Contemporary Clinical Trials Communications最新文献

{"title":"Efficacy of an evidence-based telehealth-delivered weight-loss intervention to expand reach and enhance access to underserved groups after stroke","authors":"Evan Elizabeth McShan ,&nbsp;Shahad Alrawi ,&nbsp;Stephanie Calhoun ,&nbsp;Taylor Gilliland ,&nbsp;Monica Bennett ,&nbsp;Rosemary Dubiel ,&nbsp;Simon Driver","doi":"10.1016/j.conctc.2025.101458","DOIUrl":"10.1016/j.conctc.2025.101458","url":null,"abstract":"<div><div>Obesity is a risk factor for stroke, and survivors of stroke have a high rate of obesity and greater burden of obesity-related chronic conditions (e.g., heart disease, hypertension, re-occurring stroke) compared to the general population. Despite the health disparity, there is a lack of evidence-based weight-loss interventions tailored to individuals post stroke, as most health promotion programs exclude this population. Our team's work modifying and examining the efficacy of a modified version of the Diabetes Prevention Program Group Lifestyle Balance for people post stroke (GLB-CVA) is promising with results from an in-person randomized controlled trial (RCT) showing significant weight-loss (10.1 ± 16.8 lbs. [4.88 %]) and improvements in waist circumference, diastolic blood pressure, pain, social participation, eating practices, and health habits at 12-months post intervention. To expand the reach and accessibility of the GLB-CVA intervention, we will complete a RCT to assess the efficacy of telehealth delivery by enrolling 94 participants post stroke over a 3-year period. Results may provide an evidence-based, scalable telehealth weight-loss program designed for people post stroke that clinicians and community workers can use to increase accessibility to underserved groups.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101458"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing the impact of foot and hand reflexology on anxiety and physiological indices in colonoscopy candidates: A randomized clinical trial","authors":"Mohamad Golitaleb ,&nbsp;Ali Safdari ,&nbsp;Fatemeh Rafiei ,&nbsp;Ameneh Yaghoobzadeh ,&nbsp;Najmeh Mohamadi ,&nbsp;Razieh Mokhtari","doi":"10.1016/j.conctc.2025.101449","DOIUrl":"10.1016/j.conctc.2025.101449","url":null,"abstract":"<div><h3>Introduction and objective</h3><div>Colonoscopy is a standard diagnostic procedure, yet pre-procedural anxiety remains a prevalent concern. While pharmacological interventions are available, non-pharmacological approaches such as reflexology offer a promising alternative. Despite its therapeutic potential, comparative evidence on foot and hand reflexology in this setting is limited. This study aimed to evaluate their effects on pre-colonoscopy anxiety and physiological parameters.</div></div><div><h3>Methods</h3><div>This randomized clinical study was conducted from November 2022 to August 2023 at the Amir al-Momenin Educational and Therapeutic Center in Arak, Iran. A total of 105 patients were randomly assigned to three equal-sized groups (n = 35) using block randomization: foot reflexology, hand reflexology, and a control group. Patients in the intervention groups received a 30-min reflexology session. Anxiety levels were assessed using the Spielberger State-Trait Anxiety Inventory (STAI-Y1), a validated tool for measuring situational anxiety. Physiological indices, including systolic and diastolic blood pressure, heart rate, and arterial oxygen saturation (SpO2), were measured immediately before and after the intervention.</div></div><div><h3>Results</h3><div>There were no significant differences in clinical outcomes among the groups at baseline (p &gt; 0.05). However, following the intervention, the mean anxiety scores in both reflexology groups (foot reflexology: 44.39 ± 5.21; hand reflexology: 45.6 ± 4.49) were significantly lower than that of the control group (48.05 ± 4.81) (p = 0.008), as determined by one-way analysis of variance (ANOVA). The anxiety reduction was more pronounced in the foot reflexology group than the hand reflexology group, although this difference did not reach statistical significance (p &gt; 0.05). Additionally, post-intervention assessments revealed significant differences in systolic blood pressure (foot reflexology: 123.48 ± 16.40 mmHg; hand reflexology: 122.65 ± 14.97 mmHg; control group: 132.14 ± 18.48 mmHg) and heart rate (foot reflexology: 78.60 ± 9.54 bpm; hand reflexology: 78.25 ± 11.41 bpm; control group: 85.05 ± 10.82 bpm) across the groups (p &lt; 0.05). However, no significant differences were observed for diastolic blood pressure or arterial oxygen saturation (SPO2) between groups (p &gt; 0.05).</div></div><div><h3>Conclusion</h3><div>The findings of this study indicate that reflexology, particularly foot reflexology, can significantly reduce anxiety and lead to improvements in physiological parameters, such as systolic blood pressure and heart rate, in patients undergoing colonoscopy. These results highlight the potential of reflexology as an effective complementary method for managing anxiety and enhancing patient comfort during medical procedures.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101449"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the dissemination of evidence-based practices in substance use treatment: A cluster-randomized clinical trial of Colombo Plan's Innovative professional training model","authors":"Alvaro Vergés ,&nbsp;Rodrigo Portilla Huidobro ,&nbsp;Marta Oliva ,&nbsp;Víctor Landa","doi":"10.1016/j.conctc.2025.101452","DOIUrl":"10.1016/j.conctc.2025.101452","url":null,"abstract":"<div><div>The training of professionals who work in the treatment of substance use disorders is a fundamental aspect for the dissemination of evidence-based practices that ensure the quality of the treatment delivered to patients. Colombo Plan has developed a training model that allows effective, rapid, and scalable dissemination. However, this model does not have an empirical evaluation of its results to date. This project seeks to evaluate the dissemination model through a cluster-randomized clinical trial with a parallel superiority design, in which 27 treatment centers will be randomly assigned to training + action plan and technical advice, training only, or control without training, action plan or advice. The results of this study will inform public policy regarding substance use treatment at the national level and will help improve efforts by Colombo Plan at dissemination of evidence-based practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101452"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143480004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of a parent-based treatment for children and adolescents with obsessive-compulsive disorder: Protocol of a multiple baseline, single-case experimental design study","authors":"Julia D.K. Veeger ,&nbsp;Luuk Stapersma ,&nbsp;Eli R. Lebowitz ,&nbsp;Bonne Zijlstra ,&nbsp;Ramón Lindauer ,&nbsp;Elisabeth M.W.J. Utens ,&nbsp;Chaim Huijser","doi":"10.1016/j.conctc.2025.101456","DOIUrl":"10.1016/j.conctc.2025.101456","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric obsessive-compulsive disorder (OCD) is a severely impairing disorder, associated with high levels of family accommodation (FA). Approximately 40 % of youth do not benefit from first-line treatment options (cognitive behavioral therapy or pharmacotherapy). Supportive Parenting for Anxious Childhood Emotions (SPACE) is a parent-based treatment, teaching parents to reduce FA and increase supportive parenting, thereby aiming to improve the child's OCD. This article presents the protocol of a multiple baseline single-case experimental design (SCED) study to test the efficacy of SPACE in reducing OCD severity and FA in youth with OCD.</div></div><div><h3>Methods</h3><div>This SCED consists of a baseline, treatment, and follow-up phase. In total 25 youth (7–18 years) with OCD, who previously received cognitive behavioral therapy (CBT) unsuccessfully, aborted treatment early, or were not able to receive CBT due to too high levels of OCD/anxiety, and their parents will be included. They will be randomly allocated to one of three baseline phase options (4, 6 or 8 weeks). The treatment phase consists of 12 weekly sessions of SPACE with parents. Throughout all phases, OCD severity and FA will be briefly assessed thrice a week. Standard clinical measurements assessing OCD severity and FA and secondary parameters will be conducted at six timepoints, till 6 months follow-up.</div></div><div><h3>Conclusion</h3><div>Combining the innovative SPACE treatment with a SCED provides detailed insight into the relationship between OCD and FA over time. Studying this in clinical practice in complex cases that are normally understudied, helps to improve more personalized care for youth with OCD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101456"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A photo-narrative intervention protocol for clinicians and parents of children with severe neurological impairment in the PICU","authors":"Jori Bogetz ,&nbsp;Elsa Ayala ,&nbsp;Jordan Anderson ,&nbsp;Liz Morris ,&nbsp;Krysta S. Barton ,&nbsp;Miranda C. Bradford ,&nbsp;Chuan Zhou ,&nbsp;Joyce Yi-Frazier ,&nbsp;R. Scott Watson ,&nbsp;Abby R. Rosenberg","doi":"10.1016/j.conctc.2025.101455","DOIUrl":"10.1016/j.conctc.2025.101455","url":null,"abstract":"<div><h3>Background</h3><div>Children with severe neurological impairment (SNI) have central nervous system conditions that result in medical complexity and lifelong caregiver assistance. When children with SNI are admitted to the pediatric intensive care unit (PICU), their parents/families may experience elevated stress due to poor communication with clinicians.</div></div><div><h3>Methods</h3><div>To address this, we created a photo-narrative intervention designed to facilitate parent-clinician communication. The intervention asks parents/families to share 3 photos with captions that inform clinicians about their child's well-being and quality-of-life. The steps include: 1) learning about photo-narratives; 2) deciding on a story; 3) selecting photos; and 4) identifying the broader context. Clinicians receive a companion guide on how to use the photo-narrative. In this pilot randomized controlled trial, N = 40 parent/family caregivers of children with SNI and their child's PICU clinicians will be randomized to receive the photo-narrative intervention or usual care. Participants will complete study surveys at enrollment and the child's PICU discharge; intervention-arm participants will also complete semi-structured interviews at discharge. The primary aim is to describe: 1) feasibility, assessed by the recruitment (approached/enrolled) and completion (intervention completion/intervention-arm) rates; and 2) acceptability (recommend the intervention/intervention-arm). We also will evaluate proof of concept by comparing changes in parent self-reported stress, perceptions of therapeutic alliance, and effects on stigma, resilience, benefit-finding, and respect as well as clinician self-reported empathy and perspective-taking.</div></div><div><h3>Discussion</h3><div>This study will evaluate the feasibility and acceptability of a novel photo-narrative intervention designed to improve caregiver stress and communication. Findings will guide the development of future multisite studies.</div></div><div><h3>Clinical trial registration</h3><div>NCT06208332.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101455"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adapting MOVED as a web-based moral elevation intervention for veterans with PTSD: Using feedback from a pilot trial and subject matter experts","authors":"Adam P. McGuire ,&nbsp;Alexander Riera ,&nbsp;Xrystyan Lascano","doi":"10.1016/j.conctc.2025.101445","DOIUrl":"10.1016/j.conctc.2025.101445","url":null,"abstract":"<div><h3>Background</h3><div>Alternative, easily accessible treatment options are needed to aid efforts to address the negative effects of PTSD among veterans. One approach that has shown promise in a pilot trial is a moral elevation-based intervention titled, MOVED. Qualitative feedback from veterans in the pilot trial identified several strengths, but also highlighted opportunities to improve the intervention. In this adaptation phase, we incorporated feedback from pilot participants with input from subject matter experts (SMEs) to inform adaptation decisions using the Model for Adaptation Design and Impact (MADI) framework. In this paper, we outline the process and final adaptations decisions in preparation for a future efficacy trial to assess the impact of MOVED on targeted outcomes for veterans with PTSD.</div></div><div><h3>Method</h3><div>We identified 10 SMEs that included veterans, clinicians, and researchers who participated in workgroup meetings to review 17 identified issues from the pilot and potential adaptations to address those concerns. We used the MADI framework to guide workgroup meeting discussions to determine what changes should be incorporated, including identifying potential negative outcomes for any adaptations and if they can be mitigated with other actions.</div></div><div><h3>Results</h3><div>SMEs agreed with proposed adaptations for 15 of 17 issues and proposed mitigating measures for four of those adaptations to avoid anticipated negative outcomes. Two proposed solutions were refuted and not selected for adaptation.</div></div><div><h3>Conclusions</h3><div>Using the MADI framework with input from SMEs allowed us to make informed decisions about adaptations for MOVED, thus contributing to further treatment development in preparation for a future efficacy trial.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101445"},"PeriodicalIF":1.4,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143378966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"UNIPDES - An internet-based transdiagnostic intervention for college students’ psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol","authors":"Ömer Özer ,&nbsp;Gizem Öztemür ,&nbsp;Ali Ercan Altinöz ,&nbsp;Burak Köksal ,&nbsp;Uğur Doğan ,&nbsp;Sedat Batmaz ,&nbsp;Recep Gür ,&nbsp;Ahmet Altinok","doi":"10.1016/j.conctc.2025.101443","DOIUrl":"10.1016/j.conctc.2025.101443","url":null,"abstract":"<div><div>University students often face significant mental health challenges, including depression, anxiety, and difficulties in adjustment, which can be exaggerated by the demands of independent living and increased life responsibilities. These challenges are often compounded by barriers to seeking help, such as stigma and limited access to university resources, which can further deteriorate students' well-being. This protocol was created to assist college students in overcoming these obstacles and to assess, in comparison to a control group, the impact of a guided and unguided online intervention platform based on transdiagnostic CBT (UNIPDES) on depression, anxiety, and adjustment levels. The calculated sample size for the study will include 330 students, and the participants will be selected from five different universities located in Türkiye. Participants will be randomly assigned to either guided, unguided, or control groups. Guided and unguided group participants will receive six weeks of intervention, and the waitlist control group will receive the unguided version of the program after twelve weeks of randomization. Assessments will take place at baseline, post-test (8 weeks post-baseline) and follow-up (12 weeks post-baseline). A Mixed ANOVA will be employed to analyze the data, with Group (Guided, Unguided, Control) as the between-subjects factor and Time (Baseline, Post-Test, Follow-Up) as the within-subjects factor, as well as to assess the interaction effect between Group and Time on the primary outcomes—changes in depression, anxiety, and adjustment levels. Additionally, students’ reasons for dropout will be assessed qualitatively. The results from this study can build evidence for the effectiveness of transdiagnostic guided and unguided internet-based intervention for treating depression, anxiety, and adjustment problems of students. UNIPDES can provide a flexible, easy-to-access, and cost-effective treatment for the problems that students commonly face. Trial registration is registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Protocol Registration and Results System (Trial number: NCT06245200).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101443"},"PeriodicalIF":1.4,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform","authors":"Alexia Exarchos ,&nbsp;Ariel B. Bourla ,&nbsp;Maneet Kaur ,&nbsp;Katja Schulze ,&nbsp;Sophia Maund ,&nbsp;Yi Cao ,&nbsp;Yihua Zhao ,&nbsp;Elizabeth H. Williams ,&nbsp;Sarah C. Gaffey ,&nbsp;Richard Zuniga ,&nbsp;Shaily Lakhanpal ,&nbsp;Vladan Antic ,&nbsp;Michelle Doral ,&nbsp;Johanna Sy ,&nbsp;Neal J. Meropol ,&nbsp;Anne C. Chiang","doi":"10.1016/j.conctc.2025.101446","DOIUrl":"10.1016/j.conctc.2025.101446","url":null,"abstract":"<div><h3>Background</h3><div>Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing.</div></div><div><h3>Methods</h3><div>Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling.</div></div><div><h3>Results</h3><div>Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants.</div></div><div><h3>Conclusion</h3><div>A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101446"},"PeriodicalIF":1.4,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143378967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ten years of Women's Wellness research: Key lessons from conducting randomised controlled trials of a whole-of-lifestyle behavioural intervention","authors":"Sarah M. Balaam ,&nbsp;Alexandra L. McCarthy ,&nbsp;Natalie K. Vear ,&nbsp;Mackenzie J. Petie ,&nbsp;Debra J. Anderson ,&nbsp;Janine P. Porter-Steele","doi":"10.1016/j.conctc.2025.101441","DOIUrl":"10.1016/j.conctc.2025.101441","url":null,"abstract":"<div><div>Many women are diagnosed with breast cancer and while the survival of this cohort has improved, their likelihood of developing treatment-related chronic conditions is considerable. Over the last 10 years, our research group has developed and refined a whole-of-lifestyle intervention, the Women's Wellness after Cancer Program (WWACP), for women who have finished treatment for primarily breast and gynaecological cancers. Culturally-specific iterations of this program were recently completed with younger breast cancer survivors (aged &lt;50 years) living in Australia, New Zealand/Aotearoa and Hong Kong.</div><div>Over the last decade, various approaches have been used to trial the WWACP, mostly randomised controlled trials. While this methodology is considered the gold standard to determine efficacy in health and medical research, its limitations in our interventional research are apparent. In this opinion article, we discuss these limitations as well as alternative options for the appropriate testing of behavioural studies in women treated for cancer. We also discuss how the contribution of informed consumer advocates and participant consumers has influenced changes to our study designs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101441"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rationale and design for Healthy Hearts in Manufacturing (HHM): A pragmatic single-arm hybrid effectiveness-implementation study for hypertension management and tobacco cessation","authors":"Hanzi Jiang ,&nbsp;Yao Tian ,&nbsp;Jennifer Bannon ,&nbsp;Amy E. Krefman ,&nbsp;Lawrence C. An ,&nbsp;Dustin D. French ,&nbsp;Claude R. Maechling ,&nbsp;Jane Holl ,&nbsp;Richard Chagnon ,&nbsp;Theresa L. Walunas ,&nbsp;Christopher Burch ,&nbsp;Anthony Musci ,&nbsp;Darce Latsis ,&nbsp;Dawn Carey ,&nbsp;Megan McHugh","doi":"10.1016/j.conctc.2025.101444","DOIUrl":"10.1016/j.conctc.2025.101444","url":null,"abstract":"<div><h3>Background</h3><div>Heart disease is the leading cause of mortality in the United States and contributes more than $320 billion annually in health care costs and lost productivity. Manufacturing employment is associated with higher rates of hypertension and smoking. Many large manufacturers provide health services to employees and their family members through worksite health centers (WHCs). Several quality improvement interventions for hypertension and tobacco cessation have shown to be effective in community-based primary care sites. The Healthy Hearts in Manufacturing (HHM) study aims to implement and test these interventions in WHCs.</div></div><div><h3>Methods</h3><div>Two organizations that operate WHCs at manufacturing sites volunteered to participate in the 58-month HHM research study. The HHM intervention involves monthly coaching to assist WHCs with implementing evidence-based strategies for hypertension management and tobacco cessation advocated by the Million Hearts initiative and the U.S. Preventive Services Task Force. A pragmatic, Type II hybrid effectiveness-implementation study design is used to evaluate HHM. The approach is inspired by the stepped-wedge cluster-randomized trial to assess intervention effectiveness. We will conduct interviews to identify facilitators and barriers to implementation and budget impact analysis to estimate the financial impact of the HMM interventions and the potential healthcare savings to companies and Medicare.</div></div><div><h3>Results</h3><div>Twelve WHCs were randomly selected to enroll in HHM. The WHCs are in nine states and provide primary care services for employees and family members of four manufacturing companies. Baseline patient smoking rates ranged from 13 % to 59 % across WHCs. The percentage of patients with blood pressure of 140/90 or greater ranged from 7 % to 56 % across WHCs.</div></div><div><h3>Conclusion</h3><div>This exploratory five-year research study will identify facilitators and barriers to implementing the HHM interventions in WHCs, evaluate the effectiveness of hypertension management and use of tobacco screening and cessation, and provide evidence of HHM's potential cost-effectiveness for employers and Medicare.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101444"},"PeriodicalIF":1.4,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143350705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}