Contemporary clinical trials最新文献

{"title":"Intermittent fasting for systemic triglyceride metabolic reprogramming (IFAST): Design and methods of a prospective, randomized, controlled trial","authors":"Jacob A. Quaytman ,&nbsp;Natalie L. David ,&nbsp;Sharini Venugopal ,&nbsp;Tânia Amorim ,&nbsp;Britney Beatrice ,&nbsp;Frederico G.S. Toledo ,&nbsp;Rachel G. Miller ,&nbsp;Matthew L. Steinhauser ,&nbsp;Pouneh K. Fazeli","doi":"10.1016/j.cct.2024.107698","DOIUrl":"10.1016/j.cct.2024.107698","url":null,"abstract":"<div><h3>Background</h3><div>Caloric restriction prolongs lifespan in model organisms and improves metrics of aging-related diseases in humans, but daily compliance is challenging. Intermittent fasting improves metrics of lipid and glucose metabolism in the setting of weight loss but whether these metrics are improved independent of weight loss is not known.</div></div><div><h3>Methods</h3><div>We seek to address this gap with IFAST, a single-center, three-arm, prospective, randomized, controlled clinical trial. Eligible study participants are adults with no chronic medical conditions beyond prediabetes or overweight but who are at high risk for type 2 diabetes mellitus (T2D), defined as having a history of gestational diabetes or a first-degree relative with T2D. Participants will be randomized in a 1:2:2 schema to either a control group, a fasting group, or a fasting/weight maintenance group. The fasting groups will complete a 24-h fast one day per week for 12 weeks. The key mechanistic endpoint is change in triglyceride composition (defined by carbon content and degree of saturation) as measured by longitudinal metabolomics. The key safety endpoint is percent change from baseline in bone volume fraction (BV/TV; high-resolution peripheral quantitative CT) at the radius in the fasting group. Secondary endpoints include measures of insulin sensitivity (hyperinsulinemic-euglycemic clamp), clinical lipid profiling, systemic inflammation markers, hunger assessment, bone density, and bone microarchitecture with high-resolution peripheral quantitative CT.</div></div><div><h3>Conclusion</h3><div>IFAST will investigate intrinsic metabolic benefits of intermittent fasting beyond weight loss.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID <span><span>NCT05722873</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107698"},"PeriodicalIF":2.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281568","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":"Promoting precision health using fitness wearable and apps among breast cancer survivors: Protocols of a smart health management trial","authors":"Qin Yuan ,&nbsp;John Oginni ,&nbsp;Ning Liao ,&nbsp;Hui He ,&nbsp;Zan Gao","doi":"10.1016/j.cct.2024.107693","DOIUrl":"10.1016/j.cct.2024.107693","url":null,"abstract":"<div><h3>Background</h3><p>Annually, approximately 1.7 million women are diagnosed with breast cancer worldwide. Engaging in regular physical activity (PA) post-diagnosis brings significant health benefits, enhancing breast cancer survivors' (BCS) prognosis and overall health-related quality of life (HRQoL). Despite these benefits, a low percentage of Chinese BCS adhere to the recommended moderate-to-vigorous PA levels. This highlights the need for innovative PA interventions tailored for BCS management. eHealth technology, such as fitness wearables and apps, presents an opportunity to improve BCS healthcare by offering personalized exercise programs.</p></div><div><h3>Methods</h3><p>This study focuses on developing a precision eHealth PA program for 200 Chinese BCS in Guangdong Province, using a custom micro-application and a smart band for a 12-month trial. All participants will receive a Huawei Smart Band and be divided into 1) a personalized intervention group, receiving daily PA tracking and feedback, and 2) a control group receiving standard care. The primary outcome is PA and secondary outcomes include biomarkers, weight and body composition, functional fitness, HRQoL, and individual beliefs. Outcomes will be assessed at baseline, 6 months, and 12 months (endpoint). Successful outcomes could revolutionize PA programs for Chinese BCS, providing a model for future eHealth interventions.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107693"},"PeriodicalIF":2.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142274851","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":"Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control","authors":"Carol J. Fabian ,&nbsp;Dinesh Pal Mudaranthakam ,&nbsp;Byron Gajewski ,&nbsp;Kate Young ,&nbsp;Onalisa Winblad ,&nbsp;Seema A. Khan ,&nbsp;Judy E. Garber ,&nbsp;Laura J. Esserman ,&nbsp;Lisa D. Yee ,&nbsp;Lauren Nye ,&nbsp;Kandy R. Powers ,&nbsp;Lori Ranallo ,&nbsp;Amy L. Kreutzjans ,&nbsp;Krystal Pittman ,&nbsp;Christy Altman ,&nbsp;Trina Metheny ,&nbsp;Adrian Zelenchuk ,&nbsp;Barry S. Komm ,&nbsp;Bruce F. Kimler","doi":"10.1016/j.cct.2024.107697","DOIUrl":"10.1016/j.cct.2024.107697","url":null,"abstract":"<div><h3>Background</h3><div>The combination of bazedoxifene 20 mg (BZA) and conjugated estrogens 0.45 mg (CE) marketed as Duavee® is approved for vasomotor symptom relief and osteoporosis prevention. Our pilot study suggested it had potential breast cancer risk reduction, and we proposed a multisite Phase IIB primary prevention trial assessing change in breast imaging and tissue risk biomarkers. By the time funding was acquired in February 2021, Duavee® was unavailable with an uncertain return date. A redesign was needed to salvage the study.</div></div><div><h3>Methods</h3><div>The basic trial design was minimally altered. Women age 45–64 at elevated risk for breast cancer with vasomotor symptoms and no menses for at least 2 months have mammography, phlebotomy, and benign breast tissue sampling before and after 6 months of intervention. However, instead of Duavee® (single pill) vs placebo, women are randomized to 6 months of BZA + CE vs Waitlist. Those initially randomized to Waitlist can receive BZA + CE after 6 months. The primary endpoint is between arm difference in change in a fully automated measure of mammographic density with blood and tissue-based secondary endpoints.</div></div><div><h3>Outcomes</h3><div>Accrual initiation was delayed due to contractual difficulties surrounding BZA importation during COVID-19 and deploying a fully automated method (Volpara®) to assess the primary endpoint. To accommodate this delay, a mid-grant no cost extension along with amended eligibility requirements were employed. 61/120 participants needed were entered in the initial 27 months of accrual and 37 months of funding. Despite a late start, accrual is likely to be completed within the funding period.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107697"},"PeriodicalIF":2.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281569","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":"Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients","authors":"Hannah C. Espeleta ,&nbsp;Sara M. Witcraft ,&nbsp;Taylor Raffa ,&nbsp;Susan Kartiko ,&nbsp;Danyelle Dawson ,&nbsp;Gabriela Becerra ,&nbsp;Helaina Roisman ,&nbsp;Chanita Hughes-Halbert ,&nbsp;Martina Mueller ,&nbsp;Ebonie Powell ,&nbsp;Tremaine Brock ,&nbsp;Babak Sarani ,&nbsp;Kenneth J. Ruggiero","doi":"10.1016/j.cct.2024.107694","DOIUrl":"10.1016/j.cct.2024.107694","url":null,"abstract":"<div><h3>Background</h3><div>Annually, nearly 3 million individuals in the US are hospitalized after experiencing a traumatic injury (e.g., serious automobile crash, gunshot wound, stab injury). Many traumatically injured patients experience a trajectory of resilience. However, 20–40 % develop mental health problems such as posttraumatic stress disorder and depression; population estimates exceed 600,000 patients annually. Most trauma centers do not provide direct services to address mental health recovery, but the 2022 American College of Surgeons guidelines have established this as a priority. Cost-effective interventions are needed that meet the needs of patients at each stage of the recovery process while achieving sustainability at the level of implementation. This protocol paper describes a study that rigorously tests the Trauma Resilience and Recovery Program (TRRP), a scalable, sustainable technology-enhanced intervention to support the mental health recovery of patients who have experienced a traumatic injury.</div></div><div><h3>Methods</h3><div>We describe a randomized controlled trial with 1-year follow up of TRRP vs. enhanced usual care with 350 traumatically injured patients, including recruitment and retention procedures, assessment, implementation and fidelity monitoring, and statistical plans.</div></div><div><h3>Conclusion</h3><div>Novel components of our design include integration of technology-based elements, use of a stepped-care model, and implementation in a trauma center that did not previously have a mental health program. Data collected address the impact of TRRP and inform improvements to the model and its implementation in preparation for large-scale testing and implementation initiatives. This body of work is critical to informing the field as it continues to move toward national standards and recommendations.</div><div><strong>Trial registration:</strong> <span><span>NCT05497115</span><svg><path></path></svg></span> <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107694"},"PeriodicalIF":2.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281567","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":"The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods","authors":"Kristen M. Beavers ,&nbsp;Brianna R. Wolle ,&nbsp;Jamy D. Ard ,&nbsp;Daniel P. Beavers ,&nbsp;Olivia Biehl ,&nbsp;Peter H. Brubaker ,&nbsp;Andrew J. Burghardt ,&nbsp;Christa T. Calderone ,&nbsp;Julio Carballido-Gamio ,&nbsp;Jason Fanning ,&nbsp;Wendy M. Kohrt ,&nbsp;Monica Love ,&nbsp;Catherine M. MacLean ,&nbsp;Barbara J. Nicklas ,&nbsp;Joshua Stapleton ,&nbsp;Christine M. Swanson ,&nbsp;Ashley A. Weaver ,&nbsp;Marcelina Worden ,&nbsp;Sarah J. Wherry","doi":"10.1016/j.cct.2024.107692","DOIUrl":"10.1016/j.cct.2024.107692","url":null,"abstract":"<div><h3>Background</h3><p>Among older adults living with obesity, intentional weight loss (WL) improves prognosis of many comorbidities. However, concomitant decline in bone mineral density (BMD) limits overall benefit of WL by increasing osteoporotic fracture risk. Identification of intervention strategies to maximize body fat loss, while minimizing harm to the musculoskeletal system, is an important area of clinical research. The main objective of the Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial (<span><span>NCT05764733</span><svg><path></path></svg></span>) is to compare the independent and combined effects of a 12-month intervention of resistance training (RT) plus bone-loading exercises and bisphosphonate use on dietary WL-associated bone loss among 308 older (≥60 years) adults living with an indication for WL and bisphosphonate use.</p></div><div><h3>Methods</h3><p>All participants will receive the same group-mediated dietary intervention targeting 8–10 % WL and be randomized to one of four groups: no RT and placebo capsules (NoRT+PL); progressive RT plus bone-loading exercises and placebo capsules (RT⁺+PL); no RT and oral bisphosphonate (70 mg weekly oral alendronate; NoRT+BIS); or progressive RT plus bone-loading exercises and oral bisphosphonate (RT⁺+BIS). Total hip areal (a)BMD measured via dual-energy x-ray absorptiometry (DXA) is the primary, powered study outcome. Secondary skeletal outcome measures include femoral neck and lumbar spine aBMD, high resolution peripheral quantitative computed tomography (HRpQCT) bone assessments of the radius and tibia, and biomarkers of bone turnover.</p></div><div><h3>Discussion</h3><p>BEACON will address an understudied, yet important, clinical research question by studying the independent and combined effects of two scalable intervention strategies aimed at optimizing skeletal integrity in older adults undergoing WL.</p><p>Clinical Trials Registration: <span><span>NCT05764733</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107692"},"PeriodicalIF":2.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142274852","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 and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine","authors":"Eteri Machavariani ,&nbsp;Kostyantyn Dumchev ,&nbsp;Iryna Pykalo ,&nbsp;Myroslava Filippovych ,&nbsp;Roman Ivasiy ,&nbsp;Denise Esserman ,&nbsp;Lynn M. Madden ,&nbsp;Daniel J. Bromberg ,&nbsp;Marwan Haddad ,&nbsp;Olga Morozova ,&nbsp;Bachar Ahmad ,&nbsp;David Oliveros Gómez ,&nbsp;Scott O. Farnum ,&nbsp;Sergii Dvoriak ,&nbsp;Frederick L. Altice","doi":"10.1016/j.cct.2024.107690","DOIUrl":"10.1016/j.cct.2024.107690","url":null,"abstract":"<div><h3>Introduction</h3><p>Ukraine has high HIV prevalence, concentrated among people who inject drugs (PWID), mostly of opioids. Maintenance on opioid agonist therapies (OAT) is the most effective evidence-based treatment for opioid use disorder. As PWID experience high morbidity and mortality from preventable and treatable non-communicable diseases, international agencies recommend integrating OAT into primary care centers (PCC).</p></div><div><h3>Methods</h3><p>A randomized, type-2 hybrid implementation trial was carried out to compare outcomes of OAT integration in PCC to OAT delivery at specialty treatment centers (STC) – standard-of-care. Tele-education supporting PCC providers in managing OAT, HIV, tuberculosis and non-communicable diseases along with pay-for-performance incentives were used to facilitate implementation. Consenting patients underwent 1:2 randomization to either STC or PCC. Quality health indicators (QHIs), a composite percentage of recommended primary and specialty services accessed by patients (blood/urine tests, cancer screenings, etc.), were defined as efficacy outcomes and were assessed by participant self-report at baseline and every 6 months over 24 months and electronic chart reviews after the completion of the follow-up. The primary outcome is defined as the difference in composite QHI scores at 24 months, in which a repeated measures likelihood-based mixed model with missing at random assumptions will be used. Providers at PCC completed surveys at baseline, 12 and 24 months to assess implementation outcomes including changes in stigma and attitudes towards OAT and PWID.</p></div><div><h3>Preliminary results</h3><p>Among the 1459 participants allocated to STC (<em>N</em> = 509) or PCC (<em>N</em> = 950), there were no differences in clinical and demographic characteristics. Self-reported prevalences were available for HIV (42 %), HCV (57 %), and prior tuberculosis (17 %). Study retention at 6, 12, 18, and 24 months was as 91 %, 85 %, 80 %, and 74 %, respectively.</p></div><div><h3>Conclusion</h3><p>PWID have a high prevalence of medical comorbidities and integrating OAT into primary care settings has the potential to improve the health of PWID. Findings from this study can help guide implementation of integrated care in Ukraine and throughout similar low-resource, high-burden countries in the Eastern European and Central Asian region.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107690"},"PeriodicalIF":2.0,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142232421","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":"The “Latines Lideres En Salud (LaLiSa)” study: Rationale and design","authors":"Paola Torres ,&nbsp;Carolina Bujanda ,&nbsp;Juanita Arroyo ,&nbsp;Araceli Lucio ,&nbsp;Vivian Pan ,&nbsp;Pamela Ganschow ,&nbsp;Kristin Andersen ,&nbsp;Celeste Charchalac-Zapeta ,&nbsp;Marilyn Barragan ,&nbsp;Erin Neuschler ,&nbsp;Sage J. Kim ,&nbsp;Zhengjia Chen ,&nbsp;Michelle Martinez ,&nbsp;Samantha Madrid ,&nbsp;Nathan Stackhouse ,&nbsp;Nicole M. Gastala ,&nbsp;Sean McClellan ,&nbsp;Yamilé Molina","doi":"10.1016/j.cct.2024.107689","DOIUrl":"10.1016/j.cct.2024.107689","url":null,"abstract":"<div><h3>Background</h3><p>Latines suffer from breast cancer (BC), due to elevated biological and social determinants of health (SDOH) risks. This study compares the effects of different strategies on uptake of cancer genetic services, specifically hereditary cancer risk assessment, genetic counseling, and genetic testing, and risk-based BC care.</p></div><div><h3>Design/methods</h3><p>In Chicago, Illinois, Aim 1 participants are recruited from a federally qualified health center (FQHC) and community venues. For Aim 1, eligible participants: (1) are female; (2) are Latine; (3) are 30+ years old; (4) have personal or family history of BC or cancers with shared hereditary mutations; (5) have at least one SDOH risk; and (6) have <em>not</em> received any cancer genetic services. Participants are randomly assigned to different study arms. Both arms include phone-based sessions, FQHC-based navigation for SDOH, and low- or no-cost cancer genetic services. The <em>educate</em> sessions focus on risk assessment and prevention. The <em>empower</em> sessions focus on risk assessment and equip participants with the skills to share information about FQHC-based cancer genetic services. For Aim 2, eligible participants are: (1) female; (2) network members of Aim 1 participants; and (3) eligible for BC screening based on guidelines recommended by the American Cancer Society (ACS). Primary outcomes include uptake of any cancer genetic services. Analyses will also explore intervention differences by neighborhood context.</p></div><div><h3>Discussion</h3><p>This is one of the first trials focused on Latines' participation in cancer genetic services and risk-based BC care within the context of SDOH - which has major implications for equity in precision cancer prevention.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107689"},"PeriodicalIF":2.0,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142274843","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":"Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial","authors":"Emily C. Soriano ,&nbsp;Addie L. Fortmann ,&nbsp;Susan J. Guzman ,&nbsp;Haley Sandoval ,&nbsp;Samantha R. Spierling Bagsic ,&nbsp;Alessandra Bastian ,&nbsp;McKayla Antrim ,&nbsp;Mariya Chichmarenko ,&nbsp;Athena Philis-Tsimikas","doi":"10.1016/j.cct.2024.107687","DOIUrl":"10.1016/j.cct.2024.107687","url":null,"abstract":"<div><h3>Background</h3><p>Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes. Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes effectively in the context of DD: Acceptance and Commitment Therapy (ACT). The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost-effectiveness in adults with T1D.</p></div><div><h3>Methods</h3><p>This is a two-arm, parallel group, randomized controlled superiority trial enrolling <em>N</em> = 250 adults with T1D, elevated HbA1c, and significant DD in a real-world community-based health system. Participants are randomized to receive ACT1VATE (a five-week ACT group telehealth intervention) or diabetes self-management education and support (usual care as the first-line recommended intervention for DD). The trial will examine comparative effectiveness in improving HbA1c, DD, quality of life, and cost-effectiveness over 12 months.</p></div><div><h3>Discussion</h3><p>We predict that ACT1VATE will be superior given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual’s deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. This trial will provide a valuable test of real-world effectiveness, drive sustainability and scalability, and inform the future of chronic disease care.</p><p>Trial registration: <span><span>NCT04933851</span><svg><path></path></svg></span> (<span><span>https://clinicaltrials.gov/ct2/show/NCT04933851</span><svg><path></path></svg></span>).</p><p>Clinical Trial: <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT04933851</span><svg><path></path></svg></span> <span><span>https://clinicaltrials.gov/study/NCT04933851</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107687"},"PeriodicalIF":2.0,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142239602","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":"The clinical and cost effectiveness of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS): Study protocol for a randomised controlled trial with ethnically diverse family carers","authors":"Naoko Kishita ,&nbsp;Rebecca L. Gould ,&nbsp;Lance M. McCracken ,&nbsp;Mizanur Khondoker ,&nbsp;David A. Turner ,&nbsp;Polly-Anna Ashford ,&nbsp;Emma Flanagan ,&nbsp;Barbara Czyznikowska ,&nbsp;Erica Richmond ,&nbsp;Megan Riggey ,&nbsp;Ana Paula Trucco ,&nbsp;Matthew Hammond ,&nbsp;Aditya Nautiyal ,&nbsp;Morag Farquhar","doi":"10.1016/j.cct.2024.107685","DOIUrl":"10.1016/j.cct.2024.107685","url":null,"abstract":"<div><h3>Background</h3><p>Following the successful completion of feasibility and acceptability studies of internet-delivered self-help Acceptance and Commitment Therapy for family carers of people with dementia (iACT4CARERS), a full-scale randomised controlled trial (RCT) evaluating its clinical and cost effectiveness will be conducted. This paper describes the design and protocol for a multi-site, parallel, single-blind, 2-arm RCT evaluating the clinical and cost effectiveness of iACT4CARERS plus treatment-as-usual (TAU) in comparison to TAU alone for reducing anxiety in family carers of people with dementia.</p></div><div><h3>Methods</h3><p>496 family carers aged ≥18 years, who are caring for a person with dementia, will be recruited from national healthcare services, general practices and community groups in England. Participants randomised to the intervention arm will receive iACT4CARERS over 12 weeks. Participants will complete outcome measures at baseline (0 weeks) and at 12-weeks and 24-weeks post-randomisation. The primary outcome and timepoint will be anxiety at 12 weeks. Secondary outcomes will include psychological flexibility, depression, and cost-effectiveness (cost per quality adjusted life years). Primary analyses will be by intention-to-treat and data will be analysed using linear mixed models. Fidelity and quality of implementation will be assessed and contextual factors associated with variation in outcomes identified in a process evaluation.</p></div><div><h3>Conclusion</h3><p>If iACT4CARERS is found to be effective and affordable, this self-help intervention, including minimal contact with minimally trained therapists, has the potential to be rolled out widely within healthcare services in the UK, reducing inequality in access to psychological services among this population.</p><p>Clinical trials registration: ISRCTN registry identifier ISRCTN45995725.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107685"},"PeriodicalIF":2.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1551714424002684/pdfft?md5=0a9b753137f736d6325f012e66a2cfb6&pid=1-s2.0-S1551714424002684-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230663","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":"Comparison of intravascular ultrasound-guided with optical coherence tomography-guided percutaneous coronary intervention for left main distal bifurcation lesions: Rationale and design of the ISOLEDS trial","authors":"Xiliang Zhao ,&nbsp;Yongchen Hao ,&nbsp;Xiufeng Zhao ,&nbsp;Haijun Zhang ,&nbsp;Xianzhong Wang ,&nbsp;Fangjiang Li ,&nbsp;Wenduo Zhang ,&nbsp;Ming Yang ,&nbsp;Hui Chen ,&nbsp;Zhongyu Zhu ,&nbsp;Yida Tang ,&nbsp;Lifu Miao ,&nbsp;Weiming Li ,&nbsp;Qing Yang ,&nbsp;Ning Guo ,&nbsp;Bo Chen ,&nbsp;Yong He ,&nbsp;Yicong Ye ,&nbsp;Yong Zeng","doi":"10.1016/j.cct.2024.107691","DOIUrl":"10.1016/j.cct.2024.107691","url":null,"abstract":"<div><h3>Background</h3><p>Percutaneous coronary intervention (PCI) can provide benefits for anatomically suitable left main coronary artery (LMCA) lesions. When compared to traditional coronary angiography (CAG) -guided PCI, the use of intravascular ultrasound (IVUS) guidance has shown significant long-term prognostic improvements in LMCA PCI. Optical coherence tomography (OCT) offers a higher axial resolution than IVUS. However, there is currently a lack of relevant randomized controlled trials investigating the use of OCT specifically for left main distal bifurcation lesions.</p></div><div><h3>Methods</h3><p>The ISOLEDS trial is an ongoing multicenter study that aims to compare IVUS-guided PCI with OCT-guided PCI for patients with true LMCA distal bifurcation lesions. This prospective, randomized, controlled, non-inferiority trial will enroll a total of 664 patients with visually-defined Medina 1,1,1 or 0,1,1 classification of left main distal bifurcation lesions. The patients will be randomly assigned in a 1:1 ratio to either IVUS-guided or OCT-guided PCI. The primary endpoint is to assess the occurrence of target lesion failure (TLF) within 12 months after the procedure. After undergoing PCI, patients are required to visit the hospital for a 12-month clinical follow-up. During this clinical assessment, CAG can be performed to evaluate the status of target lesions.</p></div><div><h3>Discussion</h3><p>The ISOLEDS trial represents the first attempt to compare two distinct intracoronary imaging techniques for guiding PCI in patients with true LMCA distal bifurcation lesions. By evaluating and comparing the outcomes of these two imaging techniques, the trial results will aid operators in selection of the most effective approach for guiding PCI in these patients.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107691"},"PeriodicalIF":2.0,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142239603","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}