Contemporary clinical trials最新文献

{"title":"Phase 2C clinical trial of novel short-course regimens for the treatment of pulmonary tuberculosis: TBTC study 38/CRUSH-TB design","authors":"Ekaterina V. Kurbatova ,&nbsp;Kelly E. Dooley ,&nbsp;Wendy Carr ,&nbsp;Jason E. Stout ,&nbsp;Eric L. Nuermberger ,&nbsp;Patrick P.J. Phillips ,&nbsp;Nigel A. Scott ,&nbsp;Caryn M. Upton ,&nbsp;Elisa Ignatius ,&nbsp;Michelle Haas ,&nbsp;Nicholas D. Walter ,&nbsp;Rita M. Traxler ,&nbsp;Nicole E. Brown ,&nbsp;Rosanna Boyd ,&nbsp;Kia E. Bryant ,&nbsp;Meredith G. Dixon ,&nbsp;Rada Savic ,&nbsp;Christie Eichberg ,&nbsp;Anneke Hesseling ,&nbsp;Charles Bark ,&nbsp;Daniel W. Fitzgerald","doi":"10.1016/j.cct.2025.108075","DOIUrl":"10.1016/j.cct.2025.108075","url":null,"abstract":"<div><h3>Introduction</h3><div>Preclinical and clinical study data show that combining bedaquiline (B or BDQ), moxifloxacin (M), and pyrazinamide (Z), known as BMZ, has potent antimicrobial activity that might shorten treatment duration for drug-susceptible pulmonary tuberculosis.</div></div><div><h3>Methods/Design</h3><div>We describe the design of Tuberculosis Trials Consortium (TBTC) Study 38/CRUSH-TB (<span><span>NCT05766267</span><svg><path></path></svg></span>), an open-label multicenter international randomized controlled phase 2C trial that compares two four-month regimens, BMZ plus rifabutin (Rb) (2BMZRb/2BMRb) or BMZ plus delamanid (D or DLM) (2BMZD/2BMD), with standard 6-months isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE). All drugs are administered seven days per week, under direct observation, at least five days per week. A total of 288 participants, aged ≥12 years, newly diagnosed with sputum smear-positive or Xpert MTB/RIF (Ultra)-positive drug-susceptible pulmonary tuberculosis, will be randomized 1:1:1 to receive BMZRb, BMZD, or HRZE. Participants are followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first. The primary endpoint is time to sputum culture negative in liquid media. Secondary endpoints include sustained cure, safety, and additional mycobacteriology and pharmacokinetic and pharmacodynamic outcomes. This trial has an adaptive design, wherein new arms can be added.</div></div><div><h3>Discussion</h3><div>This trial tests the hypothesis whether four-month BMZ-based regimens with Rb or D can shorten time to culture negativity while being safe and tolerable for participants. The study design is adaptive, allowing for additional study arms as new drugs become available. Findings from this trial might have important implications for clinically managing drug-susceptible pulmonary tuberculosis at individual and programmatic levels.</div><div>Trial registration</div><div><strong>IND Number:</strong> 158058.</div><div><strong>IND Sponsor:</strong> U.S. Centers for Disease Control and Prevention.</div><div><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span> <strong>Identifier:</strong> <span><span>NCT05766267</span><svg><path></path></svg></span>. Registered 13 March 2023, <span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05766267</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108075"},"PeriodicalIF":1.9,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014039","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":"Assessing the feasibility, acceptability, and efficacy of a pragmatic pilot and full-scale trial to improve care for older adults with complex care needs: The SPIRE study.","authors":"Thomas Travison, Edward Pham, Karen Donelan, Stephen Bartels, Jocelyn Carter, Katie Corelli, Steven Counsell, Carie U Michael, Maggie Crean, Ellen Flaherty, Harvey Murff, Jen Perloff, Christine S Ritchie","doi":"10.1016/j.cct.2025.108072","DOIUrl":"https://doi.org/10.1016/j.cct.2025.108072","url":null,"abstract":"<p><p>Older adults with complex health and social care needs comprise some 5 % of the United States population but contribute to roughly half of healthcare costs. Patient and caregiver perspectives in qualitative studies emphasize care fragmentation in traditional care delivery models. The need for more streamlined and personalized care for these older adults is acute, particularly in value-based care systems such as Accountable Care Organizations (ACOs). Prior studies suggest that older adults with complex health needs are best cared for through person-centered care plans conducted by interdisciplinary teams of healthcare professionals, but adoption remains suboptimal. In this study, we compare two different geriatric-focused approaches to care for older adults: Annual Wellness Visits (AWV) and/or AWV augmented with GRACE (Geriatric Resources for Assessment and Care of Elders). AWVs are a Medicare benefit with a brief geriatric assessment; GRACE is a geriatric model of care that uses a home-based geriatric assessment, structured protocols, team-based care planning and primary care co-management to support older adults with complex care needs. The two-phase study includes a Phase 1 feasibility pilot, conducted in two primary care practices in one health system; and a Phase 2 cluster-randomized trial conducted in 32 primary care practices in four ACOs. Phase 2 assesses the comparative effectiveness of AWVs vs. AWV with GRACE, with primary outcomes of hospitalizations and patient experience, and secondary outcomes of caregiver strain and clinician professional fulfillment. Results will help inform personalized care among older adults with complex health needs. NCT06287801.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108072"},"PeriodicalIF":1.9,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999810","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":"Evaluating the effect of cannabidiol on sleep quality in patients with multiple sclerosis using 15 aggregated N-of-1 trials: A study protocol","authors":"Bo A.D.F. Saals ,&nbsp;Renger F. Witkamp ,&nbsp;Anne Claire B. van Orten-Luiten ,&nbsp;Heleen A. Kuijper-Tissot van Patot ,&nbsp;Lonneke M. van der Meijden-Erkelens ,&nbsp;Angelique Pijpers ,&nbsp;Sebastiaan Overeem ,&nbsp;Jop P. Mostert","doi":"10.1016/j.cct.2025.108071","DOIUrl":"10.1016/j.cct.2025.108071","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disorders, including insomnia, are highly prevalent in individuals with multiple sclerosis (MS), significantly impacting quality of life. Patients frequently use cannabidiol (CBD) as an alternative to standard medical treatments for sleep disorders, yet its efficacy has not been rigorously investigated.</div></div><div><h3>Methods</h3><div>This study comprises 15 randomized, placebo-controlled N-of-1 trials evaluating the effect of pure CBD oil (10 % g/v) on sleep quality in MS patients. Each N-of-1 study consists of a two-week run-in period, followed by four treatment periods of three weeks, separated by a one-week washout. Participants receive both CBD and placebo twice in a randomized order. Treatment starts at 150 mg daily, increasing to 300 mg from week 2. Study outcomes are assessed during the final two weeks of each block. The primary outcome is sleep quality, measured by the Insomnia Severity Index (ISI). Secondary outcomes include patient-reported outcome measures of sleep recorded in a sleep-wake diary, and scores on the Checklist Individual Strength Fatigue-subscale (CIS-F), the Fatigue Severity Scale (FSS), and the Epworth Sleepiness Scale (ESS). Additionally, as a continuous proxy for fatigue, smartphone keyboard interactions will be collected using the Neurokeys application. Results from the individual N-of-1 trials will be aggregated for group-level analyses.</div></div><div><h3>Discussion</h3><div>This study aims to provide insight into the effects of a controlled CBD product on sleep quality in MS patients through an N-of-1 trial design. Given the substantial variability in sleep quality and the anticipated interindividual differences in CBD response, an N-of-1 design is considered a suitable methodological approach.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108071"},"PeriodicalIF":1.9,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999813","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 use of virtual rehabilitation Augmented Reality (AR) exergames for patients with osteoporosis to improve balance, muscle strength and confidence: Study design for a clinical trial","authors":"Eléa Thuilier ,&nbsp;John J. Carey ,&nbsp;John Dingliana ,&nbsp;Attracta Brennan","doi":"10.1016/j.cct.2025.108059","DOIUrl":"10.1016/j.cct.2025.108059","url":null,"abstract":"<div><div>Osteoporosis is a major bone disease, affecting more than 200 million people globally. Physical exercise is a powerful non-pharmaceutical fracture prevention strategy for people with osteoporosis or those at risk of falls. However, the participation in and adherence to an exercise regimen by older adults is often low due to a lack of motivation, a fear of falling, safety and/or cost. Despite the potential of Augmented Reality (AR) exergames to enhance engagement, motivation, and accessibility in rehabilitation, there is a notable lack of clinical research on their use for osteoporosis management.</div><div>This study protocol details a partially randomised controlled clinical trial investigating the feasibility and effectiveness of AR-exergames for osteoporosis rehabilitation. We designed four exergames using AR and a body-tracking camera, providing real-time feedback. Based on power analysis, a total of 50 participants were expected after satisfying the inclusion criteria. Forty-eight women (aged 60–86) were enrolled and assigned to the control/intervention training groups. Participants assessment at baseline and at the end of the 6-weeks training included muscle strength, flexibility, balance and pain.</div><div>This clinical trial is designed to evaluate whether novel AR exergame-based training has significantly greater effects on physical (i.e., muscle strength, balance, flexibility) and affective (i.e., pain) outcomes compared to traditional training programmes. Findings from this trial provide critical insights into the feasibility and effectiveness of immersive, technology-enhanced rehabilitation for osteoporosis management. Key lessons highlight the importance of diverse recruitment strategies, flexible yet structured scheduling, and efficient resource allocation to improve trial efficiency and participant engagement in future studies.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108059"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144933134","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":"Association of study visit interval length with follow-up completeness and adherence to assigned study drug dose: A randomized comparison of participants in the ADAPTABLE trial.","authors":"Dennis I Narcisse, Jeff Whittle, Grace M Rhodes, Amanda L Stebbins, Lisa M Wruck, Hillary Mulder, Sunil Kripalani, Daniel Muñoz, Mark B Effron, Kamal Gupta, Eileen M Handberg, Saket Girotra, Rachel Hess, Catherine P Benziger, Peter Farrehi, Jeffrey J VanWormer, Kirk U Knowlton, Tamar S Polonsky, Steven M Bradley, Holly R Robertson, Bradley G Hammill, Russell L Rothman, Robert A Harrington, W Schuyler Jones, Adrian F Hernandez","doi":"10.1016/j.cct.2025.108030","DOIUrl":"10.1016/j.cct.2025.108030","url":null,"abstract":"<p><strong>Background: </strong>Little is known of the frequency of follow-up visits impact on completion of scheduled study visits, adherence to randomized treatment assignment, and completion of the study.</p><p><strong>Methods: </strong>In ADAPTABLE, participants with ASCVD were randomized to 81 mg or 325 mg of aspirin and to follow-up at 3- or 6-month intervals. At follow-up, participants answered questions about aspirin dose, adherence, and outcome measures via internet patient portal or telephone. Differences in visit adherence and study completion were compared using logistic regression. Proportional hazard models were used to compare time to study drop out, stopping aspirin, or changing aspirin dose between the 3-and 6-month groups.</p><p><strong>Results: </strong>When compared with 6-month follow-up, participants assigned to 3-month follow-up were less likely to attend any study visit (OR 0.69, 95 % CI 0.65-0.73), but 3-month follow-up had more total visits (8 vs 5, p < 0.0001). The likelihood of completing the end-of-study visit were similar (OR 0.94, 95 % CI 0.87-1.03). Assignment to 3- vs 6-month follow-up was not associated with rates of aspirin dose switching (HR 1.02, 95 % CI = 0.94-1.09), aspirin discontinuation (HR 1.00, 95 % CI 0.88-1.14), or study drop out (HR 0.95, 95 % CI 0.88-1.03).</p><p><strong>Conclusions: </strong>More frequent study visits led to higher total visits but lower visit adherence. There were no significant differences in visit and medication adherence between 3 v. 6 months follow up. As we continue to refine approaches to designing pragmatic clinical trials, more work is needed to understand the factors that may impact adherence to randomized assignments.</p><p><strong>Clinicaltrials: </strong>govIdentifier:NCT02697916.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"108030"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728466","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 randomization strategy for a cluster-randomized controlled trial with variable operating room availability","authors":"Sheau-Chiann Chen ,&nbsp;Heidi Chen ,&nbsp;Rafael Paez ,&nbsp;Cheryl L. Gatto ,&nbsp;Robert James Lentz ,&nbsp;Fabien Maldonado","doi":"10.1016/j.cct.2025.108057","DOIUrl":"10.1016/j.cct.2025.108057","url":null,"abstract":"<div><div>A single-center, open-label, pragmatic, non-inferiority, cluster randomized controlled trial was conducted to compare the clinical outcomes of two diagnostic bronchoscopy approaches, Platform A and Platform B. A cluster was defined as an operating room (OR) day. The expected allocation ratio at the cluster level was 1:1 between Platform A and Platform B. The resources available for this trial included one Platform A, one Platform B, two ORs available for two days a week, and one OR available for the other three days. When one platform was randomly assigned to one OR, the other platform was placed in the other OR.</div><div>Due to limitations in OR and bronchoscopy platform availability precluding individual patient randomization, a stratification strategy was proposed to randomize ORs to a given platform. A simulation with 1000 replicates was performed to assess balance of assignments, using imbalance (defined as the difference/imbalance in the number of patients enrolled between Platform A and Platform B) and its standard deviation as evaluation metrics.</div><div>At day 150 (210 assignments), a permuted-block randomization method, incorporating stratification by weekdays, reduced both imbalance and variation (mean = 0.044, standard deviation (SD) = 1.110, median = 0, range = (−4, 4)), compared to a permuted-block randomization method (mean = −0.238, SD = 7.064, median = 0, range = (−24, 22)). We further explored an alternative strategy: stratification by OR availability. This evaluation analysis revealed a greater reduction in imbalance, with a range of −2 and 2 (mean = −0.006, SD = 0.690, median = 0).</div><div>Our innovative study designs, incorporating a permuted-block randomization method stratified by OR availability, effectively reduced the imbalance assignments and optimized allocation of resources.</div><div><strong>Trial registration</strong></div><div>ClinicalTrials.gov registration (NCT05705544) for RELIANT on January 30, 2023.</div><div>ClinicalTrials.gov registration (NCT06654271) for RELIANT 2 on January 12, 2024.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108057"},"PeriodicalIF":1.9,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144932383","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 of a cluster randomized trial to evaluate the Frendie PRO mobile application's effectiveness in reducing employees' loneliness and social isolation","authors":"Siiri-Liisi Kraav ,&nbsp;Eric Schoenmakers ,&nbsp;Ismo Linnosmaa ,&nbsp;Samu Sorola ,&nbsp;Tommi Tolmunen","doi":"10.1016/j.cct.2025.108060","DOIUrl":"10.1016/j.cct.2025.108060","url":null,"abstract":"<div><h3>Background</h3><div>Dissatisfaction with interpersonal relationships in the workplace negatively impacts well-being and work performance. Almost 30 % of people of working age in Finland experience loneliness all or most of the time. Cost-effective methods are needed to improve the social well-being of the general working-age population. This cluster randomized trial aims to investigate whether a mobile application can improve employees' well-being and work-life relationships and reduce their experience of loneliness.</div></div><div><h3>Methods</h3><div>The current study aims to evaluate the effectiveness of the Frendie PRO mobile application on employees' social well-being measured by loneliness, workplace loneliness, work belongingness, and depressive symptoms as primary outcomes. A cluster randomized trial will be performed in workplaces. The intervention group will be given access to and is encouraged to use the Frendie PRO mobile application. The control group will have access to the application after the follow-up period. Data will be collected at three timepoints: baseline (before using the application), 3-month, and 6-month follow-up. The effectiveness and cost-effectiveness of the application will be analyzed.</div></div><div><h3>Discussion</h3><div>The intervention is hypothesized to reduce loneliness and workplace loneliness and increase the sense of work belongingness among employees. The study results may be used to develop the Frendie PRO mobile application further and develop other similar digital loneliness interventions for adults in the general population.</div><div><strong>Trial registration:</strong> The trial has been registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, registration number NCT06495801, date of registration 11. July 2024.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108060"},"PeriodicalIF":1.9,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945491","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":"Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial","authors":"Nicola Guess ,&nbsp;Sarah Wane ,&nbsp;Charlotte Albury ,&nbsp;Penny Breeze ,&nbsp;Alan Brennan ,&nbsp;Jack B. Joyce ,&nbsp;Ushma Galal ,&nbsp;Elizabeth Morris ,&nbsp;Carolyn Newbert ,&nbsp;Caroline Mitchell ,&nbsp;Ly-Mee Yu ,&nbsp;Paul Aveyard ,&nbsp;Susan A. Jebb","doi":"10.1016/j.cct.2025.108050","DOIUrl":"10.1016/j.cct.2025.108050","url":null,"abstract":"<div><h3>Background</h3><div>The NHS Path to Remission (PtR) offers a total diet replacement (TDR) programme to help people newly-diagnosed with type 2 diabetes (T2D) lose weight. It is very effective for people who participate, but most eligible people do not take part.</div></div><div><h3>Aim</h3><div>To assess whether offering a range of weight loss programmes can increase uptake of, and persistence with, weight loss and lead to a higher proportion of the population achieving remission of T2D compared with offering PtR only.</div></div><div><h3>Method</h3><div>1788 people diagnosed with T2D in the last six years, who are willing to try to lose weight to achieve remission, will be recruited via GP practices and randomised to the NewDAWN service or PtR. Outcomes (weight, height, HbA1c, medications, BP, CVD risk score, PAID, EQ-5D, healthcare resource use) will be assessed at baseline and 12 months, with diabetes remission at 12 months as the primary outcome. An internal pilot assessment will follow 150 participants for 16 weeks to determine whether to progress using pre-specified criteria based on fidelity of programme delivery, adherence to the programme and change in weight. The decision will be reviewed by an external programme steering committee who will also advise on any other considerations they deem material to the likely successful completion of the full trial. A process evaluation will assess fidelity of delivery and collect both staff and participant feedback on the NewDAWN service to improve the effectiveness of implementation. The costs of NewDAWN and lifetime cost-effectiveness of the service will also be determined.</div><div>ISRCTN Registration: 11090437</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108050"},"PeriodicalIF":1.9,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144913597","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":"Predictors of non-arrival at initial study screening visits among Black adults: Data from the GoFresh trials","authors":"Benjamin Grobman ,&nbsp;Christian Rivera ,&nbsp;Mingyu Zhang ,&nbsp;Ruth-Alma Turkson-Ocran ,&nbsp;Jingyi Cao ,&nbsp;Md Marufuzzaman Khan ,&nbsp;Hannah Col ,&nbsp;Marian Budu ,&nbsp;Sarah Nartey ,&nbsp;Ruth Zeto ,&nbsp;Emily Aidoo ,&nbsp;Timothy B. Plante ,&nbsp;Stephen P. Juraschek","doi":"10.1016/j.cct.2025.108054","DOIUrl":"10.1016/j.cct.2025.108054","url":null,"abstract":"<div><h3>Background</h3><div>Trial recruitment is a major determinant of study success, and participants' non-arrival at study visits represents a significant barrier to study completion. Little is known about the participant and study process characteristics associated with visit non-arrival.</div></div><div><h3>Objective</h3><div>To investigate factors associated with non-arrival at initial in-person screening visits in two ongoing randomized controlled trials.</div></div><div><h3>Methods</h3><div>The Groceries for Black Residents of Boston to Stop Hypertension trials (GoFresh and GoFreshRx) studied whether home-delivered, DASH-patterned groceries can reduce blood pressure among Black adults living in urban food priority areas. In this analysis, we examined sociodemographic and study-related factors associated with participant non-arrival at their initial study visit (defined as rescheduling or not showing up at all). Associations were determined using logistic regression with adjustment for age, estimated gender, and hypertension treatment status.</div></div><div><h3>Results</h3><div>Among 2224 participants (mean age = 44.0 years, 72.5 % women), the non-arrival rate at screening visit 1 was 29.5 %. Older participants were more likely to arrive, while those with larger families and a longer duration between initial contact and visit were less likely to arrive. Participants’ method of contacting the study, visit time, and season of visit were not associated with visit non-arrival.</div></div><div><h3>Conclusion</h3><div>In this large trial recruitment drive, older age, larger family size, and a longer time between initial contact and scheduled visit were associated with non-arrival at initial study visits. These factors represent potential targets for future interventions that either accommodate patient factors or intervene upon study process barriers to achieve timely recruitment goals.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108054"},"PeriodicalIF":1.9,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945504","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 Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics","authors":"Cynthia L. Stowe ,&nbsp;Kimberly Kennedy ,&nbsp;Shannon S. Emilson ,&nbsp;Rebecca H. Neiberg ,&nbsp;Stephen B. Kritchevsky ,&nbsp;Michael E. Miller ,&nbsp;Denise K. Houston ,&nbsp;Barbara J. Nicklas ,&nbsp;Jason Fanning ,&nbsp;W. Jack Rejeski ,&nbsp;the HALLO-P Investigators","doi":"10.1016/j.cct.2025.108049","DOIUrl":"10.1016/j.cct.2025.108049","url":null,"abstract":"<div><h3>Background</h3><div>Multi-morbidity increases significantly with age, and obesity is a major risk factor for conditions like cardiovascular disease and diabetes, indicating a critical need for effective interventions.</div></div><div><h3>Objective</h3><div>We discuss the study design of the HALLO-Pilot Study that randomized older adults to in-person caloric restriction (CR), remotely delivered CR (RCR), or a time restricted eating (TRE) intervention. In addition, we emphasize inclusion/exclusion criteria, recruitment, and baseline characteristics of randomized participants.</div></div><div><h3>Methods</h3><div>The study randomized 90 participants aged 60+ to one of three 9-month interventions. Eligibility focused on including adults with an indication for weight loss while excluding for safety concerns or factors potentially affecting adherence. Screening involved telephone interviews and in-person visits. Assessments included measures for eligibility, outcomes, adherence, and safety, with data collected at baseline, 6 months, and 9 months. The intervention involved in-person or online group meetings and individual contacts with participants monthly. Interventions included nutritional and behavioral guidance and a targeted increase in steps per day. Remote monitoring technology was used for monitoring diet and weight for CR participants and logging eating times for TRE participants.</div></div><div><h3>Results</h3><div>There were a total of 1753 pre-screening contacts with 678 (39 %) completing telephone screening. Of 139 (∼21 %) who were eligible after the telephone screening and consented, 135 participants attended in-person screening visits. Of those screened in-person, 90 were eligible and randomized for a yield of 13 %.</div></div><div><h3>Conclusion</h3><div>The HALLO-Pilot Study provided valuable insights into eligibility criteria and the recruitment of older adults for future large-scale trials of CR and TRE.</div><div><strong>Clinical Trials.gov</strong>: NCT05424042.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"157 ","pages":"Article 108049"},"PeriodicalIF":1.9,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144893574","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}