Pub Date : 2025-01-18DOI: 10.1016/j.cct.2025.107815
Nia S. Mitchell , Rebecca North , Anna Hung , Kathryn N. Porter Starr , Connie W. Bales , Cynthia J. Coffman
Background
Obesity and frailty are positively linked. Compared to other groups, older African American women have the highest rates of both obesity and frailty. Several academic weight loss interventions have shown that older adults can lose weight and improve physical function through diet and exercise. However, these programs do not have infrastructure for dissemination. Take Off Pounds Sensibly (TOPS) is a peer-led, community-based weight loss program with TOPS has a nationwide infrastructure that facilitates dissemination. Retrospective analyses showed that TOPS participants could lose a clinically significant amount of weight and maintain the loss for up to 7 years. This study will evaluate how TOPS participation affects weight change; physical function; cardiovascular disease risk factors; quality of life; and healthcare utilization among older African American women.
Methods
We are recruiting 104 older African American women aged ≥55 years with a BMI ≥ 27 kg/m2 to participate in a 6-month randomized wait-list controlled trial where TOPS is facilitated by a dietitian in weekly meetings. The primary goal of the intervention is for participants to lose at least 5 % of their initial weight. Outcomes will be collected at study visits at baseline, 3 months, and 6 months.
Discussion
If successful, this study will show that the TOPS program would be an option to treat excess weight and poor physical function among older African American women.
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Pub Date : 2025-01-16DOI: 10.1016/j.cct.2025.107809
Katrina D. Burson , Michelle H. Walter , Jeanette O. Auman , Jennifer Beverly , James W. Pickett II , Brian Erman , Kristin Zaterka-Baxter
A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA. During the software's tenure, we experienced incompatibilities with other clinical research software resulting in unanticipated inefficiencies. Furthermore, the small number of periodic and suspected unexpected serious adverse reaction (SUSAR) cases rendered the annual license fee not cost-effective. An internal analysis of our workflow, systems, and processes revealed that developing a cost-effective and efficient customized solution for our existing data coordinating center (DCC) projects was feasible. The customized solution mimics the key functionality and workflow of the prior software. It utilizes existing electronic data capture systems and document management solutions, ensuring 21 CFR Part 11 compliance without incurring additional expenses. The proposed process received internal approval and launched in December 2022. The process outlined in this paper is particularly advantageous for DCCs or academic clinical research sites that must meet regulatory reporting requirements without depending on specialized pharmacovigilance software. Additionally, it is a cost-effective option for organizations with a low volume of SUSAR events. In this paper, we present the process of developing and implementing a customized safety case management solution and the lessons learned pre and post implementation.
集中的安全功能可以支持多个临床试验，并为严重不良事件的管理提供高效、标准化的流程。从2017年到2022年，集中安全工作台使用符合FDA法规的药物警戒软件，包括21 CFR第11部分。该软件协助处理受监管的临床试验的安全案例，包括允许捕获事件数据，并提供流程管理，文档存储和向FDA传输安全报告。在该软件的使用期间，我们经历了与其他临床研究软件的不兼容，导致了意想不到的低效率。此外，少量的周期性和疑似意外严重不良反应（SUSAR）病例使得年度许可费不具有成本效益。对我们的工作流程、系统和流程的内部分析表明，为我们现有的数据协调中心（DCC）项目开发一种经济高效的定制解决方案是可行的。定制的解决方案模仿了先前软件的关键功能和工作流程。它利用现有的电子数据捕获系统和文档管理解决方案，在不产生额外费用的情况下确保21 CFR Part 11的合规性。拟议的流程获得了内部批准，并于2022年12月启动。本文概述的过程对于必须满足监管报告要求而不依赖专门的药物警戒软件的dcc或学术临床研究场所特别有利。此外，对于SUSAR活动数量较少的组织来说，这是一个具有成本效益的选择。在本文中，我们介绍了开发和实施定制安全案例管理解决方案的过程以及实施前后的经验教训。
{"title":"Developing a cost-effective and efficient safety case management solution for data coordinating center projects","authors":"Katrina D. Burson , Michelle H. Walter , Jeanette O. Auman , Jennifer Beverly , James W. Pickett II , Brian Erman , Kristin Zaterka-Baxter","doi":"10.1016/j.cct.2025.107809","DOIUrl":"10.1016/j.cct.2025.107809","url":null,"abstract":"<div><div>A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA. During the software's tenure, we experienced incompatibilities with other clinical research software resulting in unanticipated inefficiencies. Furthermore, the small number of periodic and suspected unexpected serious adverse reaction (SUSAR) cases rendered the annual license fee not cost-effective. An internal analysis of our workflow, systems, and processes revealed that developing a cost-effective and efficient customized solution for our existing data coordinating center (DCC) projects was feasible. The customized solution mimics the key functionality and workflow of the prior software. It utilizes existing electronic data capture systems and document management solutions, ensuring 21 CFR Part 11 compliance without incurring additional expenses. The proposed process received internal approval and launched in December 2022. The process outlined in this paper is particularly advantageous for DCCs or academic clinical research sites that must meet regulatory reporting requirements without depending on specialized pharmacovigilance software. Additionally, it is a cost-effective option for organizations with a low volume of SUSAR events. In this paper, we present the process of developing and implementing a customized safety case management solution and the lessons learned pre and post implementation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107809"},"PeriodicalIF":2.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001534","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}
Pub Date : 2025-01-16DOI: 10.1016/j.cct.2025.107813
Lamia H. Elgarhy , Sabah H. El-Ghaiesh , Eman Hamed , Wagdy Abdelfatah
The pandemic of SARS-CoV2 is not only limited to the health issues and fatalities encountered in a worldwide overwhelming burden but also the social, economic, and well-being devastation.
Many trials were done to find a safe and reliable therapy for COVID-19. Isotretinoin was reported as a possible therapy for COVID-19 through the mining of post-transcriptomic and genomic datasets, which revealed isotretinoin as a potent down-regulator of the ACE2 protein the crucial gateway of SARS-CoV2 to hijack host cells.
A total of 106 patients with mild to moderate COVID-19 were recruited. Patients were randomized into two groups and treated with the Standard Care (STD) protocol of the Ministry of Health, Egypt, or the STD in combination with isotretinoin (0.5 mg/kg/day) for 5 days.
The study involved 66 (63 %) females and 39 (37 %) males, median age 42 years (interquartile 32–55.5 y). The main findings revealed a significant reduction in the time to improvement in the isotretinoin-treated (6.6 ± 2 d) compared to the STD-treated patients (10.4 ± 3.3). Survival analysis (HR: 4.1, 95 % CI: 2.5–6.6) in comparison to the STD-treated patients.
The main adverse event reported during the therapeutic duration was the dryness of the skin, which was of acceptable tolerability through skin care instructions to the patients.
The data presented herein highlights the efficacy of isotretinoin in the management of mild to moderate COVID-19 patients with a significant reduction of the time to recovery. The adverse events reported were tolerable and did not outweigh the therapeutic benefits.
{"title":"Evaluation of the safety and efficacy of isotretinoin in treatment of COVID-19 : A randomized controlled clinical trial","authors":"Lamia H. Elgarhy , Sabah H. El-Ghaiesh , Eman Hamed , Wagdy Abdelfatah","doi":"10.1016/j.cct.2025.107813","DOIUrl":"10.1016/j.cct.2025.107813","url":null,"abstract":"<div><div>The pandemic of SARS-CoV2 is not only limited to the health issues and fatalities encountered in a worldwide overwhelming burden but also the social, economic, and well-being devastation.</div><div>Many trials were done to find a safe and reliable therapy for COVID-19. Isotretinoin was reported as a possible therapy for COVID-19 through the mining of post-transcriptomic and genomic datasets, which revealed isotretinoin as a potent down-regulator of the ACE2 protein the crucial gateway of SARS-CoV2 to hijack host cells.</div><div>A total of 106 patients with mild to moderate COVID-19 were recruited. Patients were randomized into two groups and treated with the Standard Care (STD) protocol of the Ministry of Health, Egypt, or the STD in combination with isotretinoin (0.5 mg/kg/day) for 5 days.</div><div>The study involved 66 (63 %) females and 39 (37 %) males, median age 42 years (interquartile 32–55.5 y). The main findings revealed a significant reduction in the time to improvement in the isotretinoin-treated (6.6 ± 2 d) compared to the STD-treated patients (10.4 ± 3.3). Survival analysis (HR: 4.1, 95 % CI: 2.5–6.6) in comparison to the STD-treated patients.</div><div>The main adverse event reported during the therapeutic duration was the dryness of the skin, which was of acceptable tolerability through skin care instructions to the patients.</div><div>The data presented herein highlights the efficacy of isotretinoin in the management of mild to moderate COVID-19 patients with a significant reduction of the time to recovery. The adverse events reported were tolerable and did not outweigh the therapeutic benefits.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107813"},"PeriodicalIF":2.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001539","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}
Pub Date : 2025-01-15DOI: 10.1016/j.cct.2025.107807
Julianne D. Jett , Diana Tyutyunnyk , Rachael Beck , Katharine Palmer , Danielle Ryan , Jesus Sanchez , Douglas L. Weeks , Sterling M. McPherson , Naomi Chaytor , Brian Kiluk , Martin A. Javors , Brett C. Ginsburg , Sean Murphy , Nathalie Hill-Kapturczak , Michael G. McDonell
Background
Contingency management (CM) is an intervention for alcohol use disorder (AUD) that reinforces abstinence, as confirmed by alcohol biomarkers. CM is usually brief (12–16 weeks) despite evidence that longer interventions have better long-term outcomes. Most CM models are in-person which can also be a barrier for treatment. Studies of longer duration telehealth-based CM models are needed.
Aims
To determine if a telehealth-based CM model that utilizes phosphatidylethanol (PEth) to confirm abstinence is effective at reducing alcohol use during a 26-week intervention and 12-month follow-up. We will evaluate the impact of CM on alcohol-related outcomes, determine if Addiction Neuroclinical Assessment variables are associated with outcomes in follow-up, and whether savings related to decreased alcohol use offset intervention costs.
Methods
Adults with AUD residing in the United States will be recruited via online advertising. Research procedures will be conducted virtually. Participants who submit a PEth-positive blood sample (≥20 ng/mL) at enrollment will be randomized to 26 weeks of either 1) online cognitive behavior therapy (CBT4CBT) with rewards not contingent on PEth results (Control group) or 2) CBT4CBT with a maximum of $1,820 of rewards contingent on PEth results (CM group). Efficacy outcomes of PEth-negative tests (primary) and PEth-defined excessive drinking (≥200 ng/mL; secondary) will be assessed. Predictors of intervention outcomes and economic viability will also be investigated.
Discussion
If this telehealth-delivered PEth-based CM intervention reduces alcohol use and is cost-effective, it could be used to provide effective treatment to millions of individuals with AUD who do not receive in-person care.
{"title":"A randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder","authors":"Julianne D. Jett , Diana Tyutyunnyk , Rachael Beck , Katharine Palmer , Danielle Ryan , Jesus Sanchez , Douglas L. Weeks , Sterling M. McPherson , Naomi Chaytor , Brian Kiluk , Martin A. Javors , Brett C. Ginsburg , Sean Murphy , Nathalie Hill-Kapturczak , Michael G. McDonell","doi":"10.1016/j.cct.2025.107807","DOIUrl":"10.1016/j.cct.2025.107807","url":null,"abstract":"<div><h3>Background</h3><div>Contingency management (CM) is an intervention for alcohol use disorder (AUD) that reinforces abstinence, as confirmed by alcohol biomarkers. CM is usually brief (12–16 weeks) despite evidence that longer interventions have better long-term outcomes. Most CM models are in-person which can also be a barrier for treatment. Studies of longer duration telehealth-based CM models are needed.</div></div><div><h3>Aims</h3><div>To determine if a telehealth-based CM model that utilizes phosphatidylethanol (PEth) to confirm abstinence is effective at reducing alcohol use during a 26-week intervention and 12-month follow-up. We will evaluate the impact of CM on alcohol-related outcomes, determine if Addiction Neuroclinical Assessment variables are associated with outcomes in follow-up, and whether savings related to decreased alcohol use offset intervention costs.</div></div><div><h3>Methods</h3><div>Adults with AUD residing in the United States will be recruited via online advertising. Research procedures will be conducted virtually. Participants who submit a PEth-positive blood sample (≥20 ng/mL) at enrollment will be randomized to 26 weeks of either 1) online cognitive behavior therapy (CBT4CBT) with rewards not contingent on PEth results (Control group) or 2) CBT4CBT with a maximum of $1,820 of rewards contingent on PEth results (CM group). Efficacy outcomes of PEth-negative tests (primary) and PEth-defined excessive drinking (≥200 ng/mL; secondary) will be assessed. Predictors of intervention outcomes and economic viability will also be investigated.</div></div><div><h3>Discussion</h3><div>If this telehealth-delivered PEth-based CM intervention reduces alcohol use and is cost-effective, it could be used to provide effective treatment to millions of individuals with AUD who do not receive in-person care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107807"},"PeriodicalIF":2.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001506","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}
Pub Date : 2025-01-15DOI: 10.1016/j.cct.2025.107808
Brooke T. Nezami , Carmina G. Valle , Heather M. Wasser , Lex Hurley , Karen E. Hatley , Deborah F. Tate
Background
Young adults (YAs) are underrepresented in behavioral health and weight loss interventions and express interest in flexible, highly tailored programs. Mobile interventions are a lower-burden, scalable approach to providing behavioral support. Just-in-time-adaptive interventions (JITAI) promise to deliver the “right” support at the “right” time using real-time data from smartphones and sensors. JITAIs hold promise for promoting behavior changes needed for weight loss (dietary intake, activity, and self-weighing); however, there is limited evidence for selecting treatment components and levels of adaptation that are needed for success.
Methods
The AGILE (Adaptive Goals and Interventions for Lifestyle Enhancement) trial utilizes the Multiphase Optimization Strategy (MOST) framework and a 25 full factorial experimental trial to test the efficacy of 5 intervention components, each with two levels, on weight loss among 608 YAs recruited from around the United States. All participants will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation leads to greater weight loss, we will test standard versus adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Assessments will occur at baseline, 3 months, and 6 months.
Conclusions
Results of this trial will be used to create an optimized JITAI for weight loss in young adults.
背景：年轻人（YAs）在行为健康和减肥干预方面的代表性不足，他们对灵活的、高度定制的方案感兴趣。移动干预是提供行为支持的负担较低、可扩展的方法。即时自适应干预（JITAI）承诺利用智能手机和传感器的实时数据，在“正确”的时间提供“正确”的支持。JITAIs有望促进减肥所需的行为改变（饮食摄入、活动和自我称重）；然而，关于选择成功所需的治疗成分和适应水平的证据有限。方法：AGILE （Adaptive Goals and Interventions for Lifestyle Enhancement）试验采用多阶段优化策略（MOST）框架和25项全因子试验，对来自美国各地的608名老年人进行了5项干预措施（每项干预措施有两个水平）的减肥效果测试。所有参与者都将接受为期6个月的核心减肥干预，包括循证课程、行为技能训练和每日称重。为了确定更大的适应性是否会导致更大的体重减轻，我们将测试5个额外干预组件的标准与适应性选项：1)饮食监测方法（标准与简化），2)适应性体育活动目标（每周与每天），3)信息时间的决策点（固定与自适应），4)信息内容的决策规则（标准与自适应），5)信息选择（否与是）。评估将在基线、3个 月和6个 月进行。结论：该试验的结果将用于创建用于年轻人减肥的优化JITAI。
{"title":"Optimizing a mobile just-in-time adaptive intervention (JITAI) for weight loss in young adults: Rationale and design of the AGILE factorial randomized trial","authors":"Brooke T. Nezami , Carmina G. Valle , Heather M. Wasser , Lex Hurley , Karen E. Hatley , Deborah F. Tate","doi":"10.1016/j.cct.2025.107808","DOIUrl":"10.1016/j.cct.2025.107808","url":null,"abstract":"<div><h3>Background</h3><div>Young adults (YAs) are underrepresented in behavioral health and weight loss interventions and express interest in flexible, highly tailored programs. Mobile interventions are a lower-burden, scalable approach to providing behavioral support. Just-in-time-adaptive interventions (JITAI) promise to deliver the “right” support at the “right” time using real-time data from smartphones and sensors. JITAIs hold promise for promoting behavior changes needed for weight loss (dietary intake, activity, and self-weighing); however, there is limited evidence for selecting treatment components and levels of adaptation that are needed for success.</div></div><div><h3>Methods</h3><div>The AGILE (Adaptive Goals and Interventions for Lifestyle Enhancement) trial utilizes the Multiphase Optimization Strategy (MOST) framework and a 2<sup>5</sup> full factorial experimental trial to test the efficacy of 5 intervention components, each with two levels, on weight loss among 608 YAs recruited from around the United States. All participants will receive a core 6-month weight loss intervention that includes evidence-based lessons, behavioral skills training, and daily weighing. With the goal of determining if greater adaptation leads to greater weight loss, we will test standard versus adaptive options of 5 additional intervention components: 1) diet monitoring approach (standard vs. simplified), 2) adaptive physical activity goals (weekly vs. daily), 3) decision points for message timing (fixed vs. adaptive), 4) decision rules for message content (standard vs. adaptive), and 5) message choice (no vs. yes). Assessments will occur at baseline, 3 months, and 6 months.</div></div><div><h3>Conclusions</h3><div>Results of this trial will be used to create an optimized JITAI for weight loss in young adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107808"},"PeriodicalIF":2.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001540","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}
Pub Date : 2025-01-12DOI: 10.1016/j.cct.2025.107810
Katarina Wang , Jeanette Wong , Leslie Avilez , Kristan Olazo , Samuel Olanrewaju , Charles E. McCulloch , Rena Pasick , Shreya Patel , Ma Somsouk , Urmimala Sarkar
Background
Fecal immunochemical testing (FIT) is a widely used first step for colorectal cancer (CRC) screening. Abnormal FIT results require a colonoscopy for screening completion and CRC diagnosis, but the rate of timely colonoscopy is low, especially among patients in safety-net settings. Multi-level factors at the clinic- and patient-levels influence colonoscopy completion after an abnormal FIT. Our study aims to implement a multi-level approach consisting of a clinic- and patient-level intervention to improve the completion of diagnostic colonoscopy after an abnormal FIT.
Methods
We will test a multilevel intervention with one safety-net system across 12 primary care clinics – a clinic-level intervention using a stepped wedge design and a patient-level intervention with patient-level randomization. At the clinic level, we will implement a “best practices bundle” to improve workflow for primary care providers and staff using a stepped-wedge design. At the patient level, we will randomize 2000 patients to receive text messages and call reminders or usual care.
Results
For the main analysis, we will use a mixed effects logistic model to assess the impact of the clinic intervention on the primary outcome (completion of colonoscopy within 180 days after abnormal FIT). Secondary outcomes include median days to colonoscopy completion, rate of referral to colonoscopy at 42 days, rate of scheduled colonoscopy at 56 days, and bowel preparation quality at colonoscopy.
Discussion
This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a safety-net setting.
Trial registration
NCT, NCT06191185. Registered 20 December 2023, https://clinicaltrials.gov/study/NCT06191185.
{"title":"Multilevel intervention for follow-up of abnormal FIT in the safety-net: IMProving Adherence to Colonoscopy through Teams and Technology (IMPACTT)","authors":"Katarina Wang , Jeanette Wong , Leslie Avilez , Kristan Olazo , Samuel Olanrewaju , Charles E. McCulloch , Rena Pasick , Shreya Patel , Ma Somsouk , Urmimala Sarkar","doi":"10.1016/j.cct.2025.107810","DOIUrl":"10.1016/j.cct.2025.107810","url":null,"abstract":"<div><h3>Background</h3><div>Fecal immunochemical testing (FIT) is a widely used first step for colorectal cancer (CRC) screening. Abnormal FIT results require a colonoscopy for screening completion and CRC diagnosis, but the rate of timely colonoscopy is low, especially among patients in safety-net settings. Multi-level factors at the clinic- and patient-levels influence colonoscopy completion after an abnormal FIT. Our study aims to implement a multi-level approach consisting of a clinic- and patient-level intervention to improve the completion of diagnostic colonoscopy after an abnormal FIT.</div></div><div><h3>Methods</h3><div>We will test a multilevel intervention with one safety-net system across 12 primary care clinics – a clinic-level intervention using a stepped wedge design and a patient-level intervention with patient-level randomization. At the clinic level, we will implement a “best practices bundle” to improve workflow for primary care providers and staff using a stepped-wedge design. At the patient level, we will randomize 2000 patients to receive text messages and call reminders or usual care.</div></div><div><h3>Results</h3><div>For the main analysis, we will use a mixed effects logistic model to assess the impact of the clinic intervention on the primary outcome (completion of colonoscopy within 180 days after abnormal FIT). Secondary outcomes include median days to colonoscopy completion, rate of referral to colonoscopy at 42 days, rate of scheduled colonoscopy at 56 days, and bowel preparation quality at colonoscopy.</div></div><div><h3>Discussion</h3><div>This study will assess the extent to which a multi-level intervention can improve timely colonoscopy completion in a diverse patient population cared for in a safety-net setting.</div></div><div><h3>Trial registration</h3><div>NCT, <span><span>NCT06191185</span><svg><path></path></svg></span>. Registered 20 December 2023, <span><span>https://clinicaltrials.gov/study/NCT06191185</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"150 ","pages":"Article 107810"},"PeriodicalIF":2.0,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982614","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}
Pub Date : 2025-01-11DOI: 10.1016/j.cct.2024.107802
Ligia Kiss , Agnese Iuliano , Ana Paula Portella , Heloína Paiva , Malini Pires , Baptiste Leurent
Background
Sexual exploitation of children and adolescents (SECA) is a mostly invisible phenomenon, having negative impacts on adolescents' health and well-being. There is increasing awarenessof preventative strategies to reduce sexual exploitation of children and adolescents, but limited evidence on their effectiveness and mechanisms. This project addresses this gap through the impact and process evaluation of ‘Growing Up Without Violence’ (GWV), the largest intervention in Brazil tackling SECA.
Methods
We will conduct a two-arm cluster randomised trial (CRT) with parallel assignment in the municipalities of Cabo de Santo Agostinho and Jaboatão dos Guararapes, in Brazil. We will randomly allocate 30 schools to intervention and 30 to wait-list control arms. In each of these schools, we will randomly select independent samples of fifty students (aged 12 to 17) to participate in baseline and endline surveys. We will invite students to self-complete pre-programmed questionnaires in a private school space, under the supervision of trained researchers. Our main analysis is a cross-sectional comparison between control and intervention schools of students' levels of basic knowledge for identifying appropriate and inappropriate sexual advances and acts (primary outcome). Secondary outcomes include knowledge of risks of online sexual exploitation, willingness to report incidents of sexual abuse and exploitation, and recall of exposure SECA preventive training content.
Discussion
To our knowledge, this is the first large-scale rigorous evaluation of an intervention to prevent SECA in Brazil. Findings will inform our strategies and future interventions to prevent SECA.
背景：对儿童和青少年的性剥削（SECA）是一种大多看不见的现象，对青少年的健康和福祉产生负面影响。人们日益认识到减少对儿童和青少年进行性剥削的预防性战略，但关于其有效性和机制的证据有限。该项目通过“无暴力成长”（GWV）的影响和过程评估来解决这一差距，GWV是巴西应对SECA的最大干预措施。方法：我们将在巴西的Cabo de Santo Agostinho市和jaboat o dos Guararapes市进行平行分配的双组随机试验（CRT）。我们将随机分配30所学校进行干预，30所学校进行轮候控制。在这些学校中，我们将随机选择70名学生（12至17岁）的独立样本参加基线和终点调查。我们将邀请学生在训练有素的研究人员的监督下，在私立学校空间自行完成预编程问卷。我们的主要分析是对照学校和干预学校之间学生识别适当和不适当的性行为和行为的基本知识水平的横断面比较（主要结果）。次要结果包括对网络性剥削风险的了解，报告性侵犯和性剥削事件的意愿，以及对暴露的SECA预防性培训内容的回忆。讨论：据我们所知，这是巴西首次对预防SECA的干预措施进行大规模严格评估。研究结果将为我们预防SECA的战略和未来干预提供信息。
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Pub Date : 2025-01-01DOI: 10.1016/S1551-7144(24)00376-8
{"title":"Thank you to our Reviewers in 2024","authors":"","doi":"10.1016/S1551-7144(24)00376-8","DOIUrl":"10.1016/S1551-7144(24)00376-8","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"148 ","pages":"Article 107793"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143145985","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}
Pub Date : 2025-01-01DOI: 10.1016/j.cct.2024.107774
Anna K. Jansson , Sam Beacroft , Mitch J. Duncan , Emily R. Cox , Sara L. Robards , Wendy Ferris , Alexis Hure , Shamasunder Acharya , Ronald C. Plotnikoff
Background
This paper outlines the protocol for the ecofit implementation-effectiveness trial, a multi-component mobile Health (mHealth) intervention that aims to increase resistance and aerobic physical activity in primary care-based adults with type 2 diabetes (T2D). This study will be conducted as part of the Diabetes Alliance Program Plus (DAP+), a large-scale integrated health service intervention in a large health district in Australia. The ecofit program has previously demonstrated efficacy and effectiveness in insufficiently active people with (or at risk of) T2D and community dwelling-adults, respectively. The aim of this study is to assess the reach (primary outcome), adoption, appropriateness, feasibility and fidelity of the implementation of ecofit and the overall effectiveness of the intervention.
Research design and methods
Prospective participants are adults diagnosed with T2D, who attend primary care settings enrolled in DAP+, and are identified and referred to ecofit by a primary care clinician. To support the implementation of ecofit a host of strategies will be utilised, which includes the education and upskilling of primary care clinicians enrolled in DAP+ using brief training sessions, the supply of an information package and access to professional development. The co-primary outcomes of reach will be defined as the number of participant registrations on the ecofit platform and the number of primary care clinicians who have been introduced to ecofit.
Conclusion
This study will evaluate the implementation of ecofit among adults with T2D within the primary care setting. The results may help improve T2D lifestyle interventions in primary care settings across Australia.
{"title":"Protocol for the implementation and referral of the ecofit physical activity intervention within Diabetes Alliance Program Plus among regional, rural and remote people with type 2 diabetes in a primary care setting","authors":"Anna K. Jansson , Sam Beacroft , Mitch J. Duncan , Emily R. Cox , Sara L. Robards , Wendy Ferris , Alexis Hure , Shamasunder Acharya , Ronald C. Plotnikoff","doi":"10.1016/j.cct.2024.107774","DOIUrl":"10.1016/j.cct.2024.107774","url":null,"abstract":"<div><h3>Background</h3><div>This paper outlines the protocol for the <em>ecofit</em> implementation-effectiveness trial, a multi-component mobile Health (mHealth) intervention that aims to increase resistance and aerobic physical activity in primary care-based adults with type 2 diabetes (T2D). This study will be conducted as part of the Diabetes Alliance Program Plus (DAP+), a large-scale integrated health service intervention in a large health district in Australia. The <em>ecofit</em> program has previously demonstrated efficacy and effectiveness in insufficiently active people with (or at risk of) T2D and community dwelling-adults, respectively. The aim of this study is to assess the reach (primary outcome), adoption, appropriateness, feasibility and fidelity of the implementation of <em>ecofit</em> and the overall effectiveness of the intervention.</div></div><div><h3>Research design and methods</h3><div>Prospective participants are adults diagnosed with T2D, who attend primary care settings enrolled in DAP+, and are identified and referred to <em>ecofit</em> by a primary care clinician. To support the implementation of <em>ecofit</em> a host of strategies will be utilised, which includes the education and upskilling of primary care clinicians enrolled in DAP+ using brief training sessions, the supply of an information package and access to professional development. The co-primary outcomes of reach will be defined as the number of participant registrations on the <em>ecofit</em> platform and the number of primary care clinicians who have been introduced to <em>ecofit</em>.</div></div><div><h3>Conclusion</h3><div>This study will evaluate the implementation of <em>ecofit</em> among adults with T2D within the primary care setting. The results may help improve T2D lifestyle interventions in primary care settings across Australia.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"148 ","pages":"Article 107774"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791198","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}
Pub Date : 2025-01-01DOI: 10.1016/j.cct.2024.107714
Kathleen F. Mittendorf , Harris T. Bland , Justin Andujar , Natasha Celaya-Cobbs , Clasherrol Edwards , Meredith Gerhart , Gillian Hooker , Mryia Hubert , Sarah H. Jones , Dana R. Marshall , Rachel A. Myers , Siddharth Pratap , S. Trent Rosenbloom , Azita Sadeghpour , R. Ryanne Wu , Lori A. Orlando , Georgia L. Wiesner
Background
Hereditary cancer syndromes cause a high lifetime risk of early, aggressive cancers. Early recognition of individuals at risk can allow risk-reducing interventions that improve morbidity and mortality. Family health history applications that gather data directly from patients could alleviate barriers to risk assessment in the clinical appointment, such as lack of provider knowledge of genetics guidelines and limited time in the clinical appointment. New approaches allow linking these applications to patient health portals and their electronic health records (EHRs), offering an end-to-end solution for patient-input family history information and risk result clinical decision support for their provider.
Methods
We describe the design of the first large-scale evaluation of an EHR-integrable, patient-facing family history software platform based on the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) standard. In our study, we leverage an established implementation science framework to evaluate the success of our model to facilitate scalable, systematic risk assessment for hereditary cancers in diverse clinical environments in a large pragmatic study at two sites. We will also evaluate the success of the approach to improve the efficiency of downstream genetic counseling resulting from pre-counseling pedigree generation.
Conclusions
Our research study will provide evidence regarding a new care delivery model that is scalable and sustainable for a variety of medical centers and clinics.
Trial registration
This study was registered on ClinicalTrials.gov under NCT05079334 on 15 October 2021.
{"title":"Family history and cancer risk study (FOREST): A clinical trial assessing electronic patient-directed family history input for identifying patients at risk of hereditary cancer","authors":"Kathleen F. Mittendorf , Harris T. Bland , Justin Andujar , Natasha Celaya-Cobbs , Clasherrol Edwards , Meredith Gerhart , Gillian Hooker , Mryia Hubert , Sarah H. Jones , Dana R. Marshall , Rachel A. Myers , Siddharth Pratap , S. Trent Rosenbloom , Azita Sadeghpour , R. Ryanne Wu , Lori A. Orlando , Georgia L. Wiesner","doi":"10.1016/j.cct.2024.107714","DOIUrl":"10.1016/j.cct.2024.107714","url":null,"abstract":"<div><h3>Background</h3><div>Hereditary cancer syndromes cause a high lifetime risk of early, aggressive cancers. Early recognition of individuals at risk can allow risk-reducing interventions that improve morbidity and mortality. Family health history applications that gather data directly from patients could alleviate barriers to risk assessment in the clinical appointment, such as lack of provider knowledge of genetics guidelines and limited time in the clinical appointment. New approaches allow linking these applications to patient health portals and their electronic health records (EHRs), offering an end-to-end solution for patient-input family history information and risk result clinical decision support for their provider.</div></div><div><h3>Methods</h3><div>We describe the design of the first large-scale evaluation of an EHR-integrable, patient-facing family history software platform based on the Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART on FHIR) standard. In our study, we leverage an established implementation science framework to evaluate the success of our model to facilitate scalable, systematic risk assessment for hereditary cancers in diverse clinical environments in a large pragmatic study at two sites. We will also evaluate the success of the approach to improve the efficiency of downstream genetic counseling resulting from pre-counseling pedigree generation.</div></div><div><h3>Conclusions</h3><div>Our research study will provide evidence regarding a new care delivery model that is scalable and sustainable for a variety of medical centers and clinics.</div></div><div><h3>Trial registration</h3><div>This study was registered on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> under <span><span>NCT05079334</span><svg><path></path></svg></span> on 15 October 2021.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"148 ","pages":"Article 107714"},"PeriodicalIF":2.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459890","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}
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