Fatigue affects up to 90 % of individuals with systemic lupus erythematosus (SLE), significantly impairing quality of life. Despite its impact, fatigue remains difficult to treat due to its multifactorial nature, including behavioral, psychosocial, and pain-related contributors. While physical activity interventions show promise in reducing SLE-related fatigue, they often fail to address these broader factors and are limited by accessibility challenges. Innovative, scalable solutions are needed to improve fatigue management in SLE.
Methods
The Restore Energy, Activity Can Help (REACH) study is an open-label randomized controlled trial to evaluate the feasibility and preliminary efficacy of the REACH peer coaching intervention delivered via mobile health (mHealth) technology compared to the REACH mHealth application (app)-only control arm. Trained peer coaches with lived SLE experience will use behavior change strategies to support participants through a 12-week structured program supported by the REACH app. Participants in the control arm will receive access to the REACH app without peer coaching. Feasibility outcomes include adherence, engagement, and acceptability, while preliminary efficacy will be assessed through fatigue reduction as measured by the Fatigue Severity Scale.
Discussion
This study will pilot test the feasibility and effectiveness of the REACH peer coaching intervention, a behavioral theory-based program leveraging mHealth technology to improve fatigue management in SLE. We hypothesize that the REACH program will be feasible and address the behavioral and psychosocial drivers of SLE-related fatigue. REACH may offer a scalable, patient-centered approach that can inform implementation of mHealth-supported peer coaching programs to improve quality of life in diverse populations.
Trial registration
Clinicaltrials.gov NCT06479213; Registered: June 28, 2024.
{"title":"Study protocol for a randomized controlled trial to pilot Restore Energy, Activity Can Help (REACH): an mHealth-enabled peer coaching intervention for fatigue in systemic lupus erythematosus","authors":"Nina Gulati , Kiran Singh , Erin Morrissey , Priscilla Calvache , Jillian Rose-Smith , Monique Gore-Massy , Faye Chiu , Ludovic Trinquart , Iris Navarro-Millan , Sara Folta , Shanthini Kasturi","doi":"10.1016/j.conctc.2025.101508","DOIUrl":"10.1016/j.conctc.2025.101508","url":null,"abstract":"<div><h3>Background</h3><div>Fatigue affects up to 90 % of individuals with systemic lupus erythematosus (SLE), significantly impairing quality of life. Despite its impact, fatigue remains difficult to treat due to its multifactorial nature, including behavioral, psychosocial, and pain-related contributors. While physical activity interventions show promise in reducing SLE-related fatigue, they often fail to address these broader factors and are limited by accessibility challenges. Innovative, scalable solutions are needed to improve fatigue management in SLE.</div></div><div><h3>Methods</h3><div>The Restore Energy, Activity Can Help (REACH) study is an open-label randomized controlled trial to evaluate the feasibility and preliminary efficacy of the REACH peer coaching intervention delivered via mobile health (mHealth) technology compared to the REACH mHealth application (app)-only control arm. Trained peer coaches with lived SLE experience will use behavior change strategies to support participants through a 12-week structured program supported by the REACH app. Participants in the control arm will receive access to the REACH app without peer coaching. Feasibility outcomes include adherence, engagement, and acceptability, while preliminary efficacy will be assessed through fatigue reduction as measured by the Fatigue Severity Scale.</div></div><div><h3>Discussion</h3><div>This study will pilot test the feasibility and effectiveness of the REACH peer coaching intervention, a behavioral theory-based program leveraging mHealth technology to improve fatigue management in SLE. We hypothesize that the REACH program will be feasible and address the behavioral and psychosocial drivers of SLE-related fatigue. REACH may offer a scalable, patient-centered approach that can inform implementation of mHealth-supported peer coaching programs to improve quality of life in diverse populations.</div></div><div><h3>Trial registration</h3><div>Clinicaltrials.gov <span><span>NCT06479213</span><svg><path></path></svg></span>; Registered: June 28, 2024.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101508"},"PeriodicalIF":1.4,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144242359","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}
Pub Date : 2025-06-06DOI: 10.1016/j.conctc.2025.101507
Stephen H.A. Hernandez , Jacqueline Killian , Mark B. Parshall , Tonya Y. White , Enesha J. Hicks , Victoria Hughes , Theresa A. Bedford , Yiliang Zhu
The purpose of this study is to examine the efficacy of the Stress Management and Resilience Training (SMART) in increasing the resilience of U.S. Air Force personnel. We aim to recruit up to 500 active component Air Force personnel and provide a two-arm randomization modality to make SMART more accessible and adaptive to the personnel's schedules. Two-arm randomization will be used to assign three sites for participants to choose in-person or computer-based training (CBT) and two sites where participants are randomized into their training type (in-person or CBT). The use of two-arm randomization will enable the examination of the difference between real-world settings within the framework of causal inference, as well as, differences based upon self-selection and a randomized control trial. We propose to examine the intervention effects at 12, 24 and 36-weeks post-intervention. Initial analysis will include descriptive statistics to characterize demographic status, military grade, duty location, and military occupation. The objectives of our analyses will include testing and estimating the intervention effects by comparing pre-post intervention changes in resilience, stress, anxiety, and QoL at each follow-up. Scores will also be pooled to test for overall intervention effects over time. Intervention effectiveness will be reported by comparing mean or median effects using 95 % confidence intervals and effect size estimates. An analysis of the longitudinal trend over the study period will be conducted by simultaneously examining data from all follow-ups using mixed-effects models in which random effects will be used to characterize between and within-subject variations.
{"title":"Increasing Resiliency in U.S. Air Force Personnel: A Multi-Site Trial Protocol","authors":"Stephen H.A. Hernandez , Jacqueline Killian , Mark B. Parshall , Tonya Y. White , Enesha J. Hicks , Victoria Hughes , Theresa A. Bedford , Yiliang Zhu","doi":"10.1016/j.conctc.2025.101507","DOIUrl":"10.1016/j.conctc.2025.101507","url":null,"abstract":"<div><div>The purpose of this study is to examine the efficacy of the Stress Management and Resilience Training (SMART) in increasing the resilience of U.S. Air Force personnel. We aim to recruit up to 500 active component Air Force personnel and provide a two-arm randomization modality to make SMART more accessible and adaptive to the personnel's schedules. Two-arm randomization will be used to assign three sites for participants to choose in-person or computer-based training (CBT) and two sites where participants are randomized into their training type (in-person or CBT). The use of two-arm randomization will enable the examination of the difference between real-world settings within the framework of causal inference, as well as, differences based upon self-selection and a randomized control trial. We propose to examine the intervention effects at 12, 24 and 36-weeks post-intervention. Initial analysis will include descriptive statistics to characterize demographic status, military grade, duty location, and military occupation. The objectives of our analyses will include testing and estimating the intervention effects by comparing pre-post intervention changes in resilience, stress, anxiety, and QoL at each follow-up. Scores will also be pooled to test for overall intervention effects over time. Intervention effectiveness will be reported by comparing mean or median effects using 95 % confidence intervals and effect size estimates. An analysis of the longitudinal trend over the study period will be conducted by simultaneously examining data from all follow-ups using mixed-effects models in which random effects will be used to characterize between and within-subject variations.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101507"},"PeriodicalIF":1.4,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144242765","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}
Pub Date : 2025-06-04DOI: 10.1016/j.conctc.2025.101503
William N. Kisinza , Subam Kathet , Victor Mwingira , Maija Meri , Frank S. Magogo , Veneranda M. Bwana , Hanna Granroth-Wilding , Pendael Machafuko , Patrick Tungu , Mikko Aalto , Tomi Hakala , Markku Honkala , Seppo Meri , Ayman Khattab
Background
The rise of insecticide resistance in malaria vectors has highlighted the urgent need for alternative vector control methods that do not rely on insecticides. The 3D-Screen, an innovative window screen featuring 3D conical structures integrated into a mesh, offers a promising solution. When installed as a double-screen setup (3D-Window Double Screen, or 3D-WDS) in window openings, its unidirectional design allows mosquitoes to enter the space between the screens from either the outside or inside of the living area, effectively trapping them within the enclosure. Previous laboratory and experimental hut studies have demonstrated the high efficacy of 3D-WDS in capturing host-seeking mosquitoes. This study aims to evaluate the epidemiological, entomological, and social impacts of implementing 3D-Screens in community settings.
Methods/design
A two-arm, cluster-randomised controlled trial (cRCT) was conducted to assess whether houses equipped with both 3D-WDS and long-lasting insecticidal nets (LLINs) provide enhanced protection against malaria compared to LLINs alone. Twenty hamlets across 17 villages in Muheza, Tanzania, were evaluated for malaria prevalence, vector densities, entomological inoculation rates, and insecticide resistance levels. Fourteen hamlets with similar epidemiological and entomological profiles were then randomised: seven were assigned to the intervention group (3D-WDS + LLINs), and seven served as the control group (LLINs alone). Epidemiological and entomological surveillance were conducted at 10-week intervals over a 52-week follow-up period. Ancillary social science studies were conducted to assess community perceptions of the 3D-WDS intervention, focusing on acceptability and factors influencing its sustainability. Statistical analyses will use mixed-effects models to compare the impact of 3D-WDS combined with LLINs versus LLINs alone.
Discussion
The 3D-WDS has the potential to reduce malaria transmission by providing a non-insecticidal, sustainable approach to mosquito control. Findings from this trial will demonstrate its real-world effectiveness and contribute to the development of scalable, long-term strategies for malaria prevention.
Trial registration
ISRCTN Registry, ISRCTN87169034.
Trial status
The study was initiated in June 2019, recruitment and sampling were completed in June 2021, sample analyses, and statistical evaluations are ongoing.
{"title":"Assessing the efficacy of 3D window double screens (3D-WDS) in reducing malaria transmission in northeastern Tanzania: Study protocol for a two-arm cluster-randomised controlled trial","authors":"William N. Kisinza , Subam Kathet , Victor Mwingira , Maija Meri , Frank S. Magogo , Veneranda M. Bwana , Hanna Granroth-Wilding , Pendael Machafuko , Patrick Tungu , Mikko Aalto , Tomi Hakala , Markku Honkala , Seppo Meri , Ayman Khattab","doi":"10.1016/j.conctc.2025.101503","DOIUrl":"10.1016/j.conctc.2025.101503","url":null,"abstract":"<div><h3>Background</h3><div>The rise of insecticide resistance in malaria vectors has highlighted the urgent need for alternative vector control methods that do not rely on insecticides. The 3D-Screen, an innovative window screen featuring 3D conical structures integrated into a mesh, offers a promising solution. When installed as a double-screen setup (3D-Window Double Screen, or 3D-WDS) in window openings, its unidirectional design allows mosquitoes to enter the space between the screens from either the outside or inside of the living area, effectively trapping them within the enclosure. Previous laboratory and experimental hut studies have demonstrated the high efficacy of 3D-WDS in capturing host-seeking mosquitoes. This study aims to evaluate the epidemiological, entomological, and social impacts of implementing 3D-Screens in community settings.</div></div><div><h3>Methods/design</h3><div>A two-arm, cluster-randomised controlled trial (cRCT) was conducted to assess whether houses equipped with both 3D-WDS and long-lasting insecticidal nets (LLINs) provide enhanced protection against malaria compared to LLINs alone. Twenty hamlets across 17 villages in Muheza, Tanzania, were evaluated for malaria prevalence, vector densities, entomological inoculation rates, and insecticide resistance levels. Fourteen hamlets with similar epidemiological and entomological profiles were then randomised: seven were assigned to the intervention group (3D-WDS + LLINs), and seven served as the control group (LLINs alone). Epidemiological and entomological surveillance were conducted at 10-week intervals over a 52-week follow-up period. Ancillary social science studies were conducted to assess community perceptions of the 3D-WDS intervention, focusing on acceptability and factors influencing its sustainability. Statistical analyses will use mixed-effects models to compare the impact of 3D-WDS combined with LLINs versus LLINs alone.</div></div><div><h3>Discussion</h3><div>The 3D-WDS has the potential to reduce malaria transmission by providing a non-insecticidal, sustainable approach to mosquito control. Findings from this trial will demonstrate its real-world effectiveness and contribute to the development of scalable, long-term strategies for malaria prevention.</div></div><div><h3>Trial registration</h3><div>ISRCTN Registry, <span><span>ISRCTN87169034</span><svg><path></path></svg></span>.</div></div><div><h3>Trial status</h3><div>The study was initiated in June 2019, recruitment and sampling were completed in June 2021, sample analyses, and statistical evaluations are ongoing.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101503"},"PeriodicalIF":1.4,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144242358","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}
Pub Date : 2025-06-04DOI: 10.1016/j.conctc.2025.101499
Joshua Miller , Jordan Cuby , Sharon M. Hall , Maxine Stitzer , Margot Kushel , Donna Appiah , Maya Vijayaraghavan
{"title":"Corrigendum to “Tobacco use behaviors and views on engaging in clinical trials for tobacco cessation among individuals who experience homelessness” [Contemporary Clinic. Trials Commun. 32 (2023) 101094]","authors":"Joshua Miller , Jordan Cuby , Sharon M. Hall , Maxine Stitzer , Margot Kushel , Donna Appiah , Maya Vijayaraghavan","doi":"10.1016/j.conctc.2025.101499","DOIUrl":"10.1016/j.conctc.2025.101499","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101499"},"PeriodicalIF":1.4,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144678978","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}
Pub Date : 2025-06-01DOI: 10.1016/j.conctc.2025.101490
Rahel Pearson , Paul J. Rathouz , Corina Mendoza , Emma Harris , Allison Metts , Kathryn Roe , Justin Benzer , Casey Taft , Suzannah K. Creech
{"title":"Corrigendum to “Protocol for a randomized clinical trial of strength at home parents: A trauma informed parenting intervention for veterans” [Contempor. Clin. Trials Commun. 41 (2024) 101363]","authors":"Rahel Pearson , Paul J. Rathouz , Corina Mendoza , Emma Harris , Allison Metts , Kathryn Roe , Justin Benzer , Casey Taft , Suzannah K. Creech","doi":"10.1016/j.conctc.2025.101490","DOIUrl":"10.1016/j.conctc.2025.101490","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101490"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221046","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}
Pub Date : 2025-05-27DOI: 10.1016/j.conctc.2025.101500
Laura J. Caccavale , Randi Streisand , Jessica Gokee LaRose , Edmond P. Wickham III , Marisa E. Hilliard , Laura M. Thornton , Melanie K. Bean
Background
A striking 83 % of adolescents and young adults (AYA) with type 1 diabetes (T1D) have glycemic outcomes outside the target range, placing them at risk for acute and chronic complications. Identification of evidence-based strategies to enhance T1D management in AYAs, prior to the transition from pediatric to adult healthcare, is needed to optimize AYA health and adequately prepare them for independence. We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation intervention for AYAs with T1D.
Methods
Participants will be 50 AYAs with T1D (age 16–22 years) and their parent/caregiver, and 10 pediatric endocrinology practitioners. All practitioners will receive video education about their role in preparing AYAs for transition and strategies for communication with AYAs. Families will be randomized to either: 1) SHIFT, a 6-month multisystem transition preparation program, or 2) enhanced treatment as usual (TAU+). SHIFT includes evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and practitioner communication. Parents in SHIFT receive psychoeducation and training in developmentally-appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. TAU + includes usual care plus patient education matched to the intervention contact schedule. Assessments of hemoglobin A1c, transition readiness, and diabetes self-management behaviors will occur at 0 (baseline), 6 (post; primary endpoint), and 9 and 12 (follow-ups) months.
Conclusion
Findings regarding intervention preliminary efficacy will be the foundation of future fully-powered trials on healthcare transition for AYAs with T1D.
{"title":"A clinic-based healthcare transition preparation program for adolescents and young adults with type 1 diabetes: Study protocol for the SHIFT randomized clinical trial","authors":"Laura J. Caccavale , Randi Streisand , Jessica Gokee LaRose , Edmond P. Wickham III , Marisa E. Hilliard , Laura M. Thornton , Melanie K. Bean","doi":"10.1016/j.conctc.2025.101500","DOIUrl":"10.1016/j.conctc.2025.101500","url":null,"abstract":"<div><h3>Background</h3><div>A striking 83 % of adolescents and young adults (AYA) with type 1 diabetes (T1D) have glycemic outcomes outside the target range, placing them at risk for acute and chronic complications. Identification of evidence-based strategies to enhance T1D management in AYAs, prior to the transition from pediatric to adult healthcare, is needed to optimize AYA health and adequately prepare them for independence. We present the design of Supporting Health Improvement for Transition in T1D (SHIFT), a randomized clinical trial of a clinic-based transition preparation intervention for AYAs with T1D.</div></div><div><h3>Methods</h3><div>Participants will be 50 AYAs with T1D (age 16–22 years) and their parent/caregiver, and 10 pediatric endocrinology practitioners. All practitioners will receive video education about their role in preparing AYAs for transition and strategies for communication with AYAs. Families will be randomized to either: 1) SHIFT, a 6-month multisystem transition preparation program, or 2) enhanced treatment as usual (TAU+). SHIFT includes evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and practitioner communication. Parents in SHIFT receive psychoeducation and training in developmentally-appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. TAU + includes usual care plus patient education matched to the intervention contact schedule. Assessments of hemoglobin A1c, transition readiness, and diabetes self-management behaviors will occur at 0 (baseline), 6 (post; primary endpoint), and 9 and 12 (follow-ups) months.</div></div><div><h3>Conclusion</h3><div>Findings regarding intervention preliminary efficacy will be the foundation of future fully-powered trials on healthcare transition for AYAs with T1D.</div></div><div><h3>Trial registration</h3><div>NCT05639088.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101500"},"PeriodicalIF":1.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144222563","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}
Pub Date : 2025-05-24DOI: 10.1016/j.conctc.2025.101498
Kyongeun Shin , Sungpil Han , Hyerim Choe , Suein Choi , Seunghoon Han
Background
The writing of clinical trial protocols that conform to relevant guidelines is a labor- and time-intensive endeavor. An automated clinical trial protocol template generation system for healthy volunteer trials and a web-based schedule of activities (SoA) generator were developed in this study.
Materials and methods
R Markdown was applied as the primary template development tool to automate the creation of a clinical trial protocol template that adheres to the International Council for Harmonization (ICH) M11 guidelines by enabling the adjustment of dynamic variables and facilitating the standardized presentation of relevant data using associated R packages. To ensure broader compatibility, the template was also tested using Quarto, which produced identical outputs with slight modifications to the YAML header. Additionally, a web-based SoA generator (developed with React.js) was created, featuring user-friendly functions for flexible start day adjustments, trial parameter settings, and automatic annotations.
Results
The R Markdown script removed most manual effort in creating healthy volunteer protocol templates, thereby increasing both accuracy and productivity. The system also supports Quarto with minor modifications, providing an alternative for users preferring its framework. The web-based SoA generator also demonstrated significant advantages over conventional methods, as it reduced human errors and required less time compared to manually generating SoAs in Word documents.
Conclusions
This study introduces a novel automated protocol template generation process using R Markdown as the primary tool, with Quarto compatibility confirmed, and a web-based SoA generator designed specifically for healthy volunteer trials. By improving the efficiency and accuracy of clinical trial document preparation, these tools have the potential to advance the drug development process.
{"title":"Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials","authors":"Kyongeun Shin , Sungpil Han , Hyerim Choe , Suein Choi , Seunghoon Han","doi":"10.1016/j.conctc.2025.101498","DOIUrl":"10.1016/j.conctc.2025.101498","url":null,"abstract":"<div><h3>Background</h3><div>The writing of clinical trial protocols that conform to relevant guidelines is a labor- and time-intensive endeavor. An automated clinical trial protocol template generation system for healthy volunteer trials and a web-based schedule of activities (SoA) generator were developed in this study.</div></div><div><h3>Materials and methods</h3><div><em>R Markdown</em> was applied as the primary template development tool to automate the creation of a clinical trial protocol template that adheres to the International Council for Harmonization (ICH) M11 guidelines by enabling the adjustment of dynamic variables and facilitating the standardized presentation of relevant data using associated R packages. To ensure broader compatibility, the template was also tested using <em>Quarto</em>, which produced identical outputs with slight modifications to the YAML header. Additionally, a web-based SoA generator (developed with <em>React.js</em>) was created, featuring user-friendly functions for flexible start day adjustments, trial parameter settings, and automatic annotations.</div></div><div><h3>Results</h3><div>The <em>R Markdown</em> script removed most manual effort in creating healthy volunteer protocol templates, thereby increasing both accuracy and productivity. The system also supports <em>Quarto</em> with minor modifications, providing an alternative for users preferring its framework. The web-based SoA generator also demonstrated significant advantages over conventional methods, as it reduced human errors and required less time compared to manually generating SoAs in Word documents.</div></div><div><h3>Conclusions</h3><div>This study introduces a novel automated protocol template generation process using <em>R Markdown</em> as the primary tool, with <em>Quarto</em> compatibility confirmed, and a web-based SoA generator designed specifically for healthy volunteer trials. By improving the efficiency and accuracy of clinical trial document preparation, these tools have the potential to advance the drug development process.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101498"},"PeriodicalIF":1.4,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144195394","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}
Pub Date : 2025-05-23DOI: 10.1016/j.conctc.2025.101495
Lindsey M. Rodriguez , Cynthia D. Mohr , Katherine Nameth , Eric Pedersen , Karen Chan Osilla
Concerned partners (CPs) play a crucial role in encouraging their loved ones to moderate or seek help for their drinking but are not always equipped with the strategies to approach these conversations effectively. This research comprises three phases: First, we will conduct a dyadic ecological momentary assessment (EMA) study to establish common communication patterns associated with drinking and non-drinking behaviors. Findings from this study will be used to develop a web-based intervention (WBI) prototype, which will be used in a qualitative study with CPs assessing the WBI's feasibility and acceptability. We will evaluate the efficacy of the WBI compared to usual care on CP well-being (e.g., depression, anxiety, social support), the drinking partner's drinking, and relationship functioning via a pilot RCT. All procedures occur remotely. In Phase 1, 50 CPs and their partners (who misuse alcohol via the AUDIT-C) will be recruited from social media and participate in a dyadic EMA study, completing a baseline and follow-up survey and three daily EMA reports for 21 days. In Phase 2, we will develop the WBI and conduct qualitative interviews with 15 CPs. In Phase 3, we will recruit 80 dyads for a pilot RCT and a follow-up one-month post-intervention. Equipping CPs to effectively communicate with their loved ones around drinking may be an important catalyst for decreasing their partner's harmful drinking. The potential reach of this intervention is large such that it can be easily implemented over the web to those who may need help but would otherwise not seek care.
{"title":"Using ecological momentary data to inform a web-based intervention for romantic partners concerned about their loved ones’ drinking: Study protocol","authors":"Lindsey M. Rodriguez , Cynthia D. Mohr , Katherine Nameth , Eric Pedersen , Karen Chan Osilla","doi":"10.1016/j.conctc.2025.101495","DOIUrl":"10.1016/j.conctc.2025.101495","url":null,"abstract":"<div><div>Concerned partners (CPs) play a crucial role in encouraging their loved ones to moderate or seek help for their drinking but are not always equipped with the strategies to approach these conversations effectively. This research comprises three phases: First, we will conduct a dyadic ecological momentary assessment (EMA) study to establish common communication patterns associated with drinking and non-drinking behaviors. Findings from this study will be used to develop a web-based intervention (WBI) prototype, which will be used in a qualitative study with CPs assessing the WBI's feasibility and acceptability. We will evaluate the efficacy of the WBI compared to usual care on CP well-being (e.g., depression, anxiety, social support), the drinking partner's drinking, and relationship functioning via a pilot RCT. All procedures occur remotely. In Phase 1, 50 CPs and their partners (who misuse alcohol via the AUDIT-C) will be recruited from social media and participate in a dyadic EMA study, completing a baseline and follow-up survey and three daily EMA reports for 21 days. In Phase 2, we will develop the WBI and conduct qualitative interviews with 15 CPs. In Phase 3, we will recruit 80 dyads for a pilot RCT and a follow-up one-month post-intervention. Equipping CPs to effectively communicate with their loved ones around drinking may be an important catalyst for decreasing their partner's harmful drinking. The potential reach of this intervention is large such that it can be easily implemented over the web to those who may need help but would otherwise not seek care.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101495"},"PeriodicalIF":1.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144502380","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}
Pub Date : 2025-05-22DOI: 10.1016/j.conctc.2025.101497
Lina Feng , Sizhen Chen , Jiang Liu , Chunyan Li , Hongshuai Cao , Liyuan Tao , Fang Fang , Feijiao Huo , Lingling Liu , Palidan Wubu'er , Ming Wang , Xiaohua Zhao , Xiaojian Liu , Hui Xin , Ding Li , Weisheng Mao , Liang Gui , Jianfei Guan , Zhiyang Zhu , Haijun Song , Jingyi Ren
Background
Although contemporary guideline-directed medical therapy (GDMT) for heart failure (HF) with reduced ejection fraction (HFrEF) and heart failure with mildly-reduced ejection fraction (HFmrEF) has been shown to significantly improve prognosis, patients with these conditions still face considerable residual risk, and their quality of life (QoL) remains severely compromised. ShengXian-QuYu (SXQY) Decoction is a widely prescribed complementary and alternative medicine (CAM) therapy for HF in clinical practice. However, there is currently no robust evidence supporting its efficacy in HFrEF and HFmrEF, and its potential adverse effects have yet to be fully elucidated.
Methods
Patients with chronic HF, New York Heart Association (NYHA) class II–IV symptoms, elevated plasma natriuretic peptide levels, and a left ventricular ejection fraction (LVEF) of ≤50 % were enrolled in the ShengXian-QuYu Decoction in the Treatment of Heart Failure with Reduced and mildly reduced Ejection Fraction (SHINE-HF) trial. Patients eligibility entered a run-in period, followed by randomization in a 1:1 ratio to double-blind treatment with either 30 ml of SXQY or 30 ml of placebo, administered twice daily. The primary endpoint was the change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at week 12. Key secondary endpoints included the change from baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) and the 6-min walk test (6MWT) distance at week 12. Additionally, a safety analysis will be conducted.
Conclusion
SHINE-HF will determine the effects of SXQY on patient-reported outcomes (PROs) and symptom burden in patients with HFrEF and HFmrEF. This will shed light on the potential of SXQY as a novel treatment option in improving QoL of patients with HFrEF and HFmrEF.
{"title":"SHengXIaN-QuYu DEcoction in the Treatment of Heart Failure with Reduced and Mildly-Reduced Ejection Fraction (SHINE-HF): rationale and design for a multicenter randomized controlled trial","authors":"Lina Feng , Sizhen Chen , Jiang Liu , Chunyan Li , Hongshuai Cao , Liyuan Tao , Fang Fang , Feijiao Huo , Lingling Liu , Palidan Wubu'er , Ming Wang , Xiaohua Zhao , Xiaojian Liu , Hui Xin , Ding Li , Weisheng Mao , Liang Gui , Jianfei Guan , Zhiyang Zhu , Haijun Song , Jingyi Ren","doi":"10.1016/j.conctc.2025.101497","DOIUrl":"10.1016/j.conctc.2025.101497","url":null,"abstract":"<div><h3>Background</h3><div>Although contemporary guideline-directed medical therapy (GDMT) for heart failure (HF) with reduced ejection fraction (HFrEF) and heart failure with mildly-reduced ejection fraction (HFmrEF) has been shown to significantly improve prognosis, patients with these conditions still face considerable residual risk, and their quality of life (QoL) remains severely compromised. ShengXian-QuYu (SXQY) Decoction is a widely prescribed complementary and alternative medicine (CAM) therapy for HF in clinical practice. However, there is currently no robust evidence supporting its efficacy in HFrEF and HFmrEF, and its potential adverse effects have yet to be fully elucidated.</div></div><div><h3>Methods</h3><div>Patients with chronic HF, New York Heart Association (NYHA) class II–IV symptoms, elevated plasma natriuretic peptide levels, and a left ventricular ejection fraction (LVEF) of ≤50 % were enrolled in the ShengXian-QuYu Decoction in the Treatment of Heart Failure with Reduced and mildly reduced Ejection Fraction (SHINE-HF) trial. Patients eligibility entered a run-in period, followed by randomization in a 1:1 ratio to double-blind treatment with either 30 ml of SXQY or 30 ml of placebo, administered twice daily. The primary endpoint was the change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at week 12. Key secondary endpoints included the change from baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) and the 6-min walk test (6MWT) distance at week 12. Additionally, a safety analysis will be conducted.</div></div><div><h3>Conclusion</h3><div>SHINE-HF will determine the effects of SXQY on patient-reported outcomes (PROs) and symptom burden in patients with HFrEF and HFmrEF. This will shed light on the potential of SXQY as a novel treatment option in improving QoL of patients with HFrEF and HFmrEF.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101497"},"PeriodicalIF":1.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144134446","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}
Pub Date : 2025-05-17DOI: 10.1016/j.conctc.2025.101496
Jorge Diaz , Allex Fonseca , Lixin Yan , Dongfang Liu , Liangzhi Xie
Background/Objective
The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19.: This study was a randomized, double-blinded, placebo-controlled Phase II trial conducted to evaluate the efficacy of neutralizing monoclonal antibody (SCTA01) in high-risk outpatients diagnosed with COVID-19.
Methods
The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29.
Results
109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction (p = 0.20) or symptom score reduction (p = 0.37) between the SCTA01 total and placebo groups. Additionally, the incidence of adverse events was comparable between the SCTA01 group (23.8 %) and the placebo group (24.0 %). Notably, no treatment-related serious adverse events (SAEs) were reported.
Conclusions
There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated.
CLINICAL TRIAL
The trial was registered at ClinicalTrial.gov (NCT04709328).
{"title":"Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial","authors":"Jorge Diaz , Allex Fonseca , Lixin Yan , Dongfang Liu , Liangzhi Xie","doi":"10.1016/j.conctc.2025.101496","DOIUrl":"10.1016/j.conctc.2025.101496","url":null,"abstract":"<div><h3>Background/Objective</h3><div>The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19.<strong>:</strong> This study was a randomized, double-blinded, placebo-controlled Phase II trial conducted to evaluate the efficacy of neutralizing monoclonal antibody (SCTA01) in high-risk outpatients diagnosed with COVID-19.</div></div><div><h3>Methods</h3><div>The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29.</div></div><div><h3>Results</h3><div>109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction (<em>p</em> = 0.20) or symptom score reduction (<em>p</em> = 0.37) between the SCTA01 total and placebo groups. Additionally, the incidence of adverse events was comparable between the SCTA01 group (23.8 %) and the placebo group (24.0 %). Notably, no treatment-related serious adverse events (SAEs) were reported.</div></div><div><h3>Conclusions</h3><div>There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated.</div></div><div><h3>CLINICAL TRIAL</h3><div>The trial was registered at ClinicalTrial.gov (NCT04709328).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101496"},"PeriodicalIF":1.4,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144167475","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}
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