escaron","doi":"10.1016/j.cct.2025.108051","DOIUrl":"10.1016/j.cct.2025.108051","url":null,"abstract":"<div><h3>Background</h3><div>US colorectal cancer screening rates are suboptimal, particularly among Latino populations and patients served by federally qualified health centers (FQHCs). PRIME is a two-phased study to test effectiveness of a multi-component program to address patient social needs and improve colorectal cancer screening and follow-up in neighborhoods served by our partnering FQHC.</div></div><div><h3>Methods</h3><div>PRIME is a modified stepped-wedge study involving health-center patients in 12 neighborhoods in Southern California, followed by a scale-up study involving four additional health centers/neighborhoods. Eligible adults are ages 45–64, due for colorectal cancer screening, with a health center clinic visit in the previous 6 months. The intervention combines: (1) phone-based advance notification, a mailed FIT, and text messages with links to a short animated instructional video on FIT completion, (2) patient navigation for addressing patients' social needs, and (3) neighborhood-level events to raise awareness about the need for colorectal cancer screening.</div></div><div><h3>Results</h3><div>Recruitment for Phase I began in July 2024. Primary effectiveness outcome is receipt of any colorectal cancer screening within 6 months; primary implementation outcome is clinic-level and organizational-level rates of program delivery, by component (e.g., mailed FIT, social needs navigation, community events). Phase II scale-up activities will: use webinars, train-the-trainer workshops, and collaborative learning activities; and will assess adoption of and adaptations to the multi-component program.</div></div><div><h3>Conclusion</h3><div>This study will test the effectiveness, implementation, and scale-up of a multi-component video text message and social needs navigation program to improve colorectal cancer screening uptake in neighborhoods served by our partnering FQHC and community-based organizations.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108051"},"PeriodicalIF":1.9,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144902525","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 non-arrival at initial study screening visits among Black adults: Data from the GoFresh trials","authors":"Benjamin Grobman ,&nbsp;Christian Rivera ,&nbsp;Mingyu Zhang ,&nbsp;Ruth-Alma Turkson-Ocran ,&nbsp;Jingyi Cao ,&nbsp;Md Marufuzzaman Khan ,&nbsp;Hannah Col ,&nbsp;Marian Budu ,&nbsp;Sarah Nartey ,&nbsp;Ruth Zeto ,&nbsp;Emily Aidoo ,&nbsp;Timothy B. Plante ,&nbsp;Stephen P. Juraschek","doi":"10.1016/j.cct.2025.108054","DOIUrl":"10.1016/j.cct.2025.108054","url":null,"abstract":"<div><h3>Background</h3><div>Trial recruitment is a major determinant of study success, and participants' non-arrival at study visits represents a significant barrier to study completion. Little is known about the participant and study process characteristics associated with visit non-arrival.</div></div><div><h3>Objective</h3><div>To investigate factors associated with non-arrival at initial in-person screening visits in two ongoing randomized controlled trials.</div></div><div><h3>Methods</h3><div>The Groceries for Black Residents of Boston to Stop Hypertension trials (GoFresh and GoFreshRx) studied whether home-delivered, DASH-patterned groceries can reduce blood pressure among Black adults living in urban food priority areas. In this analysis, we examined sociodemographic and study-related factors associated with participant non-arrival at their initial study visit (defined as rescheduling or not showing up at all). Associations were determined using logistic regression with adjustment for age, estimated gender, and hypertension treatment status.</div></div><div><h3>Results</h3><div>Among 2224 participants (mean age = 44.0 years, 72.5 % women), the non-arrival rate at screening visit 1 was 29.5 %. Older participants were more likely to arrive, while those with larger families and a longer duration between initial contact and visit were less likely to arrive. Participants’ method of contacting the study, visit time, and season of visit were not associated with visit non-arrival.</div></div><div><h3>Conclusion</h3><div>In this large trial recruitment drive, older age, larger family size, and a longer time between initial contact and scheduled visit were associated with non-arrival at initial study visits. These factors represent potential targets for future interventions that either accommodate patient factors or intervene upon study process barriers to achieve timely recruitment goals.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108054"},"PeriodicalIF":1.9,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945504","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}