Contemporary Clinical Trials Communications最新文献

{"title":"Run-in periods and treatment outcomes in asthma trials: A narrative review","authors":"Emilio Pizzichini ,&nbsp;Guy Brusselle ,&nbsp;Dawn Edwards ,&nbsp;Peter G. Gibson ,&nbsp;Huib A. Kerstjens ,&nbsp;Alison Moore ,&nbsp;David Slade ,&nbsp;Robert A. Wise ,&nbsp;Shiyuan Zhang","doi":"10.1016/j.conctc.2024.101382","DOIUrl":"10.1016/j.conctc.2024.101382","url":null,"abstract":"<div><h3>Background</h3><div>The run-in period is an important element of randomized controlled trials, and is often used in respiratory disease trials. The design of the run-in period can greatly impact results and data interpretation, and as such should be designed carefully.</div></div><div><h3>Methods</h3><div>In this review, we describe the design of run-in periods across six phase 3A trials of triple therapy in asthma, and discuss how differences in run-in period design (specifically the duration, treatment, and reporting of run-in results) may have the potential to alter the interpretation of study outcomes.</div></div><div><h3>Results</h3><div>We found that the duration of run-in periods ranged between 2 and 7 weeks, with some studies including a combination of screening, run-in and stabilization periods, and others including a run-in period only. Run-in treatment also varied, with some studies running in patients on their previous inhaled corticosteroid/long-acting β₂-agonist (ICS/LABA) therapy, and others harmonizing treatment by switching to the same ICS/LABA combination used in the on-treatment phase, or a different ICS/LABA combination entirely. Most of the studies included did not report any changes to study outcomes seen prior to randomization.</div></div><div><h3>Conclusion</h3><div>We discuss the potential implications associated with the various trial designs, and propose that run-in periods should be consciously designed to meet the goals of the specific study. We also propose that standardized reporting of run-in changes would further allow for differentiation between improvements due to improved adherence and true treatment benefits, and aid with comparing data from different clinical trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101382"},"PeriodicalIF":1.4,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702693","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":"Baseline-dependent improvement in CF studies, plausibility of bias","authors":"Ellen Graham ,&nbsp;Sonya L. Heltshe ,&nbsp;Amalia S. Magaret","doi":"10.1016/j.conctc.2024.101378","DOIUrl":"10.1016/j.conctc.2024.101378","url":null,"abstract":"<div><h3>Background:</h3><div>It has been commonly reported that therapeutic treatments in cystic fibrosis (CF) have ceiling effects, such that their efficacy is diminished for persons with high pre-treatment health (Montgomery et al., 2012 and Newsome et al., 2019). Floor effects have also been reported where decline is of lower magnitude in those with below-average pre-treatment health (Harun et al., 2016; Konstan et al., 2012 and Szczesniak et al., 2017). When measurement error is present, the statistical literature has warned of exaggerated or spurious associations between pre-treatment measures and subsequent change (Chambless and Davis, 2003 and Yanez et al., 1998). Measurement error, equivalently described as day-to-day variation, has been described to occur in CF outcome measurements such as forced expiratory volume in 1 s taken by spirometry (FEV<span><math><msub><mrow></mrow><mrow><mn>1</mn></mrow></msub></math></span>pp) (Magaret et al., 2024; Stanojevic et al., 2020 and Thornton et al., 2023).</div></div><div><h3>Methods:</h3><div>We conducted a simulation study to assess the potential for spurious floor or ceiling effects in studies of CF therapeutics. We considered uncontrolled or single-arm studies, and evaluated estimated association between pre-treatment FEV<span><math><msub><mrow></mrow><mrow><mn>1</mn></mrow></msub></math></span>pp and treatment-induced change: post-versus pre-treatment.</div></div><div><h3>Results:</h3><div>When day-to-day variation was present in FEV<span><math><msub><mrow></mrow><mrow><mn>1</mn></mrow></msub></math></span>pp, at levels equivalent to those reported in large studies measuring spirometry both at home and in clinic, naive analytic approaches found spurious associations of change with baseline (Paynter et al., 2022 and Saiman et al., 2003). Type I error ranged from 31.9% to 98.3% for day-to-day variation as high as 3% to 15% relative to biological variation. Incorporating known day-to-day variation, the regression calibration approach corrected bias and controlled type I error (Chambless and Davis, 2003).</div></div><div><h3>Conclusion:</h3><div>Exaggerated ceiling effects are possible. Further studies could provide meaningful confirmation of ceiling effects in CF, perhaps reducing day-to-day variation by incorporating multiple pre- and post-treatment measurements.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101378"},"PeriodicalIF":1.4,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142438010","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":"Screening log: Challenges in community patient recruitment for gynecologic oncology clinical trials","authors":"Rubina Ratnaparkhi ,&nbsp;Gary C. Doolittle ,&nbsp;Hope Krebill ,&nbsp;Michelle Springer ,&nbsp;Elizabeth Calhoun ,&nbsp;Andrea Jewell ,&nbsp;Dinesh Pal Mudaranthakam","doi":"10.1016/j.conctc.2024.101379","DOIUrl":"10.1016/j.conctc.2024.101379","url":null,"abstract":"<div><h3>Background</h3><div>Clinical trial participation can improve overall survival and mitigate healthcare disparities for gynecologic cancer patients in low-volume community centers. This study aimed to assess the effectiveness of a centrally regulated but administratively decentralized electronic screening log system to identify eligible patients across a large catchment area for a National Cancer Institute (NCI)-designated cancer center's open clinical trials.</div></div><div><h3>Methods</h3><div>Electronic screening log data collected between 2014 and 2021 from ten community partner sites in a single NCI-designated cancer center's catchment area were reviewed retrospectively. Clinical factors assessed included cancer site, primary versus recurrent disease status, and histology. Identification efficiency (the ratio of patients screened identified with an available trial) was calculated. Identification inefficiencies (failures to identify patients with a potentially relevant trial) were assessed, and etiologies were characterized.</div></div><div><h3>Results</h3><div>Across ten community partner sites, 492 gynecologic cancer patients were screened for seven open clinical trials during the study period. This included 170 (34.5 %) ovarian cancer patients, 156 (31.7 %) endometrial cancer patients, and 119 (24.2 %) cervical cancer patients. Over 40 % had advanced stage disease, and 10.6 % had recurrent disease. Only three patients were identified as having a relevant open trial; none ultimately enrolled due to not meeting trial eligibility criteria. An additional 2–52 patients were retrospectively found to have a relevant trial available despite not being identified as such within the electronic screening log system. Up to 14.4 % of patients had one or more missing minimum data elements that hindered full evaluation of clinical trial availability. Re-screening patients when new trials open may identify 12-15 additional patients per recurrent disease trial.</div></div><div><h3>Conclusions</h3><div>An electronic screening log system can increase awareness of gynecologic oncology clinical trials at a NCI-designated cancer center's community partner sites. However, it is inadequate as a single intervention to increase clinical trial enrollment. Providing adequate support staff, documenting clinical factors consistently, re-screening patients at relevant intervals, and coordinating with central study personnel may increase its utility.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101379"},"PeriodicalIF":1.4,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424973","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 character-strengths based coaching intervention to improve wellbeing of rural community health workers in Madhya Pradesh, India: Protocol for a single-blind randomized controlled trial","authors":"Ameya P. Bondre ,&nbsp;Azaz Khan ,&nbsp;Abhishek Singh ,&nbsp;Spriha Singh ,&nbsp;Ritu Shrivastava ,&nbsp;Narendra Verma ,&nbsp;Aashish Ranjan ,&nbsp;Jyotsna Agrawal ,&nbsp;Seema Mehrotra ,&nbsp;Rahul Shidhaye ,&nbsp;Anant Bhan ,&nbsp;John A. Naslund ,&nbsp;Steve D. Hollon ,&nbsp;Deepak Tugnawat","doi":"10.1016/j.conctc.2024.101377","DOIUrl":"10.1016/j.conctc.2024.101377","url":null,"abstract":"<div><h3>Background</h3><div>There is scarce knowledge on the use of structured positive psychology interventions for reducing work-stress and improving wellbeing of rural community health workers in India, particularly the Accredited Social Health Activists (ASHAs) who are village-level (resident women, incentivised) lay health workers. This trial will test the effectiveness of a ‘character-strengths’ based coaching intervention compared to routine supervision on wellbeing (‘authentic happiness’) of ASHAs.</div></div><div><h3>Methods</h3><div>This protocol is for a single-blind, parallel group randomized controlled trial comparing the effectiveness of a five-day residential workshop focusing on the use of character-strengths and subsequent 8- to 10-week remote telephonic coaching (weekly) to individually support ASHAs to improve their wellbeing, against routine health system support. The arms are intervention added to routine ASHA supervision (weekly, by the ASHA supervisor), and routine supervision alone (control arm). The target sample comprises 330 rural ASHAs in Madhya Pradesh, India. The primary outcome of mean Authentic Happiness Inventory (AHI) scores will be compared between arms at 3-month follow-up. Secondary outcomes will include an assessment of ASHA's self-reported affect, self-efficacy, flourishing, burnout, motivation, physical health symptoms, quality of life, and routine work performance indicators, and the consequent patient-level outcomes [e.g., service satisfaction and depression remission rates after receiving brief psychological treatment by trained ASHAs]. We will also evaluate the costs of developing and delivering the intervention.</div></div><div><h3>Discussion</h3><div>This trial will determine whether a character-strengths based coaching intervention is an effective and scalable approach for reducing work-stress and improving wellbeing of rural ASHAs in low-resource settings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101377"},"PeriodicalIF":1.4,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424974","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":"Recruitment issues in a multicenter randomized controlled trial about the effect of the Cultural Formulation Interview on therapeutic working alliance","authors":"Alma M. Brand ,&nbsp;Simon P.N. Groen ,&nbsp;Samrad Ghane ,&nbsp;Nathalie Destoop ,&nbsp;Hannah E. Jongsma ,&nbsp;Bernard G.C. Sabbe ,&nbsp;Özlem Becan ,&nbsp;Dhiya Alyan ,&nbsp;Mario H. Braakman","doi":"10.1016/j.conctc.2024.101373","DOIUrl":"10.1016/j.conctc.2024.101373","url":null,"abstract":"<div><div>This short communication concerns recruitment issues in a multicenter randomized controlled trial. An overview of anticipated and unexpected recruitment issues at various organizational levels is discussed as encountered in this trial. These experiences are shared to assist researchers in avoiding similar experiences, prevent wasting valuable research resources, and justify the time and energy committed by enrolled participants.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101373"},"PeriodicalIF":1.4,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424975","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":"Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study","authors":"Keishi Kohyama ,&nbsp;Hisakazu Kato ,&nbsp;Hideshi Okada ,&nbsp;Takuma Ishihara ,&nbsp;Yuji Yasue ,&nbsp;Ryo Kamidani ,&nbsp;Kodai Suzuki ,&nbsp;Takahito Miyake ,&nbsp;Hiroshi Okuda ,&nbsp;Hirofumi Shibata ,&nbsp;Hiroyuki Tomita ,&nbsp;Takenori Ogawa","doi":"10.1016/j.conctc.2024.101375","DOIUrl":"10.1016/j.conctc.2024.101375","url":null,"abstract":"<div><div>Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101375"},"PeriodicalIF":1.4,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142323200","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 roadmap for improving representation in clinical trials","authors":"Amanda F. Petrik ,&nbsp;Nora B. Henrikson ,&nbsp;Gloria D. Coronado ,&nbsp;Erin Keast ,&nbsp;Matthew P. Banegas","doi":"10.1016/j.conctc.2024.101374","DOIUrl":"10.1016/j.conctc.2024.101374","url":null,"abstract":"<div><div>Clinical trials continue to struggle with recruiting diverse participants that include historically underrepresented and minoritized patients, who are typically patients in non-white racial and ethnic groups and have low income (Medicaid). Enrolling diverse participants will benefit the health sciences by providing more generalizable findings. The Cancer Financial Experience project (CAFÉ) study sought to improve financial distress by providing financial navigation for newly diagnosed cancer patients, and intentionally recruited diverse participants. All diverse participants consented at slightly higher rates than non-diverse participants (21.3 % vs. 20.1 %). Spanish-speaking patients consented at a much higher rate than non-Spanish speakers (36.4 % vs. 20.2 % respectively). Here we discuss how we increased our recruitment of diverse participants. Obtaining diverse participation is achievable and will provide more meaningful findings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101374"},"PeriodicalIF":1.4,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142319478","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":"The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocol","authors":"K. Jobin ,&nbsp;C. Campbell ,&nbsp;S.M. Schabrun ,&nbsp;K.J. Schneider ,&nbsp;A. Smith ,&nbsp;C.T. Debert","doi":"10.1016/j.conctc.2024.101370","DOIUrl":"10.1016/j.conctc.2024.101370","url":null,"abstract":"<div><h3>Background</h3><div>Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limited efficacy. Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown promise in treating other chronic pain conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with ET for the treatment of CGH.</div></div><div><h3>Methods</h3><div>Adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS followed by ET or sham tDCS followed by ET. Transcranial direct current stimulation will be applied over M1 three times per week for 6-weeks and ET will be performed daily. The primary outcomes of this trial will be the feasibility and safety of the intervention. Feasibility will be defined as greater than 30 % recruitment, 70 % protocol adherence, and 80 % retention rate. Safety will be defined as no severe adverse events. Secondary exploratory outcomes will assess improvement in pain, strength, function, and quality of life.</div></div><div><h3>Conclusions</h3><div>This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH. Cervicogenic headaches can be difficult to treat contributing to significant impairments function and quality of life. Transcranial direct current stimulation is a potential novel treatment to improve health outcomes in these patients.</div></div><div><h3>Registration</h3><div>ClinicalTrials.gov-NCT05582616.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101370"},"PeriodicalIF":1.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142357614","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":"Constricting Gaps: Protocol development, implementation challenges and lessons learned for the reality map of unmet needs for Palliative Care Interventions in advanced cancer patients study in Romania and Switzerland","authors":"Kalbermatten Natalie ,&nbsp;Curca Razvan ,&nbsp;Grigorescu Alexandru ,&nbsp;Mosoiu Daniela ,&nbsp;Pop Florina ,&nbsp;Poroch Vladimir ,&nbsp;Rosiu Ariana ,&nbsp;Achimas-Cadariu Patriciu ,&nbsp;Strasser Florian ,&nbsp;Swiss-Romanian Partnership IZERZO","doi":"10.1016/j.conctc.2024.101360","DOIUrl":"10.1016/j.conctc.2024.101360","url":null,"abstract":"<div><h3>Background</h3><p>Patients with advanced cancer experience many symptoms and needs requiring a Palliative Care Intervention (PCI). Identifying gaps between needs for PCIs and experienced delivery may improve health care, furthermore the association of gaps with quality indicators (QI). The multicentre Romanian (RO)-Swiss (CH) reality map study implemented a novel protocol based on needs concepts and culturally adapted quality indicators (QI).</p></div><div><h3>Methods</h3><p>An interactive mapping guide measuring unmet needs for PCIs monthly over six months, patient characteristics (cognition, EAPC basic data set, Cofactors) and QI (Inappropriate Anticancer Treatment, High Symptom Burden [IPOS, EQ5D], Repeated ER Admissions, Aggressive End-of-Life Care, and Quality of Death-and-Dying) were developed, applying swiss standards for quality assurance. A composite endpoint (QI, cofactors) was planned. Finally, local solutions responding to gaps were piloted.</p></div><div><h3>Results</h3><p>From 308 patients (RO: 262, CH: 46, age 62j [mean], 74 % ECOG PS 1&amp;2, 81 % current anticancer treatment) baseline and first follow-up data revealed main gaps (symptom management, spiritual needs, family support), country differences (e.g. illness understanding, spiritual needs) and a significant association of the number of gaps with depression. Later data become less, and data quality on QI variable, revealing gaps in research conduct competences, resources, and applicability of over-sophisticated quality assurance tools. Nevertheless, the unmet needs data promoted local initiatives, 81 patients participated in feasibility studies. Finally, the joint experience stimulated academic developments and national integration of palliative care into oncology.</p></div><div><h3>Conclusions</h3><p>Pairing motivation and enthusiasm with more modest aims, feasibility testing of all outcomes and investment in research competences may disperse gaps.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101360"},"PeriodicalIF":1.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001078/pdfft?md5=b74ce7b1dbbe5bda766e9f8e34705576&pid=1-s2.0-S2451865424001078-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238455","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":"Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach","authors":"Jillian E. Urban ,&nbsp;Justin B. Moore ,&nbsp;Madison E. Marks ,&nbsp;Ty D. Holcomb ,&nbsp;Robert Patterson ,&nbsp;Alexis McCoy ,&nbsp;Christopher M. Miles ,&nbsp;Joel D. Stitzel ,&nbsp;Kristie L. Foley","doi":"10.1016/j.conctc.2024.101371","DOIUrl":"10.1016/j.conctc.2024.101371","url":null,"abstract":"<div><p>Subconcussive, repetitive head impacts sustained in collision sports may negatively affect brain health. American football practices are controlled environments amenable to intervention. Engaging community members is essential for successful development, implementation, and sustainability of viable interventions. The objective of this study is to develop and pilot test an evidence-based intervention to reduce head impact exposure in youth American football (i.e., football), using a community-engaged approach. This manuscript describes the co-design of the intervention and associated implementation plan and the study protocol for evaluating the effectiveness and feasibility of the intervention and implementation plan. In the first part of this study, focus groups with parents and coaches, and individual interviews with organizational leaders associated with two teams at the middle school level were conducted. An anonymous survey assessing beliefs and perceptions of non-concussive head impacts was given to parents, coaches, and organizational leaders within the local youth football league. Following the football season, qualitative and quantitative data describing determinants of head acceleration events in football were shared with 12 stakeholders of coaches, league and school administrators, parents, an athletic trainer, and local university player development director. Together, we co-designed COACH (COmmunities Aligned to reduce Concussion and Head impact exposure) and implementation plan using a strategic planning approach. The preliminary effectiveness and feasibility were assessed in the second part of this study. Youth football players participating on the teams in year 1 (control teams) were fitted with mouthpiece-based head kinematic sensors which measure head acceleration events (HAEs). HAEs were collected and quantified during team activities. Preliminary effectiveness of the intervention to reduce HAEs was measured among two new teams pilot testing COACH with mouthpiece-based sensors, while simultaneously monitoring implementation of the intervention. We report our study design and evaluation, and opportunities and challenges with our approach. The results will inform a future full-scale pragmatic trial to assess the implementation and effectiveness of the intervention program.</p><p>NCT04908930.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"42 ","pages":"Article 101371"},"PeriodicalIF":1.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001182/pdfft?md5=83c04fcea6ccc6dcb01c52415fa91438&pid=1-s2.0-S2451865424001182-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142238454","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}