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Contemporary Clinical Trials

Luca Cabrini, Claudia Brusasco, Agostino Roasio, Francesco Corradi, Pasquale Nardelli, Matteo Filippini, Virginia Cotticelli, Alessandro Belletti, Lorenzo Ferrara, Elio Antonucci, Martina Baiardo Redaelli, Marco Lattuada, Sergio Colombo, Luigi Olper, Giuseppe Ponzetta, Sofia Ananiadou, Giacomo Monti, Luca Severi, Giulia Maj, Giuseppe Giardina, Giuseppe Biondi Zoccai, Umberto Benedetto, Marco Gemma, Sarah Sophia Michelle Cavallero, Ludhmila Abrahao Hajjar, Alberto Zangrillo, Rinaldo Bellomo, Giovanni Landoni
OBJECTIVE: Few randomized trials have evaluated the use of non-invasive ventilation (NIV) for early acute respiratory failure (ARF) in non-intensive care unit (ICU) wards. The aim of this study is to test the hypothesis that early NIV for mild-moderate ARF in non-ICU wards can prevent development of severe ARF. DESIGN: Pragmatic, parallel group, randomized, controlled, multicenter trial. SETTING: Non-intensive care wards of tertiary centers...
February 7, 2019: Contemporary Clinical Trials
Tricia S Tang, Rowshanak Afshar, Thomas Elliott, Jason Kong, Sabrina Gill
BACKGROUND: The objective of this randomized controlled trial is to examine the effects of a 12-month telephone-based peer-led diabetes self-management support (DSMS) intervention on long-term diabetes-related health outcomes. METHODS: In total, 197 participants with type 2 diabetes were recruited from specialty care settings (diabetes and endocrinology clinics). They were randomly assigned to 1) a 12-month Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED) program where they received 12 weekly contacts from their peer supporter (PS) in the first 3 months, followed by 18 biweekly telephone support contacts over the last 9 months, or 2) usual care...
February 7, 2019: Contemporary Clinical Trials
Jong-Sung Yoon, Nelson A Roque, Ronald Andringa, Erin R Harrell, Katharine G Lewis, Thomas Vitale, Neil Charness, Walter R Boot
Age-related perceptual and cognitive declines are associated with difficulties performing everyday tasks required to remain independent. Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence. This project compares the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance...
January 31, 2019: Contemporary Clinical Trials
Philip J Batterham, Alison L Calear, Matthew Sunderland, Frances Kay-Lambkin, Louise M Farrer, Amelia Gulliver
BACKGROUND: There is substantial evidence that psychosocial programs delivered online can be effective in treating and preventing mental health problems. However, use of evidence-based programs in the community is currently suboptimal, and there is a lack of evidence around how to increase engagement with existing evidence-based programs. Novel approaches to increasing the acceptability of online programs such as the use of brief engagement-facilitation interventions (EFI) require evaluation...
January 31, 2019: Contemporary Clinical Trials
Christi A Patten, Harry A Lando, Chris A Desnoyers, Yvette Barrows, Joseph Klejka, Paul A Decker, Christine A Hughes, Martha J Bock, Rahnia Boyer, Kenneth Resnicow, Linda Burhansstipanov
BACKGROUND: Tobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics. DESIGN: Cluster-randomized controlled trial with village as the unit of assignment...
January 28, 2019: Contemporary Clinical Trials
Heather M Johnson, Lisa Sullivan-Vedder, KyungMann Kim, Patrick E McBride, Maureen A Smith, Jamie N LaMantia, Jennifer T Fink, Megan R Knutson Sinaise, Laura M Zeller, Diane R Lauver
Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Young adults need hypertension self-management programs (i.e., home blood pressure monitoring and lifestyle modifications) tailored to their unique needs to lower blood pressure and reduce the risks and medication burden they may face over a lifetime...
January 21, 2019: Contemporary Clinical Trials
Richard I Stein, Jaime R Strickland, Rachel G Tabak, Ann Marie Dale, Graham A Colditz, Bradley A Evanoff
Weight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus, the workplace offers a useful setting to target low-SES workers. The current paper presents the design of a study testing a workplace intervention aimed at low-SES employees. Partnering with a large healthcare system and affiliated university, this project will test an innovative multi-level intervention ("Working for You") adapted from existing group- and individual-level intervention models to promote healthy weight among low-wage workers...
January 18, 2019: Contemporary Clinical Trials
Monica Tang, Kathryn V Blake, John J Lima, Edward B Mougey, James Franciosi, Stephan Schmidt, Md Jobayer Hossain, Marjan Cobbaert, Bernard M Fischer, Jason E Lang
Asthma causes enormous suffering and cost for children in the US and around the world [1-3]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more difficult due to increased symptoms. Proton pump inhibitor (PPI) drugs are effective at improving to GERD symptoms, however they have demonstrated only modest and variable effects on asthma control in the setting of co-morbid GERD. Importantly, PPI metabolism and efficacy depend on CYP2C19 genotype. The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial to determine if genotype-tailored PPI dosing improves asthma symptoms among children with inadequately controlled asthma and GERD symptoms...
January 16, 2019: Contemporary Clinical Trials
Alaina P Vidmar, Sarah Salvy, Robert Pretlow, Steven D Mittelman, Choo Phei Wee, Cassandra Fink, D Steven Fox, Jennifer K Raymond
BACKGROUND: The notion of obesity as an addictive process is controversial. However, studies show that between 5.9 and 30.7% of adolescents with obesity report food or eating addiction. Few weight management interventions have tested techniques based on addiction medicine principles. METHODS: This multi-center randomized control trial (RCT) is designed to test the effectiveness of a mobile health (mHealth) weight-loss intervention based on addiction principles, such as withdrawal and tolerance, in a sample of 180 adolescents (ages 14-18) recruited from four pediatric weight management clinics in Southern California...
January 14, 2019: Contemporary Clinical Trials
Maria L Murphy, David R Lubans, Kristen E Cohen, Sara L Robards, Magdalena Wilczynska, Sarah G Kennedy, Erica L James, Wendy J Brown, Kerry S Courneya, Ronald J Sigal, Ronald C Plotnikoff
INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a global public health concern. Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM. The aim of this pilot trial is to determine the preliminary efficacy and confirm feasibility of referral to exercise physiologists, psychologists, and provision of a technology-based behavior change support package to promote aerobic PA and RT in school teachers 'at risk' of or diagnosed with T2DM...
January 10, 2019: Contemporary Clinical Trials
M Guo, G A Wells, D Glineur, J Fortier, S Gibson, M Ruel
RATIONALE: Minimally invasive cardiac surgery has emerged as a safe alternative to standard cardiac surgery. Minimally invasive coronary surgery (MICS CABG) was developed to allow adequate exposure and complete revascularization in CABG from a small thoracotomy incision without cardiopulmonary bypass. Multiple studies have reported significantly shorter length of hospital stay and earlier postoperative physical recovery for MICS CABG patients when compared to sternotomy CABG patients...
January 8, 2019: Contemporary Clinical Trials
Beverly B Green, Melissa L Anderson, Jerry Campbell, Andrea J Cook, Kelly Ehrlich, Sarah Evers, Yoshio N Hall, Clarissa Hsu, Dwayne Joseph, Predrag Klasnja, Karen L Margolis, Jennifer B McClure, Sean A Munson, Mathew J Thompson
BACKGROUND: The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study comparing the accuracy and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols...
January 8, 2019: Contemporary Clinical Trials
Yumna Masood, Peter Bower, Muhammad Wali Waheed, Gill Brown, Waquas Waheed
BACKGROUND: People from ethnic minorities are reported to have higher rates of physical illness (diabetes and ischemic heart disease) and mental disorders. Disparities relate not just to diagnosis, but also to care pathways and treatment outcomes. Despite this, they are underrepresented in clinical research. This reduces the generalisability of research findings across multi ethnic populations and hinders the development of accessible services. Researchers often face difficulties in recruiting ethnic minority participants to clinical research due to low levels of cultural competence and limited resources...
January 8, 2019: Contemporary Clinical Trials
Jacob P Beckerman, Alyssa Aftosmes-Tobio, Nicole Kitos, Janine M Jurkowski, Kindra Lansburg, Crystal Kazik, Adam Gavarkovs, Adrienne Vigilante, Begum Kalyoncu, Roger Figueroa, Rachel Klabunde, Rachel Barouch, Sebastien Haneuse, Elsie Taveras, Kirsten K Davison
BACKGROUND: Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. This protocol paper outlines the design, content, implementation, and evaluation of CHL...
January 7, 2019: Contemporary Clinical Trials
Ann M Davis, Gretchen Beaver, Meredith Dreyer Gillette, Eve-Lynn Nelson, Kandace Fleming, Rebecca Swinburne Romine, Debra K Sullivan, Robert Lee, Kelley Pettee Gabriel, Kelsey Dean, Megan Murray, Myles Faith
Children in rural areas are disproportionately affected by pediatric obesity. Poor access to healthcare providers, lack of nutrition education, lower socioeconomic status, and fewer opportunities to be physically active are all unique barriers that contribute to this growing health concern. There are very few pediatric obesity interventions that have been developed that target this unique population. iAmHealthy is a family-based behavioral, nutrition and physical activity intervention developed with input from rural children and families that capitalizes on the innovative use of mobile health applications (mHealth)...
January 7, 2019: Contemporary Clinical Trials
Lida Faroqi, Saniya Bonde, Daniella Tatianna Goni, Chi Wai Wong, Myo Wong, Khalil Walai, Saron Araya, Sayed Azamey, Gabriella Schreiner, Monica Bandy, Sonia Sunita Raghuram, Anuva Mittal, Aishee Mukherji, Tenzin Wangdak, Ruth Talamoa, Katherine Vera, Carla Nacif-Coelho, Leah Groppo Cde, Mary Christensen, Neil Johannsen, Francois Haddad, Minal Moharir, Latha Palaniappan
BACKGROUND: Currently, there is a lack of data on effective lifestyle recommendations for normal-weight diabetics (NWD), who can represent up to 1 in 5 individuals with Type II Diabetes Mellitus (T2DM). NWD is especially prevalent in Asian populations and the elderly. Specific exercise treatment recommendations are needed for patients with normal-weight diabetes (NWD), as those in this category face higher mortality rates than overweight and obese diabetics. Standard T2DM treatment recommends aerobic training; however, performing aerobic training alone may not be appropriate for NWD and strength training may be a more effective treatment recommendation...
January 6, 2019: Contemporary Clinical Trials
Susan Fletcher, Patty Chondros, Victoria J Palmer, Mary Lou Chatterton, Matthew J Spittal, Cathrine Mihalopoulos, Anna Wood, Meredith Harris, Philip Burgess, Bridget Bassilios, Jane Pirkis, Jane Gunn
Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room...
December 26, 2018: Contemporary Clinical Trials
Christine A Sorkness, Tonya S King, Anne-Marie Dyer, Vernon M Chinchilli, David T Mauger, Jerry A Krishnan, Kathryn Blake, Mario Castro, Ronina Covar, Elliot Israel, Monica Kraft, Jason E Lang, Njira Lugogo, Stephen P Peters, Michael E Wechsler, Sally E Wenzel, Stephen C Lazarus
Precision medicine is expected to impact the care of people with asthma, given its high disease prevalence, heterogeneity of pathophysiologic mechanisms, and consequent clinical phenotypes. A novel phenotype-stratified clinical trial conducted by the NHLBI AsthmaNet Consortium, titled Steroids in Eosinophil Negative Asthma (SIENA), was a randomized, multicenter, clinical trial that prospectively stratified individuals according to their baseline level of sputum inflammation during a screening period. Two phenotypic strata were assigned based on an a priori defined extent of sputum eosinophilia (Eos Low versus Eos High)...
December 26, 2018: Contemporary Clinical Trials
Tzu Tsun Luk, William Ho Cheung Li, Derek Yee Tak Cheung, Sze Wing Wong, Antonio Cho Shing Kwong, Vienna Wai Yin Lai, Sophia Siu-Chee Chan, Tai Hing Lam, Man Ping Wang
BACKGROUND: Novel approaches to engage community smokers in smoking cessation are needed as smokers typically lack motivation to quit or use evidence-based tobacco dependence treatment. Mobile instant messaging apps (e.g., WhatsApp, Facebook Messenger) are widely used but under-studied as a mobile health modality for delivering smoking cessation support. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a chat-based intervention using mobile instant messaging combined with brief interventions for community smokers...
December 26, 2018: Contemporary Clinical Trials
Kayla de la Haye, Michelle Fluke, Paula Chandler Laney, Michael Goran, Titus Galama, Chi-Ping Chou, Sarah-Jeanne Salvy
BACKGROUND: Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS: This two-arm, parallel, randomized controlled trial (RCT) tests whether delivering obesity prevention, as part of an ongoing home visitation program (HVP), is an effective approach for primary (infants) and secondary (mothers) obesity prevention among low-income, underserved families...
December 19, 2018: Contemporary Clinical Trials
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