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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28918120/moment-by-moment-in-women-s-recovery-randomized-controlled-trial-protocol-to-test-the-efficacy-of-a-mindfulness-based-intervention-on-treatment-retention-and-relapse-prevention-among-women-in-residential-treatment-for-substance-use-disorder
#1
Hortensia Amaro, David S Black
Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evidence gaps persist for the use of mindfulness-based interventions (MBIs) among racially and ethnically diverse women with SUDs, especially regarding the efficacy of MBIs adapted to prevent residential dropout and relapse...
September 13, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28899813/re-inventing-drug-development-a-case-study-of-the-i-spy-2-breast-cancer-clinical-trials-program
#2
Sonya Das, Andrew W Lo
BACKGROUND: In this case study, we profile the I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And molecular anaLysis 2), a unique breast cancer clinical trial led by researchers at 20 leading cancer centers across the US, and examine its potential to serve as a model of drug development for other disease areas. This multicenter collaboration launched in 2010 to reengineer the drug development process to be more efficient and patient-centered...
September 9, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28893676/rationale-and-design-of-the-staying-positive-with-arthritis-spa-study-a-randomized-controlled-trial-testing-the-impact-of-a-positive-psychology-intervention-on-racial-disparities-in-pain
#3
Leslie R M Hausmann, Said A Ibrahim, C Kent Kwoh, Ada Youk, D Scott Obrosky, Debra K Weiner, Ernest Vina, Rollin M Gallagher, Genna T Mauro, Acacia Parks
Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature, suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management...
September 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28893675/design-recruitment-outcomes-and-sample-characteristics-of-the-strategies-for-prescribing-analgesics-comparative-effectiveness-space-trial
#4
Erin E Krebs, Agnes C Jensen, Sean Nugent, Beth DeRonne, Indulis Rutks, David Leverty, Amy Gravely, Siamak Noorbaloochi, Matthew J Bair, Kurt Kroenke
This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded...
September 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28887069/better-respiratory-education-and-treatment-help-empower-breathe-study-methodology-and-baseline-characteristics-of-a-randomized-controlled-trial-testing-a-transitional-care-program-to-improve-patient-centered-care-delivery-among-chronic-obstructive-pulmonary
#5
H Aboumatar, M Naqibuddin, S Chung, H Adebowale, L Bone, T Brown, L A Cooper, A P Gurses, A Knowlton, D Kurtz, L Piet, N Putcha, C Rand, D Roter, E Shattuck, C Sylvester, A Urteaga-Fuentes, R Wise, J L Wolff, T Yang, J Hibbard, E Howell, M Myers, K Shea, J Sullivan, L Syron, Wang Nae-Yuh, P Pronovost
BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of hospitalizations. Interventional studies focusing on the hospital-to-home transition for COPD patients are few. In the BREATHE (Better Respiratory Education and Treatment Help Empower) study, we developed and tested a patient and family-centered transitional care program that helps prepare hospitalized COPD patients and their family caregivers to manage COPD at home. METHODS: In the study's initial phase, we co-developed the BREATHE transitional care program with COPD patients, family-caregivers, and stakeholders...
September 5, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28887068/the-rationale-design-and-methods-of-a-randomized-controlled-trial-to-evaluate-the-effectiveness-of-collaborative-telecare-in-preserving-function-among-patients-with-late-stage-cancer-and-hematologic-conditions
#6
Andrea L Cheville, Timothy Moynihan, Jeffrey R Basford, John A Nyman, Marty L Tuma, Debra A Macken, Terry Therneau, Daniel Satelel, Kurt Kroenke
Disablement affects over 40% of patients with advanced stage cancer, devastates their quality of life (QoL), and increases their healthcare costs. Proactively treating the causes of disablement; physical impairments, pain, and immobility, can prolong functional independence, improve QoL and, potentially, reduce utilization. However rehabilitation service delivery models are reactive in nature and focus on catastrophic rather than incipient disability. A validated collaborative approach, the Three Component Model (TCM), optimizes important clinical outcomes and may provide an ideal framework to overcome barriers to proactively integrating rehabilitation into cancer care...
September 5, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28866294/impact-of-adaptation-algorithm-timing-and-stopping-boundaries-on-the-performance-of-bayesian-response-adaptive-randomization-in-confirmative-trials-with-a-binary-endpoint
#7
Yunyun Jiang, Wenle Zhao, Valerie Durkalski-Mauldin
Despite the concerns of time trend in subject profiles, the use of Bayesian response adaptive randomization (BRAR) in large multicenter phase 3 confirmative trials has been reported in recent years, motivated by the potential benefits in subject ethics and/or trial efficiency. However three issues remain unclear to investigators: 1) among several BRAR algorithms, how to choose one for the specific trial setting; 2) when to start and how frequently to update the allocation ratio; and 3) how to choose the interim analyses stopping boundaries to preserve the type 1 error...
September 1, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28867396/the-healthy-hearts-and-kidneys-hhk-study-design-of-a-2%C3%A3-2-rct-of-technology-supported-self-monitoring-and-social-cognitive-theory-based-counseling-to-engage-overweight-people-with-diabetes-and-chronic-kidney-disease-in-multiple-lifestyle-changes
#8
Mary Ann Sevick, Kathleen Woolf, Aditya Mattoo, Stuart D Katz, Huilin Li, David E St-Jules, Ram Jagannathan, Lu Hu, Mary Lou Pompeii, Lisa Ganguzza, Zhi Li, Alex Sierra, Stephen K Williams, David S Goldfarb
Patients with complex chronic diseases usually must make multiple lifestyle changes to limit and manage their conditions. Numerous studies have shown that education alone is insufficient for engaging people in lifestyle behavior change, and that theory-based behavioral approaches also are necessary. However, even the most motivated individual may have difficulty with making lifestyle changes because of the information complexity associated with multiple behavior changes. The goal of the current Healthy Hearts and Kidneys study was to evaluate, different mobile health (mHealth)-delivered intervention approaches for engaging individuals with type 2 diabetes (T2D) and concurrent chronic kidney disease (CKD) in behavior changes...
August 31, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28844986/design-and-challenges-for-a-randomized-multi-site-clinical-trial-comparing-the-use-of-service-dogs-and-emotional-support-dogs-in-veterans-with-post-traumatic-stress-disorder-ptsd
#9
Gabrielle H Saunders, Kousick Biswas, Tracey Serpi, Stephanie McGovern, Shirley Groer, Eileen M Stock, Kathryn M Magruder, Daniel Storzbach, Kelly Skelton, Thad Abrams, Mark McCranie, Joan Richerson, Patricia A Dorn, Grant D Huang, Michael T Fallon
Posttraumatic stress disorder (PTSD) is a leading cause of impairments in quality of life and functioning among Veterans. Service dogs have been promoted as an effective adjunctive intervention for PTSD, however published research is limited and design and implementation flaws in published studies limit validated conclusions. This paper describes the rationale for the study design, a detailed methodological description, and implementation challenges of a multisite randomized clinical trial examining the impact of service dogs on the on the functioning and quality of life of Veterans with PTSD...
August 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28844985/pediatric-advance-care-planning-pacp-for-teens-with-cancer-and-their-families-design-of-a-dyadic-longitudinal-rcct
#10
Katherine B Curtin, Anne E Watson, Jichuan Wang, Obianuju C Okonkwo, Maureen E Lyon
Cancer is the leading cause of disease-related death for adolescents and young adults (AYAs) in the United States. Parents of AYAs with life-threatening illnesses have expressed the desire to talk to their children about end of life (EOL) care, yet, like caregivers of adult patients, struggle to initiate this conversation. Building Evidence for Effective Palliative/End of Life Care for Teens with Cancer is a longitudinal, randomized, controlled, single-blinded clinical trial aimed at evaluating the efficacy of FAmily CEntered disease-specific advance care planning (ACP) for teens with cancer (FACE-TC)...
August 24, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28838813/on-study-designs-and-hypotheses-for-clinical-trials-with-predictive-biomarkers
#11
Weichung J Shih, Yong Lin
Recent interest in conducting clinical trials with predictive biomarkers has generated research in comparing relative efficiency of different trial designs. We find these comparisons of efficiency mostly misleading since they are based on different hypotheses. In this paper, we discuss several commonly used trial designs and consider the hypotheses that each design is capable to address. We first consider the ideal situation of no classification errors, then the more realistic situation where marker assay's sensitivity, specificity and the rule of classification are imperfect...
August 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28827160/multi-site-trial-using-short-mobile-messages-sms-to-improve-infant-weight-in-low-income-minorities-development-implementation-lessons-learned-and-future-applications
#12
Jinan Banna, Maribel Campos, Cheryl Gibby, Rafael Enrique Graulau, Marytere Meléndez, Alexandra Reyes, Jae Eun Lee, Cristina Palacios
No abstract text is available yet for this article.
August 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28823927/development-and-rationale-for-a-multifactorial-randomized-controlled-trial-to-test-strategies-to-promote-adherence-to-complex-drug-regimens-among-older-adults
#13
Stacy Cooper Bailey, Guisselle A Wismer, Ruth M Parker, Surrey M Walton, Alastair J J Wood, Amisha Wallia, Samantha A Brokenshire, Alexandra C Infanzon, Laura M Curtis, Mary J Kwasny, Michael S Wolf
BACKGROUND: Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation. OBJECTIVE: To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults...
August 18, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28823926/comparison-of-two-screening-strategies-for-gestational-diabetes-gdm-2-trial-design-and-rationale
#14
Kaleab Z Abebe, Christina Scifres, Hyagriv N Simhan, Nancy Day, Patrick Catalano, Lisa M Bodnar, Tina Costacou, Deanna Matthew, Alexandra Illes, Steven Orris, Jessica Duell, Kathleen Ly, Esa M Davis
Gestational diabetes mellitus (GDM) affects approximately 5 to 7% of pregnancies and is associated with increased risk for fetal overgrowth, cesarean delivery, birth trauma, and pre-eclampsia. GDM is commonly diagnosed in the US using a two-step screening and confirmatory approach, whereas a one-step approach is commonly used outside the US. Recent guidelines have suggested that the one-step approach should be used to diagnose GDM, although concern that this may increase the prevalence of GDM to approximately 18%-as well as the lack of clinical trials-based evidence regarding the difference in perinatal outcomes-has led to skepticism about adopting the one-step approach...
August 18, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28823925/recruitment-methods-for-survey-research-findings-from-the-mid-south-clinical-data-research-network
#15
William J Heerman, Natalie Jackson, Christianne L Roumie, Paul A Harris, S Trent Rosenbloom, Jill Pulley, Consuelo H Wilkins, Neely A Williams, David Crenshaw, Cardella Leak, Jon Scherdin, Daniel Muñoz, Justin Bachmann, Russell L Rothman, Sunil Kripalani
PURPOSE: The objective of this study was to report survey response rates and demographic characteristics of eight recruitment approaches to determine acceptability and effectiveness of large-scale patient recruitment among various populations. METHODS: We conducted a cross sectional analysis of survey data from two large cohorts. Patients were recruited from the Mid-South Clinical Data Research Network using clinic-based recruitment, research registries, and mail, phone, and email approaches...
August 17, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28822828/targeted-lowering-of-central-blood-pressure-in-patients-with-hypertension-baseline-recruitment-rationale-and-design-of-a-randomized-controlled-trial-the-low-cbp-study
#16
James E Sharman, Tony Stanton, Christopher M Reid, Anthony Keech, Philip Roberts-Thomson, Simon Stewart, Robert Greenough, Michael Stowasser, Walter P Abhayaratna
BACKGROUND: High blood pressure (BP) is the most common modifiable cause of death from cardiovascular disease. Lowering BP with medication improves patient outcomes, but even in populations with normal upper arm (brachial) BP there remains considerable residual risk for cardiovascular disease and this may be due to persistently elevated central BP. There has never been a trial to determine the value of targeted central BP lowering among patients with hypertension, and this was the aim of this study...
August 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28821470/design-of-the-drepagreffe-trial-a-prospective-controlled-multicenter-study-evaluating-the-benefit-of-genoidentical-hematopoietic-stem-cell-transplantation-over-chronic-transfusion-in-sickle-cell-anemia-children-detected-to-be-at-risk-of-stroke-by-transcranial
#17
Sylvie Chevret, Suzanne Verlhac, Elisabeth Ducros-Miralles, Jean-Hugues Dalle, Regis Peffault de Latour, Mariane de Montalembert, Malika Benkerrou, Corinne Pondarré, Isabelle Thuret, Corinne Guitton, Emmanuelle Lesprit, Maryse Etienne-Julan, Gisèle Elana, Jean-Pierre Vannier, Patrick Lutz, Bénédicte Neven, Claire Galambrun, Catherine Paillard, Camille Runel, Charlotte Jubert, Cécile Arnaud, Annie Kamdem, Valentine Brousse, Florence Missud, Marie Petras, Lydia Doumdo-Divialle, Claire Berger, Françoise Fréard, Olivier Taieb, Elise Drain, Monique Elmaleh, Manuela Vasile, Yacine Khelif, Myriam Bernaudin, Philippe Chadebech, France Pirenne, Gérard Socié, Françoise Bernaudin
BACKGROUND: Children with sickle cell anemia (SCA) have an 11% risk of stroke by the age of 18. Chronic transfusion applied in patients detected to be at risk by transcranial Doppler allows a significant reduction of stroke risk. However, chronic transfusion exposes to several adverse events, including alloimmunization and iron overload, and is not curative. Hematopoietic stem cell transplantation allows termination of the transfusion program, but its benefit has not been demonstrated...
August 15, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28821469/a-cluster-randomized-trial-of-a-middle-school-gender-violence-prevention-program-design-rationale-and-sample-characteristics
#18
Kaleab Z Abebe, Kelley A Jones, Samantha Ciaravino, Lisa Ripper, Taylor Paglisotti, Sarah Elizabeth Morrow, Melanie Grafals, Courtney Van Dusen, Elizabeth Miller
INTRODUCTION: High rates of adolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youth. This is a cluster randomized controlled trial to test an athletic coach-delivered ARA/SV prevention program in 41 middle schools (38 clusters). Trained coaches talk to their male athletes about 1) what constitutes harmful vs. respectful relationship behaviors, 2) dispelling myths that glorify male sexual aggression and promoting more gender-equitable attitudes, and 3) positive bystander intervention when aggressive male behaviors toward females are witnessed...
August 15, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28821468/design-and-development-of-a-stepped-care-behavioral-intervention-to-support-parents-of-young-children-newly-diagnosed-with-type-1-diabetes
#19
Marisa E Hilliard, Carrie Tully, Maureen Monaghan, Jichuan Wang, Randi Streisand
One of the most common chronic conditions of childhood, the prevalence of type 1 diabetes (T1D) in young children is increasing. Early childhood development complicates optimal T1D management and glycemic outcomes. Parents are at risk for elevated psychological distress, especially immediately following diagnosis. Few empirically supported interventions are available to support parents and promote optimal T1D management during this vulnerable period. This paper reports on the development and study design of First STEPS: Study of Type 1 in Early childhood and Parenting Support...
August 15, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28818434/adjusting-for-covariates-in-evaluating-markers-for-selecting-treatment-with-application-to-guiding-chemotherapy-for-treating-estrogen-receptor-positive-node-positive-breast-cancer
#20
Holly Janes, Marshall D Brown, Michael R Crager, Dave P Miller, William E Barlow
In many clinical contexts, biomarkers that predict treatment efficacy are highly sought after. Such treatment selection or predictive biomarkers have the potential to identify subgroups most likely to benefit from the treatment, and may therefore be used to improve clinical outcomes and reduce medical costs. A methodological challenge in evaluating these biomarkers is determining how to take into account other variables that predict clinical outcomes, or that influence the biomarker distribution, generically termed covariates...
August 14, 2017: Contemporary Clinical Trials
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