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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28315481/a-patient-advocate-to-facilitate-access-and-improve-communication-care-and-outcomes-in-adults-with-moderate-or-severe-asthma-rationale-design-and-methods-of-a-randomized-controlled-trial
#1
Andrea J Apter, Knashawn H Morales, Xiaoyan Han, Luzmercy Perez, Jingru Huang, Grace Ndicu, Anna Localio, Alyssa Nardi, Heather Klusaritz, Marisa Rogers, Alexis Phillips, Zuleyha Cidav, J Sanford Schwartz
Few interventions to improve asthma outcomes have targeted low-income minority adults. Even fewer have focused on the real-world practice where care is delivered. We adapted a patient navigator, here called a Patient Advocate (PA), a term preferred by patients, to facilitate and maintain access to chronic care for adults with moderate or severe asthma and prevalent co-morbidities recruited from clinics serving low-income urban neighborhoods. We describe the planning, design, methodology (informed by patient and provider focus groups), baseline results, and challenges of an ongoing randomized controlled trial of 312 adults of a PA intervention implemented in a variety of practices...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315480/evaluation-of-mhealth-strategies-to-optimize-adherence-and-efficacy-of-option-b-prevention-of-mother-to-child-hiv-transmission-rationale-design-and-methods-of-a-3-armed-randomized-controlled-trial
#2
Alison L Drake, Jennifer A Unger, Keshet Ronen, Daniel Matemo, Trevor Perrier, Brian DeRenzi, Barbra A Richardson, John Kinuthia, Grace John-Stewart
No abstract text is available yet for this article.
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315479/biopsychosocial-influence-on-shoulder-pain-rationale-and-protocol-for-a-pre-clinical-trial
#3
Steven Z George, Roland Staud, Paul A Borsa, Samuel S Wu, Margaret R Wallace, Warren H Greenfield, Lauren N Mackie, Roger B Fillingim
BACKGROUND: Chronic musculoskeletal pain conditions are a prevalent and disabling problem. Preventing chronic musculoskeletal pain requires multifactorial treatment approaches that address its complex etiology. Prior cohort studies identified a high risk subgroup comprised of variation in COMT genotype and pain catastrophizing. This subgroup had increased chance of heightened pain responses (in a pre-clinical model) and higher 12month post-operatives pain intensity ratings (in a clinical model)...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28315478/improving-palliative-care-trough-teamwork-impactt-in-nursing-homes-study-design-and-baseline-findings
#4
Helena Temkin-Greener, Susan Ladwig, Zhiqiu Ye, Sally A Norton, Dana B Mukamel
BACKGROUND: The 2014 Institute of Medicine report recommended that healthcare providers caring for individuals with advanced illness have basic palliative care competencies in communication, inter-professional collaboration, and symptom management. Nursing homes, where one in three American decedents live and die, have fallen short of these competency goals. We implemented an intervention study to examine the efficacy of nursing home-based integrated palliative care teams in improving the quality of care processes and outcomes for residents at the end of life...
March 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28302569/successful-strategies-to-improve-follow-up-for-longitudinal-birth-cohort-studies
#5
LETTER
Eileen C O'Brien, Aisling A Geraghty, Fionnuala M McAuliffe
No abstract text is available yet for this article.
March 13, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28279782/a-prospective-study-investigating-the-impact-of-multiparametric-mri-in-biopsy-na%C3%A3-ve-patients-with-clinically-suspected-prostate-cancer-the-prokomb-study
#6
Alexander D J Baur, Thomas Henkel, Manfred Johannsen, Thomas Speck, Lothar Weißbach, Bernd Hamm, Frank König
BACKGROUND: Patients with suspected prostate cancer (PCa) undergo systematic transrectal ultrasound (TRUS)-guided biopsy of the prostate in order to verify or rule out PCa. However, TRUS-guided biopsy is error-prone resulting in underdetection of clinically significant cancers as well as diagnosis of clinically insignificant cancers. Multiparametric MRI (mpMRI) might improve this diagnostic pathway and help to avoid unnecessary biopsies. DESIGN AND METHODS: The PROKOMB (Prostata - Kooperatives MRT-Projekt Berlin) study is a prospective two-arm multicentre study designed to evaluate the potential role of mpMRI as a triage test before biopsy...
March 6, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28257920/a-web-based-personalized-risk-communication-and-decision-making-tool-for-women-with-dense-breasts-design-and-methods-of-a-randomized-controlled-trial-within-an-integrated-health-care-system
#7
Sarah Knerr, Karen J Wernli, Kathleen Leppig, Kelly Ehrlich, Amanda L Graham, David Farrell, Chalanda Evans, George Luta, Marc D Schwartz, Suzanne C O'Neill
BACKGROUND: Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk counseling and decision support through a web-based tool may be an effective way to allow women to make informed, values-consistent risk-management decisions without increasing distress...
February 28, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28257919/progressing-moodswings-the-upgrade-and-evaluation-of-moodswings-2-0-an-online-intervention-for-bipolar-disorder
#8
S Lauder, V E Cosgrove, E Gliddon, D Grimm, S Dodd, L Berk, D Castle, T S Suppes, M Berk
MoodSwings 2.0 is a self-guided online intervention for bipolar disorder. The intervention incorporates technological improvements on an earlier validated version of the intervention (MoodSwings 1.0). The previous MoodSwings trial provides this study with a unique opportunity to progress previous work, whilst being able to take into consideration lesson learnt, and technological enhancements. The structure and technology of MoodSwings 2.0 are described and the relevance to other online health interventions is highlighted...
February 28, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28245996/the-application-of-group-sequential-stopping-boundaries-to-evaluate-the-treatment-effect-of-an-experimental-agent-across-a-range-of-biomarker-expression
#9
Eric Holmgren
Using stopping boundaries developed for group sequential trials, we control the overall type 1 error for a series of tests that evaluate the treatment effect of an experimental agent in each of several predefined marker subgroups. We then go on to present a procedure based on these group sequential stopping boundaries that provides strong control of type 1 error for testing a series of hypothesis regarding the treatment effect over a range of marker expression. Finally this use of group sequential procedures to control the type 1 error in biomarker subset testing will be compared with some other benchmark procedures in a simulation...
February 25, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28254404/measuring-differential-treatment-benefit-across-marker-specific-subgroups-the-choice-of-outcome-scale
#10
Jaya M Satagopan, Alexia Iasonos
Clinical and epidemiological studies of anticancer therapies increasingly seek to identify predictive biomarkers to obtain insights into variation in treatment benefit. For time to event endpoints, a predictive biomarker is typically assessed using the interaction between the biomarker and treatment in a proportional hazards model. Interactions are contrasts of summaries of outcomes and depend upon the choice of the outcome scale. In this paper we investigate interaction contrasts under three scales - the natural logarithm of hazard ratio, the natural logarithm of survival probability, and survival probability at a pre-specified time...
February 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28188841/bayesian-clinical-trial-design-using-markov-models-with-applications-to-autoimmune-disease
#11
Barry S Eggleston, Joseph G Ibrahim, Diane Catellier
Immune Thrombocytopenia is an autoimmune disease associated with bleeding that is treated by increasing the platelet count to a level where the chance of uncontrollable bleeding is low. Failure occurs when platelet counts are not raised sufficiently (initial failure), or when high platelet counts are not maintained after initial success (relapse). In this paper, we propose a Bayesian clinical trial design that uses a Markov multistate model along with a power prior for the parameters which incorporates historical control data to estimate transition rates among two randomized groups as defined by the model...
February 7, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185997/rationale-and-design-of-asteroid-2-a-randomized-placebo-and-active-comparator-controlled-study-to-assess-the-efficacy-and-safety-of-vilaprisan-in-patients-with-uterine-fibroids
#12
Christian Seitz, Žana Bumbuliene, Ana Rosa Costa, Oskari Heikinheimo, Andrea Heweker, Robert Hudeček, Yves Jacquemyn, Gian Benedetto Melis, Pooja Parashar, Tomasz Rechberger, Antonio Cano Sánchez, Bart van Aken, János Zatik, Kristina Gemzell-Danielsson
BACKGROUND: Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185996/rationale-design-and-baseline-data-of-a-cross-national-randomized-trial-on-the-effect-of-built-shade-in-public-parks-for-sun-protection
#13
David B Buller, Suzanne Dobbinson, Dallas R English, Melanie Wakefield, Mary Klein Buller
Environments can be structured to reduce solar ultraviolet radiation (UV) exposure to prevent skin cancer. A prospective randomized trial is being conducted to test whether introducing shade sails in passive recreation areas (PRAs) in public parks will increase use and decrease UV exposure in the shaded compared to unshaded PRAs. Shade effects will be compared between Melbourne, Australia and Denver, USA. The trial enrolled 145 public parks with PRAs suitable for shade construction and randomized parks to intervention or control in a 1:3 ratio...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185995/study-protocol-community-links-to-establish-alcohol-recovery-clear-for-women-leaving-jail
#14
Jennifer E Johnson, Yael Chatav Schonbrun, Bradley Anderson, Megan Kurth, Christine Timko, Michael Stein
PURPOSE: This article describes the protocol for a randomized effectiveness trial of a method to link alcohol use disordered women who are in pretrial jail detention with post-release 12-step mutual help groups. BACKGROUND: Jails serve 15 times more people per year than do prisons and have very short stays, posing few opportunities for treatment or treatment planning. Alcohol use is associated with poor post-jail psychosocial and health outcomes including sexually transmitted diseases and HIV, especially for women...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28185994/motivational-interviewing-to-improve-self-care-in-heart-failure-patients-motivate-hf-study-protocol-of-a-three-arm-multicenter-randomized-controlled-trial
#15
Ercole Vellone, Marco Paturzo, Fabio D'Agostino, Antonio Petruzzo, Stefano Masci, Davide Ausili, Paola Rebora, Rosaria Alvaro, Barbara Riegel
AIMS: Heart Failure (HF) self-care improves patient outcomes but trials designed to improve HF self-care have shown inconsistent results. Interventions may be more effective in improving self-care if they mobilize support from providers, promote self-efficacy, increase understanding of HF, increase the family involvement, and are individualized. All of these elements are emphasized in motivational interviewing (MI); few trials have been conducted using MI in HF patients and rarely have caregivers been involved in MI interventions...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28159703/cognitive-behavioral-therapy-for-insomnia-in-stable-heart-failure-protocol-for-a-randomized-controlled-trial
#16
Nancy S Redeker, Andrea K Knies, Christopher Hollenbeak, H Klar Yaggi, John Cline, Laura Andrews, Daniel Jacoby, Anna Sullivan, Meghan O'Connell, Joanne Iennaco, Lisa Finoia, Sangchoon Jeon
BACKGROUND: Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients. OBJECTIVES: The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28153768/physical-activity-behavior-change-for-older-veterans-after-dysvascular-amputation
#17
Matthew J Miller, Jennifer Stevens-Lapsley, Thomas T Fields, David Coons, Susan Bray-Hall, William Sullivan, Cory L Christiansen
OBJECTIVE: Determine the feasibility of using a physical-activity behavior-change (PABC) intervention for increasing physical activity and reducing disability in Veterans 1-5years following dysvascular lower-limb amputation (LLA). DESIGN: Cross-over, feasibility trial SETTING: VA Geriatric Research Education and Clinical Center and Veterans Homes PARTICIPANTS: 32 Veterans with dysvascular LLA (1-5years after major LLA) INTERVENTION: The home-based study, using telerehabilitation technology, is intended to reduce participant burden by removing transportation and time barriers...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28132876/study-protocol-the-technology-enhanced-coaching-tec-program-to-improve-diabetes-outcomes-a-randomized-controlled-trial
#18
Michele Heisler, Rebecca Mase, Brianne Brown, Shayla Wilson, Pamela J Reeves
No abstract text is available yet for this article.
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28126455/a-coaching-by-telephone-intervention-for-veterans-and-care-team-engagement-activate-a-study-protocol-for-a-hybrid-type-i-effectiveness-implementation-randomized-controlled-trial
#19
Eugene Z Oddone, Laura J Damschroder, Jennifer Gierisch, Maren Olsen, Angela Fagerlin, Linda Sanders, Jordan Sparks, Marsha Turner, Carrie May, Felicia McCant, David Curry, Courtney White-Clark, Karen Juntilla
INTRODUCTION: A large proportion of deaths and many illnesses can be attributed to three modifiable risk factors: tobacco use, overweight/obesity, and physical inactivity. Health risk assessments (HRAs) are widely available online but have not been consistently used in healthcare systems to activate patients to participate in prevention programs aimed at improving lifestyle behaviors. OBJECTIVES: The goal of this study is to test whether adding telephone-based coaching to use of a comprehensive HRA increases at-risk patients' activation and enrollment into a prevention program compared to HRA use alone...
April 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28153769/letter-to-the-editor-in-response-to-n-folschweiller-v-berlaimont-sr-skinner-cm-wheeler-n-karkada-f-struyf-m-ryser-letter-to-the-editor-in-response-to-o-m-bautista-a-luxembourg-deconstructing-the-measure-of-vaccine-efficacy-against-disease-irrespective-of-hpv
#20
LETTER
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