Contemporary Clinical Trials Communications最新文献

{"title":"Investigation of the improvement of swallowing function with low-frequency pulse waves or interference waves delivered via cervical electrical stimulation in patients with Parkinson's disease: A randomized controlled study protocol","authors":"Masahiro Nakamori ,&nbsp;Ryotaro Matsuyama ,&nbsp;Megumi Toko ,&nbsp;Hidetada Yamada ,&nbsp;Yuki Hayashi ,&nbsp;Kohei Yoshikawa ,&nbsp;Mineka Yoshikawa ,&nbsp;Toshikazu Nagasaki ,&nbsp;Yoshitaka Shimizu ,&nbsp;Hirofumi Maruyama","doi":"10.1016/j.conctc.2025.101463","DOIUrl":"10.1016/j.conctc.2025.101463","url":null,"abstract":"<div><div>Parkinson's disease (PD) is associated with a high rate of swallowing dysfunction, which may lead to aspiration pneumonia. This randomized controlled trial aims to investigate the effects of cervical electrical stimulation interventions (interferential current or low-frequency pulse wave stimulation) on swallowing dysfunction in patients with PD. The study will include patients with PD with Hoehn–Yahr stages 2–4 and will assess the swallowing function in a multifaceted manner using tools such as the 1 % citric acid cough test, videofluoroscopic swallowing study (VFSS), Functional Oral Intake Scale score, and Eating Assessment Tool-10 score. The primary endpoint is an improvement in the cough reflex, as measured by the citric acid cough test, whereas the secondary endpoints include changes in the swallowing function, including the VFSS, tongue pressure, and salivary substance P levels. Participants will receive 30 min of cervical stimulation daily for 2 weeks. This study also explores the use of novel instruments such as multichannel surface electromyography and electronic stethoscopes for the detailed assessment of swallowing physiology. By investigating these two electrical stimulation techniques, this study seeks to provide insights into the pathophysiology of swallowing dysfunction in PD and to evaluate the efficacy and safety of these interventions.</div></div><div><h3>Trial registration number</h3><div>jRCTs062240041; pre-results.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101463"},"PeriodicalIF":1.4,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Operating characteristics of unequal allocation ratios in platform trials with the staggered addition of drugs using binary endpoints","authors":"Yosuke Shimizu ,&nbsp;Ryoichi Hanazawa ,&nbsp;Hiroyuki Sato ,&nbsp;Akihiro Hirakawa","doi":"10.1016/j.conctc.2025.101450","DOIUrl":"10.1016/j.conctc.2025.101450","url":null,"abstract":"<div><h3>Background</h3><div>One recommendation for the allocation ratio between multiple drugs and a shared placebo control group in platform trials (PTs) is to use a <span><math><mrow><msqrt><mi>k</mi></msqrt></mrow></math></span>:1 allocation ratio for the placebo group relative to the drug group, where <span><math><mrow><mi>k</mi></mrow></math></span> is the number of drug groups with ongoing patient enrollment during the trials. However, the practical utility of such unequal allocation ratios in PTs lacks adequate study.</div></div><div><h3>Methods</h3><div>We compared the performances of equal and unequal allocation ratios through simulations to imitate practical PTs using only concurrent controls and binary endpoints for hospitalized patients with infectious diseases. The operating characteristics, including the type I error rate, power of hypothesis testing, and total sample size, were evaluated.</div></div><div><h3>Results</h3><div>In PTs, using an unequal allocation ratio (i) results in a considerable augmentation of the total sample size and prolongs the study duration when monthly patient enrollment is low, but (ii) the target power of hypothesis testing is often preserved compared to an equal allocation ratio, even when we incorrectly specify the drug and placebo group mortality rates assumed in the sample size calculation. The average power increase using an unequal allocation ratio relative to the equal allocation ratio per 100-patient increase in the placebo group was approximately 1.9 % in the selected scenarios of our simulation studies.</div></div><div><h3>Conclusion</h3><div>The results of the current study highlight the quantitative advantages and disadvantages of using unequal allocation ratios in PTs using only concurrent controls under the specific conditions assumed in our simulations and analyses.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101450"},"PeriodicalIF":1.4,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Participant recruitment and retention in randomised controlled trials of melanoma surveillance: A scoping review","authors":"Deonna M. Ackermann ,&nbsp;Karen Bracken ,&nbsp;Jolyn K. Hersch ,&nbsp;Monika Janda ,&nbsp;Robin M. Turner ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.conctc.2025.101461","DOIUrl":"10.1016/j.conctc.2025.101461","url":null,"abstract":"<div><h3>Background</h3><div>This scoping review aims to collate and describe data on recruitment, retention, and strategies used to improve these, in randomised controlled trials of melanoma surveillance.</div></div><div><h3>Methods</h3><div>We searched MEDLINE, EMBASE, CINAHL and CENTRAL databases from inception until October 23, 2023. Two reviewers screened titles and abstracts, and full-texts, and one reviewer extracted data (convenience sample (n = 5) checked by a second). Eligibility criteria included: (i) RCT design, (ii) clinical setting, (iii) participants at increased risk of melanoma, (iv) interventions for early melanoma detection, and (v) early detection outcomes or surrogates such as improved skin self-examination. We calculated summary statistics and undertook qualitative data synthesis.</div></div><div><h3>Results</h3><div>From 1746 records, 21 trials (reported in 28 papers) were included. Recruitment sources included dermatology clinics, general practice sites, and hospital databases or registries. Trials reported proportions of those screened who were eligible (mean 75 %, range 24–100 %), proportions of those eligible who were randomised (mean 63 %, range 24–95 %), numbers randomised per month (mean 25 participants, range 2–74), and proportion of those randomised who completed outcome measurements (mean 85 %, range 59–100 %) for self-report questionnaires at primary timepoints). Recruitment strategies included targeted participant identification and flexible consent processes. Retention strategies included setting narrow eligibility criteria, reminders, and financial incentives. Reporting on strategies was limited and there were no reports on effectiveness. Few studies reported recruiter facing initiatives or public and patient involvement.</div></div><div><h3>Discussion</h3><div>More consistent and detailed reporting of recruitment and retention strategies in RCTs is needed, alongside evaluations of their effectiveness.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101461"},"PeriodicalIF":1.4,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A framework for upskilling the clinical trial site: Learnings from a clinical trial coordinator workforce capability building pilot program","authors":"Thobekile Mthethwa-Pitt ,&nbsp;Prudence Perry ,&nbsp;Jhodie Duncan ,&nbsp;Felicity Osmond ,&nbsp;Anne Woollett","doi":"10.1016/j.conctc.2025.101460","DOIUrl":"10.1016/j.conctc.2025.101460","url":null,"abstract":"<div><h3>Aim</h3><div>This paper describes a simple education model for health service organisations engaging in clinical trials. Clinical trial coordinators (CTCs) are essential to operations of the clinical trial workforce; however, there is significant disparity in their skills and knowledge. The TrialHub upskilling pilot program is a novel, multimodal upskilling initiative which aims to develop an innovative clinical trial education framework to build consistent standards across the workforce, irrespective of site location and maturity.</div></div><div><h3>Method</h3><div>The upskilling pilot program was implemented across 7 health service organisations with varying levels of clinical trial maturity. The program adopted a stepwise engagement approach, and incorporated elements including mentorship, in-house training program strategies, and ongoing professional development initiatives. This approach was guided by consultation at individual CTC level to health service organisation governance levels, enabling education programs driven by CTC needs and oversight strategies for upskilling standards at each site. Site activity engagement sessions were tracked to map the progress of upskilling element implementation, and informed on framework development.</div></div><div><h3>Results</h3><div>Over a 30-month period (January 2022 to June 2024) site engagement tracking indicated diverse needs at each site, aligned with varying levels of site maturity and evolving upskilling priorities and focus throughout the pilot period. These insights underscore a requirement for tailoring upskilling elements and education initiatives to sites’ specific circumstances and changing maturity during development. Subsequently an upskilling framework, informed by these program learnings, was established to guide future workforce development and growth needs.</div></div><div><h3>Conclusion</h3><div>Although limited by a small sample size, this pilot program has demonstrated the potential of a tailored multi-modal upskilling approach to provide valuable professional learning experiences in clinical trial coordination, and support clinical trial site capability development. Clinical trial sites adoption of upskilling programs requires harmonisation and structured support through adaptive implementation, as described by the CTC upskilling framework. Upskilling CTCs in parallel with increasing clinical trial site capability is required if sites are to be adequately mature, and be able to meet the growing demands of Australian communities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101460"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143474770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intervention delivery complexity and adaptations for implementation of non-pharmacologic pain interventions","authors":"Lindsay A. Ballengee ,&nbsp;Maggie E. Horn ,&nbsp;Trevor A. Lentz ,&nbsp;Devon Check ,&nbsp;Leah L. Zullig ,&nbsp;Steven Z. George","doi":"10.1016/j.conctc.2025.101453","DOIUrl":"10.1016/j.conctc.2025.101453","url":null,"abstract":"<div><h3>Background</h3><div>Delivering evidence-based interventions remains challenging, particularly for complex conditions like chronic musculoskeletal pain. Non-pharmacologic treatments are recommended for many pain conditions, but implementing these can be difficult due to their complexity and resource demands. Pragmatic trials, especially embedded designs, provide a method to see how interventions are being implemented and adapted in real-world settings throughout the trial process. This study explored how intervention delivery complexity and adaptations differ between non-pharmacologic pain trials and non-pain trials to provide guidance on future treatment delivery and implementation.</div></div><div><h3>Methods</h3><div>From July to October 2023, an online survey was distributed to members of three NIH Trial Collaboratories to assess intervention delivery complexity and adaptations during their pragmatic trials. Participants rated their trial's intervention delivery complexity using a 7-item tool and reported any adaptations to intervention delivery throughout the trial process. Data analysis compared complexity and adaptations between the two trial types to explore differences and relationships between intervention delivery complexity and adaptations.</div></div><div><h3>Results</h3><div>We analyzed 12 pain and 12 non-pain trials and found that intervention delivery complexity was not discernibly different between the two trial types, however, pain trials did have a slightly higher average intervention delivery complexity, overall. Pain trials also had more adaptations in the workflow domain compared to non-pain trials, while adaptations across other domains were similar between the two types. Workflow emerged as the most challenging domain for adaptation among all trials.</div></div><div><h3>Conclusion</h3><div>Intervention delivery complexity may be higher for pragmatic trials that are investigating non-pharmacologic pain interventions versus non-pain trials, but only in very specific areas.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101453"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143465005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study","authors":"Florent Dubois ,&nbsp;Emilie Champiot-Bayard ,&nbsp;Bogdan Cireașă ,&nbsp;Paul Loubet ,&nbsp;Jérôme Vallat ,&nbsp;Julie Bonnet ,&nbsp;Valérie Jacob ,&nbsp;Pauline Puyo ,&nbsp;Ioana Pînzar ,&nbsp;Sarah Théret ,&nbsp;Emmanuelle Dubois ,&nbsp;Elisabeth Peus ,&nbsp;Laurent Giraudon ,&nbsp;Clarisse Roux-Marson ,&nbsp;Pascale Fabbro-Peray ,&nbsp;Géraldine Leguelinel-Blache ,&nbsp;Jean-Marie Kinowski","doi":"10.1016/j.conctc.2025.101462","DOIUrl":"10.1016/j.conctc.2025.101462","url":null,"abstract":"<div><h3>Background</h3><div><em>Streptococcus pneumoniae</em> causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but none evaluates pharmacist-physician collaboration in hospital on PV coverage of inpatients at-risk of invasive pneumococcal disease (IPD).</div></div><div><h3>Methods</h3><div>This study is a multicentric stepped-wedged randomized trial involving 12 units in 9 French hospitals (3 university and 6 local) during 4 periods of 90 days each. Three clusters will be made, each composed randomly of clinical and surgical units from one university hospital and clinical and surgical units of 2 local hospitals. For each period, one unit will have to include 16 non-vaccinated inpatients at risk of IPD. Patients in the control phase will receive usual care. During the interventional phase, the pharmacist will inform the physician on PV necessity, who will report recommendation and prescribe it at discharge. The pharmacist will perform a consultation and send a discharge letter to the patient's community pharmacist. The primary outcome will assess the impact of intervention on PV coverage after 6 months. Secondary outcomes will evaluate vaccines dispensing, uncompleted protocol rate and intervention process. A subgroup analysis between university and local hospitals and clinical and surgical units, respectively will be made.</div></div><div><h3>Discussion</h3><div>This study will assess the impact of medico-pharmaceutical collaboration in hospital on PV coverage in inpatients at risk of IPD. Hospitalization could be a way to promote vaccination and enhance healthcare system performance.</div></div><div><h3>Trial registration</h3><div>Clinicaltrials.gov, NCT05060146. Registered on September 16th, 2021.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101462"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143454532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardio-metabolic health and sleep quality in adults at risk for Type 2 Diabetes using the Fos Biomedical Non-Transdermal Patch System via photo-biomodulation: A randomized, placebo-controlled crossover trial","authors":"Valentine Y. Njike ,&nbsp;Rockiy G. Ayettey ,&nbsp;Judith A. Treu ,&nbsp;Beth Patton Comerford ,&nbsp;Maureen Onuigbo","doi":"10.1016/j.conctc.2025.101448","DOIUrl":"10.1016/j.conctc.2025.101448","url":null,"abstract":"<div><h3>Background</h3><div>The impact of the Fos Biomedical non-transdermal patch system (NTPS) that stimulates the skin with low light levels to generate photo-biomodulation (PBM) effects on cardio-metabolic health and sleep quality is unclear. We examined the impact of FBPS compared with placebo on cardio-metabolic risk and sleep quality in persons at risk for type 2 diabetes mellitus (T2DM).</div></div><div><h3>Methods</h3><div>The study was a randomized, controlled, double-blind, crossover trial of 39 adults (mean age 64.4 years; 28 women, 11 men; 38 Caucasians, 1 African American) at risk for T2DM assigned to one of two possible sequence permutations of two treatments (Fos Biomedical NTPS and placebo), with an 8-week washout period. Fos Biomedical NTPSs are designed to stimulate the skin with low light levels to produce PBM effects. Participants were instructed to apply the active or placebo patches above and below the belly button for 12 h each day for 12 weeks. Primary outcome measure was glycated hemoglobin (HbA1c). Secondary outcome measures included insulin sensitivity, lipid profile, blood pressure, body composition, C-reactive protein, endothelial function, and sleep quality.</div></div><div><h3>Results</h3><div>Compared with the placebo, the Fos Biomedical NTPS did not improve glycemic control: HbA1c (0.1 ± 0.2 % vs. 0.1 ± 0.2 %; p = 0.5154). Compared with placebo, Fos Biomedical NTPS reduced endothelial function (−1.7 ± 12.1 % vs. 3.9 ± 10.0 %; p = 0.0344) while other markers of cardiovascular risk (i.e., body composition, blood pressure, lipid profile, and inflammatory biomarker) and sleep quality were unaffected (p &gt; 0.05).</div></div><div><h3>Conclusions</h3><div>Photo-biomodulation generated from Fos Biomedical NTPS did not improve biomarkers of cardio-metabolic risk and sleep quality among those at risk for T2DM.</div></div><div><h3>Clinical trial registration number</h3><div>NCT05628597.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101448"},"PeriodicalIF":1.4,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143529593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phase 1 clinical trial on Orgasmic Meditation (OM): Assessing safety and feasibility as a meditation practice for individuals with PTSD","authors":"Daniel Kriegman,&nbsp;Rachel Pelletier,&nbsp;Caroline Griggs,&nbsp;Caryn Roth","doi":"10.1016/j.conctc.2025.101451","DOIUrl":"10.1016/j.conctc.2025.101451","url":null,"abstract":"<div><h3>Background</h3><div>We measured the safety and efficacy of a treatment protocol that includes Orgasmic Meditation (OM), a structured attention training practice conducted between two people who follow a predefined set of detailed instructions. The practice involves one person gently stroking the clitoris of the other person for 15 minutes while both place their attention on the point of contact and notice what they feel. Practitioners of OM have reported that this practice is distinct both from typical sexual engagement and other forms of meditation (Siegel et al., 2022).</div></div><div><h3>Methods</h3><div>Approved by Advarra Pro00061665. The study involved 28 participants (14 pairs), who were recruited based on residence in the Massachusetts area, being in a relationship, and having no history of practicing OM. Twenty-three of these participants identified and scored as having PTSD symptoms (PCL-5 scores &gt;31). Participants were instructed to perform the OM practice a minimum of 12 times over a 4-week period and met weekly with the principal investigator to determine if any safety issues were manifesting. A series of surveys (Daily: Tumescence Survey and OM journal. Baseline and weekly: PCL-5. Baseline, completion and follow up: Eudaimonia assessment, PHQ-9, Gad-7, BIPF, and OM perception survey at) were administered to measure the results.</div></div><div><h3>Results</h3><div>Orgasmic Meditation showed positive results in persons with PTSD. Orgasmic meditation is safe and may offer improvement in symptoms. OM showed 47 % improvement in PTSD scores Average score decreased from 60 to 28. Average score across 23 participants rate 4.9/5 that OM is safe.</div></div><div><h3>Conclusion</h3><div>These results suggest that Orgasmic Meditation may be safe for this traumatized population, and may ameliorate symptoms of PTSD. Further research appears to be warranted to determine the efficacy of OM in treatment of PTSD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101451"},"PeriodicalIF":1.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143643065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention","authors":"Carrington CJ. Shepherd ,&nbsp;Melissa A. Dunham ,&nbsp;Lina Gubhaju ,&nbsp;Karen E. Lamb ,&nbsp;Digsu N. Koye ,&nbsp;Phoebe Fitzpatrick ,&nbsp;Emily Banks ,&nbsp;Kaarin J. Anstey ,&nbsp;Melinda Carrington ,&nbsp;Daniel McAullay ,&nbsp;Ofra Kalter-Leibovici ,&nbsp;Grace Joshy ,&nbsp;Lesley Nelson ,&nbsp;Jason Agostino ,&nbsp;Ellie Paige ,&nbsp;Kathleen Abu-Saad ,&nbsp;Elise Alexander ,&nbsp;Rona MacNiven ,&nbsp;Kelsey Griffen ,&nbsp;Fiona Collins ,&nbsp;Sandra Eades","doi":"10.1016/j.conctc.2025.101457","DOIUrl":"10.1016/j.conctc.2025.101457","url":null,"abstract":"<div><h3>Background</h3><div>Limited available data indicate that dementia prevalence rates among Aboriginal and Torres Strait Islander (hereafter Aboriginal) peoples are 3–5 times higher than the overall Australian population. Effective, pragmatic and scalable interventions are urgently required to address this disproportionate burden of dementia in Aboriginal populations.</div></div><div><h3>Methods</h3><div>Kaat Koort is a pragmatic two-arm parallel-group randomized controlled trial which will recruit a sample of 354 participants from two Aboriginal community-controlled health services in the south-west of Western Australia. Eligible participants are aged 35–60 years with risk factors for cardiovascular disease. Participants will be randomized in a 1:1 ratio to receive either a 12-month multifactorial lifestyle intervention (guided by Aboriginal Health Practitioners) that involves cardiovascular risk management, a lifestyle program targeting diet and physical activity, and support for smoking cessation and depression, or usual care (control). The primary endpoints are change in (i) systolic, and (ii) diastolic blood pressure. Secondary endpoints are changes in other cardiovascular risk factors (elevated blood pressure, HDL cholesterol, HbA1c, waist circumference, and absolute cardiovascular risk score), cognitive functioning, and adherence to Australian dietary and physical activity guidelines. Outcomes will be collected at baseline, and 6- and 12-months post-baseline.</div></div><div><h3>Discussion</h3><div>This trial aims to determine the efficacy of a multifactorial lifestyle intervention in reducing blood pressure among Aboriginal people aged 35–60 years at risk of dementia.</div></div><div><h3>Trial registration number</h3><div>ACTRN12621001022853; Australian New Zealand Clinical Trial Registry identifier.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101457"},"PeriodicalIF":1.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial","authors":"He Chen ,&nbsp;Sixing Liu ,&nbsp;Shuai Gao ,&nbsp;Jiamin Yi ,&nbsp;Hangyu Shi ,&nbsp;Jiufei Fang ,&nbsp;Weiming Wang ,&nbsp;Huan Chen ,&nbsp;Zhishun Liu","doi":"10.1016/j.conctc.2025.101454","DOIUrl":"10.1016/j.conctc.2025.101454","url":null,"abstract":"<div><h3>Background</h3><div>Senile pruritus (SP), characterized by idiopathic itch in individuals aged 60 years and older without primary skin lesions, significantly impacts sleep and quality of life. Effective alternative treatments are needed. Acupuncture has been suggested as a potential intervention to alleviate pruritus; however, its role in managing SP remains uncertain. This study aims to evaluate the efficacy and safety of acupuncture for SP.</div></div><div><h3>Methods</h3><div>This single-center, parallel, two-arm, randomized, sham-controlled trial will enroll 200 patients diagnosed with SP in a 1:1 ratio to either the acupuncture or sham acupuncture group, receiving acupuncture or sham acupuncture three sessions weekly for six weeks. Participants, outcome assessors, and the statisticians will be blinded. The primary outcome is the change from baseline in the Average Pruritus Numerical Rating Scale (AP-NRS) score at week 6. Secondary outcomes include changes in AP-NRS (at other timepoints), Peak Pruritus Numerical Rating Scale (PP-NRS), number of scratch episodes, itchy area of body surface, overall dry skin score (ODS), the Dermatology Life Quality Index (DLQI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and Patient Global Impression of Change (PGIC). Long-term effects of acupuncture will also be explored. Adverse events and additional treatments will be monitored throughout the study period. The modified intention-to-treat (mITT) population which includes participants who complete baseline assessments and receive at least one treatment session will be analyzed.</div></div><div><h3>Discussion</h3><div>This trial represents the first rigorously designed, single-center, randomized, sham-controlled study assessing the effects and safety of acupuncture for senile pruritus. We used valid outcome measurements which can provide valuable insights into the patient's symptoms and facilitate tracking symptoms over time and evaluate treatment effectiveness. This study may provide valuable insights into the research topic and inform future research.</div></div><div><h3>Ethics and dissemination</h3><div>This study has received ethical approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2024-087-KY).</div></div><div><h3>Trial registration</h3><div>Registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT06506240) on July 11, 2024.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101454"},"PeriodicalIF":1.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}