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Contemporary Clinical Trials

Jamie A Green, Patti L Ephraim, Felicia F Hill-Briggs, Teri Browne, Tara S Strigo, Chelsie L Hauer, Rebecca A Stametz, Jonathan D Darer, Uptal D Patel, Katina Lang-Lindsey, Brian L Bankes, Shakur A Bolden, Patricia Danielson, Suzanne Ruff, Lana Schmidt, Amy Swoboda, Peter Woods, Brandy Vinson, Diane Littlewood, George Jackson, Jane F Pendergast, Jennifer St Clair Russell, Kelli Collins, Evan Norfolk, Ion D Bucaloiu, Shravan Kethireddy, Charlotte Collins, Daniel Davis, Jeremy dePrisco, Dave Malloy, Clarissa J Diamantidis, Sherri Fulmer, Jennifer Martin, Dori Schatell, Navdeep Tangri, Amanda Sees, Cory Siegrist, Jeffrey Breed, Angela Medley, Elisabeth Graboski, Jonathan Billet, Matthew Hackenberg, Dale Singer, Stephanie Stewart, Aviel Alkon, Nrupen A Bhavsar, LaPricia Lewis-Boyer, Caitlin Martz, Christina Yule, Raquel C Greer, Milda Saunders, Blake Cameron, L Ebony Boulware
Care for patients transitioning from chronic kidney disease to kidney failure often falls short of meeting patients' needs. The PREPARE NOW study is a cluster randomized controlled trial studying the effectiveness of a pragmatic health system intervention, 'Patient Centered Kidney Transition Care,' a multi-component health system intervention designed to improve patients' preparation for kidney failure treatment. Patient-Centered Kidney Transition Care provides a suite of new electronic health information tools (including a disease registry and risk prediction tools) to help providers recognize patients in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences...
September 12, 2018: Contemporary Clinical Trials
Brenda Happell, Jackie Curtis, Michelle Banfield, John Goss, Theophile Niyonsenga, Andrew Watkins, Chris Platania-Phung, Lynelle Moon, Philip Batterham, Brett Scholz, Vanessa Prescott, Robert Stanton
BACKGROUND: Over 690,000 Australians experience psychosis annually, significantly impacting cardiometabolic illness and healthcare costs. Current models of care are fragmented and a critical implementation gap exists regarding the delivery of coordinated physical healthcare for Australians with psychosis. OBJECTIVES: To describe a trial implementing a Physical Health Nurse Consultant (PHNC) role to coordinate physical health care in a community mental health setting...
September 9, 2018: Contemporary Clinical Trials
Maria-Eleni Roumelioti, Jennifer L Steel, Jonathan Yabes, Kevin E Vowles, Yoram Vodovotz, Scott Beach, Bruce Rollman, Steven D Weisbord, Mark L Unruh, Manisha Jhamb
Most hemodialysis (HD) patients experience symptoms of depression, pain and fatigue that impair their health-related quality of life (HRQOL) significantly. These symptoms are associated with increased hospitalization and mortality, mediated by behavioral factors (e.g. non-adherence to medication and dialysis) and biological factors (e.g. inflammatory cytokines). Prior interventions to alleviate symptoms and improve HRQOL showed limited effectiveness in HD patients and their effect on bio-behavioral mediators is lacking evidence...
September 9, 2018: Contemporary Clinical Trials
Lida Faroqi Dpm, Myo Wong, Saniya Bonde, Chi Wai Wong, Khalil Walai, Wendy West, Daniella Tatianna Goni, Saron Araya, Sayed Azamey, Carla Nacif-Coelho, Sonia Sunita Raghuram, Katherine Vera, Anuva Mittal, Leah Groppo Cde, Mary Christensen, Neil Johannsen, Francois Haddad, Minal Moharir, Latha Palaniappan
BACKGROUND: The American Diabetes Association (ADA) currently recommends 150 min of moderate-intensity aerobic exercise per week and resistance exercise at least twice per week in individuals with type 2 diabetes (T2DM) to improve overall health.1 However, approximately 38% of patients with T2DM do not exercise at recommended levels and 31% do not exercise at all.2 The efficacy of structured exercise interventions has been proven effective in reducing glycosylated hemoglobin A1c (HbA1c) levels in patients, but practical approaches are needed to translate these findings into the clinical setting...
September 8, 2018: Contemporary Clinical Trials
Stephen D Persell, Kunal N Karmali, Natalie Stein, Jim Li, Yaw A Peprah, Dawid Lipiszko, Jody D Ciolino, Hironori Sato
BACKGROUND: Hypertension is a major cause of morbidity and mortality but frequently remains uncontrolled. A smartphone application that provides coaching regarding home blood pressure monitoring and other aspects of hypertension self-care and related behavior change may be a scalable way to help manage hypertension. METHODS/DESIGN: The Smart Hypertension Control Study is a prospective, randomized controlled trial. It will assess the effects of a hypertension personal control program (HPCP), which consists of an automated artificial intelligence smartphone application that provides individualized support and coaching, to promote home monitoring and healthy behavior changes related to hypertension self-management along with home blood pressure monitoring compared to home blood pressure monitoring alone...
August 29, 2018: Contemporary Clinical Trials
Karin Nelson, Tiffanie Fennell, Kristen E Gray, Jennifer L Williams, Marie C Lutton, Julie Silverman, Kamala Jain, Matthew R Augustine, Walter Kopf, Leslie Taylor, George Sayre, Christopher Vanderwarker
BACKGROUND: Peer support can improve health for patients with chronic conditions; however, evidence for disease prevention is less clear and peer recruitment strategies are not well described. This paper describes a study protocol to evaluate a peer support intervention to improve hypertension control and reduce cardiovascular disease (CVD) risk. METHODS & RESEARCH DESIGN: Target enrollment for this two-site study is n = 400. Eligibility criteria include Veterans enrolled in Veterans Health Administration (VHA) primary care with poorly controlled hypertension and one other cardiovascular disease risk (smoking, overweight/obesity, or hyperlipidemia) who live in census tracts with high rates of hypertension...
August 29, 2018: Contemporary Clinical Trials
Shayan Shirazian, Arlene Smaldone, Maya K Rao, Jeffrey Silberzweig, Alan M Jacobson, Melissa Fazzari, Katie Weinger
INTRODUCTION: Poor health-related quality of life (HrQOL) is highly prevalent in patients on hemodialysis (HD), and is associated with increased hospitalizations and mortality. Cognitive behavioral (CB) techniques have improved HrQOL in HD patients but have not been routinely translated into clinical practice. The investigators present the rationale, study design and protocol of a randomized controlled trial to pilot the feasibility and effect of a translatable, behavioral-education intervention using CB techniques to improve poor HrQOL and self-management in hemodialysis patients...
August 29, 2018: Contemporary Clinical Trials
Anna T Rayward, Beatrice Murawski, Ronald C Plotnikoff, Corneel Vandelanotte, Wendy J Brown, Elizabeth G Holliday, Mitch J Duncan
INTRODUCTION: Poor sleep health is common and has a substantial negative health impact. Physical activity has been shown to improve sleep health. Many sleep interventions do not explicitly target physical activity, potentially limiting changes in activity and also sleep. Few intervention target those with poor sleep health but without a diagnosed disorder. This study aims to examine the efficacy of a combined physical activity and sleep intervention to improve sleep quality in middle-aged adults and its effect on physical activity, depression and quality of life...
August 24, 2018: Contemporary Clinical Trials
Lauren T Ptomey, Richard A Washburn, Matthew S Mayo, J Leon Greene, Robert H Lee, Amanda N Szabo-Reed, Jeffery J Honas, Joseph R Sherman, Joseph E Donnelly
Adults with intellectual and developmental disabilities (IDD) represent an underserved segment of the US population with a high prevalence of obesity and limited options for weight management. Previous research has demonstrated clinically meaningful weight loss of 7% of total body weight in in adults with IDD using an enhanced Stop Light Diet (eSLD) in combination with monthly at-home face-to-face (FTF) behavioral sessions, and a recommendation for increased physical activity. However, the time and cost associated with FTF delivery (travel + sessions) limits the potential for scaling and implementation and suggests the need for the evaluation of less costly and burdensome strategies for intervention delivery...
August 24, 2018: Contemporary Clinical Trials
Sudie E Back, Julianne C Flanagan, Jennifer L Jones, Isabel Augur, Alan L Peterson, Stacey Young-McCaughan, David W Shirley, Aisling Henschel, Jane E Joseph, Brett T Litz, Allison K Hancock, John D Roache, Jim Mintz, Jennifer S Wachen, Terence M Keane, Kathleen T Brady
Posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD) are two of the most common mental health disorders affecting civilians as well as military populations. If left untreated, individuals with co-occurring PTSD/AUD are at increased risk for developing other mental health problems (e.g., depression, anxiety), physical health problems, reduced resiliency and military readiness, and vocational and social impairment. Substantial gaps in the treatment of co-occurring PTSD/AUD exist and there is a critical need to develop more effective pharmacological treatments...
August 24, 2018: Contemporary Clinical Trials
Diane Flynn, Linda H Eaton, Dale J Langford, Nicholas Ieronimakis, Honor McQuinn, Richard O Burney, Samuel L Holmes, Ardith Z Doorenbos
Chronic pain is a leading cause of disability among active duty service members in the U.S. armed forces. Standard rehabilitative care and complementary and integrative health therapies are used for chronic pain rehabilitation. However, the optimal sequence and duration of these therapies has yet to be determined. This article describes a sequential multiple assignment randomized trial (SMART) protocol being used to identify the optimal components and sequence of standard rehabilitative care and complementary and integrative health therapies for reducing pain impact and improving other patient outcomes...
August 24, 2018: Contemporary Clinical Trials
William J Heerman, Laura E Burgess, Juan Escarfuller, Leah Teeters, Lauren Slesur, Jia Liu, Ally Qi, Lauren R Samuels, Marcy Singer-Gabella
Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children. COACH focuses on improving personal agency for health behavior change by tailoring content to overcome contextual barriers. The intervention focuses on diet, physical activity, sleep, media use, and engaged parenting. The content is individually adapted based on routine assessments of competency in specific health behaviors using a mobile health platform and novel measurement tools developed by our team...
August 23, 2018: Contemporary Clinical Trials
Alan L Peterson, Patricia A Resick, Jim Mintz, Stacey Young-McCaughan, Donald D McGeary, Cindy A McGeary, Dawn I Velligan, Alexandra Macdonald, Emma Mata-Galan, Stephen L Holliday, Kirsten H Dillon, John D Roache, Iman Williams Christians, John C Moring, Lindsay M Bira, Paul S Nabity, Allison K Hancock, Willie J Hale
Approximately 14% of military personnel and veterans who have deployed to the combat theater are at risk for combat-related posttraumatic stress disorder (PTSD). The treatment of combat-related PTSD in active duty service members and veterans is challenging. Combat trauma may involve multiple high levels of exposure to different types of traumatic events (e.g., human carnage after explosive blasts, life threat/injuries to self/others, etc.). Many service members and veterans are unable or unwilling to receive treatment in government facilities due to avoidance, scheduling difficulties, transportation or parking problems, concerns about career advancement, or stigma associated with seeking treatment...
August 23, 2018: Contemporary Clinical Trials
Erin D Michos, Christine M Mitchell, Edgar R Miller, Alice L Sternberg, Stephen P Juraschek, Jennifer A Schrack, Sarah L Szanton, Jeremy D Walston, Rita R Kalyani, Timothy B Plante, Robert H Christenson, Dave Shade, James Tonascia, David L Roth, Lawrence J Appel, Lawrence J Appel, Nicole Cronin, Stephen P Juraschek, Scott McClure, Christine M Mitchell, Timothy B Plante, Rita R Kalyani, David L Roth, Jennifer A Schrack, Sarah L Szanton, Jacek Urbanek, Jeremy Walston, Sheriza Baksh, Amanda L Blackford, Shumon Chattopadhyay, John Dodge, Cathleen Ewing, Rosetta Jackson, Andrea Lears, Curtis Meinert, David Shade, Michael Smith, Alice L Sternberg, James Tonascia, Mark L Van Natta, Annette Wagoner, Erin D Michos, Pamela Bowers, Josef Coresh, Tammy Crunkleton, Briana Dick, Rebecca Evans, Mary Godwin, Lynne Hammann, Deborah Hawks, Karen Horning, Melissa Minotti, Melissa Myers, Leann Raley, Cassie Reid, Adria Spikes, Rhonda Stouffer, Kelly Weicht, Edgar R Miller, Bernellyn Carey, Jeanne Charleston, Naomi DeRoche-Brown, Debra Gayles, Ina Glenn-Smith, Duane Johnson, Mia Johnson, Eva Keyes, Kristen McArthur, Danielle Santiago, Chanchai Sapun, Valerie Sneed, Letitia Thomas, Robert H Christenson, Show-Hong Duh, Heather Rebuck, Clifford Rosen, Tom Cook, Pamela Duncan, Karen Hansen, Anne Kenny, Sue Shapses, Judy Hannah, Sergei Romashkan, Cindy D Davis, Jack M Guralnik, J C Gallagher
Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ≥70 years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29 ng/mL and at elevated fall risk, will be randomized to one of four vitamin D3 (cholecalciferol) supplement doses: 200 (control), 1000, 2000, or 4000 IU/day and treated for up to 2 years...
August 20, 2018: Contemporary Clinical Trials
Alexander Procaskey, Heather White, Tregony Simoneau, Nadav Traeger, Thomas Lahiri, Elie Abu Jawdeh, Ted Kremer, Catherine Sheils, Kathleen Meyer, Ted Rosenkrantz, Krishnan Sankaran, Tyler Hartman, Henry Feldman, Lawrence Rhein
Improved survival among preterm infants has led to an increase in diagnosis of chronic lung disease and infants discharged home from the NICU on supplemental oxygen. Despite this increased prevalence, no clearly defined guidelines for the management of home oxygen therapy (HOT) exist. This lack of consensus leads to significant variability in the duration of home oxygen therapy and a general paucity of evidence-based practice. Our team has identified recorded home oxygen therapy (RHO) as a potential new resource to guide clinical decision making in the outpatient pulmonology clinic...
August 11, 2018: Contemporary Clinical Trials
Denise E Wilfley, Ellen E Fitzsimmons-Craft, Dawn M Eichen, Dorothy J Van Buren, R Robinson Welch, Athena H Robinson, Booil Jo, Ramesh Raghavan, Enola K Proctor, G Terence Wilson, W Stewart Agras
Mental disorders often emerge in adolescence and young adulthood, and these disorders can have lasting effects on students' health, social functioning, and education. Although evidence-based treatments have been established for many mental disorders, few community therapists use such treatments. What is needed is a practical, economically feasible means of training clinicians to implement evidence-based treatments suitable for widespread use. This cluster randomized trial will randomize 26 college counseling centers to one of two implementation strategies for training counselors to use interpersonal psychotherapy (IPT), an evidence-based treatment for depression and eating disorders: 1) an external expert consultation model comprising a workshop, therapy manual, and expert follow-up consultation (n = 13); or 2) a train-the-trainer model in which a staff member from the counseling center is coached to train other staff members to implement IPT (n = 13)...
September 2018: Contemporary Clinical Trials
Chuen Peng Lee, Tyson Holmes, Eric Neri, Clete A Kushida
Deceptive practices by participants in clinical research are prevalent. It has been shown that as high as 75% of participants withheld information to avoid exclusion from studies. Self-reported adherence has been found to be largely inaccurate. Overcoming deception is a critical issue, since the safety of study participants, the integrity of research data and research resources are at risk. In this review article, we examine deception from the perspective of investigators conducting clinical trials; we describe the types (concealment, fabrication, drug holidays and collusion), prevalence, risks, and predictors of deception, and propose an approach to reduce the impact of deception, especially on adherence, in clinical trials...
September 2018: Contemporary Clinical Trials
Hannah Fish-Trotter, Sean P Collins, Shooshan Danagoulian, Benton Hunter, Xiaochun Li, Phillip D Levy, Frank Messina, Susan Pressler, Peter S Pang
Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED) with acute heart failure are hospitalized. Once hospitalized, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve long-term outcomes. ED treatment is largely the same today as 40 years ago. Admitting patients who could have avoided hospitalization may contribute to adverse outcomes...
September 2018: Contemporary Clinical Trials
Eric D Zaizar, F Gonzalez-Lima, Michael J Telch
This RCT will test whether transcranial infrared laser stimulation (TILS) administered immediately following standard exposure therapy enhances the retention of fear extinction for naturally acquired pathological fear. A second aim is to investigate the efficacy of TILS as a stand-alone intervention for reducing pathological fear. Participants with elevated fear in any one of the following four domains: (a) fear of enclosed spaces, (b) fear of contamination, (c) fear of public speaking, or (d) fear of anxiety (i...
September 2018: Contemporary Clinical Trials
Marc J Weigensberg, Donna Spruijt-Metz, Cheng K Fred Wen, Jaimie N Davis, Quintilia Ávila, Magaly Juarez, Niquelle Brown-Wadé, Christianne J Lane
Innovative lifestyle interventions are needed to reduce type 2 diabetes risk in adolescents. This report describes the protocol of the Imagine HEALTH cluster randomized control trial, that tests an intervention based in Self-Determination Theory (SDT) and uses lifestyle education combined with the mind-body, complementary health modality of guided imagery (GI), to address obesity prevention and treatment in predominantly Latino adolescents. The primary aim is to determine the unique effects of each of the three major components of the 12-week lifestyle intervention (lifestyle education, stress reduction guided imagery, and lifestyle behavior guided imagery) compared to control on primary outcomes of physical activity (accelerometry), dietary intake (3-day recall), and stress biomarker levels (salivary cortisol)...
September 2018: Contemporary Clinical Trials
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