Contemporary clinical trials最新文献

{"title":"Study design and methodologies for the men moving forward lifestyle intervention trial with black prostate cancer survivors","authors":"Iwalola Awoyinka ,&nbsp;Patricia Sheean ,&nbsp;Paula Papanek ,&nbsp;Kathryn E. Flynn ,&nbsp;Kathryn Bylow ,&nbsp;Deepak Kilari ,&nbsp;Peter Gann ,&nbsp;Anjishnu Banerjee ,&nbsp;Melinda Stolley","doi":"10.1016/j.cct.2025.108205","DOIUrl":"10.1016/j.cct.2025.108205","url":null,"abstract":"<div><h3>Backgound</h3><div>Prostate cancer (PC) incidence and mortality rates are significantly higher among Black/African-American (Black) men compared to men of other race/ethnicities. Comorbidities and compromised quality of life are also greater challenges for this community of men. Many factors drive these differences among which body composition and health behaviors are important, yet modifiable contributors. Lifestyle interventions report beneficial results for PC survivors; however, the inclusion of Black men is critically limited. This paper describes Men Moving Forward (MMF) –a community-based lifestyle intervention for Black men with PC.</div></div><div><h3>Methods/Design</h3><div>This trial will randomize (1:1) 200 Black men with PC who completed treatment or are on active surveillance. The 16-week MMF intervention, conducted in partnership with the Milwaukee Recreation system, supports adoption of the American Cancer Society Nutrition and Physical Activity guidelines. Measures of body composition (primary), behavior (diet, physical activity), fitness, quality of life, and biomarkers of general health and PC recurrence risk are collected at baseline, post-intervention and at a 12-month follow-up. The primary hypothesis is that men receiving the MMF intervention will exhibit greater changes in body composition than those in the wait-list control group.</div></div><div><h3>Discussion</h3><div>The MMF trial addresses an important gap in the current literature, evaluating the potential efficacy of a lifestyle program developed with and for Black men with PC. Outcomes including body composition and biomarkers of general health and PC recurrence risk add to our knowledge and methodologies on health behaviors and PC survivorship. Study results will inform survivorship efforts for this high-risk, underrepresented population.</div><div>U.S. <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> number: <span><span>NCT03971591</span><svg><path></path></svg></span>, 06.01.2019.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108205"},"PeriodicalIF":1.9,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843578","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":"Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial","authors":"Madeline E. Shivgulam ,&nbsp;Mathieu Dumont ,&nbsp;Shirko Ahmadi ,&nbsp;Molly Courish ,&nbsp;Luc Barrieau ,&nbsp;Luc Cormier ,&nbsp;Olga Theou ,&nbsp;Saïd Mekari ,&nbsp;Myles W. O'Brien","doi":"10.1016/j.cct.2025.108204","DOIUrl":"10.1016/j.cct.2025.108204","url":null,"abstract":"<div><h3>Background</h3><div>Hospitalized older adults spend excessive amounts of time in sedentary postures (sitting/lying while awake). Mobilizing patients may prevent physical deconditioning, exacerbated frailty levels, and worsened hospital outcomes. The purpose of this study will be to test the hypothesis that compared to usual care, patients who receive multiple kinesiologist visits each day will, 1) increase their step counts and upright time, 2) decrease their frailty levels from admission to discharge, and 3) have shorter lengths of stays and decreased readmission rates.</div></div><div><h3>Methods</h3><div>Sixty middle-aged-to-older adult patients (≥50 years) from a general/internal medicine unit will be randomized into a usual care control (visit from the kinesiologist once/day) or intervention group (multiple visits from the kinesiologist/day). Kinesiologist visits will include individualized patient mobilization. All participants will be equipped with three waterproofed activPAL inclinometers positioned on their thigh, torso, and shin for 24-h/day throughout hospitalization to measure physical activity (step counts, physical activity intensity), upright postures, and detailed sedentary postures (bent-legged sitting, straight-legged sitting, lying). Frailty will be assessed via a validated 65-item index and the Clinical Frailty Scale two weeks before admission (retrospectively), at admission, and at discharge. Secondary measures will include length of stay and hospital re-admissions. Mixed models for repeated measures will determine whether daily activity differed between groups, changed throughout hospital stay, and effected frailty levels.</div></div><div><h3>Discussion</h3><div>This randomized controlled trial will aim to refine mobilization strategies and individualize interventions for the prevention of decline in mobility and worsening frailty among hospitalized patients.</div><div>Trial Registration: The protocol has been registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (identifier: <span><span>NCT06802289</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108204"},"PeriodicalIF":1.9,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843541","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":"Pediatric asthma management via integration of a remote spirometry device into an EHR-based artificial intelligence-powered clinical decision support system: A feasibility pragmatic clinical trial","authors":"Lynnea Myers ,&nbsp;Tracey A. Brereton ,&nbsp;Shauna Overgaard ,&nbsp;Jason D. Greenwood ,&nbsp;Lu Zheng ,&nbsp;Joshua W. Ohde ,&nbsp;Matthew Spiten ,&nbsp;R.N. Kathy Ihrke ,&nbsp;Kristi Lang ,&nbsp;Kevin Peterson ,&nbsp;Stephen Hawley ,&nbsp;Madison Beenken ,&nbsp;M. Malik ,&nbsp;Josh Bublitz ,&nbsp;Taylor Galloway ,&nbsp;Quantia Wilkes ,&nbsp;Danielle Shrader ,&nbsp;Lydia Mercado ,&nbsp;Miguel Park ,&nbsp;Manuel Arteta ,&nbsp;Young Juhn","doi":"10.1016/j.cct.2025.108209","DOIUrl":"10.1016/j.cct.2025.108209","url":null,"abstract":"<div><h3>Background</h3><div>Asthma is the most common chronic disease in children. Suboptimal asthma control is prevalent and causes significant health care costs. Electronic health records (EHRs) contain vast data which pose a major challenge for timely and efficient access to relevant information for clinical decision making. To address this challenge, a machine learning and natural language processing models-powered clinical decision support system (CDS) called Asthma-Guidance Prediction System (A-GPS) was developed. A-GPS automatically extracts and synthesizes pertinent patient data from EHRs for asthma management. To further enhance A-GPS, real-time patient data was added from a home spirometry device and mobile app system (AsthmaTuner), that remotely collected patient-reported outcomes for asthma control and lung function and delivered a clinician-prescribed Asthma Action Plan from EHR to patients. The goal of the study was to assess the feasibility and satisfaction of implementation of an integrated A-GPS with AsthmaTuner for remote asthma management within pediatric primary care.</div></div><div><h3>Methods</h3><div>Study design was a parallel-group, non-blinded, dual-site, 2-arm pragmatic, randomized clinical trial (RCT) with 22 dyads (one clinician and one pediatric patient) at Mayo Clinic Health System and Mayo Clinic, Rochester, Minnesota. The primary endpoint was successful implementation of the integrated A-GPS with AsthmaTuner in primary care and study participants' satisfaction.</div></div><div><h3>Conclusion</h3><div>The technological integration and application of the integrated A-GPS and AsthmaTuner in primary care as a clinical CDS for remote asthma management was feasible. This protocol provides developers with a framework for the best practices for evaluating AI tools and enables digital technology via an RCT.</div><div>Trial Registration: Registered via <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06062433</span><svg><path></path></svg></span></div></div><div><h3>Significance</h3><div>We anticipate this study will establish a conceptual and operational framework for implementing AI-powered CDS in pediatric asthma management, with the goal that these methodological advancements will be expanded to the management of adults with asthma and other chronic complex diseases. Reporting a clinical trial protocol for the evaluation of an AI tool and following the reporting guidelines are valuable for establishing best practices evaluating AI tools, specifically for the developers and other key stakeholders who plan to evaluate AI models via RCTs in health care settings. We plan to communicate our trial results via publication and reporting in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> database (<span><span>NCT06062433</span><svg><path></path></svg></span>). Authorship on publications will follow international standards for authorship (i.e., ICMJE).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108209"},"PeriodicalIF":1.9,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843562","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":"STARRS-PC: A stepped approach to reducing suicide in primary care: Design and methods of a hybrid type 1 effectiveness-implementation trial","authors":"Cynthia A. Fontanella ,&nbsp;Jennifer L. Hughes ,&nbsp;Guy Brock ,&nbsp;Donna A. Ruch ,&nbsp;Alex R. Kemper ,&nbsp;Alicia C. Bunger ,&nbsp;Dan M. Walker ,&nbsp;Ann Scheck McAlearney ,&nbsp;Tensing Maa ,&nbsp;Melissa Miller ,&nbsp;Priyanka Desirazu ,&nbsp;Jeremy Obee ,&nbsp;Jeffrey A. Bridge","doi":"10.1016/j.cct.2025.108208","DOIUrl":"10.1016/j.cct.2025.108208","url":null,"abstract":"<div><h3>Background</h3><div>Suicide is the second leading cause of death among youth aged 12–17. Although most at-risk youth receive primary care, routine screening is limited in primary care due to provider discomfort, time constraints, limited training, and inadequate referral sources. Research evaluating and implementing suicide prevention strategies in pediatric primary care is vitally needed.</div></div><div><h3>Purpose</h3><div>We aim to test the effectiveness of the Stepped Approach to Reducing Suicide in Primary Care (STARRS-PC), a population-based quality improvement intervention implementing a structured clinical pathway consisting of risk detection, assessment and triage, and follow-up with transitional care.</div></div><div><h3>Methods</h3><div>A stepped wedge cluster randomized design will evaluate the effectiveness of STARRS-PC compared to treatment as usual (TAU) across 16 primary care sites. 2324 adolescents aged 12–17 screening positive for suicide risk will be enrolled (1033 in the TAU phase; 1291 in the intervention phase). Primary outcomes include suicide attempts and deaths. Secondary outcomes are suicidal ideation, non-suicidal self-injury, and family satisfaction. Youth and parents will complete assessments at baseline, 3, 6, and 12 months. Tests of moderation and mediation will be conducted to understand finding generalizability and identify variables that change as a result of the intervention and are associated with suicide attempts/death. Implementation outcomes (reach, adoption, maintenance, feasibility, and acceptability) will be evaluated through provider surveys and qualitative interviews.</div></div><div><h3>Conclusions</h3><div>This study will provide evidence on the effectiveness and implementation of a quality improvement supported, structured suicide prevention pathway in pediatric primary care, which could transform youth suicide risk identification and management.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108208"},"PeriodicalIF":1.9,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145838280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"iMprovIng the meNtal hEalth of home healTh AiDeS: A study protocol for the MINDSET study","authors":"Madeline R. Sterling ,&nbsp;Michelle Shum ,&nbsp;Ronica Peramsetty ,&nbsp;Joselyne Aucapina ,&nbsp;Faith Wiggins ,&nbsp;Carmen Colon ,&nbsp;Joanna Bryan Ringel ,&nbsp;Ariel C. Avgar ,&nbsp;Nicola Dell ,&nbsp;Bibi N. Habib ,&nbsp;Samprit Banerjee ,&nbsp;Emma Tsui ,&nbsp;Susan J. Andreae ,&nbsp;Elissa Kozlov ,&nbsp;Courtney Landis ,&nbsp;Ian René Solano-Kamaiko ,&nbsp;Monika M. Safford","doi":"10.1016/j.cct.2025.108200","DOIUrl":"10.1016/j.cct.2025.108200","url":null,"abstract":"<div><div>Home health aides and attendants (HHAs) are a fast-growing healthcare workforce who are integral to the rising movement that allows older adults to age in place. However, HHAs themselves are a vulnerable group of caregivers. Mostly middle-aged women of color paid dismally low wages, HHAs' work is physically taxing, emotionally challenging, and socially isolating. Consequently, HHAs have high levels of depressive symptoms and stress. Prior studies suggest that HHAs want to address this, but do not know how and cannot access or afford traditional mental health services. Here we describe the protocol for a pilot randomized control trial (RCT) that aims to improve the mental health of HHAs through peer coaching (PC), an established and effective behavioral health intervention which has never been applied to HHAs or their workplace, the home environment. In collaboration with a labor and management fund of the largest healthcare union in the US (1199SEIU), we will conduct a single-site parallel arm pilot RCT with 100 HHAs to evaluate the feasibility, acceptability, and effectiveness of an adapted <em>Living Healthy Program for HHAs</em> delivered by PCs (intervention arm) vs. a general health promotion program (attention control arm). Primary effectiveness outcome will be a reduction in depressive symptoms; secondary effectiveness outcomes will be a reduction in stress and loneliness. This study offers a novel and potentially scalable way to improve the health of HHAs, an often overlooked, undervalued, but increasingly vital workforce that is needed to care for our rapidly aging population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108200"},"PeriodicalIF":1.9,"publicationDate":"2025-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145818368","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 pharmaceutically enhanced reinforcement for reduced alcohol and smoking (PERRAS) study: Protocol for a randomized clinical trial","authors":"Paola Palombo ,&nbsp;Nicole Akana ,&nbsp;Abigail Bowen ,&nbsp;Alex Schmidt ,&nbsp;Rachel Ryan ,&nbsp;Sean Hovland ,&nbsp;B. Connor Stark ,&nbsp;Nicole Rodin ,&nbsp;Naomi Chaytor ,&nbsp;Michael G. McDonell ,&nbsp;Ekaterina Burduli ,&nbsp;Matthew Layton ,&nbsp;John M. Roll ,&nbsp;Crystal L. Smith ,&nbsp;André Q. Miguel ,&nbsp;Sterling M. McPherson","doi":"10.1016/j.cct.2025.108189","DOIUrl":"10.1016/j.cct.2025.108189","url":null,"abstract":"<div><h3>Background</h3><div>Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes.</div></div><div><h3>Methods</h3><div>Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months.</div></div><div><h3>Conclusions</h3><div>If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108189"},"PeriodicalIF":1.9,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145803361","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":"Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents","authors":"Andrea B. Goldschmidt ,&nbsp;Adrian Ortega ,&nbsp;Isabel R. Rooper ,&nbsp;Katrina T. Obleada ,&nbsp;Danielle A.N. Chapa ,&nbsp;Basia Silverberg ,&nbsp;Erin Stalvey ,&nbsp;Macarena Kruger Camino ,&nbsp;Michele D. Levine ,&nbsp;Lan Yu ,&nbsp;Dawn M. Eichen ,&nbsp;Andrea K. Graham","doi":"10.1016/j.cct.2025.108192","DOIUrl":"10.1016/j.cct.2025.108192","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with overweight/obesity that may undermine weight control treatment outcome. Cognitive-behavioral therapy (CBT) has promising effects on dysregulated eating, but effects on weight are modest, access is limited, and developmental changes in self-regulation (which may limit implementation of treatment skills) are often ignored. <u>Methods</u>: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (<em>n</em> = 25–30) who have body mass index (BMI; kg/m²) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets. <u>Conclusions</u>: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes.</div><div><strong>Clinical trial registration number</strong>: <span><span>NCT06819813</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108192"},"PeriodicalIF":1.9,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789069","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":"Geographic location and clinical trial knowledge, invitation, and participation among adults in the United States","authors":"Henry K. Onyeaka ,&nbsp;Manfred N. Mate-Kole ,&nbsp;Irene A. Acheampong ,&nbsp;Abigail Arthur ,&nbsp;M. Tim Song ,&nbsp;Ted O. Akhiwu ,&nbsp;Diana Mensah ,&nbsp;Chioma Ozoalor ,&nbsp;Onyema G. Chido-Amajuoyi ,&nbsp;Hermioni L. Amonoo","doi":"10.1016/j.cct.2025.108193","DOIUrl":"10.1016/j.cct.2025.108193","url":null,"abstract":"<div><h3>Background/Aims</h3><div>Clinical trials are essential to evaluating novel treatments and improving disease-related outcomes through innovative therapies. Despite underrepresentation of rural communities in clinical trial outreach and participation, geographic disparities in clinical trials have been minimally explored. We examined clinical trial knowledge, invitation, and participation among participants in urban and rural geographic locations in the United States.</div></div><div><h3>Methods</h3><div>We conducted cross-sectional data analysis on self-reported data from Health Information National Trends Survey (HINTS) 5 Cycle 4. Population-level estimates were obtained using jack-knife replicate weights.</div></div><div><h3>Results</h3><div>Geographic location was not associated with clinical trial knowledge, invitation, and participation. However, the relatively low absolute invitation rates across urban and rural populations may suggest that substantial gaps in recruitment persist universally, regardless of geographic location in the United States.</div></div><div><h3>Conclusions</h3><div>In this nationally representative study, we found no statistically significant differences in clinical trial knowledge, invitation or participation by geographical location in the United States. Our findings suggest that geographic residence may not be a primary barrier to clinical trial engagement once sociodemographic differences are accounted for. Targeted efforts to improve awareness and reduce structural barriers, along with continued investment in equitable recruitment strategies, will be important to ensuring that clinical trials reflect the diversity of the populations they aim to serve.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108193"},"PeriodicalIF":1.9,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800107","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":"Remotely-delivered exercise training program among older adults with multiple sclerosis: Feasibility results of a randomized controlled trial","authors":"Peixuan Zheng ,&nbsp;Sydney R. DeJonge ,&nbsp;Noah G. DuBose ,&nbsp;Ariel Kidwell-Chandler ,&nbsp;Trevor B. Martin ,&nbsp;Trinh L.T. Huynh ,&nbsp;Shane A. Phillips ,&nbsp;Jennifer Duffecy ,&nbsp;Robert W. Motl","doi":"10.1016/j.cct.2025.108190","DOIUrl":"10.1016/j.cct.2025.108190","url":null,"abstract":"<div><h3>Background</h3><div>Older adults with multiple sclerosis (MS) are often physically inactive and present with walking and cognitive impairments that may be remediated through rehabilitation approaches such as exercise training.</div></div><div><h3>Objectives</h3><div>We conducted a phase-Ib, randomized controlled trial (RCT) that examined the feasibility and initial efficacy of a 16-week remotely-delivered, home-based exercise training program in older adults with MS who had moderate mobility disability.</div></div><div><h3>Methods</h3><div>This study utilized a parallel-group RCT design. Participants (<em>n</em> = 51; mean age = 60.5 years, 78 % females) were randomized into exercise training (aerobic and resistance) or active control (stretching) conditions. Both conditions were undertaken within a participant's home/community and remotely supported by a behavioral coach. Participants received training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and social cognitive theory-based newsletters. Feasibility was assessed across process, resource, management, and scientific domains. Scientific outcomes focused on physical function, cognition, and physical activity, with data collected by treatment-blinded assessors.</div></div><div><h3>Results</h3><div>The intervention was cost-effective, accessible, well-received, and safe based on formative evaluation. Forty-one (80.4 %) participants completed the conditions, with adherence and compliance rates across conditions exceeding 80 %. There were moderate-to-large improvements in walking speed, functional mobility, lower-extremity function, and verbal learning and memory (<em>p</em> &lt; 0.05, <em>|d|</em> = 0.58–0.80) in the exercise condition, but not in control (<em>p</em> &gt; 0.05).</div></div><div><h3>Conclusions</h3><div>This study established the feasibility and initial efficacy of a theory-based, remotely-delivered exercise training intervention for older adults with MS. The promising results support the design and implementation of a subsequent, phase-II RCT for improving physical and cognitive functions in the older MS population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108190"},"PeriodicalIF":1.9,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789180","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":"Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol","authors":"Mukoso N. Ozieh ,&nbsp;Charity G. Patterson ,&nbsp;Joni S. Williams ,&nbsp;Rebekah J. Walker ,&nbsp;Leonard E. Egede","doi":"10.1016/j.cct.2025.108183","DOIUrl":"10.1016/j.cct.2025.108183","url":null,"abstract":"<div><h3>Background</h3><div>Diabetic kidney disease (DKD) is the leading cause of end stage kidney disease (ESKD) in the United States. African Americans have a risk of developing chronic kidney disease and are almost four times more likely to progress to ESKD compared to non-Hispanic whites. The presence of social adversities impacts the complex self-management of DKD and negatively impacts health outcomes. Patient navigation interventions offer a promising strategy to improve health outcomes in individuals with chronic disease. However, it is not known whether a basic needs navigation intervention that addresses social adversities in combination with patient education and lifestyle coaching leads to improved clinical and patient-centered outcomes.</div></div><div><h3>Methods and analysis</h3><div>This ongoing 3-year two-arm pilot randomized clinical trial will test the feasibility of a basic needs navigation intervention in African American adults with DKD experiencing multidimensional adversity (having one or more social adversity). Fifty African American adults with DKD experiencing one or more social adversity and who have uncontrolled diabetes (HbA1c 8 % or more) will be randomized into one of two arms: 1) basic needs navigation intervention arm or 2) enhanced usual care arm. The primary clinical outcome is feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention.</div></div><div><h3>Discussion</h3><div>The results of this study will serve as a first step in addressing current gaps in knowledge and will provide feasibility data for a large-scale appropriately powered, randomized clinical trial focused on addressing social adversity in African American adults with DKD.</div></div><div><h3>Ethics and dissemination</h3><div>This trial was approved by Medical College of Wisconsin IRB Protocol # PRO00041675.</div></div><div><h3>Trial registration number</h3><div>Registration for this trial can be found under ID: <span><span>NCT05357742</span><svg><path></path></svg></span> and online (<span><span>https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&amp;draw=2&amp;rank=1</span><svg><path></path></svg></span>) on the NIH U.S. National Library of Medicine Clinical Trials Database.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108183"},"PeriodicalIF":1.9,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145793408","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}