Contemporary clinical trials最新文献

{"title":"The Diet Guidelines: 3 Diets (DG3D) study protocol of a behavioral teaching kitchen intervention for type-2 diabetes prevention among African American adults","authors":"Shiba Bailey ,&nbsp;Gabrielle M. Turner-McGrievy ,&nbsp;Enid A. Keseko ,&nbsp;Taylor Duncan ,&nbsp;Denine Ward-Johnson ,&nbsp;Briana Davis ,&nbsp;Sara Wilcox ,&nbsp;Daniela B. Friedman ,&nbsp;Mark A. Sarzynski ,&nbsp;Angela D. Liese","doi":"10.1016/j.cct.2025.108109","DOIUrl":"10.1016/j.cct.2025.108109","url":null,"abstract":"<div><h3>Background</h3><div>The U.S. Dietary Guidelines (USDG) serve as a foundational public health resource, yet their cultural applicability to underserved populations, including Black and African American (AA) adults, remains limited. The AA population is disproportionately affected by obesity and type 2 diabetes mellitus (T2DM), highlighting the need for culturally tailored interventions.</div></div><div><h3>Objectives</h3><div>To describe the design and methodology of the Dietary Guidelines: 3 Diets (DG3D) study, aimed at evaluating the effectiveness of culturally adapted USDG dietary patterns in improving diet quality and reducing risk factors associated with T2DM among AA adults. The intervention focuses on nutritional education and the promotion of healthy eating behaviors to support sustainable dietary change.</div></div><div><h3>Methods</h3><div>The DG3D study is a 12-month, single-masked, three-arm randomized behavioral nutrition intervention designed to evaluate three culturally adapted USDG dietary patterns: Healthy US, Mediterranean, and Vegetarian. The study recruited AA adults with overweight or obesity and at least three additional risk factors for T2DM. Participants were randomized to one of three dietary patterns and received group-based classes, cooking demonstrations, and web-based educational content. Primary outcomes include changes in diet quality (Healthy Eating Index [HEI]), body weight, and hemoglobin A1c (HbA1c), assessed at baseline, 6 months, and 12 months.</div></div><div><h3>Conclusion</h3><div>The DG3D study is a novel and comprehensive randomized trial evaluating culturally tailored dietary patterns in the AA population, a high-risk population. Findings are expected to inform inclusive dietary policy and contribute to reducing health disparities related to obesity and T2DM.</div><div>Trial registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> identifier <span><span>NCT05254496</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108109"},"PeriodicalIF":1.9,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145279189","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":"Nutrition effects on brain outcomes and recovery in stroke after hospitalization (NOURISH): Randomized controlled trial protocol and rationale","authors":"Laurel Cherian ,&nbsp;Puja Agarwal ,&nbsp;Klodian Dhana ,&nbsp;Vincent Carey ,&nbsp;Mark A. Espeland ,&nbsp;Nancy Laranjo ,&nbsp;Xavier Reilly ,&nbsp;Cheng Hong ,&nbsp;Pyone Maung ,&nbsp;Chiquia Hollings ,&nbsp;Beth Lukaszewicz ,&nbsp;Jennifer Ventrelle ,&nbsp;Jameszetta James ,&nbsp;Amy Tran ,&nbsp;Santosh Basapur ,&nbsp;Thomas Holland ,&nbsp;Kristin R. Krueger ,&nbsp;Xiaoran Liu ,&nbsp;Dixon Yang ,&nbsp;James R. Brorson ,&nbsp;Neelum T. Aggarwal","doi":"10.1016/j.cct.2025.108108","DOIUrl":"10.1016/j.cct.2025.108108","url":null,"abstract":"<div><h3>Background</h3><div>Risk of dementia doubles after stroke. There is limited information on reduction of risk, but diet is a significant modifiable risk factor for both vascular health and cognition.</div></div><div><h3>Objective</h3><div><strong>N</strong>utrition effects on brain <strong>Ou</strong>tcomes and <strong>R</strong>ecovery <strong>I</strong>n <strong>S</strong>troke after <strong>H</strong>ospitalization (NOURISH; registration no. <span><span>NCT04337255</span><svg><path></path></svg></span>) is a phase III randomized controlled trial designed to test the effects of the MIND diet on changes in cognition following an acute ischemic stroke.</div></div><div><h3>Study methods</h3><div>Eligible participants aged 55 and older were randomized to either the MIND diet intervention facilitated by credentialled nutritionists plus post-stroke care (Coach) or a post-stroke care intervention led by health educators (Self) for 24–36 months. Repeated assessments included anthropometric measurements, cognitive testing, blood and urinary biomarkers, and a variety of validated post-stroke outcome measures and follow-up visits for up to 3 years, with MRI scans conducted on a subset of participants at baseline and the study's end.</div><div>Unique features of this study include:<ul><li><span>•</span><span><div>Lifestyle and diet counseling to support the adoption of the MIND diet post-stroke in the Coach group</div></span></li><li><span>•</span><span><div>Post-stroke counseling which includes counseling for reduced sodium and saturated fat consumption by both groups</div></span></li><li><span>•</span><span><div>90 days of delivered meals</div></span></li><li><span>•</span><span><div>Detailed cognitive assessments, tracking longitudinal changes in cognitive function post-stroke</div></span></li><li><span>•</span><span><div>MRI scans to assess brain structure, potentially providing evidence of diet-related effects on the brain</div></span></li></ul></div></div><div><h3>Conclusions</h3><div>This study will evaluate the MIND diet intervention in preventing cognitive impairment in older adults after acute stroke. Findings will provide insights for the development of dietary guidelines for post-stroke care.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108108"},"PeriodicalIF":1.9,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145263167","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 pragmatic pre-post intervention trial to address adherence to lung cancer screening follow-up in community settings (the ACCELL trial): Study protocol","authors":"Tinnie Louie ,&nbsp;Madison Snidarich ,&nbsp;Daniel S. Hippe ,&nbsp;Karen J. Wernli ,&nbsp;Lorella Palazzo ,&nbsp;Laurel Hansell ,&nbsp;Meagan Brown ,&nbsp;Gloria D. Coronado ,&nbsp;Saba Lodhi ,&nbsp;Richard Leone ,&nbsp;Katie DeCell ,&nbsp;Kelly Mardesich ,&nbsp;Nicholas Wysham ,&nbsp;Matthew Triplette","doi":"10.1016/j.cct.2025.108106","DOIUrl":"10.1016/j.cct.2025.108106","url":null,"abstract":"<div><h3>Background</h3><div>Lung cancer remains the leading cause of cancer death in the United States. Annual lung cancer screening (LCS) with low-dose chest CT (LDCT) can prevent lung cancer deaths in high-risk individuals; However, these benefits are tempered by low adherence to annual screening and low rates of follow-up for those with abnormal findings.</div></div><div><h3>Objective</h3><div>To evaluate the impact of centralized approaches to care coordination on LCS follow-up in community settings through a hybrid implementation-effectiveness trial.</div></div><div><h3>Methods</h3><div>This is a pre-post intervention trial of a pragmatic and flexible approach to LCS care coordination delivered at the system-level at two community LCS programs based at regional hospitals in Washington state. Care coordination approaches include standardized LCS follow-up workflows incorporating universal tracking of LCS results, universal results delivery to patients, stepped approaches to follow-up reminders and personalized approaches to positive findings. Participants who are eligible for and undergo LCS during either period (n ∼ 6750) will be included. Primary outcomes include adjusted changes in screening adherence to annual follow-up and follow-up for positive findings between the pre- (August 2022–March 2025) and post- (March 2025–September 2027) intervention period. Secondary outcomes include assessing the impact of interventions by community site, patient ethnicity, socioeconomic status, and rurality. We will also assess the implementation of the intervention with attention to adaptation, sustainability and equity.</div></div><div><h3>Discussion</h3><div>Implementing centralizing care coordination models may decrease barriers and improve adherence to LCS in community settings and serve as a model to improve LCS follow-up in clinical care settings.</div><div>Registration: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID <span><span>NCT06324110</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"159 ","pages":"Article 108106"},"PeriodicalIF":1.9,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274006","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":"Examining the efficacy of a digital therapeutic to prevent suicidal ideation and behaviors in a primary care setting: Design and methodology of a randomized controlled trial with military service members","authors":"M. David Rudd ,&nbsp;Michelle Wine ,&nbsp;Rhea Pedler ,&nbsp;Melissa Wright ,&nbsp;Vivian L. Gleason ,&nbsp;Andrea Pérez-Muñoz ,&nbsp;Burak Tuna ,&nbsp;Jacob Tempchin ,&nbsp;Taylor A. Flowers ,&nbsp;Craig J. Bryan","doi":"10.1016/j.cct.2025.108107","DOIUrl":"10.1016/j.cct.2025.108107","url":null,"abstract":"<div><div>Suicide is a leading cause of death among active-duty military personnel. Although specialty mental health services are readily available, primary care clinics represent the most frequently accessed clinical setting immediately preceding suicide deaths and suicide attempts among service members. Primary care clinics offer a critical and unique opportunity to implement interventions targeting suicide prevention. Effective engagement and response to servicemembers with elevated suicide risk requires scalable alternatives to traditional mental health care. The central focus of this study is to test the efficacy of Aviva, a scalable, digital adaptation of Brief Cognitive Behavioral Therapy for Suicide Prevention in three primary care clinics with active-duty military servicemembers in comparison to treatment as usual. This paper describes the design, methodology, and protocol of an active randomized controlled trial comparing Aviva to treatment as usual. The impact on subsequent suicidal ideation and behaviors during a year-long follow-up period will be evaluated.</div><div>Clinical Trial Registration: <span><span>NCT06318962</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108107"},"PeriodicalIF":1.9,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274010","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 peer recovery coaching linkage (RC-link) intervention study: Protocol for a randomized controlled trial for alcohol use disorder recovery in the inpatient hospital setting","authors":"Kaileigh A. Byrne ,&nbsp;Irene Pericot-Valverde ,&nbsp;Lesley A. Ross ,&nbsp;Josephine Pittman ,&nbsp;Olivia Murphy ,&nbsp;Moonseong Heo ,&nbsp;Alain H. Litwin","doi":"10.1016/j.cct.2025.108097","DOIUrl":"10.1016/j.cct.2025.108097","url":null,"abstract":"<div><h3>Background</h3><div>Alcohol Use Disorder (AUD) can cause significant physical health complications, including withdrawal, pancreatitis, and cirrhosis, that require inpatient hospitalization. However, few evidence-based recovery support interventions have been implemented in inpatient settings, and sustained recovery rates remain low. One potential intervention to bridge this gap in post-discharge continuity of care is linkage to peer recovery coaching (PRC) services, a psychosocial model of care in which trained, certified professionals in recovery guide others through their recovery journey.</div></div><div><h3>Objectives</h3><div>This study seeks to test the Peer <u>R</u>ecovery <u>C</u>oaching <u>Link</u>age (RC-Link) intervention's impact on recovery outcomes, hospital utilization, and cost-effectiveness, as well as examine potential psychosocial mechanisms of change.</div></div><div><h3>Methods</h3><div>The RC-Link Study is a multi-site, prospective, two-arm randomized controlled trial that compares recovery outcomes in urban and rural settings over six months with a twelve-month follow-up. Participants with AUD will be recruited and randomized to either the RC-Link intervention or a control group receiving a brief, one-time intervention during hospitalization. The RC-Link intervention entails hospital-initiated linkage to a PRC plus six months of personalized support. The primary outcomes are changes in heavy drinking days and hospital costs. Secondary outcomes include AUD remission, biopsychosocial functioning, mortality, hospital utilization, and breath alcohol content. The predicted mechanisms of change are social support and self-efficacy. Measures will be assessed through longitudinal panel surveys and ecological momentary assessment.</div></div><div><h3>Conclusion</h3><div>The RC-Link Study will inform whether implementing of a long-term inpatient PRC linkage improves AUD recovery outcomes and reduces hospital utilization in a cost-effective manner.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108097"},"PeriodicalIF":1.9,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250214","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":"Implementation strategies for self-measured blood pressure monitoring in racially and ethnically diverse populations (InSPIRED): A study protocol","authors":"Elaine C. Khoong ,&nbsp;Hyunjin Cindy Kim ,&nbsp;Junhong Li ,&nbsp;Jorge Larreynaga ,&nbsp;Isabel Luna ,&nbsp;Andersen Yang ,&nbsp;Dhruv S. Kazi ,&nbsp;Courtney R. Lyles ,&nbsp;Charles McCulloch ,&nbsp;Sarah B. Rahman ,&nbsp;Urmimala Sarkar ,&nbsp;Natalie Curtis","doi":"10.1016/j.cct.2025.108101","DOIUrl":"10.1016/j.cct.2025.108101","url":null,"abstract":"<div><h3>Introduction</h3><div>Self-measured blood pressure (SMBP) monitoring with clinical support is an evidence-based practice to improve hypertension control. However, it can be challenging to implement in safety-net systems that disproportionately serve low-income and/or racial/ethnic minority populations at risk of worse hypertension outcomes. We therefore propose a hybrid effectiveness-implementation trial to evaluate the effectiveness of multi-level implementation strategies to increase the use of SMBP monitoring in two urban safety-net systems.</div></div><div><h3>Methods</h3><div>We will conduct a patient-level randomized controlled trial with 330 English-, Spanish-, and Chinese (Cantonese)-speaking patients with uncontrolled hypertension across six study sites with patients randomized to a low-intensity (SMBP education, text message education and reminders) vs. high-intensity intervention (adds group classes and engagement of identified caregivers). To support increased use of SMBP data by the clinical team, we will concurrently deliver a staggered roll-out of a clinic-level implementation strategy (clinic education, shadowing, auditing with feedback, and optimization of electronic health record [EHR] use).</div></div><div><h3>Results</h3><div>The primary outcomes will be clinic-measured systolic BP (SBP) among enrolled participants for the patient-level intervention and among all patients assigned to the clinic for the clinic-level intervention. We will additionally collect secondary clinical outcomes (BP control, home SBP), implementation outcomes (adoption, reach, and costs), and patient-reported outcomes (patient activation).</div></div><div><h3>Discussion</h3><div>The results of this trial will address gaps in identifying cost-conscious implementation strategies for increasing adoption of SMBP in safety-net systems with the overarching goal of improving blood pressure control in low-income, diverse patient populations.</div><div><strong>Trial registration</strong></div><div>NCT, <span><span>NCT06871462</span><svg><path></path></svg></span>. Registered 4 March 2025, <span><span>https://clinicaltrials.gov/study/NCT06871462</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108101"},"PeriodicalIF":1.9,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243758","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 chronic pain and suicide risk using Mindfulness-Based Cognitive Therapy: Rationale, design and baseline characteristics","authors":"Lisham Ashrafioun ,&nbsp;Anna Stephens ,&nbsp;Hugh F. Crean ,&nbsp;Autumn M. Gallegos ,&nbsp;Kyle Possemato ,&nbsp;Wilfred R. Pigeon","doi":"10.1016/j.cct.2025.108105","DOIUrl":"10.1016/j.cct.2025.108105","url":null,"abstract":"<div><h3>Introduction</h3><div>Suicide risk and chronic pain are significant public health problems affecting veterans at a disproportionally high rate. There is a dearth of interventions directly targeting both chronic pain and suicide risk. Mindfulness-Based Cognitive Therapy for Pain and Suicide (MBCT-P/S) integrates components from MBCT-Pain and MBCT-Suicide, both of which demonstrate promising effects on their respective targets. We provide an overview of the rationale, design, and baseline characteristics of a randomized clinical trial of MBCT-P/S to assess feasibility and treatment acceptability.</div></div><div><h3>Methods</h3><div>We refined a version of the MBCT-P/S drafted by the researchers through an evidence-based consensus method, integrating feedback from relevant subject matter experts. Veterans (<em>n</em> = 76) reporting death or suicidal ideation and functional impairment from chronic pain were recruited using Veterans Health Administration electronic medical record data. After consent, participants completed a baseline assessment and randomized to MBCT-P/S or Health Education.</div></div><div><h3>Results</h3><div>Baseline data revealed a diverse sample of veterans with a clinically severe profile that differed by condition on key suicide risk variables. Recruitment was completed faster than anticipated, supporting recruitment feasibility. Upcoming milestones include the completion of interventions and 1-, 3-, and 6-month follow-up assessments evaluating pain, suicide risk, and other key clinical indicators. Feasibility assessment will also include study retention by condition and therapist fidelity to the MBCT-P/S. Treatment acceptability will be assessed at the 1-month follow-up.</div></div><div><h3>Conclusions</h3><div>Data generated from this study will provide critical insights into conducting a fully-powered efficacy trial evaluating the impact of MBCT-P/S on pain and suicide risk outcomes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108105"},"PeriodicalIF":1.9,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243813","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 framework for monitoring intervention fidelity: The NOURISH trial","authors":"Jennifer Ventrelle ,&nbsp;Beth Lukaszewicz ,&nbsp;Megan Claysen ,&nbsp;Bhayva Setia ,&nbsp;Neelum T. Aggarwal ,&nbsp;Christy C. Tangney ,&nbsp;for the NOURISH Study Team","doi":"10.1016/j.cct.2025.108104","DOIUrl":"10.1016/j.cct.2025.108104","url":null,"abstract":"<div><h3>Background</h3><div>Nutrition can have a profound impact on chronic disease outcomes, but without periodic assessment of treatment fidelity, one cannot know whether the outcomes are due to an effective intervention or other unknown factors. Repeated measurement of fidelity of all treatments and across all interventionists will ensure the likelihood that treatment differences are maintained for the duration of the trial. This paper summarizes our efforts to assess treatment fidelity throughout the ongoing Phase III dietary intervention trial known as <strong>N</strong>utrition effects on Brain <strong>Ou</strong>tcomes and <strong>R</strong>ecovery <strong>i</strong>n <strong>S</strong>troke after <strong>H</strong>ospitalization (NOURISH), which tests whether acute stroke survivors' adoption of the <strong>M</strong>editerranean-DASH <strong>I</strong>ntervention for <strong>N</strong>eurodegenerative <strong>D</strong>elay (MIND) diet will slow annual cognitive decline compared to those assigned to receive enhanced usual care.</div></div><div><h3>Methods</h3><div>Templates and measures for treatment fidelity were developed according to five key components of treatment fidelity for the NOURISH trial: (1) intervention design and protocol, (2) training of interventionists, (3) treatment delivery (includes content and process), (4) treatment receipt, and (5) treatment enactment.</div></div><div><h3>Results</h3><div>Through periodic assessments of such measures, investigators ensured that the interventionists were delivering the intervention consistently according to protocol and learning what the participant understood and was willing to adopt. Moreover, the intervention was further refined to make it more responsive to the needs of the diverse participants during their stroke recovery.</div></div><div><h3>Conclusions</h3><div>The future success of disseminating and implementing public health programming for stroke recovery relies on finding the right balance between maintaining intervention fidelity and allowing for adaptability.</div><div><em>NCT 04337255.</em></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108104"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238421","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":"Self-Management for Youth Living with Sickle Cell Disease (SMYLS): A study protocol for a multisite randomized controlled trial testing a behavioral, mHealth app","authors":"Shannon Phillips ,&nbsp;Kaila Martin ,&nbsp;Alyssa M. Schlenz ,&nbsp;Julie Kanter ,&nbsp;Martina Mueller ,&nbsp;Jeffery Lebensburger ,&nbsp;Najibah Galandanci ,&nbsp;Beng R. Fuh ,&nbsp;Chelsea Rivenbark ,&nbsp;Ofelia A. Alvarez ,&nbsp;Rochelle F. Hanson ,&nbsp;Mohan Madisetti ,&nbsp;Margaret Prentice ,&nbsp;Teresa J. Kelechi","doi":"10.1016/j.cct.2025.108103","DOIUrl":"10.1016/j.cct.2025.108103","url":null,"abstract":"<div><div>Adolescents and young adults (AYA) with sickle cell disease (SCD) encounter adverse health events during transition to adult care. While AYA with SCD face complex barriers to care, negative outcomes can be mitigated by the development of self-management behaviors. Self-Management for Youth Living with Sickle Cell Disease (SMYLS) is an application designed to improve SCD specific self-management, with promising results from feasibility studies. This paper describes the next stage of SMYLS, a multisite, hybrid type 1 effectiveness-implementation randomized controlled trial. Trial aims are to evaluate the effectiveness of the mHealth application, including the role of patient activation; assess potential for wide-scale implementation; and explore the impact of socioenvironmental and psychosocial factors on outcomes. There will be 272 AYA with SCD and their caregivers enrolled and randomized to control or intervention arm (1:1) after assessing activation level. The intervention arm will receive usual care and be encouraged to use the application daily for an initial intervention period and a later “booster” period, while the control arm will receive usual care plus a version of the application with SCD educational materials. Study aims will be evaluated using mixed methods (participant surveys at 1, 3, 6, 9, and 12 months and interviews with participants and providers/clinic administrators post-intervention). The SMYLS intervention has the potential to inform widescale adoption of a self-management intervention for AYA with SCD. The results may have broader applicability for conducting trials among youth with chronic illnesses facing similar barriers to care and for studying engagement in mHealth self-management interventions.</div><div><strong>Clinical trial registration number.</strong></div><div><span><span>NCT06035939</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108103"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238338","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":"Randomized controlled trial of an Asian culture-tailored lung health intervention study for Chinese and Korean Americans: Study protocol","authors":"Sun S. Kim ,&nbsp;Manan M. Nayak ,&nbsp;Ling Shi ,&nbsp;Hua Chen ,&nbsp;Sohyon Pak ,&nbsp;Joosun Shin ,&nbsp;Chi-Fu Yang ,&nbsp;Fang Lei ,&nbsp;Mary E. Cooley","doi":"10.1016/j.cct.2025.108102","DOIUrl":"10.1016/j.cct.2025.108102","url":null,"abstract":"<div><div>Asian Americans are less likely to receive smoking cessation advice and more likely to be diagnosed with lung cancer at a distant stage of the disease than the general U.S. population. The primary outcomes of this study are the uptake of a lung cancer screening (LCS) test and biochemically verified smoking cessation abstinence 6 months after baseline assessment among 128 Asian Americans. The secondary outcomes include self-reported 7-day point prevalence abstinence at 1, 3, and 6 months. Participants will be randomized to either an experimental or a control group. The experimental group will receive a deep-level Asian culturally tailored lung health (ACT) intervention consisting of eight smoking cessation counseling sessions, education about the LCS test, and family coaching. Participants in the control group will receive a surface-level ACT intervention that includes six smoking cessation counseling sessions. Both groups will have the option of having counseling sessions via either video or telephone calls, depending on their preference. Counselors in both groups will be matched with participants based on ethnicity and language. Additionally, all participants irrespective of group allocation will receive combined nicotine replacement therapy (NRT) products and educational materials about LCS decision-aids and NRT products. The deep-level ACT intervention is a departure from previous interventions conducted with the Asian American population since it integrates smoking cessation with lung cancer screening education and actively addresses negative attitudes and beliefs toward NRT assessed at baseline during counseling sessions.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108102"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238356","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}