Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV
By 2020, 70% of people living with HIV in the United States will be greater than 50  years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventi ons exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographi...
Source: Contemporary Clinical Trials - May 28, 2020 Category: Radiology Authors: Julie Kahler, Timothy G. Heckman, Ye Shen, Marilyn S. Huckans, Sarah W. Feldstein Ewing, Jeffrey T. Parsons, Alissa Phelps, Mark Sutton, Julia Holloway, Travis I. Lovejoy Source Type: research

Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial
Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE —delivered through pre-recorded videos by DVD or online streaming—previously efficacious in a general p...
Source: Contemporary Clinical Trials - May 27, 2020 Category: Radiology Authors: Katherine D. Hoerster, Margaret Collins, David H. Au, Amber Lane, Eric Epler, Jennifer McDowell, Anna E. Bar ón, Peter Rise, Robert Plumley, Tanya Nguyen, Mary Schooler, Linnaea Schuttner, Jun Ma Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 19, 2020 Category: Radiology Source Type: research

Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (partnerships for reducing overweight and obesity with patient-centered strategies)
Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 16, 2020 Category: Radiology Authors: Heather J. Baer, Barbara A. De La Cruz, Ronen Rozenblum, Nyryan V. Nolido, E. John Orav, Kristina Metzler, Jason P. Block, Florencia Halperin, Katherine D. McManus, Louis J. Aronne, Guadalupe Minero, David W. Bates Source Type: research

Corrigendum to “Study protocol: CareAvenue program to improve unmet social risk factors and diabetes outcomes - A randomized controlled trial” [Contemporary Clinical Trials 89 (2020) 105933]
The authors regret they missed to one of the authors Xu Shi by mistake. The authorship now stands corrected in this corrigendum. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - May 14, 2020 Category: Radiology Authors: Minal R. Patel, Michele Heisler, John D. Piette, Kenneth Resnicow, Peter X.K. Song, Hae Mi Choe, Xu Shi, Julie Tobi, Alyssa Smith Tags: Corrigendum Source Type: research

Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial
Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advi...
Source: Contemporary Clinical Trials - May 10, 2020 Category: Radiology Authors: M.L. Erickson, J.M. Mey, C.L. Axelrod, D. Paul, L. Gordesky, K. Russell, H. Barkoukis, P. O'Tierney-Ginn, R.A. Fielding, J.P. Kirwan, P.M. Catalano Source Type: research

Editorial Board
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 29, 2020 Category: Radiology Source Type: research

Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study
Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 29, 2020 Category: Radiology Authors: Aboumatar Hanan, Naqibuddin Mohammad, Neiman Joseph, Saunders Jamia, Kim Samuel, Chaudhry Hina, Garcia-Morales Emmanuel, Robinson Nancy, McBurney Marjorie, Jager Leah, Ajayi Tokunbo, Bone Lee, Chung Suna, Farrell Bernard, Joo Jin Hui, Linnell John, Pirfo Source Type: research

Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations
Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. (...
Source: Contemporary Clinical Trials - April 27, 2020 Category: Radiology Authors: Theresa Winhusen, Michelle Lofwall, Hendr ée E. Jones, Christine Wilder, Robert Lindblad, Davida M. Schiff, Scott Wexelblatt, Stephanie Merhar, Sean M. Murphy, Shelly F. Greenfield, Mishka Terplan, Elisha M. Wachman, Frankie Kropp, Jeff Theobald, Mitra L Source Type: research

Risk reduction through family therapy (RRFT): Protocol of a randomized controlled efficacy trial of an integrative treatment for co-occurring substance use problems and posttraumatic stress disorder symptoms in adolescents who have experienced interpersonal violence and other traumatic events
Decades of research demonstrate that childhood exposure to traumatic events, particularly interpersonal violence experiences (IPV; sexual abuse, physical abuse, witnessing violence), increases risk for negative behavioral and emotional outcomes, including substance use problems (SUP) and posttraumatic stress disorder (PTSD). Despite this well-established link —including empirical support for shared etiological and functional connections between SUP and PTSD –the field has been void of a gold standard treatment for adolescent populations. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 24, 2020 Category: Radiology Authors: Austin M. Hahn, Zachary Adams, Jason Chapman, Michael McCart, Ashli J. Sheidow, Michael A. de Arellano, Carla Kmett Danielson Source Type: research

The ‘Take a Break’ game: Randomized trial protocol for a technology-assisted brief abstinence experience designed to engage lower-motivated smokers
While smoking continues to be the most preventable cause of mortality in the United States, most current smokers remain not ready to quit at any given time. Engaging these ‘motivation phase’ smokers with brief experiences to build confidence and practice skills related to cessation could lead to sooner and more successful quit attempts. Increasingly available mobile technology and gamification can be used to provide smokers with accessible and engaging support. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 23, 2020 Category: Radiology Authors: Daniel J. Amante, Amanda C. Blok, Catherine S. Nagawa, Jessica G. Wijesundara, Jeroan J. Allison, Sharina D. Person, Jeanne Morley, Joseph Conigliaro, Kristin M. Mattocks, Lawrence Garber, Thomas K. Houston, Rajani S. Sadasivam Source Type: research

Isradipine enhancement of virtual reality cue exposure for smoking cessation: Rationale and study protocol for a double-blind randomized controlled trial
Cigarette smoking remains a leading cause of preventable death in the United States, contributing to over 480,000 deaths each year. Although significant strides have been made in the development of effective smoking cessation treatments, most established interventions are associated with high relapse rates. One avenue for increasing the effectiveness of smoking cessation interventions is to design focused, efficient, and rigorous experiments testing engagement of well-defined mechanistic targets. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 23, 2020 Category: Radiology Authors: Santiago Papini, Cara C. Young, Catherine S. Gebhardt, Alex Perrone, Hitoshi Morikawa, Michael W. Otto, John D. Roache, Jasper A.J. Smits Source Type: research

Targeted assessment and context-tailored implementation of change strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study
Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external faci...
Source: Contemporary Clinical Trials - April 21, 2020 Category: Radiology Authors: Craig S. Rosen, C. Adrian Davis, David Riggs, Jeffery Cook, Alan L. Peterson, Stacey Young-McCaughan, Katherine Anne Comtois, Christopher K. Haddock, Elisa V. Borah, Katherine A. Dondanville, Erin P. Finley, Sara A. Jahnke, Walker S.C. Poston, Shannon Wil Source Type: research

Proactive health support (PaHS) – telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial
This article describes the protocol for Proactive Health Support: a national randomized controlled trial of telephone-based self-management support (ClinicalTrials.gov, NCT03628469). The main aim of the intervention is to reduce hospital admissions and improve quality of life at six months. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 19, 2020 Category: Radiology Authors: Kirstine Skov Benthien, Knud Rasmussen, Camilla Palmh øj Nielsen, Louise Hjarnaa, Maja Kjær Rasmussen, Kristian Kidholm, Berit Kjærside Nielsen, Nina Konstantin Nissen, Mia Fredens, Susanne Winther, Mette Grønkjær, Ulla Toft Source Type: research

Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers
Persons living with Alzheimer's disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 19, 2020 Category: Radiology Authors: Alycia A. Bristol, Kimberly A. Convery, Victor Sote, Catherine E. Schneider, Shih-Yin Lin, Jason Fletcher, Randall Rupper, George E. Wahlen, James E. Galvin, Abraham A. Brody Source Type: research

Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial
Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aim to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 19, 2020 Category: Radiology Authors: Tzu Tsun Luk, Chi Ju Hsieh, Wing-cheong Leung, Kwok-yin Leung, Ka Wang Cheung, Carina Kwa, Kar-hung Siong, Kwok-keung Tang, Kai-wan Lee, William Ho-cheung Li, Tai Hing Lam, Man Ping Wang Source Type: research

Determining the effectiveness of early intensive versus escalation approaches for the treatment of relapsing-remitting multiple sclerosis: The DELIVER-MS study protocol
Multiple Sclerosis (MS) is a common cause of neurological disability among young adults and has a high economic burden. Currently there are 18 disease modifying agents for relapsing MS, which were tested in clinical trials versus placebo or an active comparator in a pairwise manner. However, there is currently no consensus on the fundamental principles of treatment approach and initial therapy selection. These factors result in variable use of disease modifying therapies. Here we describe the study protocol for Determining the Effectiveness of earLy Intensive Versus Escalation approaches for the Treatment of Relapsing-remi...
Source: Contemporary Clinical Trials - April 19, 2020 Category: Radiology Authors: Daniel Ontaneda, Emma C. Tallantyre, Praneeta C. Raza, Sarah M. Planchon, Kunio Nakamura, Deborah Miller, Carrie Hersh, Mathew Craner, Clare Bale, Burhan Chaudhry, Douglas D. Gunzler, Thomas E. Love, Stephen Gerry, Alasdair Coles, Jeffrey A. Cohen, Nikos Source Type: research

Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment
The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 19, 2020 Category: Radiology Authors: Margaret T. Anton, Leigh E. Ridings, Rochelle Hanson, Tatiana Davidson, Benjamin Saunders, Matthew Price, Carla Kmett Danielson, Brian Chu, Clara E. Dismuke, Zachary W. Adams, Kenneth J. Ruggiero Source Type: research

Translating research into practice: Protocol for a community-engaged, stepped wedge randomized trial to reduce disparities in breast cancer treatment through a regional patient navigation collaborative
Racial and socioeconomic disparities in breast cancer mortality persist. In Boston, MA, Black, Non-Hispanic women and Medicaid-insured individuals are 2 –3 times more likely to have delays in treatment compared to White or privately insured women. While evidence-based care coordination strategies for reducing delays exist, they are not systematically implemented across healthcare settings. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 16, 2020 Category: Radiology Authors: Tracy A. Battaglia, Karen M. Freund, Jennifer S. Haas, Nicole Casanova, Sharon Bak, Howard Cabral, Rachel A. Freedman, Karen Burns White, Stephenie C. Lemon, the TRIP Consortium Source Type: research

Computerized intervention for reducing intimate partner victimization for perinatal women seeking mental health treatment: A multisite randomized clinical trial protocol
Intimate partner victimization (IPV) is a significant social and public health problem among perinatal women. Research suggests that 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places women at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 16, 2020 Category: Radiology Authors: Dawn M. Johnson, Golfo Tzilos Wernette, Ted R. Miller, Maria Muzik, Christina A. Raker, Caron Zlotnick Source Type: research

IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods
African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 15, 2020 Category: Radiology Authors: Cynthia Owusu, Nora L. Nock, Paul Hergenroeder, Kristina Austin, Elizabeth Bennet, Stephen Cerne, Halle Moore, Jean Petkac, Mark Schluchter, Kathryn H. Schmitz, Monica Webb-Hooper, Lindsay Atkins, Oghenerukeme Asagba, Leonard Wimbley, Nathan A. Berger Source Type: research

Study Protocol: A randomized controlled trial of suicide risk reduction in the year following jail release (the SPIRIT Trial)
This article describes the protocol for a randomized effectiveness and cost-effectiveness trial of Stanley and Brown's Safety Planning Intervention (SPI) during pretrial jail detention to reduce post-release suicide events (suicide attempts, suicide behaviors, and suicide-related hospitalizations). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 15, 2020 Category: Radiology Authors: Jennifer E. Johnson, Richard Jones, Ted Miller, Ivan Miller, Barbara Stanley, Greg Brown, Sarah A. Arias, Louis Cerbo, Julie Rexroth, Holly Fitting, Danis Russell, Sheryl Kubiak, Michael Stein, Christopher Matkovic, Lauren M. Weinstock, Brandon Gaudiano, Source Type: research

Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial
Focal therapy (FT) targets individual areas of cancer within the prostate, providing oncological control with minimal side-effects. Early evidence demonstrates encouraging short-medium-term outcomes. With no randomized controlled trials (RCT) comparing FT to radical therapies, Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (CHRONOS) will compare the cancer control of these two strategies. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 14, 2020 Category: Radiology Authors: Deepika Reddy, Taimur T. Shah, Tim Dudderidge, Stuart McCracken, Manit Arya, Chris Dobbs, Mark Emberton, Francesca Fiorentino, Emily Day, A.T. Prevost, John Staffurth, Matthew Sydes, Mathias Winkler, Hashim U. Ahmed Source Type: research

A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol
This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim). (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 14, 2020 Category: Radiology Authors: M.A. Day, D.M. Ehde, J. Burns, L.C. Ward, J.L. Friedly, B.E. Thorn, M.A. Ciol, E. Mendoza, J.F. Chan, S. Battalio, J. Borckardt, M.P. Jensen Source Type: research

Improving health engagement and lifestyle management for breast cancer survivors with diabetes
Breast cancer survivors with type 2 diabetes are at high risk for cancer recurrence, serious health complications, more severe symptoms, psychological distress, and premature death relative to breast cancer survivors without diabetes. Maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Many breast cancer survivors with type 2 diabetes have difficulty maintaining diabetes self-management behaviors and achieving glycemic control. Both cancer and diabetes-related symptoms (e.g., physical symptoms and psychological distress) are often barriers to engaging in diabetes self-ma...
Source: Contemporary Clinical Trials - April 11, 2020 Category: Radiology Authors: Rebecca A. Shelby, Caroline S. Dorfman, Sarah S. Arthur, Hayden B. Bosworth, Leonor Corsino, Linda Sutton, Lynda Owen, Alaattin Erkanli, Francis Keefe, Cheyenne Corbett, Gretchen Kimmick Source Type: research

Does the COVID-19 outbreak identify a broader need for an urgent transformation of cancer clinical trials research?
(Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - April 6, 2020 Category: Radiology Authors: Hala T. Borno, Eric J. Small Source Type: research

Use of real-world data for HPV vaccine trial follow-up in the Nordic region
Post-marketing studies are commonly performed to follow-up on the safety and effectiveness of a drug or vaccine after approval has been obtained. These post-marketing studies may involve the collection of real-world data from registries and clinical biobanks in order to obtain real-world evidence. As this approach can monitor the effects of pharmaceutical products over decades, it is particularly necessary for the development of safe and effective vaccines. A long-term follow-up (LTFU) study was initiated as an extension of a phase 3 clinical study (V501 –015; NCT00092534) to assess the effectiveness, immunogenicity ...
Source: Contemporary Clinical Trials - April 1, 2020 Category: Radiology Authors: Espen Enerly, Sophie Berger, Susanne K. Kj ær, Karin Sundström, Suzanne Campbell, Laufey Tryggvadóttir, Christian Munk, Maria Hortlund, Thomas Group, Amita Joshi, Alfred J. Saah, Mari Nygård Source Type: research

Impacting child health outcomes in congenital heart disease: Cluster randomized controlled trial protocol of in-clinic physical activity counselling
Most (>90%) children with congenital health defects are not active enough for optimal health. Proactively promoting physical activity during every clinic visit is recommended, but rarely implemented due to a lack of appropriate resources. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 25, 2020 Category: Radiology Authors: Olivia Lemire, Jenna Yaraskavitch, Jane Lougheed, Andrew S. Mackie, Kambiz Norozi, Patricia E. Longmuir Source Type: research

The South Asian Healthy Lifestyle Intervention (SAHELI) trial: Protocol for a mixed-methods, hybrid effectiveness implementation trial for reducing cardiovascular risk in South Asians in the United States
Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites a...
Source: Contemporary Clinical Trials - March 24, 2020 Category: Radiology Authors: Namratha R. Kandula, Veronica Bernard, Swapna Dave, Linda Ehrlich-Jones, Catherine Counard, Nirav Shah, Santosh Kumar, Goutham Rao, Ronald Ackermann, Bonnie Spring, Juned Siddique Source Type: research

Dynamic treatment regimens in small n, sequential, multiple assignment, randomized trials: An application in focal segmental glomerulosclerosis
Focal segmental glomerulosclerosis (FSGS) is a rare kidney disease with an annual incidence of 0.2 –1.8 cases per 100,000 individuals. Most rare diseases like FSGS lack effective treatments, and it is difficult to implement clinical trials to study rare diseases because of the small sample sizes and difficulty in recruitment. A novel clinical trial design, a small sample, sequential, multiple a ssignment, randomized trial (snSMART) has been proposed to efficiently identify effective treatments for rare diseases. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - March 18, 2020 Category: Radiology Authors: Yan-Cheng Chao, Howard Trachtman, Debbie S. Gipson, Cathie Spino, Thomas M. Braun, Kelley M. Kidwell Source Type: research

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 17, 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 17, 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 14, 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 14, 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 11, 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 6, 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 6, 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. (...
Source: Contemporary Clinical Trials - March 6, 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 5, 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 5, 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 4, 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 4, 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 - March 1, 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 ...
Source: Contemporary Clinical Trials - February 28, 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 27, 2020 Category: Radiology Authors: Greg Clarke, Christina R. Sheppler, Alison J. Firemark, Andreea M. Rawlings, John F. Dickerson, Michael C. Leo Source Type: research

Feasibility and preliminary effects of a peer-led motivationally-embellished workplace walking intervention: A pilot cluster randomized trial (the START trial)
Walking interventions can be effective in increasing physical activity amongst physically inactive employees. However, despite their promising potential regarding sustainability and scalability, peer-led workplace walking interventions have not been tested. We evaluated a peer-led workplace group walking intervention designed to engage physically inactive employees. A 16-week pilot cluster randomized controlled trial consisted of enhanced (5 worksites; n  = 50 participants) and minimal treatment (3 worksites; n = 47) conditions. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 27, 2020 Category: Radiology Authors: C. Th øgersen-Ntoumani, E. Quested, B.S. Smith, J. Nicholas, J. McVeigh, S.A.M. Fenton, E. Stamatakis, S. Parker, G. Pereira, D.F. Gucciardi, N. Ntoumanis Source Type: research

Evaluating the effect of individually-targeted food incentives on grocery purchases: The smart cart study protocol for a randomized controlled cross-over trial
Health stakeholders are interested in the promise of healthy food incentives to improve dietary quality. The Smart Cart Study tested whether targeting healthful food incentives based on customer preferences and purchase history was effective for improving grocery purchase quality. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 21, 2020 Category: Radiology Authors: Maya K. Vadiveloo, Xintong Guan, Haley W. Parker, Elie Perraud, Ashley Buchanan, Stephen Atlas, Anne N. Thorndike Source Type: research

The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight
Self-monitoring food intake and physical activity (PA) is positively related to weight loss and the addition of feedback (FB) messages has been shown to reinforce behavior change. Moreover, the more immediate the delivery of reinforcing FB messages, the more likely they will promote the desired behaviors. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 19, 2020 Category: Radiology Authors: Lora E. Burke, Susan M. Sereika, Bambang Parmanto, Britney Beatrice, Mia Cajita, India Loar, Wayan Pulantara, Yuhan Wang, Jacob Kariuki, Yang Yu, Maribel Cedillo, Jess Cheng, Molly B. Conroy Source Type: research

The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state
This study aimed to evaluate the impact of different financial incentive strategies on the utilization of the DPP for Medicaid managed care adults in New York State.A four-arm randomized controlled trial was conducted among Medicaid managed care adult enrollees diagnosed with prediabetes and/or obesity. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 19, 2020 Category: Radiology Authors: Jo-Yu Chin, Jacqueline Matson, Susan McCauley, Joseph Anarella, Foster Gesten, Patrick Roohan Source Type: research

N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial
Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. (Source: Contemporary Clinical Trials)
Source: Contemporary Clinical Trials - February 19, 2020 Category: Radiology Authors: Sudie E. Back, Kevin Gray, Elizabeth Santa Ana, Jennifer L. Jones, Amber M. Jarnecke, Jane E. Joseph, James Prisciandaro, Therese Killeen, Delisa G. Brown, Linda Taimina, Ebele Compean, Robert Malcolm, Julianne C. Flanagan, Peter W. Kalivas Source Type: research