Contemporary clinical trials最新文献

{"title":"Effect of cyclic daytime versus continuous enteral nutrition on circadian rhythms in critical illness (CIRCLES): Study protocol for a randomized controlled trial","authors":"Floor W. Hiemstra ,&nbsp;Marit F. van Gent ,&nbsp;Evert de Jonge ,&nbsp;David J. van Westerloo ,&nbsp;Laura Kervezee","doi":"10.1016/j.cct.2025.107927","DOIUrl":"10.1016/j.cct.2025.107927","url":null,"abstract":"<div><h3>Background</h3><div>Circadian rhythms and sleep are often disrupted in critically ill patients in the intensive care unit (ICU), which has been linked to poor clinical outcomes. Feeding-fasting cycles serve as a synchronizing cue for the circadian timing system, indicating that optimizing these cycles in the ICU could reinforce circadian rhythms. The CIRCLES trial evaluates whether cyclic daytime enteral nutrition improves 24-h rhythms in critically ill patients compared to continuous enteral nutrition.</div></div><div><h3>Objective</h3><div>To describe the study protocol for the CIRCLES study.</div></div><div><h3>Study design</h3><div>The CIRCLES study is an investigator-initiated randomized controlled trial in a tertiary care ICU in the Netherlands. Patients (aged ≥18 years) admitted to the ICU with an expected stay ≥48 h receiving or with intention to start enteral nutrition are eligible for inclusion. Patients (<em>n</em> = 60) are randomized to the <em>continuous</em> enteral nutrition (nutrition around the clock) or <em>cyclic</em> daytime enteral nutrition group (nutrition between 08:00 h to 20:00 h).</div></div><div><h3>Main outcome measures</h3><div>The primary outcome is the amplitude of 24-h rhythms in core body temperature. Secondary outcomes include 24-h rhythms in heart rate, mean blood pressure heart rate variability, melatonin and gene expression, glucose regulation, insulin administration, caloric intake and feeding intolerance.</div></div><div><h3>Conclusion</h3><div>We hypothesize that a cyclic daytime feeding strategy will result in a higher amplitude of 24-h rhythms in vital signs, heart rate variability, and melatonin, compared to continuous feeding, thereby suggesting improved circadian rhythm strength. This study aims to provide insight into strategies to optimize circadian rhythms in ICU patients.</div></div><div><h3>Trial registration</h3><div>Registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05795881</span><svg><path></path></svg></span>), April 2023.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107927"},"PeriodicalIF":2.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143899630","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":"Workforce and systems change to treat adolescent substance use disorder within integrated pediatric primary care: A cluster-randomized stepped-wedge trial","authors":"Leslie A. Hulvershorn ,&nbsp;Matthew Aalsma ,&nbsp;Trey V. Dellucci ,&nbsp;Ashlyn Burns ,&nbsp;Brigid R. Marriott ,&nbsp;Bernice Pescosolido ,&nbsp;Harold D. Green Jr. ,&nbsp;Lisa Saldana ,&nbsp;Jason Chapman ,&nbsp;Patrick Monahan ,&nbsp;Sarah E. Wiehe ,&nbsp;Edward J. Miech ,&nbsp;Zachary W. Adams","doi":"10.1016/j.cct.2025.107928","DOIUrl":"10.1016/j.cct.2025.107928","url":null,"abstract":"<div><h3>Background</h3><div>While the overdose crisis has impacted all ages, overdose-related deaths among adolescents have been increasing more rapidly than any other age group, doubling between 2019 and 2020. Identifying and treating substance use disorders (SUDs) among adolescents is critical to preventing adolescent overdose deaths. While evidence-based interventions for adolescents with SUDs exist, they remain underutilized. Implementing SUD interventions in primary care settings through integrated behavioral health (IBH) is one approach for increasing access to evidence-based SUD services for adolescents.</div></div><div><h3>Methods</h3><div>This is a Hybrid Type 2, cluster-randomized, stepped-wedge trial comparing SUD IBH to standard primary care treatment. In our open cohort stepped-wedge design, primary care clinics will be randomly designated to one of three cohorts. We will use a mixed-methods approach to evaluate both implementation and effectiveness outcomes, with a focus on assessing the impact of IBH on primary care provider behaviors around SUD interventions. All cohorts will complete baseline surveys during the control condition and then every 6 months. At each time point, we will also collect and analyze patient administrative data to assess patient engagement and outcomes. In addition, we will conduct qualitative interviews at pre-, mid-, and post-implementation during sustainment of the intervention.</div></div><div><h3>Conclusion</h3><div>Addressing the overdose crisis is a national priority. IBH has the potential to reduce overdose rates by enhancing primary care provider willingness to deliver SUD services for adolescents.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107928"},"PeriodicalIF":2.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143892153","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 data credibility in online recruitment: Signs and strategies for detecting fraudulent participants when using ResearchMatch","authors":"Lauren M. Pageau,&nbsp;Jiying Ling","doi":"10.1016/j.cct.2025.107925","DOIUrl":"10.1016/j.cct.2025.107925","url":null,"abstract":"<div><h3>Introduction</h3><div>Online recruitment platforms are valuable tools that allow researchers to efficiently reach large pools of potential participants for clinical trials and observational studies. However, challenges associated with fraudulent respondents and bots threaten data credibility. This paper discusses signs we identified for recognizing potentially fraudulent respondents when using one online recruitment tool, ResearchMatch, to recruit study participants.</div></div><div><h3>Methods</h3><div>Participants were recruited via ResearchMatch for a study focused on stress and coping among U.S. young, low-income parents. Participants completed an online survey via Qualtrics. To screen for fraudulent respondents, we compared reports generated from Qualtrics with those from ResearchMatch.</div></div><div><h3>Results</h3><div>We identified six signs of fraudulent respondents, including 1) suspicious metadata, 2) fake addresses listed in ResearchMatch profile, 3) a common Western name for both first and last names, 4) inconsistent and duplicate data, 5) extensive list of medications and/or medical conditions, and 6) short survey completion time. We contacted 63,284 accounts through ResearchMatch and received 928 survey responses. About 46 % (<em>n</em> = 425) of responses were deemed fraudulent.</div></div><div><h3>Conclusions</h3><div>Fraudulent respondents and bots undermine the integrity of data, which may result in adverse implications for research, policy, and patient health. Given that nearly half of the survey respondents in our study were deemed fraudulent, it is evident that this is a significant issue for recruiting research participants via online recruitment platforms. To ensure reliability and accuracy of study findings, it is critical for researchers to thoroughly examine their data for signs of fraudulence.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107925"},"PeriodicalIF":2.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143886426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rationale and design of a randomized controlled trial evaluating the effects of blueberry consumption versus placebo on brain health in older adults","authors":"Zachary Uttke ,&nbsp;Olivia Gabriel ,&nbsp;Ceilidh Smith ,&nbsp;Eric T. Guardino ,&nbsp;Kenneth Mukamal ,&nbsp;Luc Djousse","doi":"10.1016/j.cct.2025.107926","DOIUrl":"10.1016/j.cct.2025.107926","url":null,"abstract":"<div><h3>Background</h3><div>Age-related cognitive decline results in significant clinical and public health costs. Cognitive decline predisposes individuals to dementia and leads to difficulties with activities of daily living and increased hospitalizations. While a few dietary interventions have shown considerable promise at delaying cognitive decline, studies of the effects of long-term blueberry consumption on brain health among older adults have been limited and equivocal.</div></div><div><h3>Objective</h3><div>To test the hypothesis that a 24-week intervention with blueberry powder versus placebo will improve (i) plasma biomarkers of brain health and (ii) cognitive performance in older adults.</div></div><div><h3>Methods</h3><div>This randomized, double-blind, placebo-controlled trial will be conducted in older Americans aged 65–99 years old. Sixty-seven participants will be randomly assigned to receive either blueberry powder (20 g/d – equivalent of one (1) cup of fresh blueberries) or a placebo powder (20 g/d) for 24 weeks. Participants will undergo four clinic visits (baseline and 8 weeks, 16 weeks, and 24 weeks after randomization) for cognitive assessments, blood pressure measurements, and blood sample collections. Primary outcomes will be plasma levels of neurofilament light chain (NFL) and phosphorylated tau protein (pTau-181). Secondary outcomes will be plasma levels of glial fibrillary acidic protein (GFAP) and non-esterified fatty acids (NEFA); blood pressure during visits; and cognitive function.</div></div><div><h3>Conclusion</h3><div>Findings from this trial will answer the question whether a long-term intervention with blueberry powder can improve (i) plasma biomarkers of brain health and (ii) cognitive function in older adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107926"},"PeriodicalIF":2.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903962","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":"Study protocol for a randomized, placebo-controlled, double-masked mechanistic clinical trial of transdermal estrogen replacement in hypoestrogenic eating disorders to explore the role of estrogen on cognitive flexibility and reward processing","authors":"Lauren Breithaupt ,&nbsp;Meghan Slattery ,&nbsp;Meghan Lauze ,&nbsp;Felicia Petterway ,&nbsp;Lauren Lindman ,&nbsp;Mia Cravitz ,&nbsp;Sarah Naticchia ,&nbsp;Siddarth Seenivasa ,&nbsp;Macy Powers ,&nbsp;Kristin N. Javaras ,&nbsp;David J. Alperovitz ,&nbsp;Judith Halperin ,&nbsp;Esther Dechant ,&nbsp;Jennifer J. Thomas ,&nbsp;Elizabeth A. Lawson ,&nbsp;Hang Lee ,&nbsp;Diego A. Pizzagalli ,&nbsp;Adrienne L. Romer ,&nbsp;Poornima Kumar ,&nbsp;Franziska Plessow ,&nbsp;Kamryn T. Eddy","doi":"10.1016/j.cct.2025.107924","DOIUrl":"10.1016/j.cct.2025.107924","url":null,"abstract":"<div><h3>Background</h3><div>Restrictive eating disorders (EDs) are associated with cognitive inflexibility, reduced reward responsiveness, and tendency to favor delayed rewards, which contribute to illness maintenance and poor outcomes. Low estrogen is common in EDs and has been linked to poor cognitive flexibility and reward processing in other conditions. We describe a randomized controlled double-masked trial of short-term (12 weeks) transdermal estrogen (100 μg 17-β) replacement versus placebo to test estrogen-effects on cognitive flexibility, reward responsiveness, delay discounting, and ED pathology in females with EDs and low estrogen (ED-LE).</div></div><div><h3>Methods</h3><div>Participants will include <em>N</em> = 120 females with ED-LE (14–35 years) with clinical, neuropsychological, and neural assessments occurring at baseline, eight weeks, and 12 weeks.</div></div><div><h3>Results</h3><div>Primary outcomes will include between-group differences in 8-week change in cognitive flexibility, reward responsiveness, and delay discounting, and between-group differences in 12-week change in ED pathology. Secondary outcomes will include between-group differences in 8-week change in neural activation during cognitive flexibility and reward-related functional magnetic resonance imaging paradigms and mediation effects of 8-week change in cognitive flexibility, reward responsiveness, and delay discounting on 12-week change in ED pathology.</div></div><div><h3>Conclusion</h3><div>We hypothesize that estrogen replacement will (1) increase cognitive flexibility, reward responsiveness, and delay discounting, and (2) reduce ED pathology; and (3) 8-week changes in cognitive flexibility, reward responsiveness, and delay discounting will mediate 12-week changes in ED pathology. These data will systematically probe the role of estrogen in key neurocognitive features associated with poor ED outcomes to guide development of novel interventions for this population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107924"},"PeriodicalIF":2.0,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143916394","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":"OUTPACE: Outcomes of urinary incontinence treatment in primary care – APP co-management and electronic consult","authors":"C. Pangelina ,&nbsp;J. Bergman ,&nbsp;T. Cheng ,&nbsp;R. Fantus ,&nbsp;A. Galvez ,&nbsp;G. Gin ,&nbsp;T. Grisales ,&nbsp;J. Koola ,&nbsp;E.S. Lukacz ,&nbsp;M. Millen ,&nbsp;A. Moore ,&nbsp;K. Okamuro ,&nbsp;D. Reuben ,&nbsp;Y. Santiago-Lastra ,&nbsp;J. Singer ,&nbsp;M. Suarez ,&nbsp;M. Tai-Seale ,&nbsp;F. Vaida ,&nbsp;C. Souders ,&nbsp;J. Anger","doi":"10.1016/j.cct.2025.107922","DOIUrl":"10.1016/j.cct.2025.107922","url":null,"abstract":"<div><h3>Introduction</h3><div>Quality of care (QOC) research surrounding urinary incontinence (UI) management is limited, yet electronic (<em>E</em>-consult) and Advanced Practice Provider (APP) co-managements have proven QOC impact. We describe the design and methodology of a cluster randomized comparative effectiveness of these primary care provider (PCP) referral practices.</div></div><div><h3>Methods</h3><div>Outcomes of Urinary Incontinence Treatment in Primary Care – APP Co-management and Electronic Consult (OUTPACE) is a pragmatic clinical trial being conducted at the University of California – San Diego (UCSD), the University of California – Los Angeles (UCLA), and the University of Kansas Medical Center (KU). Approximately 300 providers within 60 PCP offices are randomized to utilize either <em>E</em>-consult or APP co-management. The first aim is to compare the relative effectiveness of these two referral mechanisms in improving UI care over a six-month period. The second and third aims include patient-reported outcomes (PROs) using validated instruments, patient knowledge, and participation in shared decision making. Secondary analyses will identify potential disparities in UI QOC related to race, ethnicity, and spoken language.</div></div><div><h3>Results</h3><div>Provider and patient enrollment began in February 2024 and is ongoing. Baseline provider QOC is assessed through retrospective chart review of 3–5 patient visits with an ICD-10 code for UI. PROs are assessed at baseline, three-month, and six-month timepoints. Both provider and patient knowledge is measured using a Pelvic Floor Awareness and Knowledge Survey at baseline and six-month timepoints.</div></div><div><h3>Conclusions</h3><div>OUTPACE will determine whether the <em>E</em>-consult or APP co-management referral mechanism has a greater impact on provider QOC, patient-reported UI outcomes, and shared decision-making scores.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107922"},"PeriodicalIF":2.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143869390","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 Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE): Protocol for a randomised controlled feasibility trial","authors":"Neil Kearney ,&nbsp;Deirdre Connolly ,&nbsp;Katayoun Bahramian ,&nbsp;Grainne Sheill ,&nbsp;Kelly Coghlan-Lynch ,&nbsp;Jacintha O'Sullivan ,&nbsp;Niamh Coleman ,&nbsp;Ciara O'Hanlon Brown ,&nbsp;David Gallagher ,&nbsp;Catherine O'Gorman ,&nbsp;Catherine O'Brien ,&nbsp;Antonia Tierney ,&nbsp;Kate Rankin ,&nbsp;Linda O'Neill ,&nbsp;Emer Guinan","doi":"10.1016/j.cct.2025.107923","DOIUrl":"10.1016/j.cct.2025.107923","url":null,"abstract":"<div><h3>Background</h3><div>Exercise is an important tool which has been shown to help patients manage many of the side effects of their cancer treatment, reduce toxicities, and improve prognosis. The benefits of exercise have been well documented, however, performing regular exercise during treatment remains a challenge for most patients. The Flexible Individualised ExeRcise programme for cancer patients during ChEmotherapy (FIERCE) is an exercise programme that has been co-designed by healthcare professionals and people with a personal lived experience of chemotherapy. The primary aim of this study is to examine the feasibility of delivering the FIERCE programme for cancer patients during chemotherapy.</div></div><div><h3>Methods</h3><div>The FIERCE study is a randomised controlled feasibility trial which will include 50 participants who are scheduled to receive chemotherapy for the treatment of breast, colorectal, or ovarian cancer. Participants will be randomly allocated to Group 1: FIERCE programme, or Group 2: Self-managed pedometer programme in a 2:1 ratio. Participants will be enrolled in the study for the duration of their chemotherapy treatment. The primary outcome of feasibility will be measured using a mixed-methods approach. Secondary outcomes of cardiorespiratory fitness, muscular strength, skeletal muscle mass, physical function, fatigue, and quality of life will be measured at baseline (T0) and post-intervention (T1).</div></div><div><h3>Discussion</h3><div>The FIERCE feasibility study aims to explore if a flexible, individualised exercise programme will support individuals to be active during chemotherapy treatment. If proven to be feasible, a large-scale randomised controlled trial will be undertaken focusing on the efficacy of the FIERCE programme on different health outcomes.</div></div><div><h3>Trial Registration</h3><div>The study is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, registration number: <span><span>NCT06280885</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107923"},"PeriodicalIF":2.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143882865","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 4 youth by youth (4YBY) crowdsourced HIV prevention intervention: A stepped-wedge longitudinal trial on HIV self-testing uptake among adolescents and young people in Nigeria","authors":"Juliet Iwelunmor ,&nbsp;Chisom Obiezu-Umeh ,&nbsp;Titilola Gbaja-Biamila ,&nbsp;David Oladele ,&nbsp;Ucheoma Nwaozuru ,&nbsp;Adesola Z. Musa ,&nbsp;Olunike R. Abodunrin ,&nbsp;Folahanmi T. Akinsolu ,&nbsp;Temitope Ojo ,&nbsp;Olufunto Olusanya ,&nbsp;Tajudeen Bamidele ,&nbsp;Nkiru Ezeama ,&nbsp;Chinyere Okeke ,&nbsp;Ifiok Johnny ,&nbsp;Moses Ekene ,&nbsp;Nurudeen Rahman ,&nbsp;Tomilola Musari-Martins ,&nbsp;Sola Ajibaye ,&nbsp;Akeem Lateef ,&nbsp;Victor Ojo ,&nbsp;Oliver Ezechi","doi":"10.1016/j.cct.2025.107919","DOIUrl":"10.1016/j.cct.2025.107919","url":null,"abstract":"<div><div>Adolescents and young adults (AYAs) participatory approaches for HIV control have increased across LMICs, but there are few trials to evaluate effectiveness. We assessed a crowdsourced HIV self-testing (HIVST) intervention among a cohort of AYA in Nigeria.</div></div><div><h3>Methods</h3><div>We conducted a pragmatic stepped-wedge cluster randomized control trial recruiting participants (aged 14–24 years) from 32 local government areas across four geo-political zones in Nigeria. Eligible AYA were HIV negative or unknown HIV status, residing in study sites, spoke English, and consented. Areas were randomly assigned to one of four steps and AYA were followed for 24 months. AYA research facilitators implemented a 4YBY crowdsourced HIV prevention bundle. The primary outcome was self-reported HIVST uptake. We compared the probability of HIVST between the control and intervention periods using a generalized linear mixed model. We examined the fixed cost and per capita cost of the intervention. The protocol was registered with Clinical <span><span>Trials.gov</span><svg><path></path></svg></span> on January 15, 2021, under registration <span><span>NCT04710784</span><svg><path></path></svg></span>.</div></div><div><h3>Results</h3><div>2652 AYA were screened, and 1500 were enrolled in the study (March 10, 2021- August 31, 2023). 1333/1500 (89 %) were followed up at 24 months. The mean age of AYA was 20 ± 2.65 years old, most were students (1155/1500, 77 %), and unemployed (915/1500, 61 %). The intervention led to a 9.96-fold increase in HIV self-testing uptake compared to the control period (95 % CI: 8.36–11.85, <em>p</em> &lt; 0.0001). The annual fixed cost of the intervention was estimated at US$42,237, with a per capita testing cost of US$14.8. No significant adverse events were reported.</div></div><div><h3>Conclusion</h3><div>A crowdsourced HIV prevention intervention increased HIVST uptake among Nigerian AYA. Greater participation of AYA in the design and implementation of clinical trials is needed to achieve UNAIDS targets.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107919"},"PeriodicalIF":2.0,"publicationDate":"2025-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143886427","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":"Recruitment and retention in a real-world comparative effectiveness trial to improve diabetes self-care behaviors","authors":"Satya Surbhi ,&nbsp;Mace Coday ,&nbsp;Cardella Leak ,&nbsp;Ming Chen ,&nbsp;James E. Bailey","doi":"10.1016/j.cct.2025.107914","DOIUrl":"10.1016/j.cct.2025.107914","url":null,"abstract":"<div><h3>Background</h3><div>Effective strategies are needed to recruit and retain participants in trials, especially for minority patients. This paper describes recruitment phases of the Management of Diabetes in Everyday Life (MODEL) study, with an emphasis on examining factors that predicted study enrollment and retention.</div></div><div><h3>Methods</h3><div>The MODEL study was a pragmatic clinical trial designed to compare the effectiveness of Text Messaging versus Health Coaching with Educational Materials on improving diabetes self-care among patients of African-American race with uncontrolled diabetes. Descriptive statistics including counts and proportions were used to describe the recruitment process. Multivariable logistic regression was used to examine factors associated with study enrollment and retention.</div></div><div><h3>Results</h3><div>Of 4310 patients contacted, 2300 (53.4 %) were prescreened, of those 1221 (28.3 %) were screened, and 666 (15.4 %) eligible screenees were randomized. Of those who got excluded after signing consent, about 48 % were excluded because they did not respond to text messages and/or voice messages and 26.8 % did not have a recent A1c test. Of those screened, the majority were contacted using a diabetes registry (70.5 %) followed by physician referral (15.7 %). Patients randomized had higher education levels than those who were excluded, and patients in the Health Coaching were significantly less likely to complete the study.</div></div><div><h3>Conclusions</h3><div>The study showed that technology barriers, not having regular follow-up, and being unaware of their chronic conditions, are recruitment barriers for minority populations. Practice participation in a registry can facilitate recruitment of underserved minority populations. Furthermore, patients participating in the time-intensive health coaching intervention experienced lowest study retention.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107914"},"PeriodicalIF":2.0,"publicationDate":"2025-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143892114","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":"Protocol for a wait list randomised controlled trial: Using social media for health promotion, communication and advocacy – A massive open online course","authors":"Kahlia McCausland ,&nbsp;Katharina Wolf ,&nbsp;Becky Freeman ,&nbsp;Justine E. Leavy ,&nbsp;Tama Leaver ,&nbsp;HuiJun Chih ,&nbsp;Barbara A. Mullan ,&nbsp;Sonya Girdler ,&nbsp;Gwyneth Peaty ,&nbsp;Mark Chenery ,&nbsp;Jonine Jancey","doi":"10.1016/j.cct.2025.107920","DOIUrl":"10.1016/j.cct.2025.107920","url":null,"abstract":"<div><h3>Introduction</h3><div>Social media can be a powerful tool for raising awareness, engaging and mobilising communities, collecting data, fostering behaviour change and advancing advocacy efforts. However, many public health professionals hesitate to incorporate social media into their work. In responding to this need, we developed a 6-module massive open online course (MOOC) designed to improve knowledge and understanding of how to effectively frame health promotion messages and increase confidence in using social media for health promotion, communication and advocacy. This paper outlines the protocol for a mixed-methods evaluation of this MOOC.</div></div><div><h3>Methods</h3><div>A wait list randomised controlled trial, guided by elements of the RE-AIM and Kirkpatrick models, will collect qualitative and quantitative data from eligible participants at three time points: baseline (T0), interim post-test (T1) and final post-test (T2). The primary outcome measure will be participants' social media context awareness. Secondary outcomes will be social media competency and the impact of the MOOC on professional practice. Additionally, a process evaluation will examine implementation, participant engagement and satisfaction with the MOOC.</div></div><div><h3>Conclusion</h3><div>This research will assess the effectiveness of a MOOC in enhancing health promotion knowledge, framing health messages, and confidence in using social media for health promotion, communication and advocacy among public health professionals. The findings will inform the design and evaluation of future online programs in this field, with results disseminated upon completion of the study.</div><div>Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12624001486516.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"153 ","pages":"Article 107920"},"PeriodicalIF":2.0,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143869389","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}