Pub Date : 2026-02-01Epub Date: 2025-12-17DOI: 10.1016/j.cct.2025.108183
Mukoso N. Ozieh , Charity G. Patterson , Joni S. Williams , Rebekah J. Walker , Leonard E. Egede
Background
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.
Methods and analysis
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.
Discussion
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.
Ethics and dissemination
This trial was approved by Medical College of Wisconsin IRB Protocol # PRO00041675.
Trial registration number
Registration for this trial can be found under ID: NCT05357742 and online (https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&draw=2&rank=1) on the NIH U.S. National Library of Medicine Clinical Trials Database.
{"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 , Charity G. Patterson , Joni S. Williams , Rebekah J. Walker , 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&draw=2&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":"2026-02-01","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}
Pub Date : 2026-02-01Epub Date: 2025-12-18DOI: 10.1016/j.cct.2025.108193
Henry K. Onyeaka , Manfred N. Mate-Kole , Irene A. Acheampong , Abigail Arthur , M. Tim Song , Ted O. Akhiwu , Diana Mensah , Chioma Ozoalor , Onyema G. Chido-Amajuoyi , Hermioni L. Amonoo
Background/Aims
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.
Methods
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.
Results
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.
Conclusions
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.
{"title":"Geographic location and clinical trial knowledge, invitation, and participation among adults in the United States","authors":"Henry K. Onyeaka , Manfred N. Mate-Kole , Irene A. Acheampong , Abigail Arthur , M. Tim Song , Ted O. Akhiwu , Diana Mensah , Chioma Ozoalor , Onyema G. Chido-Amajuoyi , 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":"2026-02-01","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}
Pub Date : 2026-02-01Epub Date: 2025-12-15DOI: 10.1016/j.cct.2025.108182
Paulo Henrique Leite Souza , Fernanda Marciano Consolim-Colombo , Bruno Paulino Venancio , Katia de Angelis , João Carlos Ferrari Corrêa , Márcio Gonçalves de Sousa , Raphael Mendes Ritti Dias , Fernanda Ishida Corrêa
Introduction
Hypertensive individuals experience chronic inflammation, higher sympathetic nervous system activity, and decreased functional capacity. While Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and aerobic training have shown benefits for hypertension, their combined effects have not been explored.
Objective
To evaluate the effects of taVNS combined with aerobic training on blood pressure, cardiac autonomic modulation, inflammation, oxidative stress, and functional capacity in individuals with hypertension.
Methods
This protocol outlines a randomized, controlled, single-blind clinical trial involving hypertensive adults. Participants will be randomly assigned to one of three groups: aerobic training with taVNS, aerobic training alone, or taVNS alone. Aerobic training will consist of 50 min of stationary cycling, while taVNS will be applied using a neuromuscular stimulator with an electrode placed on the left ear for 30 min. The intervention will be administered three times per week for 8 weeks, totaling 24 sessions. The primary outcome is blood pressure measurement, while secondary outcomes include heart rate variability, functional capacity, serum inflammatory mediators, and biomarkers of systemic oxidative stress. Assessments will be conducted before the intervention, after 24 sessions, and 30 days of post-treatment.
Results
The groups will be compared to the outcome measures to determine the taVNS benefits combined with aerobic training for hypertensive individuals.
Conclusion
This is the first clinical trial to assess the taVNS effects combined with physical exercise in hypertensive individuals. The study will provide data on this approach's efficacy for improving blood pressure, cardiac autonomic modulation, oxidative stress, and functional capacity in hypertensive people.
{"title":"Effects of auricular vagus nerve stimulation and aerobic training in individuals with hypertension – Protocol for a controlled, randomized, and blind clinical trial","authors":"Paulo Henrique Leite Souza , Fernanda Marciano Consolim-Colombo , Bruno Paulino Venancio , Katia de Angelis , João Carlos Ferrari Corrêa , Márcio Gonçalves de Sousa , Raphael Mendes Ritti Dias , Fernanda Ishida Corrêa","doi":"10.1016/j.cct.2025.108182","DOIUrl":"10.1016/j.cct.2025.108182","url":null,"abstract":"<div><h3>Introduction</h3><div>Hypertensive individuals experience chronic inflammation, higher sympathetic nervous system activity, and decreased functional capacity. While Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and aerobic training have shown benefits for hypertension, their combined effects have not been explored.</div></div><div><h3>Objective</h3><div>To evaluate the effects of taVNS combined with aerobic training on blood pressure, cardiac autonomic modulation, inflammation, oxidative stress, and functional capacity in individuals with hypertension.</div></div><div><h3>Methods</h3><div>This protocol outlines a randomized, controlled, single-blind clinical trial involving hypertensive adults. Participants will be randomly assigned to one of three groups: aerobic training with taVNS, aerobic training alone, or taVNS alone. Aerobic training will consist of 50 min of stationary cycling, while taVNS will be applied using a neuromuscular stimulator with an electrode placed on the left ear for 30 min. The intervention will be administered three times per week for 8 weeks, totaling 24 sessions. The primary outcome is blood pressure measurement, while secondary outcomes include heart rate variability, functional capacity, serum inflammatory mediators, and biomarkers of systemic oxidative stress. Assessments will be conducted before the intervention, after 24 sessions, and 30 days of post-treatment.</div></div><div><h3>Results</h3><div>The groups will be compared to the outcome measures to determine the taVNS benefits combined with aerobic training for hypertensive individuals.</div></div><div><h3>Conclusion</h3><div>This is the first clinical trial to assess the taVNS effects combined with physical exercise in hypertensive individuals. The study will provide data on this approach's efficacy for improving blood pressure, cardiac autonomic modulation, oxidative stress, and functional capacity in hypertensive people.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108182"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773894","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}
Pub Date : 2026-02-01Epub Date: 2026-01-02DOI: 10.1016/j.cct.2025.108211
Jennifer J. Salinas , Susan W. Buchholz , Zenong Yin , Jennifer L. Gay , Jing Wang , Janani Rajbhandari-Thapa , Mark G. Wilson , Erin Finley , Zuber Mulla , Elizabeth Ramirez , Deborah Parra Medina
Introduction
Mexican Americans living in the U.S.-Mexico border region suffer disproportionately from preventable cardiometabolic and cancer diseases. Workplace health promotion programs that include physical activity promotion are promising strategies to address this public health problem to improve physical activity engagement. Workplace-based programs can increase moderate to vigorous physical activity (MVPA) engagement while addressing barriers associated with inactivity.
Methods
We plan to conduct a clustered Sequential Multiple Assignment Randomized Trial (SMART) to determine the effectiveness of a workplace walking challenge intervention – 50,000 for Life (50K4Life) – in improving brisk walking engagement (at least 7000 steps/day, representing approximately 50,000 steps/week) for public school employees. The two-phase trial will include 30 public schools in two cohorts (15 per cohort) with predominantly Mexican American employees from El Paso County area schools in Texas on the U.S.-Mexico border. In Phase 1, the schools will be randomly assigned to 50K4Life or 50K4Life plus app-based push notifications. In Phase 2, schools with 50 % or more participants accumulating 50,000 steps/week will continue receiving the same intervention. The remaining schools will be randomly assigned to receive individual or school-level intervention. As part of our intervention evaluation, we will conduct a process and cost-effectiveness evaluation to provide insight into cost and scalability.
Discussion
This study will provide evidence to support the implementation of walking challenge-based interventions that improve engagement among Mexican Americans living in the U.S.-Mexico border region.
简介：生活在美墨边境地区的墨西哥裔美国人患可预防的心脏代谢疾病和癌症的比例过高。包括促进体育锻炼在内的工作场所健康促进计划是解决这一公共健康问题、提高体育锻炼参与度的有希望的策略。以工作场所为基础的项目可以增加中度到剧烈身体活动（MVPA）的参与度，同时解决与不活动相关的障碍。方法：我们计划进行一项聚类顺序多分配随机试验（SMART），以确定工作场所步行挑战干预- 50,000 for Life (50K4Life) -在改善公立学校员工的快走参与度（至少7000步/天，约50,000步/周）方面的有效性。这个两阶段的试验将包括30所公立学校，分为两组（每组15所），主要是墨西哥裔美国人，他们来自美墨边境德克萨斯州埃尔帕索县地区的学校。在第一阶段，学校将被随机分配到50K4Life或50K4Life加上应用程序推送通知。在第二阶段，有50% 或更多参与者每周累积50,000步的学校将继续接受相同的干预。剩下的学校将被随机分配接受个人或学校层面的干预。作为干预评估的一部分，我们将进行流程和成本效益评估，以深入了解成本和可扩展性。讨论：本研究将提供证据，支持基于步行挑战的干预措施的实施，以提高生活在美墨边境地区的墨西哥裔美国人的参与度。
{"title":"50k4Life: A SMART study protocol to improve walking engagement in public school employees on the US-Mexico border","authors":"Jennifer J. Salinas , Susan W. Buchholz , Zenong Yin , Jennifer L. Gay , Jing Wang , Janani Rajbhandari-Thapa , Mark G. Wilson , Erin Finley , Zuber Mulla , Elizabeth Ramirez , Deborah Parra Medina","doi":"10.1016/j.cct.2025.108211","DOIUrl":"10.1016/j.cct.2025.108211","url":null,"abstract":"<div><h3>Introduction</h3><div>Mexican Americans living in the U.S.-Mexico border region suffer disproportionately from preventable cardiometabolic and cancer diseases. Workplace health promotion programs that include physical activity promotion are promising strategies to address this public health problem to improve physical activity engagement. Workplace-based programs can increase moderate to vigorous physical activity (MVPA) engagement while addressing barriers associated with inactivity.</div></div><div><h3>Methods</h3><div>We plan to conduct a clustered Sequential Multiple Assignment Randomized Trial (SMART) to determine the effectiveness of a workplace walking challenge intervention – 50,000 for Life (50K4Life) – in improving brisk walking engagement (at least 7000 steps/day, representing approximately 50,000 steps/week) for public school employees. The two-phase trial will include 30 public schools in two cohorts (15 per cohort) with predominantly Mexican American employees from El Paso County area schools in Texas on the U.S.-Mexico border. In Phase 1, the schools will be randomly assigned to 50K4Life or 50K4Life plus app-based push notifications. In Phase 2, schools with 50 % or more participants accumulating 50,000 steps/week will continue receiving the same intervention. The remaining schools will be randomly assigned to receive individual or school-level intervention. As part of our intervention evaluation, we will conduct a process and cost-effectiveness evaluation to provide insight into cost and scalability.</div></div><div><h3>Discussion</h3><div>This study will provide evidence to support the implementation of walking challenge-based interventions that improve engagement among Mexican Americans living in the U.S.-Mexico border region.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108211"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145899306","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}
Pub Date : 2026-02-01Epub Date: 2025-12-24DOI: 10.1016/j.cct.2025.108204
Madeline E. Shivgulam , Mathieu Dumont , Shirko Ahmadi , Molly Courish , Luc Barrieau , Luc Cormier , Olga Theou , Saïd Mekari , Myles W. O'Brien
Background
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.
Methods
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.
Discussion
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.
Trial Registration: The protocol has been registered at clinicaltrials.gov (identifier: NCT06802289).
{"title":"Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial","authors":"Madeline E. Shivgulam , Mathieu Dumont , Shirko Ahmadi , Molly Courish , Luc Barrieau , Luc Cormier , Olga Theou , Saïd Mekari , 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":"2026-02-01","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}
Pub Date : 2026-02-01Epub Date: 2025-12-16DOI: 10.1016/j.cct.2025.108188
Shivan J. Mehta , Pamela A. Shaw , Catherine Reitz , Caitlin Brophy , Evelyn Okorie , Keyirah Williams , Abraham Segura , Jinming Tao , Christopher K. Snider , Colin Wollack , Sadie Friday , Katharine A. Rendle , Tamar Klaiman , Karen Glanz , Corinne Rhodes , David A. Asch
Background
Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR).
Methods
In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year.
Analysis
For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b).
Conclusion
This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design.
{"title":"Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial","authors":"Shivan J. Mehta , Pamela A. Shaw , Catherine Reitz , Caitlin Brophy , Evelyn Okorie , Keyirah Williams , Abraham Segura , Jinming Tao , Christopher K. Snider , Colin Wollack , Sadie Friday , Katharine A. Rendle , Tamar Klaiman , Karen Glanz , Corinne Rhodes , David A. Asch","doi":"10.1016/j.cct.2025.108188","DOIUrl":"10.1016/j.cct.2025.108188","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR).</div></div><div><h3>Methods</h3><div>In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year.</div></div><div><h3>Analysis</h3><div>For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b).</div></div><div><h3>Conclusion</h3><div>This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design.</div><div><em>Clinical Trials Identifier:</em> <span><span>NCT05693649</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108188"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780538","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}
Pub Date : 2026-02-01Epub Date: 2025-12-24DOI: 10.1016/j.cct.2025.108208
Cynthia A. Fontanella , Jennifer L. Hughes , Guy Brock , Donna A. Ruch , Alex R. Kemper , Alicia C. Bunger , Dan M. Walker , Ann Scheck McAlearney , Tensing Maa , Melissa Miller , Priyanka Desirazu , Jeremy Obee , Jeffrey A. Bridge
Background
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.
Purpose
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.
Methods
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.
Conclusions
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.
{"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 , Jennifer L. Hughes , Guy Brock , Donna A. Ruch , Alex R. Kemper , Alicia C. Bunger , Dan M. Walker , Ann Scheck McAlearney , Tensing Maa , Melissa Miller , Priyanka Desirazu , Jeremy Obee , 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":"2026-02-01","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}
Pub Date : 2026-02-01Epub Date: 2025-12-21DOI: 10.1016/j.cct.2025.108200
Madeline R. Sterling , Michelle Shum , Ronica Peramsetty , Joselyne Aucapina , Faith Wiggins , Carmen Colon , Joanna Bryan Ringel , Ariel C. Avgar , Nicola Dell , Bibi N. Habib , Samprit Banerjee , Emma Tsui , Susan J. Andreae , Elissa Kozlov , Courtney Landis , Ian René Solano-Kamaiko , Monika M. Safford
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 Living Healthy Program for HHAs 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.
{"title":"iMprovIng the meNtal hEalth of home healTh AiDeS: A study protocol for the MINDSET study","authors":"Madeline R. Sterling , Michelle Shum , Ronica Peramsetty , Joselyne Aucapina , Faith Wiggins , Carmen Colon , Joanna Bryan Ringel , Ariel C. Avgar , Nicola Dell , Bibi N. Habib , Samprit Banerjee , Emma Tsui , Susan J. Andreae , Elissa Kozlov , Courtney Landis , Ian René Solano-Kamaiko , 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":"2026-02-01","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}
Pub Date : 2026-02-01Epub Date: 2025-12-24DOI: 10.1016/j.cct.2025.108209
Lynnea Myers , Tracey A. Brereton , Shauna Overgaard , Jason D. Greenwood , Lu Zheng , Joshua W. Ohde , Matthew Spiten , R.N. Kathy Ihrke , Kristi Lang , Kevin Peterson , Stephen Hawley , Madison Beenken , M. Malik , Josh Bublitz , Taylor Galloway , Quantia Wilkes , Danielle Shrader , Lydia Mercado , Miguel Park , Manuel Arteta , Young Juhn
Background
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.
Methods
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.
Conclusion
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.
Trial Registration: Registered via ClinicalTrials.govNCT06062433
Significance
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 ClinicalTrials.gov database (NCT06062433). Authorship on publications will follow international standards for authorship (i.e., ICMJE).
{"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 , Tracey A. Brereton , Shauna Overgaard , Jason D. Greenwood , Lu Zheng , Joshua W. Ohde , Matthew Spiten , R.N. Kathy Ihrke , Kristi Lang , Kevin Peterson , Stephen Hawley , Madison Beenken , M. Malik , Josh Bublitz , Taylor Galloway , Quantia Wilkes , Danielle Shrader , Lydia Mercado , Miguel Park , Manuel Arteta , 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":"2026-02-01","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}
Pub Date : 2026-02-01Epub Date: 2025-12-16DOI: 10.1016/j.cct.2025.108191
Kerri N. Boutelle , Dawn M. Eichen , Michael Manzano , Noe C. Crespo , Ingrid Rivera-Iñiguez , Eduardo Castro , David R. Strong , Isabella Newell , Kristie Reed , Becky Marquez , Kyung E. Rhee
Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB.
{"title":"Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families","authors":"Kerri N. Boutelle , Dawn M. Eichen , Michael Manzano , Noe C. Crespo , Ingrid Rivera-Iñiguez , Eduardo Castro , David R. Strong , Isabella Newell , Kristie Reed , Becky Marquez , Kyung E. Rhee","doi":"10.1016/j.cct.2025.108191","DOIUrl":"10.1016/j.cct.2025.108191","url":null,"abstract":"<div><div>Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB.</div><div>Clinical trials # <span><span>NCT05437406</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108191"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780530","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}
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