Contemporary clinical trials最新文献

{"title":"Protocol for a multisite, parallel-group, randomized clinical trial comparing a brief tele-cognitive behavioral therapy intervention (BRIGHT) with attention control for the reduction of body image-related distress among head and neck cancer survivors","authors":"Evan M. Graboyes ,&nbsp;Stacey N. Maurer ,&nbsp;Emily Kistner-Griffin ,&nbsp;Kent Armeson ,&nbsp;Ella Starr ,&nbsp;Taylor McLeod ,&nbsp;Wendy E. Balliet ,&nbsp;Jacquelyn Doenges ,&nbsp;Olga Slavin-Spenny ,&nbsp;Jessica R. Vanderlan ,&nbsp;Andrew Day ,&nbsp;Patrik Pipkorn ,&nbsp;Sidharth V. Puram ,&nbsp;Samantha H. Tam ,&nbsp;Kenneth J. Ruggiero ,&nbsp;Katherine R. Sterba","doi":"10.1016/j.cct.2025.107888","DOIUrl":"10.1016/j.cct.2025.107888","url":null,"abstract":"<div><div>One in four head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a devastating psychosocial morbidity that adversely affects quality of life. To date, effective interventions for these patients are lacking. BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief cognitive behavioral treatment (CBT), has shown potential efficacy as a novel treatment paradigm for HNC survivors with BID. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that BRIGHT improves BID among HNC survivors relative to an Attention Control (AC) intervention. In this multisite RCT, <em>N</em> = 180 HNC survivors with BID will be randomized 1:1 to six weeks of BRIGHT or AC of dose and delivery-matched survivorship education. Outcomes are assessed at baseline and 2, 3, 6, and 9-months post-randomization. The primary endpoint is the IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE–Head and Neck) score, a validated patient-reported outcome of HNC-related BID. Secondary endpoints include the HN Shame and Stigma Scale, the PROMIS SF v1.0-Depression 8a, Anxiety 8a, and Ability to Participate in Social Activities 8a, the Beck Scale for Suicidal Ideation, and the EORTC QLQ-HN35 Trouble with Social Eating and Trouble with Social Contact subscales. The trial will also evaluate whether the effect of BRIGHT on BID is mediated through improvements in automatic thinking and body image coping strategies. Findings from this multisite RCT will provide a rigorous test of the efficacy of BRIGHT as the first evidence-based strategy to manage BID among HNC survivors.</div></div><div><h3>Trial registration ID</h3><div><span><span>NCT05442957</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107888"},"PeriodicalIF":2.0,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143725097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Restricted mean survival time based on Wu-Kolassa estimator compared to Kaplan-Meier estimator","authors":"Yaoshi Wu ,&nbsp;John Kolassa ,&nbsp;Ning Dong","doi":"10.1016/j.cct.2025.107877","DOIUrl":"10.1016/j.cct.2025.107877","url":null,"abstract":"<div><h3>Objective</h3><div>The purpose of the paper is to introduce the Wu-Kolassa estimator (WKE) and the RMST based on it for its less biased estimation and substantial power gain, compared to the Kaplan-Meier estimator (KME), to researchers working in medical and health sciences to evaluate and compare patient survival times.</div></div><div><h3>Results</h3><div>The seven numerical studies showed that the power gain in WKE-based RMST analysis can reach more than 80 %, depending on the size of the study and the trend of failure rate. For the phase III study of iniparib plus gemcitabine and carboplatin (GCI) versus gemcitabine and carboplatin (GC) in patients with metastatic triple-negative breast cancer, GCI is superior to GC demonstrated by WKE-based RMST analysis (point estimate of treatment difference in RMST = 0.807; 95 % CI: 0.0214 to 1.592, 1.5 times higher than the estimate based on KME = 0.542; 95 % CI: −0.385 to 1.470). For the phase III trial that studied ovarian suppression (os) with tamoxifen or exemestane, tamoxifen plus os is superior to tamoxifen alone using WKE-based RMST (point estimate of difference = 0.228; 95 % CI: 0.016 to 0.439, more than 2-fold higher than the estimated difference based on KME = 0.113; 95 % CI: −0.008 to 0.234).</div></div><div><h3>Conclusions</h3><div>The Wu-Kolassa estimator is superior to the Kaplan-Meier estimator as it reduces the estimation bias and increases the power in the RMST analysis when the censoring rate is high or when the reference group has more censoring data than the test group.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107877"},"PeriodicalIF":2.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143680513","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":"An adaptive imputation method of missing data for sparsely retrieved dropouts in treatment policy strategy","authors":"Chuanji Yuan ,&nbsp;Zhenyu Yang ,&nbsp;Jiaqing Liu ,&nbsp;Xiaozhou Li ,&nbsp;Bokai Chen ,&nbsp;Tao Han ,&nbsp;Qian Yu ,&nbsp;Zuojing Li","doi":"10.1016/j.cct.2025.107886","DOIUrl":"10.1016/j.cct.2025.107886","url":null,"abstract":"<div><div>The ICH E9 R1 Addendum suggests using a treatment-policy strategy as an approach to handle intercurrent events for estimating de facto estimand. Under this strategy, regardless of the occurrence of intercurrent events, the value for the variable of interest is analyzed. After discontinuing treatment, participants who remain in the trial to complete the assessment of the primary endpoints are referred to as retrieved dropouts, while early withdrawal by participants results in missing data. To mitigate the effects of missing data, strategies like mixed model for repeated measures or the retrieved dropout multiple imputation method are used. The bias of retrieved dropout methods is relatively small. However, if retrieved dropouts are scarce, it could significantly inflate variance.</div><div>This article introduces an innovative adaptive model that refines the On/Off Intercepts with Common Slopes using Residuals (RD_OICSR) model, which is a model within the retrieved dropout methods, and evaluates it using simulated data from a depression trial. The findings indicate that when the proportion of retrieved dropouts falls below the predetermined threshold set by researchers, our method minimizes unrealistic variance inflation by incorporating data from placebo completers. Conversely, the model adaptively matches the RD_OICSR model. This ensures that irrespective of the retrieved dropouts' proportions, the analysis remains accurate.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107886"},"PeriodicalIF":2.0,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691386","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 study protocol to engage religious leaders to reduce blood pressure in Tanzanian communities: A cluster randomized trial","authors":"Bazil Kavishe ,&nbsp;Megan Willkens ,&nbsp;Agrey H. Mwakisole ,&nbsp;Fredrick Kalokola ,&nbsp;Elialilia Okello ,&nbsp;Philip Ayieko ,&nbsp;Edmund Kisanga ,&nbsp;Myung Hee Lee ,&nbsp;Saidi Kapiga ,&nbsp;Jennifer A. Downs ,&nbsp;Robert Peck","doi":"10.1016/j.cct.2025.107884","DOIUrl":"10.1016/j.cct.2025.107884","url":null,"abstract":"<div><h3>Background</h3><div>Most people with hypertension in Sub-Saharan Africa are unaware of their status. Low perceived need for hypertension screening, low trust in biomedical health care, unhealthy norms for diet and exercise, and prioritization of spiritual over physical health are key barriers to blood pressure (BP) control in Tanzanian communities. We seek to determine whether engaging religious leaders to screen for hypertension and educate communities on cardiovascular health can lead to a sustained community BP reduction.</div></div><div><h3>Methods</h3><div>This trial aims to determine the efficacy of an intervention that engages religious leaders to reduce BP in Tanzanian communities. After refinement of the intervention following pilot testing, a hybrid type I randomized control trial will be conducted across 20 rural communities (10 intervention and 10 control communities). The intervention will consist of educational sessions for religious leaders, equipping them to provide community cardiovascular health teachings, and BP screening organized jointly by religious leaders and health care workers. We will measure the reduction in mean community BP and changes in hypertension awareness and treatment, diet, physical activity, body mass index, and waist circumference after one year. Key elements that contribute to the intervention's implementation and effectiveness to strengthen its adoption and broader use during and after the intervention up to 24 months will be evaluated.</div></div><div><h3>Discussion</h3><div>Community-level barriers to BP control inhibit awareness and treatment of hypertension in Tanzania. Through innovative partnerships with trusted religious leaders, we seek to study an intervention with the potential to reduce BP and improve overall community health.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107884"},"PeriodicalIF":2.0,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673514","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":"Corrigendum to “Intervention to reduce barriers to type 1 diabetes self-management: Diabetes Journey study design and participant characteristics” [Contemporary Clinical Trials 152 (2025) 107849].","authors":"Kimberly A. Driscoll ,&nbsp;Paige J. Trojanowski ,&nbsp;Desirée N. Williford ,&nbsp;Holly K. O'Donnell ,&nbsp;Erin Flynn ,&nbsp;Constance A. Mara ,&nbsp;Sara E. Wetter ,&nbsp;Alexandra C. Himelhoch ,&nbsp;Hannah Manis ,&nbsp;Alicia Pardon ,&nbsp;Cheyenne M. Reynolds ,&nbsp;Emily R. Shaffer ,&nbsp;Bailey Tanner ,&nbsp;Jessica Kichler ,&nbsp;Laura Smith ,&nbsp;Sarah Westen ,&nbsp;Anastasia Albanese-O'Neill ,&nbsp;Sarah D. Corathers ,&nbsp;Laura M. Jacobsen ,&nbsp;Amy Poetker ,&nbsp;Avani C. Modi","doi":"10.1016/j.cct.2025.107880","DOIUrl":"10.1016/j.cct.2025.107880","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107880"},"PeriodicalIF":2.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656285","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":"Structural innovation for hypoglycemia prevention in high-risk patients with type 2 diabetes: Design and implementation of a pragmatic, randomized, quality improvement trial","authors":"Minnie W. Chen ,&nbsp;Melissa M. Parker ,&nbsp;Andrew J. Karter ,&nbsp;Richard W. Grant ,&nbsp;Lisa K. Gilliam","doi":"10.1016/j.cct.2025.107885","DOIUrl":"10.1016/j.cct.2025.107885","url":null,"abstract":"<div><div>Severe hypoglycemia is a potentially life-threatening complication of diabetes treatment, associated with increased risks of falls, cardiovascular events, cognitive decline, and mortality. This critical public health concern remains inadequately recognized and addressed in many clinical settings. Here we describe the development of a clinical guideline and associated protocol for a quality improvement randomized trial for hypoglycemia prevention, embedded within an integrated healthcare system. First, we engaged expert clinical stakeholders and experienced guideline developers to create an evidence-based hypoglycemia prevention algorithm, “<strong>Hypoglycemia on a Page” (HOAP</strong>), which was published internally as a healthcare system guideline. After system-wide, passive dissemination of HOAP, a pragmatic, quality improvement, randomized trial was implemented to study the benefit of a proactive, HOAP protocol-driven outreach by a clinical pharmacist targeting hypoglycemia-prone patients with T2D (Intervention Arm) compared to usual care (Usual Care Arm). As the primary outcome, we will assess whether patients in the Intervention Arm are prescribed safer (less hypoglycemia-prone) diabetes regimens compared to the Usual Care Arm. We hypothesize that the proactive, protocol-driven outreach will result in safer diabetes regimens compared to HOAP dissemination alone. Secondary outcomes of interest include prescribing of glucagon (for rapid treatment of severe hypoglycemia episodes), prescribing and dispensing of continuous glucose monitoring (CGM), documenting hypoglycemia on the problem list, glycemic control (HbA1c &lt;8 %), and ED visit or hospital admission for hypoglycemia. This pragmatic clinical trial will evaluate a structural innovation that included care strategies designed to reduce harm, improve patient outcomes and reduce healthcare resource utilization and cost.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107885"},"PeriodicalIF":2.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662922","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":"Pirfenidone to prevent fibrosis in acute respiratory distress syndrome: The PIONEER study protocol","authors":"Giacomo Monti ,&nbsp;Matteo Marzaroli ,&nbsp;Maria Teresa Tucciariello ,&nbsp;Brian Ferrara ,&nbsp;Francesco Meroi ,&nbsp;Cristina Nakhnoukh ,&nbsp;Massimo Zambon ,&nbsp;Giovanni Borghi ,&nbsp;Fabio Guarracino ,&nbsp;Marco Manazza ,&nbsp;Valentina Ajello ,&nbsp;Alessandro Belletti ,&nbsp;Cesare Biuzzi ,&nbsp;Valentina Plumari ,&nbsp;Matteo Filippini ,&nbsp;Raffaele Cuffaro ,&nbsp;Gabriele Racanelli ,&nbsp;Domenico Pontillo ,&nbsp;Simon Rauch ,&nbsp;Federico Mattia Oliva ,&nbsp;Luca Cabrini","doi":"10.1016/j.cct.2025.107883","DOIUrl":"10.1016/j.cct.2025.107883","url":null,"abstract":"<div><h3>Background</h3><div>Pulmonary fibrosis is a major complication of the Acute Respiratory Distress Syndrome (ARDS). Pirfenidone is an approved treatment for idiopathic pulmonary fibrosis. It may attenuate ARDS-related fibrosis and decrease the need for prolonged ventilation. Accordingly, we aimed to evaluate the effect of pirfenidone on ventilator-free days in patients with ARDS.</div></div><div><h3>Methods</h3><div>In a multi-center, randomized, double-blind, placebo-controlled trial, we plan to randomly assign 130 adults invasively ventilated for ARDS to receive pirfenidone or placebo for up to 28 days. The primary outcome is days alive and ventilator free at 28 days. Secondary outcomes include ICU-free days, hospital free days all at 28 day, ICU mortality and hospital mortality. We will also assess fibroproliferative changes on high-resolution CT scans at ICU discharge and quality of life. Data analysis will be on an intention-to-treat basis.</div></div><div><h3>Discussion</h3><div>The trial is ongoing and currently recruiting. It will be the first randomized controlled study to investigate whether, compared to placebo, pirfenidone increases the number of days alive and ventilator-free in patients with ARDS. Its double-blind multicenter design will provide internal validity, minimal bias, and a degree of external validity. If our hypothesis is confirmed, this treatment would justify larger trials of this intervention.</div><div>Trial registration: This trial was registered on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> with the trial identification <span><span>NCT05075161</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107883"},"PeriodicalIF":2.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639481","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":"Improving maternal postpartum access to care through telemedicine (IMPACT): A multi-center randomized controlled trial of postpartum interventions to improve access and outcomes","authors":"Ran Zhang ,&nbsp;Sheree L. Boulet ,&nbsp;David B. Nelson ,&nbsp;Peggy Goedken ,&nbsp;Jacqueline Catchings ,&nbsp;Donald McIntire ,&nbsp;Marissa Platner ,&nbsp;Robert B. Martin ,&nbsp;Catherine Y. Spong ,&nbsp;Elaine L. Duryea","doi":"10.1016/j.cct.2025.107882","DOIUrl":"10.1016/j.cct.2025.107882","url":null,"abstract":"<div><h3>Background</h3><div>Postpartum care is essential for maternal health and significantly impacts long-term health outcomes, yet it remains inadequately addressed, particularly among Non-Hispanic Black and Hispanic individuals. The primary objective of the Improving Maternal Postpartum Access to Care through Telemedicine (IMPACT) study is to compare the effectiveness of two postpartum care models on early postpartum complication detection, hospital readmission prevention, postpartum health knowledge, quality of life, and chronic medical condition management among medically underserved individuals.</div></div><div><h3>Method</h3><div>The IMPACT study is a multi-center, randomized controlled trial conducted at Parkland Hospital in Dallas, Texas, and Grady Memorial Hospital in Atlanta, Georgia. It aims to compare two postpartum care models (intensive education vs. enhanced virtual care) among 3500 Non-Hispanic Black and Hispanic postpartum individuals of lower socioeconomic status. Phase I (year 1) involves collecting baseline data and refining the study based on patient feedback. Phase II (year 2–4) continues recruiting participants and assigns them to each model randomly. Data collection spans a one-year follow-up period (1 week, 6 weeks, 3 months, 6 months, and 1 year after enrollment), including maternal health outcomes, mental health assessments, laboratory tests, and patient-reported measures.</div></div><div><h3>Conclusion</h3><div>The IMPACT study provides an innovative approach to postpartum care, utilizing telemedicine to enhance access and education for underserved populations. The study findings will have significant implications for healthcare providers and policymakers, offering evidence-based guidance for optimizing postpartum care delivery and informing clinical guidelines that can help reduce maternal health disparities.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107882"},"PeriodicalIF":2.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639477","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":"Comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals: Statistical analysis plan for a cluster-randomised controlled trial","authors":"Gabor Mihala ,&nbsp;Ruth Eleanor Hubbard ,&nbsp;Benignus Logan ,&nbsp;David Wayne Johnson ,&nbsp;Andrea Katharina Viecelli ,&nbsp;Andrew Benjamin Forbes","doi":"10.1016/j.cct.2025.107881","DOIUrl":"10.1016/j.cct.2025.107881","url":null,"abstract":"<div><h3>Background</h3><div>Frailty is highly prevalent in older people with chronic kidney disease (CKD) and associated with more complex healthcare needs. As part of person-centred care, healthcare planning should be tailored to the individual's needs and their desired outcomes. Comprehensive Geriatric Assessment (CGA) is an intervention which can help facilitate this by identifying a person's medical, functional, and psychosocial problems, and then tailoring a coordinated, targeted management plan. The GOAL trial was designed to establish whether, compared to usual care, a CGA would better enable a person to achieve their own set goals, as measured by Goal Attainment Scaling (GAS). This paper presents the statistical analysis plan (SAP) for the GOAL trial.</div></div><div><h3>Methods</h3><div>The GOAL trial is a pragmatic, multi-centre, superiority, open-label, cluster-randomised controlled trial designed to enrol 500 frail, older people (Frailty Index &gt;0.25, aged ≥65 or ≥ 55 years if First Nations people) with moderate to severe CKD (estimated glomerular filtration rate &lt; 59 mL/min/1.73m²) across 16 hospital sites in Australia, and 12 months of follow-up. The primary question (effect of CGA on GAS at 3 months) will be modelled using mixed-effects linear regression. The SAP details the analysis and reporting methods.</div></div><div><h3>Conclusions</h3><div>The SAP described here resulted from an iterative, collaborative effort among statisticians and clinician leads of the GOAL trial. Specification of statistical methods prior to trial completion will contribute to unbiased analyses of the collected data.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04538157</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107881"},"PeriodicalIF":2.0,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Championing hypertension remote monitoring for equity and dissemination (CHARMED): A multi-site factorial randomized controlled trial protocol","authors":"Courtney R. Lyles ,&nbsp;Elaine C. Khoong ,&nbsp;Rachel J. Stern ,&nbsp;Nooshin Abtahi ,&nbsp;Anjana E. Sharma ,&nbsp;Mark J. Pletcher ,&nbsp;Fan Xia ,&nbsp;Faviola Garcia ,&nbsp;Nilpa D. Shah ,&nbsp;Lina Tieu ,&nbsp;Urmimala Sarkar ,&nbsp;the CHARMED consortium","doi":"10.1016/j.cct.2025.107879","DOIUrl":"10.1016/j.cct.2025.107879","url":null,"abstract":"<div><h3>Introduction</h3><div>We have evidence-based strategies such as remote patient monitoring and digital health tools to improve hypertension outcomes. Still, we lack large-scale studies focusing on disseminating these practices into routine clinical care. This is especially important to study within safety-net healthcare settings that disproportionately care for marginalized patient populations.</div></div><div><h3>Methods</h3><div>We will conduct a hybrid type 1 implementation trial (2 × 2 factorial design) with 25 safety-net clinics across three of California's public healthcare delivery systems, enrolling 2500 English- and Spanish-speaking patients with uncontrolled hypertension. Clinics will be randomized to receive baseline training on best practices in remote monitoring for hypertension management vs. training plus ongoing practice facilitation to support its implementation. Patients within these clinics will be randomized to receive cellular-enabled blood pressure monitors and automatic text message reminders to check their blood pressure at home vs. receipt of the same monitors as well as additional support via individually tailored text message feedback and support for hypertension management.</div></div><div><h3>Results</h3><div>The primary outcome will be a change in systolic blood pressure collected during routine office visits. Secondary outcomes include changes in home blood pressure and patient-reported assessments of clinical care and medication adherence. Given the hybrid type I trial implementation, the primary implementation outcomes will be the adoption of intervention at the patient and clinic levels.</div></div><div><h3>Discussion</h3><div>The evidence from this trial will advance implementation-focused research on hypertension management, such as the essential combination of both patient- and clinic-facing intervention strategies.</div></div><div><h3>Trial Registration</h3><div>NCT, <span><span>NCT06113458</span><svg><path></path></svg></span>. Registered 23 October 2023, <span><span>https://clinicaltrials.gov/study/NCT06113458</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107879"},"PeriodicalIF":2.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630036","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}