Contemporary Clinical Trials Communications最新文献

{"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":"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":"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":"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}

{"title":"Efficacy of an evidence-based telehealth-delivered weight-loss intervention to expand reach and enhance access to underserved groups after stroke","authors":"Evan Elizabeth McShan ,&nbsp;Shahad Alrawi ,&nbsp;Stephanie Calhoun ,&nbsp;Taylor Gilliland ,&nbsp;Monica Bennett ,&nbsp;Rosemary Dubiel ,&nbsp;Simon Driver","doi":"10.1016/j.conctc.2025.101458","DOIUrl":"10.1016/j.conctc.2025.101458","url":null,"abstract":"<div><div>Obesity is a risk factor for stroke, and survivors of stroke have a high rate of obesity and greater burden of obesity-related chronic conditions (e.g., heart disease, hypertension, re-occurring stroke) compared to the general population. Despite the health disparity, there is a lack of evidence-based weight-loss interventions tailored to individuals post stroke, as most health promotion programs exclude this population. Our team's work modifying and examining the efficacy of a modified version of the Diabetes Prevention Program Group Lifestyle Balance for people post stroke (GLB-CVA) is promising with results from an in-person randomized controlled trial (RCT) showing significant weight-loss (10.1 ± 16.8 lbs. [4.88 %]) and improvements in waist circumference, diastolic blood pressure, pain, social participation, eating practices, and health habits at 12-months post intervention. To expand the reach and accessibility of the GLB-CVA intervention, we will complete a RCT to assess the efficacy of telehealth delivery by enrolling 94 participants post stroke over a 3-year period. Results may provide an evidence-based, scalable telehealth weight-loss program designed for people post stroke that clinicians and community workers can use to increase accessibility to underserved groups.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101458"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438057","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":"Evaluating the dissemination of evidence-based practices in substance use treatment: A cluster-randomized clinical trial of Colombo Plan's Innovative professional training model","authors":"Alvaro Vergés ,&nbsp;Rodrigo Portilla Huidobro ,&nbsp;Marta Oliva ,&nbsp;Víctor Landa","doi":"10.1016/j.conctc.2025.101452","DOIUrl":"10.1016/j.conctc.2025.101452","url":null,"abstract":"<div><div>The training of professionals who work in the treatment of substance use disorders is a fundamental aspect for the dissemination of evidence-based practices that ensure the quality of the treatment delivered to patients. Colombo Plan has developed a training model that allows effective, rapid, and scalable dissemination. However, this model does not have an empirical evaluation of its results to date. This project seeks to evaluate the dissemination model through a cluster-randomized clinical trial with a parallel superiority design, in which 27 treatment centers will be randomly assigned to training + action plan and technical advice, training only, or control without training, action plan or advice. The results of this study will inform public policy regarding substance use treatment at the national level and will help improve efforts by Colombo Plan at dissemination of evidence-based practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101452"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143480004","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":"Comparing the impact of foot and hand reflexology on anxiety and physiological indices in colonoscopy candidates: A randomized clinical trial","authors":"Mohamad Golitaleb ,&nbsp;Ali Safdari ,&nbsp;Fatemeh Rafiei ,&nbsp;Ameneh Yaghoobzadeh ,&nbsp;Najmeh Mohamadi ,&nbsp;Razieh Mokhtari","doi":"10.1016/j.conctc.2025.101449","DOIUrl":"10.1016/j.conctc.2025.101449","url":null,"abstract":"<div><h3>Introduction and objective</h3><div>Colonoscopy is a standard diagnostic procedure, yet pre-procedural anxiety remains a prevalent concern. While pharmacological interventions are available, non-pharmacological approaches such as reflexology offer a promising alternative. Despite its therapeutic potential, comparative evidence on foot and hand reflexology in this setting is limited. This study aimed to evaluate their effects on pre-colonoscopy anxiety and physiological parameters.</div></div><div><h3>Methods</h3><div>This randomized clinical study was conducted from November 2022 to August 2023 at the Amir al-Momenin Educational and Therapeutic Center in Arak, Iran. A total of 105 patients were randomly assigned to three equal-sized groups (n = 35) using block randomization: foot reflexology, hand reflexology, and a control group. Patients in the intervention groups received a 30-min reflexology session. Anxiety levels were assessed using the Spielberger State-Trait Anxiety Inventory (STAI-Y1), a validated tool for measuring situational anxiety. Physiological indices, including systolic and diastolic blood pressure, heart rate, and arterial oxygen saturation (SpO2), were measured immediately before and after the intervention.</div></div><div><h3>Results</h3><div>There were no significant differences in clinical outcomes among the groups at baseline (p &gt; 0.05). However, following the intervention, the mean anxiety scores in both reflexology groups (foot reflexology: 44.39 ± 5.21; hand reflexology: 45.6 ± 4.49) were significantly lower than that of the control group (48.05 ± 4.81) (p = 0.008), as determined by one-way analysis of variance (ANOVA). The anxiety reduction was more pronounced in the foot reflexology group than the hand reflexology group, although this difference did not reach statistical significance (p &gt; 0.05). Additionally, post-intervention assessments revealed significant differences in systolic blood pressure (foot reflexology: 123.48 ± 16.40 mmHg; hand reflexology: 122.65 ± 14.97 mmHg; control group: 132.14 ± 18.48 mmHg) and heart rate (foot reflexology: 78.60 ± 9.54 bpm; hand reflexology: 78.25 ± 11.41 bpm; control group: 85.05 ± 10.82 bpm) across the groups (p &lt; 0.05). However, no significant differences were observed for diastolic blood pressure or arterial oxygen saturation (SPO2) between groups (p &gt; 0.05).</div></div><div><h3>Conclusion</h3><div>The findings of this study indicate that reflexology, particularly foot reflexology, can significantly reduce anxiety and lead to improvements in physiological parameters, such as systolic blood pressure and heart rate, in patients undergoing colonoscopy. These results highlight the potential of reflexology as an effective complementary method for managing anxiety and enhancing patient comfort during medical procedures.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101449"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395391","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}