Sean D. Regnier, Jennifer R. Havens, Thomas P. Shellenberg, David H. Cox, Thomas S. Baker, J. Lile, C. Rush, Reuben Adatorwovor, L. Hays, Danielle M. Anderson, Mary B. Fisher, S. Segerstrom, Joy M. Schmitz, W. Stoops
OBJECTIVES/GOALS: Contingency management (CM) procedures yield measurable reductions in cocaine use. This poster describes a trial aimed at using CM as a vehicle to show the biopsychosocial health benefits of reduced use, rather than total abstinence, the currently accepted metric for treatment efficacy. METHODS/STUDY POPULATION: In this 12-week, randomized controlled trial, CM was used to reduce cocaine use and evaluate associated improvements in cardiovascular, immune, and psychosocial well-being. Adults aged 18 and older who sought treatment for cocaine use (N=127) were randomized into three groups in a 1:1:1 ratio: High Value ($55) or Low Value ($13) CM incentives for cocaine-negative urine samples or a non-contingent control group. They completed outpatient sessions three days per week across the 12-week intervention period, totaling 36 clinic visits and four post-treatment follow-up visits. During each visit, participants provided observed urine samples and completed several assays of biopsychosocial health. RESULTS/ANTICIPATED RESULTS: Preliminary findings from generalized linear mixed effect modeling demonstrate the feasibility of the CM platform. Abstinence rates from cocaine use were significantly greater in the High Value group (47% negative; OR = 2.80; p = 0.01) relative to the Low Value (23% negative) and Control groups (24% negative;). In the planned primary analysis, the level of cocaine use reduction based on cocaine-negative urine samples will serve as the primary predictor of cardiovascular (e.g., endothelin-1 levels), immune (e.g., IL-10 levels) and psychosocial (e.g., Addiction Severity Index) outcomes using results from the fitted models. DISCUSSION/SIGNIFICANCE: This research will advance the field by prospectively and comprehensively demonstrating the beneficial effects of reduced cocaine use. These outcomes can, in turn, support the adoption of reduced cocaine use as a viable alternative endpoint in cocaine treatment trials.
{"title":"546 Using Contingency Management to Understand the Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use: A Protocol for a Randomized Controlled Trial","authors":"Sean D. Regnier, Jennifer R. Havens, Thomas P. Shellenberg, David H. Cox, Thomas S. Baker, J. Lile, C. Rush, Reuben Adatorwovor, L. Hays, Danielle M. Anderson, Mary B. Fisher, S. Segerstrom, Joy M. Schmitz, W. Stoops","doi":"10.1017/cts.2024.466","DOIUrl":"https://doi.org/10.1017/cts.2024.466","url":null,"abstract":"OBJECTIVES/GOALS: Contingency management (CM) procedures yield measurable reductions in cocaine use. This poster describes a trial aimed at using CM as a vehicle to show the biopsychosocial health benefits of reduced use, rather than total abstinence, the currently accepted metric for treatment efficacy. METHODS/STUDY POPULATION: In this 12-week, randomized controlled trial, CM was used to reduce cocaine use and evaluate associated improvements in cardiovascular, immune, and psychosocial well-being. Adults aged 18 and older who sought treatment for cocaine use (N=127) were randomized into three groups in a 1:1:1 ratio: High Value ($55) or Low Value ($13) CM incentives for cocaine-negative urine samples or a non-contingent control group. They completed outpatient sessions three days per week across the 12-week intervention period, totaling 36 clinic visits and four post-treatment follow-up visits. During each visit, participants provided observed urine samples and completed several assays of biopsychosocial health. RESULTS/ANTICIPATED RESULTS: Preliminary findings from generalized linear mixed effect modeling demonstrate the feasibility of the CM platform. Abstinence rates from cocaine use were significantly greater in the High Value group (47% negative; OR = 2.80; p = 0.01) relative to the Low Value (23% negative) and Control groups (24% negative;). In the planned primary analysis, the level of cocaine use reduction based on cocaine-negative urine samples will serve as the primary predictor of cardiovascular (e.g., endothelin-1 levels), immune (e.g., IL-10 levels) and psychosocial (e.g., Addiction Severity Index) outcomes using results from the fitted models. DISCUSSION/SIGNIFICANCE: This research will advance the field by prospectively and comprehensively demonstrating the beneficial effects of reduced cocaine use. These outcomes can, in turn, support the adoption of reduced cocaine use as a viable alternative endpoint in cocaine treatment trials.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"68 1","pages":"163 - 163"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140795063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Arlet Hernandez, M. Gwin, LA Wiggins, H. Bryant, M. Vasilyev, VL Dal Zotto, ML Bates, M. Schuler, NR Gassman
OBJECTIVES/GOALS: Electronic cigarettes have become increasingly popular, with various combustion products generated in the process. Dihydroxyacetone (DHA), a carbohydrate made during the heating process. Exposures may reach high micromolar to low millimolar doses of DHA per day and no studies have been done to understand the effects of DHA in the heart. METHODS/STUDY POPULATION: Here, we examine if DHA contributes to these using rat cardiomyocytes, H9c2 cells, and rat cardiac tissues to DHA evaluating metabolic and mitochondrial effects. Using the cells, we will investigate metabolic and mitochondrial pathways using Seahorse, protein expression changes in nutrient sensing pathways, and understand dose-dependent effects of DHA in the heart. Metabolite pools will also be evaluated to understand the changes promoted by DHA. Oxidative stress as previously observed in other cell models will also be measured. Key findings in the cardiac cells will be investigated in the cardiac tissues exposed to DHA. RESULTS/ANTICIPATED RESULTS: We have previously shown DHA induces oxidative stress, metabolic changes, and mitochondrial dysfunction in various cell line models. Interestingly, these effects are highly cell-type dependent. E-cigarettes are known to have toxic cardiac effects, including arterial stiffness, endothelial dysfunction, vascular injury, and oxidative stress. Changes in glycolytic, fatty acid synthesis, and the citric acid cycle enzymes and metabolites were found in the H9c2 cells. We also observed increased mitochondrial ROS and fuel changes due to DHA exposure. In DHA exposed cardiac tissues, we observed oxidative stress and mitochondrial fission and fusion dynamics altered. DISCUSSION/SIGNIFICANCE: These data suggest further study at physiologically relevant doses is warranted to understand how DHA inhaled impacts the long-term health of vapers. As well as the regulation of DHA in e-cigarettes as it has been deemed as safe for topical applications and warned against inhalation.
目的/目标：电子香烟越来越受欢迎，在使用过程中会产生各种燃烧产物。二羟基丙酮（DHA）是加热过程中产生的一种碳水化合物。每天接触的 DHA 剂量可能从高微摩尔到低毫摩尔不等，目前还没有研究了解 DHA 对心脏的影响。方法/研究人群：在此，我们将使用大鼠心肌细胞、H9c2 细胞和大鼠心脏组织来研究 DHA 是否会对新陈代谢和线粒体效应产生影响。利用这些细胞，我们将使用海马研究代谢和线粒体途径、营养传感途径中的蛋白质表达变化，并了解 DHA 在心脏中的剂量依赖性效应。还将对代谢物池进行评估，以了解 DHA 所促进的变化。还将测量之前在其他细胞模型中观察到的氧化应激。心脏细胞中的主要发现将在暴露于 DHA 的心脏组织中进行研究。结果/预期结果：我们以前曾在各种细胞系模型中发现 DHA 会诱导氧化应激、新陈代谢变化和线粒体功能障碍。有趣的是，这些影响高度依赖于细胞类型。众所周知，电子烟具有毒性心脏效应，包括动脉僵化、内皮功能障碍、血管损伤和氧化应激。在 H9c2 细胞中发现了糖酵解、脂肪酸合成、柠檬酸循环酶和代谢物的变化。我们还观察到线粒体 ROS 的增加以及 DHA 暴露导致的燃料变化。在暴露于 DHA 的心脏组织中，我们观察到氧化应激和线粒体裂变与融合动力学发生了改变。讨论/意义：这些数据表明，有必要对生理相关剂量进行进一步研究，以了解吸入的 DHA 如何影响吸食者的长期健康。以及对电子烟中 DHA 的监管，因为 DHA 被认为对局部应用是安全的，但警告不要吸入。
{"title":"504 Dihydroxyacetone, a combustion of electronic cigarettes, promotes cardiac-specific injury through metabolic and mitochondrial imbalances","authors":"Arlet Hernandez, M. Gwin, LA Wiggins, H. Bryant, M. Vasilyev, VL Dal Zotto, ML Bates, M. Schuler, NR Gassman","doi":"10.1017/cts.2024.427","DOIUrl":"https://doi.org/10.1017/cts.2024.427","url":null,"abstract":"OBJECTIVES/GOALS: Electronic cigarettes have become increasingly popular, with various combustion products generated in the process. Dihydroxyacetone (DHA), a carbohydrate made during the heating process. Exposures may reach high micromolar to low millimolar doses of DHA per day and no studies have been done to understand the effects of DHA in the heart. METHODS/STUDY POPULATION: Here, we examine if DHA contributes to these using rat cardiomyocytes, H9c2 cells, and rat cardiac tissues to DHA evaluating metabolic and mitochondrial effects. Using the cells, we will investigate metabolic and mitochondrial pathways using Seahorse, protein expression changes in nutrient sensing pathways, and understand dose-dependent effects of DHA in the heart. Metabolite pools will also be evaluated to understand the changes promoted by DHA. Oxidative stress as previously observed in other cell models will also be measured. Key findings in the cardiac cells will be investigated in the cardiac tissues exposed to DHA. RESULTS/ANTICIPATED RESULTS: We have previously shown DHA induces oxidative stress, metabolic changes, and mitochondrial dysfunction in various cell line models. Interestingly, these effects are highly cell-type dependent. E-cigarettes are known to have toxic cardiac effects, including arterial stiffness, endothelial dysfunction, vascular injury, and oxidative stress. Changes in glycolytic, fatty acid synthesis, and the citric acid cycle enzymes and metabolites were found in the H9c2 cells. We also observed increased mitochondrial ROS and fuel changes due to DHA exposure. In DHA exposed cardiac tissues, we observed oxidative stress and mitochondrial fission and fusion dynamics altered. DISCUSSION/SIGNIFICANCE: These data suggest further study at physiologically relevant doses is warranted to understand how DHA inhaled impacts the long-term health of vapers. As well as the regulation of DHA in e-cigarettes as it has been deemed as safe for topical applications and warned against inhalation.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"505 1","pages":"149 - 149"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140787706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Priscilla A. Barnes, Erin Ables, Caleb Pittman, Mylan Gaston, Chelsea Simpkins, Shaina Bradley, Carrie Shaw
OBJECTIVES/GOALS: Rural recovery community organizations (RCOs) are key to fostering people’s resilience in the face of the nation’s substance use crisis. However, their development is often a black box. METHODS/STUDY POPULATION: A community-engaged multiple-methods approach was conducted to elucidate stakeholders' perspectives about the creation of two RCOs through a consortium intended to build peer recovery support services in a rural Southern Indiana designated health professional shortage area. Document review (e.g., meeting minutes, event photography, and administrative reports) were extracted to map activities, products, and milestones of the development of the RCOs. Consortium members, RCO leadership and staff, and community members identified by consortium or RCO leadership/staff participated in one-on-one interviews or community roundtable sessions were held to reflect on the evolving development of the RCOs. Procedures were approved by the Institutional Review Board of Indiana University. RESULTS/ANTICIPATED RESULTS: This designated health professional shortage area is unique as it is the nonmetropolitan county with two accredited RCOs. Each RCOs has its own distinct brand. One RCO primarily provide support services to prepare justice-involved individuals who are re-entering the community from jail or probation. The second RCO operates a recovery café – a drug free space that offers accountability groups (recovery circles), volunteer opportunities, and multiple pathway (e.g., 12-steps, referral to medication assisted treatment) meetings. Services are facilitated through peer recovery coaches. Services are provided by certified peer recovery coaches (individuals who has lived experience with addiction and recovery) who offers informational, socio-emotional, and instrumental/basic needs support. DISCUSSION/SIGNIFICANCE: This collaborative rural-based model features recovery community organizations as emerging lead agencies in providing informational, socio-emotional, and basic needs for individuals living in long-term recovery as well as individuals using substances and is not yet in recovery services or acknowledging an addiction is present.
{"title":"216 Exploring the development of recovery community organizations in non-metropolitan settings: A community-engaged multiple-methods approach","authors":"Priscilla A. Barnes, Erin Ables, Caleb Pittman, Mylan Gaston, Chelsea Simpkins, Shaina Bradley, Carrie Shaw","doi":"10.1017/cts.2024.204","DOIUrl":"https://doi.org/10.1017/cts.2024.204","url":null,"abstract":"OBJECTIVES/GOALS: Rural recovery community organizations (RCOs) are key to fostering people’s resilience in the face of the nation’s substance use crisis. However, their development is often a black box. METHODS/STUDY POPULATION: A community-engaged multiple-methods approach was conducted to elucidate stakeholders' perspectives about the creation of two RCOs through a consortium intended to build peer recovery support services in a rural Southern Indiana designated health professional shortage area. Document review (e.g., meeting minutes, event photography, and administrative reports) were extracted to map activities, products, and milestones of the development of the RCOs. Consortium members, RCO leadership and staff, and community members identified by consortium or RCO leadership/staff participated in one-on-one interviews or community roundtable sessions were held to reflect on the evolving development of the RCOs. Procedures were approved by the Institutional Review Board of Indiana University. RESULTS/ANTICIPATED RESULTS: This designated health professional shortage area is unique as it is the nonmetropolitan county with two accredited RCOs. Each RCOs has its own distinct brand. One RCO primarily provide support services to prepare justice-involved individuals who are re-entering the community from jail or probation. The second RCO operates a recovery café – a drug free space that offers accountability groups (recovery circles), volunteer opportunities, and multiple pathway (e.g., 12-steps, referral to medication assisted treatment) meetings. Services are facilitated through peer recovery coaches. Services are provided by certified peer recovery coaches (individuals who has lived experience with addiction and recovery) who offers informational, socio-emotional, and instrumental/basic needs support. DISCUSSION/SIGNIFICANCE: This collaborative rural-based model features recovery community organizations as emerging lead agencies in providing informational, socio-emotional, and basic needs for individuals living in long-term recovery as well as individuals using substances and is not yet in recovery services or acknowledging an addiction is present.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"284 ","pages":"66 - 66"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140792069","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVES/GOALS: There is a scarcity of research examining the views of Black and Latine HIV care consumers on healthcare experiences that influence medical mistrust. The present qualitative study aims to bridge the existing gaps in the literature pertaining to the experiences of Black and Latine HIV care consumers. METHODS/STUDY POPULATION: We conducted 21 semi-structured interviews with Black and Latine HIV care consumers from November to December 2021 to explore perceptions of provider behaviors that increase or decrease HIV care consumers’ trust and mistrust, experiences of stigma, and behaviors and responses when experiencing medical mistrust. Conventional content analysis was conducted to derive meaning from the narratives shared by participants. RESULTS/ANTICIPATED RESULTS: Provider behaviors that increase HIV care consumers’ mistrust include lack of person-centered care, lack of partnership in health decision making, perceived provider incompetence, lack of adequate follow-up to care, and lack of trustworthiness of providers and organizations. Perceived experiences of intersectional stigma in healthcare included feeling judged and discriminated against by healthcare providers regarding HIV status and observing differential care outcomes and delayed care delivery by race and ethnicity. DISCUSSION/SIGNIFICANCE: Findings can inform the development of provider-level interventions to address medical mistrust.
{"title":"205 A Qualitative Study of Black and Latine HIV Care Consumers’ Perceptions of Providers’ Behaviors, Medical Mistrust, and Experiences of Discrimination","authors":"Toluwani E. Adekunle, Lu Dong, Laura M. Bogart","doi":"10.1017/cts.2024.196","DOIUrl":"https://doi.org/10.1017/cts.2024.196","url":null,"abstract":"OBJECTIVES/GOALS: There is a scarcity of research examining the views of Black and Latine HIV care consumers on healthcare experiences that influence medical mistrust. The present qualitative study aims to bridge the existing gaps in the literature pertaining to the experiences of Black and Latine HIV care consumers. METHODS/STUDY POPULATION: We conducted 21 semi-structured interviews with Black and Latine HIV care consumers from November to December 2021 to explore perceptions of provider behaviors that increase or decrease HIV care consumers’ trust and mistrust, experiences of stigma, and behaviors and responses when experiencing medical mistrust. Conventional content analysis was conducted to derive meaning from the narratives shared by participants. RESULTS/ANTICIPATED RESULTS: Provider behaviors that increase HIV care consumers’ mistrust include lack of person-centered care, lack of partnership in health decision making, perceived provider incompetence, lack of adequate follow-up to care, and lack of trustworthiness of providers and organizations. Perceived experiences of intersectional stigma in healthcare included feeling judged and discriminated against by healthcare providers regarding HIV status and observing differential care outcomes and delayed care delivery by race and ethnicity. DISCUSSION/SIGNIFICANCE: Findings can inform the development of provider-level interventions to address medical mistrust.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"372 6","pages":"63 - 63"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140788501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Catherine McGeoch, Rebecca S. Steinberg, Siya Thadani, Alexis Cutchins
OBJECTIVES/GOALS: Total-body symptom surveys among patients with idiopathic orthostatic intolerance (OI) at our referral center suggest that non-conventional OI symptoms, such as pelvic pain, impact quality of life. We seek to identify additional common yet unconventional symptoms reported during clinic visits to improve targeted symptom management. METHODS/STUDY POPULATION: Pelvic pain symptom surveys were completed by 178 patients age 18 and over with a chief complaint of OI. Pelvic pain prevalence was assessed using the International Pelvic Pain Society (IPPS) and Pelvic Congestion Syndrome (PCS) surveys. Expanding on this work, surveys will be distributed to a population with the same inclusion criteria but with a broader symptom scope, chosen based on patient reports during clinical encounters—including presence of migraines, cold digits (Raynaud’s phenomenon), anxiety and depression. The Migraine Disability Assessment Test (MIDAS), modified Assessment of Systemic Sclerosis–Associated Raynaud’s Phenomenon (ASRAP), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) surveys, respectively, will be used to obtain symptom prevalence. RESULTS/ANTICIPATED RESULTS: Of the pelvic pain survey participants, pelvic pain was endorsed by 144/178 (80.9%) of respondents. Prevalence of the additional surveyed symptoms—migraines, cold digits, anxiety, and depression—will similarly be assessed. Given that in our referral clinic we have observed a trend of patients reporting these additional symptoms, we anticipate that at least some of them will be prevalent in a majority of the patient population formally surveyed, similar to the trend observed with pelvic pain prevalence. In particular, we anticipate many patients will report significant migraines, as migraine pain severity on a scale of 0-10 with 0 being no migraine pain and 10 being the most severe migraine pain imaginable is one of the elements of the IPSS survey, and 106/178 (59.6%) reported migraine pain of 5 or higher. DISCUSSION/SIGNIFICANCE: Novel treatment approaches for OI are needed, as lifestyle management is the current treatment paradigm. Several patients reporting pelvic pain have undergone targeted workup and subsequent symptomatic treatment that has improved their quality of life. Other targeted symptom approaches to prevalent symptoms could have the same effect.
{"title":"35 Total-body symptom assessment in patients with idiopathic orthostatic intolerance to improve symptomatic management","authors":"Catherine McGeoch, Rebecca S. Steinberg, Siya Thadani, Alexis Cutchins","doi":"10.1017/cts.2024.52","DOIUrl":"https://doi.org/10.1017/cts.2024.52","url":null,"abstract":"OBJECTIVES/GOALS: Total-body symptom surveys among patients with idiopathic orthostatic intolerance (OI) at our referral center suggest that non-conventional OI symptoms, such as pelvic pain, impact quality of life. We seek to identify additional common yet unconventional symptoms reported during clinic visits to improve targeted symptom management. METHODS/STUDY POPULATION: Pelvic pain symptom surveys were completed by 178 patients age 18 and over with a chief complaint of OI. Pelvic pain prevalence was assessed using the International Pelvic Pain Society (IPPS) and Pelvic Congestion Syndrome (PCS) surveys. Expanding on this work, surveys will be distributed to a population with the same inclusion criteria but with a broader symptom scope, chosen based on patient reports during clinical encounters—including presence of migraines, cold digits (Raynaud’s phenomenon), anxiety and depression. The Migraine Disability Assessment Test (MIDAS), modified Assessment of Systemic Sclerosis–Associated Raynaud’s Phenomenon (ASRAP), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) surveys, respectively, will be used to obtain symptom prevalence. RESULTS/ANTICIPATED RESULTS: Of the pelvic pain survey participants, pelvic pain was endorsed by 144/178 (80.9%) of respondents. Prevalence of the additional surveyed symptoms—migraines, cold digits, anxiety, and depression—will similarly be assessed. Given that in our referral clinic we have observed a trend of patients reporting these additional symptoms, we anticipate that at least some of them will be prevalent in a majority of the patient population formally surveyed, similar to the trend observed with pelvic pain prevalence. In particular, we anticipate many patients will report significant migraines, as migraine pain severity on a scale of 0-10 with 0 being no migraine pain and 10 being the most severe migraine pain imaginable is one of the elements of the IPSS survey, and 106/178 (59.6%) reported migraine pain of 5 or higher. DISCUSSION/SIGNIFICANCE: Novel treatment approaches for OI are needed, as lifestyle management is the current treatment paradigm. Several patients reporting pelvic pain have undergone targeted workup and subsequent symptomatic treatment that has improved their quality of life. Other targeted symptom approaches to prevalent symptoms could have the same effect.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"243 ","pages":"10 - 11"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140792300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kimberly McCall, Keith McGregor, Shellie Layne, Raymond Jones
OBJECTIVES/GOALS: Improving physical activity of African American women experiencing disproportionate health risks from sedentarism, educational and socio-environmental barriers. BeFit: Building Empowerment through Fitness is based on “What I Learned At Home” project, run by Women Under Construction Network, for residents of the Birmingham Housing Authority. METHODS/STUDY POPULATION: A qualitative study design to understand unique cultural context and challenges faced by African American women residing in the Birmingham Housing Authority, regarding physical activity engagement, including sedentarism. A needs assessment approach will help determine barriers, support systems, and social networks. Semi-structured, pre, mid, and post program focus groups will identify challenges and opportunities for health, such as diet and exercise, and will be analyzed by hand with a thematic analysis. The project framework uses exercise and home repair tools with a life-building/life repair curriculum to influence health, self-efficacy, and program engagement. The Study enrollment will include 50 women over two cohorts in a 12-week project. RESULTS/ANTICIPATED RESULTS: This research addresses the urgent health needs of African American women in low-income communities. These women face heightened health risks due to sedentary lifestyles, educational gaps, and socio-environmental barriers. This project targets the pronounced prevalence of allostatic burden in this population by applying a culturally sensitive, bottom-up approach. Our goal of incorporating healthy lifestyles to improve health in at-risk women and their families requires multiple projects. This project is a necessary first step in engaging with a community to identify local environmental circumstances and barriers to increasing the relevance of physical activity within the home. These barriers can then be addressed by adapting an exercise promotion program to the needs of this community. DISCUSSION/SIGNIFICANCE: Black women in under-resourced communities are more likely to be sedentary and have poor health. Exercise programs can be a powerful tool to address disparities and help prioritize health. The circumstances of women in public housing in Birmingham, AL, need community partners to adapt exercise engagement programs to meet environmental challenges.
{"title":"264 Building Empowerment through FITness (BeFIT)","authors":"Kimberly McCall, Keith McGregor, Shellie Layne, Raymond Jones","doi":"10.1017/cts.2024.240","DOIUrl":"https://doi.org/10.1017/cts.2024.240","url":null,"abstract":"OBJECTIVES/GOALS: Improving physical activity of African American women experiencing disproportionate health risks from sedentarism, educational and socio-environmental barriers. BeFit: Building Empowerment through Fitness is based on “What I Learned At Home” project, run by Women Under Construction Network, for residents of the Birmingham Housing Authority. METHODS/STUDY POPULATION: A qualitative study design to understand unique cultural context and challenges faced by African American women residing in the Birmingham Housing Authority, regarding physical activity engagement, including sedentarism. A needs assessment approach will help determine barriers, support systems, and social networks. Semi-structured, pre, mid, and post program focus groups will identify challenges and opportunities for health, such as diet and exercise, and will be analyzed by hand with a thematic analysis. The project framework uses exercise and home repair tools with a life-building/life repair curriculum to influence health, self-efficacy, and program engagement. The Study enrollment will include 50 women over two cohorts in a 12-week project. RESULTS/ANTICIPATED RESULTS: This research addresses the urgent health needs of African American women in low-income communities. These women face heightened health risks due to sedentary lifestyles, educational gaps, and socio-environmental barriers. This project targets the pronounced prevalence of allostatic burden in this population by applying a culturally sensitive, bottom-up approach. Our goal of incorporating healthy lifestyles to improve health in at-risk women and their families requires multiple projects. This project is a necessary first step in engaging with a community to identify local environmental circumstances and barriers to increasing the relevance of physical activity within the home. These barriers can then be addressed by adapting an exercise promotion program to the needs of this community. DISCUSSION/SIGNIFICANCE: Black women in under-resourced communities are more likely to be sedentary and have poor health. Exercise programs can be a powerful tool to address disparities and help prioritize health. The circumstances of women in public housing in Birmingham, AL, need community partners to adapt exercise engagement programs to meet environmental challenges.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"70 41","pages":"79 - 80"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140795244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Subramain, Kimberly J. Sprenger, Debra O’Connell-Moore, Cena Jones-Bitterman, B. Knosp
OBJECTIVES/GOALS: The CTSA consortium’s Informatics Enterprise Committee has developed a maturity assessment model for Clinical Trial Management Ecosystems (CTME). This poster will show the improvements achieved using this model at the University of Iowa as well as guidance on how to apply it at other CTSA hubs. METHODS/STUDY POPULATION: The CTME maturity model consists of 11 categories including, study management; regulatory; financial; and reporting. Each category has 3 subcategories: standardization; complexity; and monitoring, while each subcategory is comprised of 1 to 5 maturity statements: initial; developing; aspiring; capable; and efficient. The maturity assessment team at Iowa—comprised of key personnel from clinical research and compliance, accounting, and administration—have used the CTME maturity model to assess Iowa’s research performance across the 11 categories. The initial maturity ratings for each category revealed any gaps in research operations, which led to developing strategies to address the gaps. RESULTS/ANTICIPATED RESULTS: The assessment team initiated a CTME maturity planning project—holding regular meetings to review Iowa’s CTME research maturity and plan changes to improve our CTME maturity ratings. This analysis is done at the statement level to minimize the scope of actions needed and keep resource loads for improvements low. Proposed improvements are assigned to a team member who serves as an “accountability leader.” Such leaders develop action plans aimed at increasing maturity at least one level. The leaders are responsible for acquiring the resources to carry out the plan. Each action plan identifies qualifiers reviewed by the team to confirm that the maturity level has been met. DISCUSSION/SIGNIFICANCE: The CTME maturity model has been shown to be effective in identifying gaps in organizational operations at the University of Iowa, where it has led to incremental steps to improve clinical research operations. The utilization of the model at other CTSA hubs will be discussed at this session.
{"title":"532 Application of the CTME Maturity Model in a CTSA Hub: An Initiative to Improve Clinical Research Operations","authors":"M. Subramain, Kimberly J. Sprenger, Debra O’Connell-Moore, Cena Jones-Bitterman, B. Knosp","doi":"10.1017/cts.2024.454","DOIUrl":"https://doi.org/10.1017/cts.2024.454","url":null,"abstract":"OBJECTIVES/GOALS: The CTSA consortium’s Informatics Enterprise Committee has developed a maturity assessment model for Clinical Trial Management Ecosystems (CTME). This poster will show the improvements achieved using this model at the University of Iowa as well as guidance on how to apply it at other CTSA hubs. METHODS/STUDY POPULATION: The CTME maturity model consists of 11 categories including, study management; regulatory; financial; and reporting. Each category has 3 subcategories: standardization; complexity; and monitoring, while each subcategory is comprised of 1 to 5 maturity statements: initial; developing; aspiring; capable; and efficient. The maturity assessment team at Iowa—comprised of key personnel from clinical research and compliance, accounting, and administration—have used the CTME maturity model to assess Iowa’s research performance across the 11 categories. The initial maturity ratings for each category revealed any gaps in research operations, which led to developing strategies to address the gaps. RESULTS/ANTICIPATED RESULTS: The assessment team initiated a CTME maturity planning project—holding regular meetings to review Iowa’s CTME research maturity and plan changes to improve our CTME maturity ratings. This analysis is done at the statement level to minimize the scope of actions needed and keep resource loads for improvements low. Proposed improvements are assigned to a team member who serves as an “accountability leader.” Such leaders develop action plans aimed at increasing maturity at least one level. The leaders are responsible for acquiring the resources to carry out the plan. Each action plan identifies qualifiers reviewed by the team to confirm that the maturity level has been met. DISCUSSION/SIGNIFICANCE: The CTME maturity model has been shown to be effective in identifying gaps in organizational operations at the University of Iowa, where it has led to incremental steps to improve clinical research operations. The utilization of the model at other CTSA hubs will be discussed at this session.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"11 3","pages":"158 - 158"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140755671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacob Simmering, Nandakumar Narayanan, Philip Polgreen
OBJECTIVES/GOALS: Inexpensive, accurate home monitoring is the standard-of-care in many diseases like hypertension or diabetes; however, it has yet to be widely used in neurodegenerative diseases. We used wearable activity monitors and computer-vision evaluated assessments to estimate Parkinson’s disease (PD)-related disease burden. METHODS/STUDY POPULATION: We recruited 22 people from the University of Iowa Movement Disorders Clinic. Each person completed a standardized set of 3 fine motor tasks using their hands. We recorded a video of this activity, which was evaluated using MediaPipe - an open-source pose classification program from Alphabet - as well as had an nurse-practitioner evaluate the performance on a validated scale (UPDRS). Participants wore a Fitbit Inspire 3 activity tracker at home for the next two weeks. We quantified disease burden using the Parkinson’s Disease Questionnaire 39 - a validated 39-item survey about the intensity of PD-related impairment. Using data from the videos and activity trackers, we estimated 1) the standardized UPDRS assessment of motor impairment and 2) the total PDQ-39 score. RESULTS/ANTICIPATED RESULTS: We found observationally recorded fastest sustained (at least 5 minutes) walking speed was a strong predictor of PDQ-39, explaining over one third of the variability in the measure. Range of motion in the videos was a significant predictor of UPDRS scores; however, was only weakly related to the overall PDQ-39 score. Further processing of the signals from the video, including wavelets and frequency domain analysis, may provide better predictive capabilities. PDQ-39 subscores (e.g., cognition, social support, mobility) will be the subject of further analysis. DISCUSSION/SIGNIFICANCE: Home monitoring has become the standard in other fields because of the better generalizability of home measurements. Improving the detection and evaluation of PD using home monitoring will lead to more timely and accurately changes in medication and less need for clinic visits - especially off levodopa.
{"title":"471 Using Computer Vision and Wearable Devices to Improve Care of Parkinson’s Disease","authors":"Jacob Simmering, Nandakumar Narayanan, Philip Polgreen","doi":"10.1017/cts.2024.399","DOIUrl":"https://doi.org/10.1017/cts.2024.399","url":null,"abstract":"OBJECTIVES/GOALS: Inexpensive, accurate home monitoring is the standard-of-care in many diseases like hypertension or diabetes; however, it has yet to be widely used in neurodegenerative diseases. We used wearable activity monitors and computer-vision evaluated assessments to estimate Parkinson’s disease (PD)-related disease burden. METHODS/STUDY POPULATION: We recruited 22 people from the University of Iowa Movement Disorders Clinic. Each person completed a standardized set of 3 fine motor tasks using their hands. We recorded a video of this activity, which was evaluated using MediaPipe - an open-source pose classification program from Alphabet - as well as had an nurse-practitioner evaluate the performance on a validated scale (UPDRS). Participants wore a Fitbit Inspire 3 activity tracker at home for the next two weeks. We quantified disease burden using the Parkinson’s Disease Questionnaire 39 - a validated 39-item survey about the intensity of PD-related impairment. Using data from the videos and activity trackers, we estimated 1) the standardized UPDRS assessment of motor impairment and 2) the total PDQ-39 score. RESULTS/ANTICIPATED RESULTS: We found observationally recorded fastest sustained (at least 5 minutes) walking speed was a strong predictor of PDQ-39, explaining over one third of the variability in the measure. Range of motion in the videos was a significant predictor of UPDRS scores; however, was only weakly related to the overall PDQ-39 score. Further processing of the signals from the video, including wavelets and frequency domain analysis, may provide better predictive capabilities. PDQ-39 subscores (e.g., cognition, social support, mobility) will be the subject of further analysis. DISCUSSION/SIGNIFICANCE: Home monitoring has become the standard in other fields because of the better generalizability of home measurements. Improving the detection and evaluation of PD using home monitoring will lead to more timely and accurately changes in medication and less need for clinic visits - especially off levodopa.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 15","pages":"139 - 139"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140755689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVES/GOALS: In Sep 2022, Johns Hopkins Research Coordinator Support Service launched Research Personnel Onboarding Program. The program on board in experienced individuals in 6-8 weeks, tailoring training plans to Investigator and study needs. It also offers Ongoing Support to enhance sustainability and adaptability. METHODS/STUDY POPULATION: * Assess Principal Investigator (PI)’s need Evaluate study’s need Understand trainee’s background Develop a personalized training plan (∼6-8 weeks) Weekly updates Ongoing mentorship Research staff spend 200+ training hours, depending on their need. Training encompasses various modalities: Interactive 1:1 onboarding sessions, Online, and Instructor-led trainings and sessions cover a wide range of topics, including: * Mandatory JHU/Institutional Review Board trainings * Good Clinical Practice * Regulatory submissions * Screening/Consenting * Monitoring/Auditing * Visit conduct * Clinical skills * Soft Skills Figure 1. Chart shows cumulative onboarding hours that focus on “How” to do tasks Figure 2. Chart shows cumulative training hours that focus on regulations, ethics and “Why” for tasks RESULTS/ANTICIPATED RESULTS: * The program contributed nearly 4000 hrs. of research staff training in the past 1 year * The program received 26 requests from investigators; 14 Completed the onboarding program, 1 Active, 5 Projected (Future start date), and 6 Cancelled (HR issues, lack of fund, or hired a trained staff) * 22 requests opted in the “Ongoing Support” * Ongoing Support, is averaged at 1 hr./month for the first 3-6 months. This indicates program success in empowering independent task performance * Developing REDCap request had significantly reduced meetings and paperwork * Web-Based Clockify invoicing has drastically reduced monthly manually invoicing processing time DISCUSSION/SIGNIFICANCE: * Grow the next generation of clinical research professionals * Centralize and standardize expert onboarding throughout the University * Improve outcomes, enhanced productivity, knowledge sharing, collaboration, and innovation * Decrease frustration and enhance satisfaction of trainees and departments
{"title":"520 Johns Hopkins Institute for Clinical and Translational Research (ICTR) - Research Personnel Onboarding Program","authors":"Mais Hamdawi, Anthony Keyes","doi":"10.1017/cts.2024.443","DOIUrl":"https://doi.org/10.1017/cts.2024.443","url":null,"abstract":"OBJECTIVES/GOALS: In Sep 2022, Johns Hopkins Research Coordinator Support Service launched Research Personnel Onboarding Program. The program on board in experienced individuals in 6-8 weeks, tailoring training plans to Investigator and study needs. It also offers Ongoing Support to enhance sustainability and adaptability. METHODS/STUDY POPULATION: * Assess Principal Investigator (PI)’s need Evaluate study’s need Understand trainee’s background Develop a personalized training plan (∼6-8 weeks) Weekly updates Ongoing mentorship Research staff spend 200+ training hours, depending on their need. Training encompasses various modalities: Interactive 1:1 onboarding sessions, Online, and Instructor-led trainings and sessions cover a wide range of topics, including: * Mandatory JHU/Institutional Review Board trainings * Good Clinical Practice * Regulatory submissions * Screening/Consenting * Monitoring/Auditing * Visit conduct * Clinical skills * Soft Skills Figure 1. Chart shows cumulative onboarding hours that focus on “How” to do tasks Figure 2. Chart shows cumulative training hours that focus on regulations, ethics and “Why” for tasks RESULTS/ANTICIPATED RESULTS: * The program contributed nearly 4000 hrs. of research staff training in the past 1 year * The program received 26 requests from investigators; 14 Completed the onboarding program, 1 Active, 5 Projected (Future start date), and 6 Cancelled (HR issues, lack of fund, or hired a trained staff) * 22 requests opted in the “Ongoing Support” * Ongoing Support, is averaged at 1 hr./month for the first 3-6 months. This indicates program success in empowering independent task performance * Developing REDCap request had significantly reduced meetings and paperwork * Web-Based Clockify invoicing has drastically reduced monthly manually invoicing processing time DISCUSSION/SIGNIFICANCE: * Grow the next generation of clinical research professionals * Centralize and standardize expert onboarding throughout the University * Improve outcomes, enhanced productivity, knowledge sharing, collaboration, and innovation * Decrease frustration and enhance satisfaction of trainees and departments","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"189 3","pages":"154 - 155"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140758496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rebecca K. Delaney, Alexander J. Alexander, Ian Lindsay, Nelangi Pinto, Teresa Hagan Thomas, Ellen Lipstein, Tamara Shepherd, Angela Fagerlin
OBJECTIVES/GOALS: Serious video games are designed for skill-building and are increasingly being used for healthcare interventions with adolescents and young adults (AYAs). The study goal was to identify AYAs’ preferred game features, by demographic groups, to inform the development of a game to improve AYA’s engagement in their congenital heart disease (CHD) care. METHODS/STUDY POPULATION: Pediatric patients, 12-18 years old, completed surveys at a routine CHD care visit. Participants rated their likelihood of using games to learn CHD management skills (5-point Likert) and preferences for ten game features commonly used, such as: personalization (make your own avatar) and levels (unlock new, advanced stages as you do better). Participants selected one of three response options: 1=would make me less interested in the game, 2=doesn’t matter, 3=would make me more interested in the game. Descriptives and frequencies assessed interest in different game features. Chi-square tests were used to identify potential differences in game feature preferences by gender identity, age group (early/mid-adolescence vs. late adolescence), and race and ethnicity. RESULTS/ANTICIPATED RESULTS: Of 83 participants who completed surveys, the mean age was 15 years old (12-18; SD=1.73), 55% were male, 79% were Non-Hispanic White, and 70% were interested in video games for gaining CHD management skills. The top-rated game features were: levels (78%; unlock advanced stages), conflict (74%; face challenges), personalization (70%; create avatar), and story (70%; journey-based). The three lowest-ranked features were: time (29%; restricted time to complete challenge), competition (47%; score/play against others), strategy (53%; plan to reach goal). No significant differences in game feature preferences were found by demographic characteristics. DISCUSSION/SIGNIFICANCE: Most AYAs with CHD were interested in games, offering a promising avenue for future healthcare interventions. Given no significantly different preferences by demographics, the game may not require tailoring game features for certain groups. However, additional research with diverse participants is needed to fully inform game development.
{"title":"78 Empowering Patients with Congenital Heart Disease: Insights into Serious Video Game Preferences","authors":"Rebecca K. Delaney, Alexander J. Alexander, Ian Lindsay, Nelangi Pinto, Teresa Hagan Thomas, Ellen Lipstein, Tamara Shepherd, Angela Fagerlin","doi":"10.1017/cts.2024.79","DOIUrl":"https://doi.org/10.1017/cts.2024.79","url":null,"abstract":"OBJECTIVES/GOALS: Serious video games are designed for skill-building and are increasingly being used for healthcare interventions with adolescents and young adults (AYAs). The study goal was to identify AYAs’ preferred game features, by demographic groups, to inform the development of a game to improve AYA’s engagement in their congenital heart disease (CHD) care. METHODS/STUDY POPULATION: Pediatric patients, 12-18 years old, completed surveys at a routine CHD care visit. Participants rated their likelihood of using games to learn CHD management skills (5-point Likert) and preferences for ten game features commonly used, such as: personalization (make your own avatar) and levels (unlock new, advanced stages as you do better). Participants selected one of three response options: 1=would make me less interested in the game, 2=doesn’t matter, 3=would make me more interested in the game. Descriptives and frequencies assessed interest in different game features. Chi-square tests were used to identify potential differences in game feature preferences by gender identity, age group (early/mid-adolescence vs. late adolescence), and race and ethnicity. RESULTS/ANTICIPATED RESULTS: Of 83 participants who completed surveys, the mean age was 15 years old (12-18; SD=1.73), 55% were male, 79% were Non-Hispanic White, and 70% were interested in video games for gaining CHD management skills. The top-rated game features were: levels (78%; unlock advanced stages), conflict (74%; face challenges), personalization (70%; create avatar), and story (70%; journey-based). The three lowest-ranked features were: time (29%; restricted time to complete challenge), competition (47%; score/play against others), strategy (53%; plan to reach goal). No significant differences in game feature preferences were found by demographic characteristics. DISCUSSION/SIGNIFICANCE: Most AYAs with CHD were interested in games, offering a promising avenue for future healthcare interventions. Given no significantly different preferences by demographics, the game may not require tailoring game features for certain groups. However, additional research with diverse participants is needed to fully inform game development.","PeriodicalId":508693,"journal":{"name":"Journal of Clinical and Translational Science","volume":"103 ","pages":"20 - 21"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140760482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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