Contemporary clinical trials最新文献

{"title":"Design and implementation of data collection and linkage of electronic health records in a large UK cluster-randomised trial of asthma management (ARRISA-UK)","authors":"Polly-Anna Ashford ,&nbsp;Stanley Musgrave ,&nbsp;Allan B. Clark ,&nbsp;Susan Stirling ,&nbsp;Martin Pond ,&nbsp;David Price ,&nbsp;Francis Appiagyei ,&nbsp;Estelle Payerne ,&nbsp;Jane R. Smith ,&nbsp;Michael Noble ,&nbsp;Andrew M. Wilson","doi":"10.1016/j.cct.2026.108242","DOIUrl":"10.1016/j.cct.2026.108242","url":null,"abstract":"<div><div>Electronic health record data holds great potential for conducting large, efficient randomised controlled trials. Despite progress towards greater availability of linked NHS datasets, the use of routine clinical data remains challenging for trialists. In this paper we describe the design, adaptations and implementation of methods for data collection and linkage in ARRISA-UK: a cluster-randomised controlled trial of a complex asthma management intervention involving 275 primary care practices across England, Wales and Scotland.</div><div>Our methods were designed to build a dataset of linked primary care and secondary care data for approximately 10,000 ‘at-risk’ asthma patients to measure the trial's primary outcome (asthma crisis events comprising respiratory-related hospital admissions, emergency department attendances and/or death for ‘at-risk’ asthma patients) and secondary clinical outcomes including the impact of the intervention on ∼180,000 asthma patients at participating practices.</div><div>A high level of practice attrition (33%) was observed due to data extraction delays and technical barriers, patient identification errors, and concerns about the processing of patient identifiable data for the purpose of record linkage. We highlight the technical achievements, barriers and lessons learned from ARRISA-UK and propose recommendations to facilitate future data-enabled trials, including greater resourcing in recognition of their complex nature, improved systems of support and training in primary care, and the need to maintain and improve clinician and public trust in research data use for long term sustainability.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108242"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146036459","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":"Efficacy of a transdiagnostic guided internet-delivered intervention for anxiety, depression, trauma and stress-related symptoms: A randomized controlled trial","authors":"Anabel de la Rosa Gómez ,&nbsp;Pablo D. Valencia ,&nbsp;Dulce M. Díaz Sosa ,&nbsp;Lorena Alejandra Flores Plata ,&nbsp;Raquel García Flores ,&nbsp;Carolina Santillán Torres Torija ,&nbsp;Alejandra Mares Portillo ,&nbsp;Alfonso Mendoza Leal ,&nbsp;Alicia Ivet Flores Elvira ,&nbsp;Esteban Eugenio Esquivel-Santoveña ,&nbsp;Enrique Berra Ruiz","doi":"10.1016/j.cct.2026.108229","DOIUrl":"10.1016/j.cct.2026.108229","url":null,"abstract":"<div><h3>Objective</h3><div>There is strong evidence that online transdiagnostic interventions are effective in treating anxiety and depression, and contribute to improving patients' quality of life. This study aimed to evaluate the efficacy and acceptability of an internet-guided transdiagnostic intervention (guided UP) versus a self-guided internet-based transdiagnostic intervention (unguided UP) for the transdiagnostic treatment of emotional disorders targeting the Mexican community.</div></div><div><h3>Methods</h3><div>A randomized clinical trial was conducted to compare therapist-supported online transdiagnostic treatment with an unguided version and a waiting list control group. 247 individuals aged 18 to 70 years were assessed at four time points (before and after treatment, three and six months follow- up) to identify levels of anxiety, depression, trauma and stress-related symptoms. Participants who qualified and decided to participate were randomly assigned to one of three conditions.</div></div><div><h3>Results</h3><div>Higher levels of acceptability, satisfaction, and suitability were reported for the intervention with therapeutic support compared to the UP-unguided condition. After treatment, significant mean differences were found between the waitlist group and both the UP-guided and unguided groups in anxiety, depression, trauma and stress-related symptoms, and general distress, as well as in emotional dysregulation for the guided group only, all with large effect sizes. Direct comparisons between the UP-guided and unguided groups showed significant differences favoring the UP-guided treatment at post-test for depression and emotional dysregulation. However, at the 3- and 6-month follow-ups, the UP-unguided group continued to improve, whereas the UP-guided group tended to remain stable. As a result, by the end of the follow-up period, the UP-unguided group showed significantly lower levels of anxiety, PTSD symptoms, and emotional dysregulation.</div></div><div><h3>Conclusions</h3><div>The study supports the preliminary evidence of the clinical utility of UP online interventions in a specific sample recruited for the treatment of anxiety, depression, trauma and stress-related symptoms with the advantage of reaching a larger number of people. Even though the UP-unguided intervention showed clinical utility, the support of a therapist in an online intervention could offer an advantage that improves treatment adherence and, in particular, resulted in a greater reduction in symptoms of depression and emotional dysregulation, making it the superior option from a clinical perspective.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108229"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028602","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":"Increasing COVID-19 vaccine uptake through motivational interviewing-informed tailored digital intervention: Study protocol","authors":"C.P. Ku ,&nbsp;Alex Christian ,&nbsp;Emerson Delacroix ,&nbsp;Kirsten Trzeciak ,&nbsp;Ken Resnicow ,&nbsp;Sarah Bailey ,&nbsp;Barbara Israel ,&nbsp;Felix Valbuena ,&nbsp;Susie Williamson","doi":"10.1016/j.cct.2026.108221","DOIUrl":"10.1016/j.cct.2026.108221","url":null,"abstract":"<div><h3>Background</h3><div>Marginalized communities have been disproportionately impacted by COVID-19. In Michigan as of 2024, while 59% of Hispanic people, 46% of African American people, and 56% of White people received at least one dose of vaccine, only 8% of African American and 8% of Hispanic residents report being <em>up-to-date,</em> per CDC definition, compared to 13% of White residents. The goals of the project were to increase vaccine uptake through the implementation and evaluation of a tailored behavioral intervention.</div></div><div><h3>Methods</h3><div>This group-tailored digital intervention investigates the effect of an SMS-based health education program on vaccine intent in African American and Latino/Hispanic individuals. Recruited in-person and digitally throughout Michigan, 1327 participants were randomized into two arms, and then stratified into four audience segment groups based on vaccine readiness. The primary aim of the study is to increase uptake of the COVID-19 vaccine following receipt of the tailored text messages. Participants were evaluated pre- and post-intervention for intent to vaccinate, perceptions of barriers to vaccination, attitudes towards the vaccine, and knowledge of common vaccine misinformation.</div></div><div><h3>Discussion</h3><div>This study will inform future literature in addressing vaccine hesitancy for racial and ethnic populations, the use of motivational interviewing-based interventions, and digital health interventions in general.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108221"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003207","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":"Rationale and design of a three-arm randomized clinical trial to improve drug use and retention in care of people with opioid use disorder on buprenorphine: OVERCOME II study","authors":"Irene Pericot-Valverde ,&nbsp;Moonseong Heo ,&nbsp;Kaileigh A. Byrne ,&nbsp;Alison Karasz ,&nbsp;Angelica Perez ,&nbsp;Snehal Lopes ,&nbsp;Megan Groome ,&nbsp;Sarah Voss ,&nbsp;Ashley King ,&nbsp;Katy Barnick ,&nbsp;Alain H. Litwin","doi":"10.1016/j.cct.2026.108226","DOIUrl":"10.1016/j.cct.2026.108226","url":null,"abstract":"<div><div>Medications for opioid use disorder (MOUD) are effective in reducing opioid use, but retention to buprenorphine remains suboptimal among OUD patients. Integration of computer-based cognitive behavioral therapy (CBT4CBT) and utilization of recovery coaches (RCs), called RC + CBT4CBT-Buprenorphine, into OUD care could improve drug use and retention in care among patients taking buprenorphine. The OVERCOME II (<u><strong>O</strong></u>UD Inter<u><strong>ve</strong></u>ntion <u><strong>R</strong></u>ecovery <u><strong>C</strong></u>oach CBT and <u><strong>O</strong></u>UD <u><strong>Me</strong></u>dications II) study is a three-arm 1:1:1 randomized clinical trial designed to test the remotely delivered RC + CBT4CBT-Buprenorphineintervention as an adjunct to buprenorphine treatment for patients with OUD, and to compare it with both CBT4CBT-Buprenorphine alone and the treatment as usual (TAU). Patients (<em>n</em> = 90) who have newly initiated buprenorphine in the past 90 days are planned to be recruited. Comprehensive measures on demographics, various conditions/constructs, and outcomes will be collected from medical charts and survey instruments. Additionally, neurophysiological outcomes and neurocognitive inhibitory controls will be measured using the NEXUS-10-MKII physiological system with BioTrace+ software and computerized Drug Go/NoGo Task, respectively. Qualitative analysis of interviews with <em>N</em> = 2 RCs and <em>N</em> = 15 participants will also be conducted. The study will be the first to examine the effectiveness of the remotely delivered RC + CBT4CBT-Buprenorphine intervention on drug use (during the first 8 weeks and follow-up) and retention in care, as well as on various neurophysiological and cognitive performances in comparison to CBT4CBT-Buprenorphine alone and TAU.</div><div><strong>Clinical Trial Registration:</strong> This study was registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT06102200, <span><span>www.clinicaltrials.gov/</span><svg><path></path></svg></span>) on August 31, 2023, with a title, An Integrated Intervention Involving Recovery Coaching and Cognitive Behavioral Therapy for Opioid Use Disorder (OVERCOME 2).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108226"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003132","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":"Early intervention versus treatment as usual for adolescents with first-episode psychosis: Protocol for the randomized OPUS YOUNG trial","authors":"Mathilde S. Madsen ,&nbsp;Marianne Melau ,&nbsp;Naja K. Andersen ,&nbsp;Caroline Friis Nielsen ,&nbsp;Natascha Larsen ,&nbsp;Thomas Lind Andersen ,&nbsp;Merete Nordentoft ,&nbsp;Jens Richardt M. Jepsen ,&nbsp;Anne A.E. Thorup ,&nbsp;Pia Jeppesen ,&nbsp;Birgitte Fagerlund ,&nbsp;Martin Køster Rimvall ,&nbsp;Patrick McGorry ,&nbsp;Swaran Singh ,&nbsp;Ditte Lammers Vernal ,&nbsp;Lene Halling Hastrup ,&nbsp;Lis Raabæk Olsen ,&nbsp;Jacob Rydkjær ,&nbsp;Christoph U. Correll ,&nbsp;Robin Christensen ,&nbsp;Anne Katrine Pagsberg","doi":"10.1016/j.cct.2026.108253","DOIUrl":"10.1016/j.cct.2026.108253","url":null,"abstract":"<div><h3>Background</h3><div>The prognosis for early onset psychosis (EOP) is poor for a broad range of outcomes. Early intervention services (EIS) have proven beneficial for adult-onset first-episode psychosis, but no randomized trials have investigated EIS in samples of patients aged &lt;18 years. We will examine benefits and harms of a new integrated intervention OPUS YOUNG for EOP. The primary objective is to compare the effect of the OPUS YOUNG intervention versus treatment as usual (TAU) on change in social functioning at end-of-treatment after two years.</div></div><div><h3>Methods</h3><div>This investigator-initiated, single-center, pragmatic randomized clinical trial with blinded outcome assessment takes place in child- and adolescent mental health services in Copenhagen, Denmark. We randomize 290 participants aged 12 to 17 years with first-onset psychosis in a 1:1 ratio to a two-year intervention with OPUS YOUNG versus TAU. The OPUS YOUNG manual builds on the Danish evidence-based intervention for young adults (OPUS) adjusted to meet the specific needs of youths. The primary outcome is social functioning (Personal and Social Performance Scale [PSP] total score). Key secondary outcomes include measures of psychotic, negative, and disorganized symptom dimensions, client satisfaction, and health-related quality of life. Analyses will follow the intention-to-treat principle and use mixed-effects repeated measures models.</div></div><div><h3>Discussion</h3><div>In a rigorous research design, we address the urgent need for evidence-based interventions integrating psychosocial and pharmacological treatments in an age-appropriate manualized program for EOP. The primary trial limitations are the risk of attrition during follow-up, and the inherent inability to mask for allocation in trials with psychosocial interventions.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>: <span><span>NCT04916626</span><svg><path></path></svg></span>, registered June 2021. Protocol and modifications is presented here:</div><div><span><span>https://classic.clinicaltrials.gov/ct2/show/NCT04916626</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108253"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146137309","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 protocol for a randomized comparative effectiveness trial for treating PTSD symptoms for LGBTQIA+ people","authors":"Madeline Price ,&nbsp;Gowri Sunder ,&nbsp;Marylene Cloitre ,&nbsp;Debra Kaysen ,&nbsp;Martha Shumway ,&nbsp;James W. Dilley ,&nbsp;Nadra E. Lisha ,&nbsp;Belin Marko ,&nbsp;William Hua ,&nbsp;Tiffany Artime ,&nbsp;Ell Hundertmark ,&nbsp;Emily Huang ,&nbsp;Antonia Clifford ,&nbsp;Annesa Flentje","doi":"10.1016/j.cct.2026.108246","DOIUrl":"10.1016/j.cct.2026.108246","url":null,"abstract":"<div><h3>Background</h3><div>LGBTQIA+ (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, and Asexual +) individuals face higher rates of posttraumatic stress disorder (PTSD) due to increased trauma exposure. Further, they may experience factors that complicate treatment, like exposure to minority stress and increased substance use. No prior large-scale clinical trial has compared the effectiveness of PTSD treatments among LGBTQIA+ populations.</div></div><div><h3>Study objectives</h3><div>We are conducting a comparative effectiveness study that will compare two evidence-based psychotherapeutic interventions to reduce PTSD and depression symptoms and improve quality of life in LGBTQIA+ populations. Treatment dropout and satisfaction will be compared between the interventions. Minority stress and substance use will be examined as moderators for treatment effectiveness. We will also examine heterogeneity of treatment effects by gender subgroups, participant residence (urban versus suburban or rural), and race and ethnicity.</div></div><div><h3>Methods</h3><div>Participants will be recruited from community mental health settings, from the community, and through organizations throughout California. Eligibility will be based on PTSD symptom severity as determined by PTSD Checklist for DSM-5 (PCL-5) scores ≥33 during an initial phone screening. Each participant will be randomized to receive either Cognitive Processing Therapy (CPT) or STAIR Narrative Therapy (SNT). Study participants will complete survey assessments at baseline, 3 months, 6 months, and 12 months.</div></div><div><h3>Discussion</h3><div>This study will fill critical research gaps to inform effective PTSD treatments for LGBTQIA+ communities.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108246"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146096904","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":"Estimating the probability of experiencing an improvement in randomized controlled trials based on anchor-based MIC studies – An alternative to responder analyses","authors":"Werner Vach ,&nbsp;Franziska Saxer","doi":"10.1016/j.cct.2026.108243","DOIUrl":"10.1016/j.cct.2026.108243","url":null,"abstract":"<div><h3>Background</h3><div>When using a patient reported outcome as primary endpoint in a randomized contolled trial (RCT), responder analyses are widely used to describe the relevance of an observed effect attributable to the intervention of interest. The choice of thresholds in responder analyses is often based on minimal important change (MIC) values.</div></div><div><h3>Methods</h3><div>As an alternative to simply computing MIC values, we suggest determining a translation function allowing to translate change scores values into the probability of experiencing an improvement. The application of such a translation function to the change scores observed in an RCT allows estimating arm-specific probabilities of experiencing an improvement. These values are conceptually similar to responder frequencies. The approach is illustrated using a pair of synthetic studies, both constructed mimicking existing studies. A simulation study investigates the gain in efficiency from avoiding the dichotomization.</div></div><div><h3>Results</h3><div>The illustrative application of the methodology demonstrates that the approach is feasible and allows drawing conclusions in a similar way as in a responder analysis, but with greater precision. The simulation study confirms that this gain in efficiency holds more generally. Considering all response levels of the anchor variable may allow gaining more nuanced insights.</div></div><div><h3>Conclusions</h3><div>Estimating the probability of experiencing an improvement provides an alternative to responder analyses. This approach makes more efficient use of information comprised in the data from anchor-based MIC studies than the translation into MIC values to inform the choice of thresholds in a responder analysis.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108243"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146092331","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 multilevel clinic- and community-based intervention to increase COVID-19 vaccination among Latinos in San Diego County: Protocol description of the vaccine promotion program","authors":"Noe C. Crespo ,&nbsp;John Elder ,&nbsp;Eyal Oren ,&nbsp;Elva Arredondo ,&nbsp;Chii-Dean Joey Lin ,&nbsp;Job Godino ,&nbsp;Hala Madanat ,&nbsp;Griselda Cervantes ,&nbsp;Amanda Patron ,&nbsp;Kiria Fraga ,&nbsp;Bianca Vargas-Tequida ,&nbsp;Christian B. Ramers","doi":"10.1016/j.cct.2026.108227","DOIUrl":"10.1016/j.cct.2026.108227","url":null,"abstract":"<div><h3>Background</h3><div>COVID-19 has disproportionately affected minority groups, including Latinos. Since the development of COVID-19 vaccines, effective implementation faced challenges due to multiple factors, necessitating multi-level and multi-sector approaches. This study describes the Vaccine Promotion Program (VPP), a multi-level intervention to increase COVID-19 vaccine uptake among Latinos in clinical and community settings.</div></div><div><h3>Methods</h3><div>VPP is a double-blind, pragmatic, 12-month cluster-randomized trial in collaboration with a large Federally Qualified Health Center (FQHC) in San Diego, CA. Ten clinics will be randomized to a Multilevel Intervention involving activities at the interpersonal, clinic, and community levels (VPP) or Standard Clinical Practice (SCP) (<em>n</em> = 5 clinics, respectively). Patients in VPP clinics will receive tailored clinic-originated messages about COVID-19 vaccination and motivational interviews (MI) (15–30-min telephone/telehealth encounters) from Health Educators (HE) to encourage COVID-19 vaccination. HEs will send emails and/or text message-based information to encourage vaccination. The community-level intervention involves targeted and tailored activities to promote COVID-19 vaccine uptake in neighborhoods surrounding the five VPP clinics. A cohort of 200 patients will be enrolled to participate in comprehensive surveys and follow-up for 24 months to assess longer-term outcomes. The primary outcome (COVID-19 aggregated vaccination rates) will be compared at baseline, 6, and 12 months between VPP and SCP clinics and neighborhoods, respectively.</div></div><div><h3>Discussion</h3><div>VPP directly addresses the most prominent COVID-19 vaccination barriers, including health literacy, community trust, and vaccine access, through a multi-level approach in collaboration with an FQHC. This approach has the potential to be an effective and scalable public health approach to vaccination among underserved communities.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108227"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146017656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of Heart Well: A randomized pilot study of a community health worker-delivered nutrition intervention for low-income adults with hypertension","authors":"Kristine D. Gu ,&nbsp;Jessica Cheng ,&nbsp;Oldy Bejarano ,&nbsp;Emily Gelsomin ,&nbsp;Ashlie Malone ,&nbsp;Katherine C. Faulkner ,&nbsp;Anne N. Thorndike","doi":"10.1016/j.cct.2026.108244","DOIUrl":"10.1016/j.cct.2026.108244","url":null,"abstract":"<div><h3>Background</h3><div>Suboptimal diet and food insecurity contribute to hypertension disparities experienced by individuals with low-income. Clinic-based nutrition counseling is limited by time constraints and low access to dietitians. Integrating community health workers (CHWs) with basic nutrition training into care teams may be an effective strategy to promote sustainable dietary modifications.</div></div><div><h3>Objective</h3><div>Describe the design of Heart Well, a study to determine whether adding nutrition counseling to a primary care-based CHW hypertension program is feasible and acceptable and improves diet and blood pressure (BP).</div></div><div><h3>Methods</h3><div>Heart Well is a 4-month randomized controlled study of low-income adults (<em>N</em> = 60) who have uncontrolled hypertension and are enrolled in a CHW hypertension coaching program. The control group receives usual care in the existing hypertension program. The intervention group additionally receives nutrition counseling on label reading, healthy eating on a budget, and simplified nutrition education (e.g., traffic light categories, green = healthy). Intervention CHWs are trained by a registered dietitian, who also provides ongoing CHW support. Primary outcomes are feasibility (i.e., proportion of participants enrolled, percent completion of nutrition modules) and acceptability (i.e., participant ratings of nutrition components). Secondary outcomes are changes over 4 months in Healthy Eating Index-2020 scores (calculated from dietary recalls) and in BP.</div></div><div><h3>Conclusions</h3><div>Heart Well tests a novel strategy integrating nutrition counseling tailored to low-income adults into an existing CHW hypertension program. Results will inform a larger trial to evaluate the intervention's impact on cardiovascular health and may have implications for CHW interventions for other diet-sensitive chronic diseases. Trial Registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06358417</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108244"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146074469","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":"Reaching rural veterans: Applying mind-body skills for pain using a whole health telehealth intervention: The RAMP pilot study","authors":"Katherine Hadlandsmyth ,&nbsp;Roni Evans ,&nbsp;Brent D. Leininger ,&nbsp;Brent C. Taylor ,&nbsp;Lee J.S. Cross ,&nbsp;Ann Bangerter ,&nbsp;Emily M. Hagel Campbell ,&nbsp;Alexander C. Haley ,&nbsp;Mallory Mahaffey ,&nbsp;Marianne S. Matthias ,&nbsp;J. Stephanie L. Taylor ,&nbsp;Diana J. Burgess","doi":"10.1016/j.cct.2026.108254","DOIUrl":"10.1016/j.cct.2026.108254","url":null,"abstract":"<div><h3>Purpose</h3><div>The current study piloted a telehealth, multicomponent intervention for rural Veterans, to increase access to non-pharmacological approaches to managing chronic pain.</div></div><div><h3>Methods</h3><div>This single arm pilot study examined the feasibility of trialing the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP consisted of an individual session followed by 11 facilitated group sessions (90-min each), that included expert-led educational and experiential physical exercise and mind-body skill-building videos. Feasibility was assessed using pre-specified milestones.</div><div>for recruitment and enrollment (<em>N</em> = 40), satisfaction (75%), fidelity (90%), intervention engagement (75%), and data collection (surveys of pain and health outcomes at 14 weeks, 80%).</div></div><div><h3>Findings</h3><div>The following milestones were met: 1) 40 rural VA patients with moderate to severe chronic pain were enrolled, 2) 90% of participants were satisfied with the intervention, and 3) facilitators delivered 100% of session activities 100% of the time. The following milestones were nearly met: 4) intervention engagement: 68% of Veterans engaged in at least 7 of 12 sessions, and 5) data collection: 75% survey completion at 14 weeks. Participants reported that the intervention supported their pain self-management capabilities, provided useful self-management opportunities and resources, and enhanced their motivation to self-manage their pain. Participant and other key stakeholders identified important areas for improvement.</div></div><div><h3>Conclusions</h3><div>Pilot results demonstrated that RAMP is feasible and acceptable to rural Veterans with chronic pain and helped identify optimization strategies to enhance future program engagement.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108254"},"PeriodicalIF":1.9,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156454","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}