Trials最新文献

{"title":"Assessing the impact of immersive virtual reality technology on the psychological recovery of patients with Parkinson's disease depression: study protocol of a randomized controlled trial.","authors":"Xinyan Chen, Lina Chen, Xiaochun Chen, Qinyong Ye, Guoen Cai, Yuqi Zeng","doi":"10.1186/s13063-024-08552-5","DOIUrl":"10.1186/s13063-024-08552-5","url":null,"abstract":"<p><strong>Background and aim: </strong>Depression in Parkinson's disease (DPD) has a high incidence rate among patients with Parkinson's disease (PD). It is a common nonmotor symptom of PD that seriously affects the quality of life of patients. Thus, improving DPD is important for improving the quality of life of patients. Psychotherapy for depression is limited for many reasons, and only a few patients are able to benefit from this therapy. Several studies have demonstrated that relaxation therapy, playing, and exercise therapy are effective treatments for depression. In recent years, virtual reality (VR) has rapidly developed as a form of rehabilitation due to its immersive characteristics and accessibility. It has also been applied in the psychological treatment of phobia and anxiety. However, no relevant research on the treatment of DPD has been conducted using VR. This study aims to assess the effects of immersive VR-assisted training on patients with DPD.</p><p><strong>Methods: </strong>This single-blind randomized controlled trial will recruit 74 patients with DPD. The patients will then be randomly allocated into two groups. The patients in the VR group (n = 37) will receive VR-assisted training (40 min) three times a week for 8 weeks. The patients in the non-VR training group (n = 37) will receive treatment as usual. The outcome measures will be assessed before intervention, and after 8 weeks, 3 months, and 6 months of the intervention. The primary outcomes will include the Hamilton Depression Scale-24. The secondary outcomes will include the 36-Item Short-Form Health Survey questionnaire, neuroinflammation factors (brain-derived neurotrophic factor, interleukin-6, and C-reactive protein), and functional magnetic resonance imaging.</p><p><strong>Discussion: </strong>The traditional treatment of depression has limited resources and requires a lot of time and energy. It is not suitable for patients with PD having mobility difficulties and residing in remote areas. VR can make up for limitations in traditional treatment methods. An advantage of VR is that it makes patients more invested in active participation. This study may provide an improved method for the clinical treatment of patients with DPD, which is suitable for clinical decision-making and future practice.</p><p><strong>Trial registration: </strong>The study has been registered in the Chinese Clinical Trial Registry ChiCTR2200065843, November 16, 2022. https://www.chictr.org.cn/showproj.html?proj=174551 {2a and 2b}.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"715"},"PeriodicalIF":2.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The fixed-effects model for robust analysis of stepped-wedge cluster trials with a small number of clusters and continuous outcomes: a simulation study.","authors":"Kenneth Menglin Lee, Yin Bun Cheung","doi":"10.1186/s13063-024-08572-1","DOIUrl":"10.1186/s13063-024-08572-1","url":null,"abstract":"<p><strong>Background: </strong>Stepped-wedge cluster trials (SW-CTs) describe a cluster trial design where treatment rollout is staggered over the course of the trial. Clusters are commonly randomized to receive treatment beginning at different time points in this study design (commonly referred to as a Stepped-wedge cluster randomized trial; SW-CRT), but they can also be non-randomized. Trials with this design regularly have a low number of clusters and can be vulnerable to covariate imbalance. To address such covariate imbalance, previous work has examined covariate-constrained randomization and analysis adjustment for imbalanced covariates in mixed-effects models. These methods require the imbalanced covariate to always be known and measured. In contrast, the fixed-effects model automatically adjusts for all imbalanced time-invariant covariates, both measured and unmeasured, and has been implicated to have proper type I error control in SW-CTs with a small number of clusters and binary outcomes.</p><p><strong>Methods: </strong>We present a simulation study comparing the performance of the fixed-effects model against the mixed-effects model in randomized and non-randomized SW-CTs with small numbers of clusters and continuous outcomes. Additionally, we compare these models in scenarios with cluster-level covariate imbalances or confounding.</p><p><strong>Results: </strong>We found that the mixed-effects model can have low coverage probabilities and inflated type I error rates in SW-CTs with continuous outcomes, especially with a small number of clusters or when the ICC is low. Furthermore, mixed-effects models with a Satterthwaite or Kenward-Roger small sample correction can still result in inflated or overly conservative type I error rates, respectively. In contrast, the fixed-effects model consistently produced the target level of coverage probability and type I error rates without dramatically compromising power. Furthermore, the fixed-effects model was able to automatically account for all time-invariant cluster-level covariate imbalances and confounding to robustly yield unbiased estimates.</p><p><strong>Conclusions: </strong>We recommend the fixed-effects model for robust analysis of SW-CTs with a small number of clusters and continuous outcomes, due to its proper type I error control and ability to automatically adjust for all potential imbalanced time-invariant cluster-level covariates and confounders.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"718"},"PeriodicalIF":2.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rationale and design of Healthy Kids Beyond the Bell: a 2x2 full factorial study evaluating the impact of summer and after-school programming on children's body mass index and health behaviors.","authors":"R Glenn Weaver, Michael W Beets, Elizabeth L Adams, Andrew T Kaczynski, Brian Chen, Bridget Armstrong, Sarah Burkart, Keagan Kiely, Aliye B Cepni, James W White, Olivia Finnegan, Meghan Savidge, Hannah Parker, Griffin A T Randolph","doi":"10.1186/s13063-024-08555-2","DOIUrl":"10.1186/s13063-024-08555-2","url":null,"abstract":"<p><strong>Background: </strong>The Structured Days Hypothesis posits that structure protects children against obesogenic behaviors (e.g., physical inactivity, unhealthy dietary intake) and, ultimately, prevents the occurrence of excessive weight gain. The hours following school (i.e., 3-6 pm school days) and summer vacation are two \"windows of vulnerability\" when children may experience less structure. Programs that provide a healthy structured environment and may prevent BMI gain exist for both time periods (i.e., after-school programs and summer day camps). Unfortunately, these programs are cost prohibitive for children from low-income families to attend. This study will test the impact of providing vouchers to access existing, community-operated after-school and summer programs on BMI z-score, body composition, and obesogenic behaviors (i.e., physical activity, screen use, diet, and sleep) of children (5-12 years) from schools that primarily serve families with low income.</p><p><strong>Methods: </strong>The study will employ a 2x2 factorial design. Participants (N = 480) attending 4 elementary schools in one school district will be randomly assigned to a no treatment control, after-school program voucher only, summer day camp voucher only, or after-school and summer day camp vouchers. Vouchers will cover the full cost of attending a pre-existing community-based after-school or summer camp program. The primary outcome (BMI z-score) will be measured at baseline (before end of school year, ~ May), 3-month follow-up (after summer, ~ August), and 12-month follow-up (end the following school year, ~ May). Secondary outcomes include body composition (i.e., whole-body fat mass, fat free mass, and percent body fat) and obesogenic behaviors (i.e., physical activity, sedentary time, sleep, screen-time, and diet). The study will also employ a rigorous process evaluation which will consider after-school and summer camp program attendance and content. Analyses will examine differences between the four groups in BMI z-score, body composition, and obesogenic behaviors. Incremental cost effectiveness ratios will determine the cost effectiveness of the intervention.</p><p><strong>Discussion: </strong>The current study will provide critical information for researchers, practitioners, and policy makers seeking to combat the childhood obesity epidemic in children from families with low-income during the school year and summer.</p><p><strong>Trial registration: </strong>NCT05880901 . Registered 27 May 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"714"},"PeriodicalIF":4.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Supporting African communities to increase resilience and mental health of kids with developmental disabilities and their caregivers using the World Health Organization's Caregiver Skills Training Programme (SPARK trial): study protocol for a cluster randomised clinical controlled trial.","authors":"Melissa Washington-Nortey, Vibian Angwenyi, Mekdes Demissie, Eva Mwangome, Tigist Eshetu, Hanna Negussie, Kimberley Goldsmith, Andrew Healey, Merga Feyasa, Girmay Medhin, Amanuel Belay, Temesgen Azmeraw, Medhanit Getachew, Rahel Birhane, Carophine Nasambu, Tsegereda Haile Kifle, Angela Kairu, Beatrice Mkubwa, Fikirte Girma, Rehana Abdurahman, Ruth Tsigebrhan, Liya Tesfaye, Leonard Mbonani, Nadine Seward, Tony Charman, Andrew Pickles, Erica Salomone, Chiara Servili, Edwine Barasa, Charles R Newton, Charlotte Hanlon, Amina Abubakar, Rosa A Hoekstra","doi":"10.1186/s13063-024-08488-w","DOIUrl":"10.1186/s13063-024-08488-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Most children with developmental disabilities (DD) live in low- and middle-income countries, but access to services is limited, impacting their ability to thrive. Pilot study findings of the World Health Organization's Caregiver Skills Training (WHO CST) intervention, which equips caregivers with strategies to facilitate learning and adaptive behaviours in children with DD, are promising but evidence from an appropriately powered trial delivered by non-specialist facilitators is lacking. This study will investigate the effectiveness and the resource impacts and costs and consequences of the WHO CST intervention in four sites in rural and urban Kenya and Ethiopia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a 2-arm multi-site hybrid type-1 effectiveness implementation cluster randomised controlled superiority trial. After baseline assessments (T0) are completed by participants in clusters comprising 7 to 10 caregiver-child dyads, the clusters will be randomised to either the WHO CST intervention arm or a waitlist enhanced care as usual control arm. Further assessments will be completed at endpoint (T1, 18 ± 2 weeks after randomisation) and follow-up (T2, 44 ± 2 weeks after randomisation). The intervention comprises three individualised home visits and nine group sessions with trained non-specialist facilitators. Participants in the control arm will receive the intervention after completing follow-up assessments. We aim to recruit 544 child-caregiver dyads, evenly distributed across the two arms and countries. The co-primary outcomes are the child-focused Child Behavior Checklist (assessing emotional and behavioural problems) and the caregiver-focused Pediatric Quality of Life Inventory (assessing caregiver quality of life), both assessed at endpoint. Secondary outcome measures comprise the two co-primary outcomes at follow-up and ten additional outcome measures at endpoint, assessing stigma-based experiences, depressive symptoms, household food insecurity, child disciplinary strategies and beliefs, CST knowledge and skill competencies, caregiver and child quality of life, social support, and children's communication modes and functions. After quantitative follow-up assessments are completed, a mixed-methods evaluation approach will be used to investigate implementation processes and acceptability, feasibility, and potential sustainability of the intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The study's findings will provide evidence of the effectiveness and resource impacts and costs and consequences of a non-specialist-delivered intervention in under-resourced contexts in one low-income and one middle-income country in East Africa. Findings will inform future research, intervention, and policy efforts to support children with DD and their families in under-resourced majority world contexts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Pan African Clinical Trial Registry PACTR202310908063134. Registered on October 16, ","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"713"},"PeriodicalIF":4.6,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515546/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigating the effect of synbiotic supplementation on inflammatory indices in critically ill septic children: a protocol study for randomized control trial.","authors":"Ali Chamani, Faezeh Mashhadi, Gholamreza Khademi, Mohsen Nematy, Maryam Emadzadeh, Majid Sezavar, Fatemeh Roudi","doi":"10.1186/s13063-024-08514-x","DOIUrl":"10.1186/s13063-024-08514-x","url":null,"abstract":"<p><strong>Background: </strong>Sepsis, a severe inflammatory response to infection, is a global health priority due to its high mortality and long-term disability rates. Its pathophysiology involves both inflammation and immune suppression. Managing sepsis requires significant healthcare resources and expenditure, with sepsis being a leading cause of hospital costs. Gut microbiotas play a crucial role in sepsis, and probiotics show promise in managing it by restoring microbial balance. Despite advances, targeted therapies for sepsis remain elusive, necessitating innovative approaches such as probiotic therapy.</p><p><strong>Method: </strong>Fifty-four eligible patients with sepsis will be randomly assigned to either the synbiotic or placebo group. The synbiotic supplement, KidiLact, comprises ten probiotic strains and prebiotic fructooligosaccharides. Participants will receive two sachets daily for 7 days, mixed with sterile water and administered orally or via gavage. Inflammatory factors including interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) will be evaluated. Anthropometric measurements, nutritional assessment, biochemical analysis, and clinical evaluation will be conducted to assess treatment outcomes. Statistical analysis will be performed to compare results between the two groups, employing SPSS version 19 with a significance level of P < .05.</p><p><strong>Conclusion: </strong>This randomized clinical trial aims to evaluate synbiotic supplementation effects on inflammatory markers and clinical outcomes in pediatric sepsis patients in the pediatric intensive care unit (PICU). Probiotics have shown promise in reducing proinflammatory cytokines like IL-6, TNF-α, and CRP, which are vital in the inflammatory response. Synbiotics can enhance gut integrity, preventing pathogen translocation and reducing inflammation. If our expectations regarding the effects of probiotics are correct, we can use them as a cost-effective supplement to improve the condition of pediatric sepsis in hospitals.</p><p><strong>Trial registration: </strong>IRCT,IRCT20230523058266N1 Registered 30 October 2023, https://irct.behdasht.gov.ir/trial/71397 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"712"},"PeriodicalIF":2.0,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515531/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Web-based training and certification of clinical staff during the randomised clinical trial SafeBoosC-III.","authors":"Marie Isabel Skov Rasmussen, Mathias Lühr Hansen, Colin Peters, Gorm Greisen","doi":"10.1186/s13063-024-08530-x","DOIUrl":"10.1186/s13063-024-08530-x","url":null,"abstract":"<p><strong>Background: </strong>SafeBoosC-III is a pragmatic, multinational clinical trial evaluating cerebral oximetry-guided treatment for extremely preterm infants. In total, 1601 infants were randomised across 70 sites in Asia, Europe, and USA. To enhance data quality and patient care, a web-based training program was implemented for staff. We now report on the processes.</p><p><strong>Methods: </strong>All training modules consisted of initial learning material followed by a case-based quiz, with elaborate responses to correct as well as to wrong answers. Modules covered trial introduction, cerebral oximetry monitoring, treatment guidelines, cerebral ultrasound, and Good Clinical Practice. The introduction module was accessible in eight languages on an online platform, while language versions varied for other modules, due to different needs. Certification was earned upon module completion, relevant to the staff category. The training was not mandatory, but for motivational purposes, principal investigators continuously received local certification rate reports.</p><p><strong>Results: </strong>A total of 926 out of 2347 staff (39%) obtained certification. Amongst 295 staff who completed the evaluation, 83% rated the program as overall good and 94% found it relevant to clinical practice. Sites exhibited varying certification rates, with 10 at 0%, 43 between 0.1 and 79.9%, and 17 exceeding 80%. There was no correlation between the rate of certification in individual sites and how often the clinical management was changed due to cerebral hypoxia nor a correlation to site-specific estimates of the intervention effect.</p><p><strong>Conclusion: </strong>Despite language barriers and a low budget, our web-based training and certification program proved feasible. Only a minority of sites reached 80% certification of staff and an impact on the trial could not be detected.</p><p><strong>Trial registration: </strong>The SafeBoosC-III trial is registered at ClinicalTrials.gov NCT03770741. The first participant was randomised in June 2019 and recruitment was completed in December 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"711"},"PeriodicalIF":2.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515472/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of heart rate control with ivabradine on hemodynamic in patients with sepsis: study protocol for a prospective, multicenter, randomized controlled trial.","authors":"Jiezhao Zheng, Deliang Wen, Zelin Pan, Xiaohua Chen, Tianyu Kong, Qirui Wen, Hongxuan Zhou, Weiyan Chen, Zhenhui Zhang","doi":"10.1186/s13063-024-08560-5","DOIUrl":"10.1186/s13063-024-08560-5","url":null,"abstract":"<p><strong>Introduction: </strong>Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of hypovolemia and hypotension have been corrected. Recently, relevant studies have shown that sustained tachycardia in sepsis was related to high mortality, and appropriate control of heart rate (HR) could improve prognosis. Ivabradine reduces HR directly without a negative inotropic effect through inhibition of the I_f ionic current, which is different from the traditional rate control drug (beta-blockers).</p><p><strong>Methods and analysis: </strong>This is a prospective, multicenter, randomized, open label study designed to investigate the effect of heart rate control with ivabradine on hemodynamic in patients with sepsis. Our study will enroll 172 patients with sepsis as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria with sinus rate of 95 bpm or higher despite a hemodynamic optimization. Patients will be randomly assigned to standard treatment group (GS) or ivabradine group (GI, standard treatment for sepsis plus enteral ivabradine). Patients in GI will receive ivabradine to maintain HR between 70 and 94 bpm. The primary outcome is the difference of a reduction in HR below 95 bpm and the effect of ivabradine on hemodynamics between GI and GS group within the first 96 h after randomization. The secondary outcomes include organ function measures, the difference in SOFA score, incidence of adverse events, need for organ support, length of ICU stay, and 28-day overall mortality.</p><p><strong>Discussion: </strong>There are limited studies on ivabradine to control heart rate in patients with sepsis. Our study aims to evaluate whether direct sinus node inhibition can improve hemodynamics, as well as its impact on organ function and prognosis in patients with sepsis, so as to provide evidence for the safe usage in clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05882708. Registered on May 11, 2023, https://clinicaltrials.gov/ct2/show/NCT05882708 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"710"},"PeriodicalIF":2.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11520163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uptake of health economic evaluations alongside clinical trials in Australia: an observational study.","authors":"Alayna Carrandi, Cynthia Wells, Rachael L Morton, Richard Norman, Helen Skouteris, Amy Grove, Alisa M Higgins","doi":"10.1186/s13063-024-08562-3","DOIUrl":"10.1186/s13063-024-08562-3","url":null,"abstract":"<p><strong>Background: </strong>Australia's clinical trials sector is highly productive with continued sector investment needed to enhance research impact. Generating economic evidence alongside trials has the potential to facilitate the implementation of trial results into practice. Ascertaining the use of health economic evaluations alongside clinical trials can assist in determining whether clinical trials fully realize and operationalize their potential to change policy and practice. The aims of this study were to ascertain the uptake of health economic evaluations alongside Australian-led clinical trials and explore associations between uptake and trial characteristics.</p><p><strong>Methods: </strong>This observational study comprised a descriptive analysis of clinical trials registries, a cross-sectional survey of Australian Clinical Trials Alliance (ACTA) networks, and a subgroup analysis of completed acute care trials. Descriptive analyses of trial registrations were conducted, with logistic regressions used to identify predictors of proposing and subsequently publishing a health economic evaluation alongside acute care trials.</p><p><strong>Results: </strong>Few randomized Australian-led clinical trials (11% of 9251) and ACTA network trials (43% of 227) proposed a health economic evaluation. In the subgroup analysis, 22% of the 324 acute care trials and 53% of the 38 ACTA network acute care trials proposed a health economic evaluation. Acute care trials funded by government bodies were significantly more likely to propose and publish a health economic evaluation than those funded by hospitals, universities, and other funders, after adjusting for phase, registration year, primary sponsor type, and comparator.</p><p><strong>Conclusions: </strong>Current uptake of health economic evaluations alongside Australian-led clinical trials is low, with uptake higher among the subset of ACTA network trials. This is despite economic evidence playing an increasingly prominent role in health system management, as well as rising health expenditure, limited budgets, and competing demands. There is significant opportunity to embed health economic evaluations alongside clinical trials, particularly phase 3 trials, to increase research outputs and optimize research translation. Investing in clinical trial networks that support funding for a health economist or a health economic evaluation may be an effective strategy to increase the uptake of health economic evaluations alongside trials.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"705"},"PeriodicalIF":4.6,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11494774/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of coaching on health information literacy in patients with chronic kidney disease: a randomized controlled trial.","authors":"Yimin Hu, Bin Zhang, Zhihao Hu, Jingwen Huang, Ling Wang, Yuting Wei, Baojia Zheng, Qing Xue","doi":"10.1186/s13063-024-08365-6","DOIUrl":"10.1186/s13063-024-08365-6","url":null,"abstract":"<p><strong>Background: </strong>Since chronic kidney disease is highly insidious in the early stages, most diagnosed patients have already developed irreversible renal failure. There is a lack of effective implementation and standardization of health education management for patients with chronic kidney disease, and the impact of health education management on health information literacy is not yet known.</p><p><strong>Methods: </strong>This randomized controlled clinical trial was conducted from March 2022 to March 2023. A total of 130 patients with chronic kidney disease stage 3-4 were selected from a tertiary hospital in Zhuhai via a convenience sampling method and were then randomly assigned to intervention and control groups. The Health Information Literacy Questionnaire for Chronic Kidney Disease was used to assess the health literacy of the patients at month 0 and month 12. In addition, the renal function-related indices of the patients were measured before and after the intervention. The study adhered to SPIRIT guidelines.</p><p><strong>Results: </strong>There was no significant difference between the two groups in health information literacy, platelet count, estimated glomerular filtration rate, or albumin level. However, the intervention group showed a significant improvement in health behavioral status such as information acquisition, checkups, and physical activity. Subgroup analysis revealed that hemoglobin was significantly higher in non-employed patients than in the intervention group. There was a significant improvement in hemoglobin level after receiving health guidance in patients with intermediate education, and acquisition capacity and estimated glomerular filtration rate in the intervention group were lower than in the control group for patients with elementary education.</p><p><strong>Conclusion: </strong>Receiving health coaching helped to improve self-management behaviors and hemoglobin levels of patients with stage 3-4 chronic kidney disease. Education level is an important factor influencing the effectiveness of health coaching techniques.</p><p><strong>Trial registration: </strong>This study was prospectively registered in the China Clinical Trial Registry on November 10, 2021, with registration number: ChiCTR2100053103.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"707"},"PeriodicalIF":2.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RELAX (REducing Levels of AnXiety): a study protocol for a parallel two-arm randomised controlled trial evaluating a web-based early intervention for pregnant women with high levels of repetitive negative thinking to prevent escalating anxiety during pregnancy and after birth.","authors":"Brittannia Volkmer, Yogini Sawjani, Mary Newburn, Jo Bennett, Megan McGovern, Laura Bridle, Nathalie Towner, Laura McCabe, Katherine Clark, Sophie Webster, Alison Hylton-Potts, Lucy Mayer, Gertrude Senevirante, Debra Bick, Jill Newby, Kimberley Goldsmith, Michelle L Moulds, Colette Hirsch","doi":"10.1186/s13063-024-08516-9","DOIUrl":"10.1186/s13063-024-08516-9","url":null,"abstract":"<p><strong>Background: </strong>Perinatal anxiety is common: up to 40% of pregnant women and new mothers experience high levels of anxiety. Given its prevalence, interventions that are low-intensity, highly accessible and cost-efficient, and target modifiable risk factors for anxiety are needed. Repetitive negative thinking (RNT)-such as worrying about ways things will go wrong in the future or ruminating about past negative events-is a risk factor for the development of anxiety. RNT is maintained by the tendency to generate negative interpretations of ambiguous situations.</p><p><strong>Methods: </strong>A parallel two-arm randomised controlled trial will assess the efficacy of adding interpretation training (RELAX) to usual maternity care. Participants (N = 268) will be randomised to (i) 12 sessions of online interpretation training (RELAX) plus usual care, or (ii) usual care alone. We will assess anxiety, depression, RNT, and work and social adjustment at baseline, plus 4, 8 and 36 weeks later.</p><p><strong>Discussion: </strong>Should the intervention result in lower levels of anxiety than usual care, it could be an accessible, cost-effective way to help women who are vulnerable to experiencing anxiety in the perinatal period.</p><p><strong>Trial registration: </strong>ISRCTN 12754931. Registered 25th May 2023, prior to recruitment.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"709"},"PeriodicalIF":2.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}