Clinical trial testing in-home multidisciplinary care management for older adults with cognitive vulnerability: Rationale and study design
Care management approaches are being widely tested in the Medicare-eligible population to manage chronic conditions, but few have focused on cognitive vulnerability as the pathway to optimizing independence in the community-dwelling older population. Cognitive vulnerability refers to living with dementia, depression, and/or a history of delirium. Many studies have shown that cognitive vulnerability is associated with poor health-related outcomes in community-dwelling older adults, raising the health policy importance of finding evidence-based approaches to improve outcomes for this target population. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 16, 2020 Category: Radiology Authors: Richard H. Fortinsky, George A. Kuchel, David C. Steffens, James Grady, Marie Smith, Julie T. Robison Source Type: research
Slow release oral morphine versus methadone for opioid use disorder in the fentanyl era (pRESTO): Protocol for a non-inferiority randomized clinical trial
North America is facing an unprecedented public health crisis of opioid-related morbidity and mortality, increasingly as a result of the introduction of illicitly manufactured fentanyl into the street drug market. Although the treatment of opioid use disorder (OUD) is a key element in the response to the opioid overdose epidemic, currently available pharmacotherapies (e.g., methadone, buprenorphine) may not be acceptable to or effective in all patients. Available evidence suggests that slow-release oral morphine (SROM) has similar efficacy rates as methadone with respect to promoting abstinence, and with improvements in a ...
Source: Contemporary Clinical Trials - March 16, 2020 Category: Radiology Authors: M. Eugenia Socias, Evan Wood, Huiru Dong, Rupinder Brar, Paxton Bach, Sean M. Murphy, Nadia Fairbairn Source Type: research
The efficacy of written exposure therapy versus imaginal exposure delivered online for posttraumatic stress disorder: Design of a randomized controlled trial in Veterans
Adapting evidence-based treatments for online delivery has potential to significantly increase the reach of effective care to Veterans with posttraumatic stress disorder (PTSD). This paper describes the rationale for and methods of a randomized controlled trial comparing the efficacy and efficiency of written exposure therapy versus imaginal exposure for PTSD delivered in a novel online and variable length format. Participants will be 300 Veterans seeking treatment for clinically significant symptoms of PTSD. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 13, 2020 Category: Radiology Authors: Carmen P. McLean, Madeleine L. Miller, Richard Gengler, Jason Henderson, Denise Sloan Source Type: research
A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP)
This study uses a stepped-wedge implementation design. Screening centers are randomized by readiness level to enter the intervention phase in three-month “steps” with pre-intervention data serving as the control. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 13, 2020 Category: Radiology Authors: Ana S. Salazar, Subhjit Sekhon, Karthik W. Rohatgi, Akua Nuako, Jingxia Lu, Courtney Harriss, Ellen Brennan, Dareld LaBeau, Ibrahim Abdalla, Christopher Schulze, Jackie Muenks, Dave Overlot, Jeri Ann Higgins, Linda S. Jones, Colleen Swick, Stacia Goings, Source Type: research
Movement pattern biofeedback training after total knee arthroplasty: Randomized clinical trial protocol
Total knee arthroplasty (TKA) reduces joint symptoms, but habitual movement compensations persist years after surgery. Preliminary research on movement training interventions have signaled initial efficacy for remediating movement compensations and restoring knee joint loading symmetry during dynamic functional tasks after TKA. The purpose of this clinical trial is to determine if physical rehabilitation that includes movement training restores healthy movement patterns after TKA and reduces the risk of osteoarthritis (OA) progression in the contralateral knee. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 10, 2020 Category: Radiology Authors: Michael J. Bade, Jesse C. Christensen, Joseph A. Zeni, Cory L. Christiansen, Michael R. Dayton, Jeri E. Forster, Victor A. Cheuy, Jennifer E. Stevens-Lapsley Source Type: research
Keyboard design for phase I drug-combination trials
The Keyboard design is a novel model-assisted dose-finding method to find the maximum tolerated dose (MTD) for single-agent trials. The Keyboard design is easy to implement and has superior performance in comparison to more complicated model-assisted designs. In this article, we extend the Keyboard design to dual-agent dose-finding trials. The proposed Keyboard combination trial design maintains the simplicity of the original single-agent Keyboard design, and its dose escalation and deescalation rules can be pre-tabulated before conducting the trial. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 5, 2020 Category: Radiology Authors: Haitao Pan, Ruitao Lin, Yanhong Zhou, Ying Yuan Source Type: research
Combined intervention approaches for initiating and maintaining physical activity in depressed individuals: Design and rationale of the project MOVE randomized clinical trial
Regular engagement in physical activity (PA) decreases risks for many chronic conditions, and there is growing evidence showing a positive impact of this behavior on the reduction of depression symptoms. However, rates of PA as well as adherence to exercise interventions remain low among depressed individuals relative to non-depressed individuals. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 5, 2020 Category: Radiology Authors: Lisa A. Uebelacker, Marie A. Sillice, Gary Epstein-Lubow, Cynthia L. Battle, Bradley Anderson, Celeste Caviness, Ivan W. Miller, Ana M. Abrantes Source Type: research
Design of a home-based intervention for Houston-area African-American adults with asthma: Methods and lessons learned from a pragmatic randomized trial
A growing body of evidence demonstrates that home-based, multicomponent interventions can effectively reduce exposures to asthma triggers and decrease asthma symptoms. However, few of these studies have targeted adults. To address this and other research gaps, we designed and implemented a pragmatic randomized clinical trial, the Houston Home-based Integrated Intervention Targeting Better Asthma Control (HIITBAC) for African Americans, to assess the effectiveness of a home-based intervention to improve asthma control and quality of life in African-American adults —a population disproportionately affected by asthma. (Sour...
Source: Contemporary Clinical Trials - March 5, 2020 Category: Radiology Authors: Rebecca J. Bruhl, William Brett Perkison, Nicola Hanania, Lorna McNeill, Abiodun Oluyomi, Ellen Fiesinger, Charles Minard, Abida Solomon, Winifred J. Hamilton, the Patient/Stakeholder Advisory Board and other members of the HIITBAC Research Team:, Brian B Source Type: research
Development of a Core outcome set for Pediatric critical care outcomes research
Pediatric Intensive Care Unit (PICU) teams provide care for critically ill children with diverse and often complex medical and surgical conditions. Researchers often lack guidance on an approach to select the best outcomes when evaluating this critically ill population. Studies would be enhanced by incorporating multi-stakeholder preferences to better evaluate clinical care. This manuscript outlines the methodology currently being used to develop a PICU Core Outcome Set (COS). This PICU COS utilizes mixed methods, an inclusive stakeholder approach, and a modified Delphi consensus process that will serve as a resource for P...
Source: Contemporary Clinical Trials - March 4, 2020 Category: Radiology Authors: Ericka L. Fink, Jessica M. Jarvis, Aline B. Maddux, Neethi Pinto, Patrick Galyean, Lenora M. Olson, Susan Zickmund, Melissa Ringwood, Samuel Sorenson, J. Michael Dean, Joseph A. Carcillo, Robert A. Berg, Athena Zuppa, Murray M. Pollack, Kathleen L. Meert, Source Type: research
A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures
Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue. ...
Source: Contemporary Clinical Trials - March 4, 2020 Category: Radiology Authors: Heather S.L. Jim, Aasha I. Hoogland, Hyo Sook Han, Eva Culakova, Charles Heckler, Michelle Janelsins, Geoffrey C. Williams, Julienne Bower, Stephen Cole, Zeruesenay Desta, Margarita Bobonis Babilonia, Gary Morrow, Luke Peppone Source Type: research
A randomized trial of a multi-level intervention to improve advance care planning and symptom management among low-income and minority employees diagnosed with cancer in outpatient community settings
Equitable delivery of advance care planning and symptom management among patients is crucial to improving cancer care. Existing interventions to improve the uptake of these services have predominantly occurred in clinic settings and are limited in their effectiveness, particularly among low-income and minority populations. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 3, 2020 Category: Radiology Authors: Manali I. Patel, Sana Khateeb, Tumaini Coker Source Type: research
Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study
Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 3, 2020 Category: Radiology Authors: Anurag Mehta, Kreton Mavromatis, Yi-An Ko, Steven C. Rogers, Devinder S. Dhindsa, Cydney Goodwin, Risha Patel, Mohammad A. Martini, Mahadev Prasad, Ali Mokhtari, Iraj G. Hesaroieh, Stephen C. Frohwein, Michael H. Kutner, Arash Harzand, Bryan J. Wells, Yaz Source Type: research
Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 29, 2020 Category: Radiology Source Type: research
A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol
Annually approximately 2 –3 million Americans are so severely injured that they require inpatient hospitalization. The study team, which includes patients, clinical researchers, front-line provider and policy maker stakeholders, has been working together for over a decade to develop interventions that target improvements for US trauma care systems nationally. This pragmatic randomized trial compares a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists, versus trauma team notification of patient emotional distress with mental health consult atio...
Source: Contemporary Clinical Trials - February 27, 2020 Category: Radiology Authors: Hannah Scheuer, Allison Engstrom, Peter Thomas, Rddhi Moodliar, Kathleen Moloney, Mary Lou Walen, Peyton Johnson, Sara Seo, Natalie Vaziri, Alvaro Martinez, Ronald Maier, Joan Russo, Stella Sieber, Pete Anziano, Kristina Anderson, Eileen Bulger, Lauren Wh Source Type: research
Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial
Extant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 26, 2020 Category: Radiology Authors: Greg Clarke, Christina R. Sheppler, Alison J. Firemark, Andreea M. Rawlings, John F. Dickerson, Michael C. Leo Source Type: research
