Magaly Ramirez, Parth D Shah, Helen Y Chu, Lorenzo Garza, Sandra Linde, Michelle M Garrison, Chuan Zhou, Sonia Bishop, Genoveva Ibarra, Linda K Ko
INTRODUCTION: ROSSEY is a community-academic partnership aiming to develop and test a COVID-19 risk communication intervention for elementary school students and families in Yakima County, Washington. We describe the ROSSEY study protocol that will be implemented in the Yakima School District. METHODS: Aim 1 is to identify the community's social, ethical, and behavioral needs and resources for students to return to school and maintain onsite learning. We will conduct semi-structured interviews with students and school employees and focus groups with parents...
February 19, 2024: Contemporary Clinical Trials
Sarah Meshberg-Cohen, Joan M Cook, Amirah Bin-Mahfouz, Ismene L Petrakis
There are high rates of posttraumatic stress disorder (PTSD) among treatment-seeking veterans with substance use disorders (SUD). While addiction programs traditionally do not address PTSD, there is evidence that trauma treatments for individuals with this comorbidity have improved PTSD and SUD outcomes. Written exposure therapy (WET), a five-session evidence-based psychotherapy (EBP) for PTSD, has high patient satisfaction, and lower dropout compared to other EBPs for PTSD. WET may be ideally suited for clinical settings that may not have the trauma expertise found in PTSD specialty clinics, given it requires less training time, treatment sessions, preparation time, and therapist involvement than existing EBPs, and no homework assignments...
February 14, 2024: Contemporary Clinical Trials
Hui Quan, Yuqing Xu, Ying Liu, Xun Chen
There are very rich publications devoted to group sequential design, adaptive design and trial monitoring for continuous, binary and time to event endpoints. Many authors also discuss fixed design, blinded sample size re-estimation design and group sequential design for studies with a negative binomial outcome. Nonetheless, literature is sparse in adaptive design for a trial with a negative binomial endpoint. The features of such an endpoint in a flexible trial design setting remains inadequately understood...
February 6, 2024: Contemporary Clinical Trials
Aditi Gupta, Hira Chouhdry, Shellie D Ellis, Kate Young, Jonathan Mahnken, Branden Comfort, Denton Shanks, Sheila McGreevy, Courtney Rudy, Tahira Zufer, Sharissa Mabry, Jennifer Woodward, Amber Wilson, Heidi Anderson, Jennifer Loucks, Sravani Chandaka, Noor Abu-El-Rub, Diego R Mazzotti, Xing Song, Nolan Schmitz, Molly Conroy, Mark A Supiano, Lemuel R Waitman, Jeffrey M Burns
Hypertension control remains poor. Multiple barriers at the level of patients, providers, and health systems interfere with implementation of hypertension guidelines and effective lowering of BP. Some strategies such as self-measured blood pressure (SMBP) and remote management by pharmacists are safe and effectively lower BP but have not been effectively implemented. In this study, we combine such evidence-based strategies to build a remote hypertension program and test its effectiveness and implementation in large health systems...
February 6, 2024: Contemporary Clinical Trials
S M Nyenhuis, A E Dixon, L Wood, N Lv, N E Wittels, C R Ronneberg, L Xiao, S Dosala, A Marroquin, A Barve, W Harmon, M E Poynter, A Parikh, C A Camargo, L J Appel, J Ma
No abstract text is available yet for this article.
February 2, 2024: Contemporary Clinical Trials
Mark L Wieland, Luz Molina, Miriam Goodson, Graciela Porraz Capetillo, Ahmed Osman, Yahye Ahmed, Hindi Elmi, Omar Nur, Sheila O Iteghete, Gloria Torres-Herbeck, Hana Dirie, Matthew M Clark, Abby M Lohr, Kaiti Smith, Katherine Zeratsky, Thomas Rieck, Jeph Herrin, Thomas W Valente, Irene G Sia
BACKGROUND: Immigrants to the United States face structural barriers that contribute to rising cardiovascular risk factors and obesity after immigration. This manuscript describes the development of the Healthy Immigrant Community protocol and baseline measures for a stepped wedge cluster randomized trial to test the effectiveness of a social network intervention for cardiovascular risk reduction among two immigrant populations. METHODS: We developed a social network-informed, community-based, participatory research-derived health promotion intervention with Hispanic and Somali immigrant communities in Minnesota consisting of mentoring, educational and motivational sessions, group activities, and a community toolkit for healthy weight loss delivered by culturally concordant health promoters (HPs) to their social networks...
February 1, 2024: Contemporary Clinical Trials
Inbal Nahum-Shani, Zara M Greer, Anna L Trella, Kelly W Zhang, Stephanie M Carpenter, Dennis Ruenger, David Elashoff, Susan A Murphy, Vivek Shetty
Dental disease continues to be one of the most prevalent chronic diseases in the United States. Although oral self-care behaviors (OSCB), involving systematic twice-a-day tooth brushing, can prevent dental disease, this basic behavior is not sufficiently practiced. Recent advances in digital technology offer tremendous potential for promoting OSCB by delivering Just-In-Time Adaptive Interventions (JITAIs)- interventions that leverage dynamic information about the person's state and context to effectively prompt them to engage in a desired behavior in real-time, real-world settings...
January 31, 2024: Contemporary Clinical Trials
Valentina Micheluzzi, Gavino Casu, Giuseppe Damiano Sanna, Antonella Canu, Paolo Iovino, Gabriele Caggianelli, Ercole Vellone
BACKGROUND: To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes)...
January 30, 2024: Contemporary Clinical Trials
Julia E Hooker, Julie R Brewer, Katherine McDermott, Millan Kanaya, Tamara J Somers, Francis Keefe, Sarah Kelleher, Hannah M Fisher, John Burns, Rebecca Wilson, Ronald Kulich, Gary Polykoff, Robert A Parker, Jonathan Greenberg, Ana-Maria Vranceanu
BACKGROUND: Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain)...
January 27, 2024: Contemporary Clinical Trials
Rachel Proffitt, Erin L Robinson, Blaine Reeder, Emily Leary, Leah Botkin, Sheila Marushak, Lori L Popejoy, Marjorie Skubic
BACKGROUND: There is a critical need to improve quality of life for community-dwelling older adults with disabilities. Prior research has demonstrated that a smart, in-home sensor system can facilitate aging in place for older adults living in independent living apartments with care coordination support by identifying early illness and injury detection. Self-management approaches have shown positive outcomes for many client populations. Pairing the smart, in-home sensor system with a self-management intervention for community-dwelling older adults with disabilities may lead to positive outcomes...
January 25, 2024: Contemporary Clinical Trials
Daniel Yang, Richard Newcomb, Alison R Kavanaugh, Dania Khalil, Joseph A Greer, Yi-Bin Chen, Zachariah DeFilipp, Jennifer Temel, Stephanie J Lee, Thomas W LeBlanc, Areej El-Jawahri
BACKGROUND: Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) commonly experience debilitating physical and psychological symptoms during a 3-4-week-hospitalization. During hospitalization, caregivers (i.e., family and friends) also endure immense emotional stress as they witness their loved one struggle with HSCT toxicities. Yet interventions to improve quality of life (QOL) and reduce psychological distress during HSCT are limited. METHODS: We are conducting a multi-site randomized controlled trial of inpatient integrated palliative and transplant care versus usual care in 360 patients hospitalized for HSCT and their caregivers at three academic centers...
January 25, 2024: Contemporary Clinical Trials
Amanda E Staiano, Alyssa M Button, Alison Baker, Robbie Beyl, Anne-Marie Conn, Angela Lima, Jeanne Lindros, Robert L Newton, Richard I Stein, R Robinson Welch, Stephen Cook, Denise E Wilfley
BACKGROUND: Family-based behavioral treatment (FBT) is an effective intensive health behavior and lifestyle treatment for obesity reduction in children and adolescents, but families have limited access. The purpose of this randomized, pragmatic, comparative effectiveness trial was to examine changes in child relative weight in a 12-month, enhanced standard of care (eSOC) intervention combined with FBT (eSOC+FBT) vs. eSOC alone. METHODS: Children aged 6 to 15 years with obesity, and their primary caregiver, were recruited from primary care clinics...
January 24, 2024: Contemporary Clinical Trials
David E Conroy, James Marks, Alyssa Cutshaw, Nilam Ram, Edison Thomaz, Necole M Streeper
BACKGROUND: Risk of kidney stone recurrence can be reduced by increasing fluid intake and urine production but most patients fail to adhere to recommended clinical guidelines. Patients have indicated that common barriers to fluid intake include a lack of thirst, forgetting to drink, and not having access to water. We developed the sipIT intervention to support patients' fluid intake with semi-automated tracking (via a mobile app, connected water bottle and a smartwatch clockface that detects drinking gestures) and provision of just-in-time text message reminders to drink when they do not meet the hourly fluid intake goal needed to achieve the recommended volume...
January 20, 2024: Contemporary Clinical Trials
Isabelle R Weir, Linda J Harrison
BACKGROUND: Clinical trials often include interim analyses of the proportion of participants experiencing an event by a fixed time-point. A pre-specified proportion excluded from a corresponding confidence interval (CI) may lead an independent monitoring committee to recommend stopping the trial. Frequently this cumulative proportion is estimated by the Kaplan-Meier estimator with a Wald approximate CI, which may have coverage issues with small samples. METHODS: We reviewed four alternative CI methods for cumulative proportions (Beta Product Confidence Procedure (BPCP), BPCP Mid P, Rothman-Wilson, Thomas-Grunkemeier) and two CI methods for simple proportions (Clopper-Pearson, Wilson)...
January 20, 2024: Contemporary Clinical Trials
James D Ralston, Melissa Anderson, Janet Ng, Ayat Bashir, Kelly Ehrlich, Dena Burns-Hunt, Meredith Cotton, Laurel Hansell, Clarissa Hsu, Helen Hunt, Andrew J Karter, Shaula M Levy, Evette Ludman, Lawrence Madziwa, Emily M Omura, Kristine Rogers, Brandie Sevey, James A M Shaw, Susan M Shortreed, Umesh Singh, Jane Speight, Amber Sweeny, Katherine Tschernisch, S Sergei Tschernisch, Laura Yarborough
BACKGROUND: Severe hypoglycemia is a common and feared complication of medications used to lower blood glucose levels in individuals with diabetes. Psychoeducational interventions can prevent severe hypoglycemia in individuals with type 1 diabetes (T1D). We aim to determine the effectiveness of this approach among adults with type 2 diabetes (T2D) at elevated risk for severe hypoglycemia. METHODS: Preventing Hypoglycemia in Type 2 diabetes (PHT2) is a two-arm, parallel, randomized controlled trial...
January 20, 2024: Contemporary Clinical Trials
Ateka A Contractor, Heidemarie Blumenthal, David Rosenfield, M Tracie Shea, Daniel Taylor, Andrea Fentem, Jakob Vingren
BACKGROUND: Research indicates that positive memories have a role in posttraumatic stress disorder's (PTSD) symptomatology and treatment. Following treatment development guidelines, a novel PTSD intervention - Processing of Positive Memories Technique (PPMT) - was developed and subsequently examined for its effects and feasibility in pilot studies. Extending this research, the proposed pilot randomized clinical trial with PPMT and Supportive Counseling (SC) arms will examine PPMT's effects on PTSD severity and biomarkers of stress systems' dysregulation (awakening salivary alpha amylase [sAA] and cortisol concentrations); examine mechanistic targets (affect) underlying PPMT's effects; and refine PPMT...
January 20, 2024: Contemporary Clinical Trials
Robert W Motl, Brian M Sandroff, Ralph H B Benedict, Roberto Aldunate, Gary Cutter, Emily Barron
BACKGROUND: We propose a randomized controlled trial(RCT) of a Social Cognitive Theory-based(SCT), Internet-delivered behavioral intervention targeting lifestyle physical activity(LPA) for yielding improvements in cognitive processing speed(CPS), learning and memory(L/M), symptoms, and quality of life(QOL) among persons with mild multiple sclerosis(MS)-related ambulatory impairment who have impaired CPS. METHODS/DESIGN: The study involves a Phase-II, parallel group, RCT design...
January 17, 2024: Contemporary Clinical Trials
Gabriella T Ponzini, Natalie E Hundt, Israel C Christie, Patricia V Chen, Anthony H Ecker, Jan A Lindsay, Ellen J Teng, Eric A Storch, Ursula S Myers, Milena S Roussev, Terri L Fletcher
BACKGROUND: Obsessive compulsive disorder (OCD) is effectively treated with exposure and response prevention (ERP), yet very few veterans receive ERP for OCD within the Veterans Health Administration (VHA). Veterans are a clinically complex population, and no prior research has evaluated the effectiveness of ERP in veterans with OCD or comorbid OCD and posttraumatic stress disorder (PTSD). Given the limited accessibility of ERP-trained providers within VHA, assessment of video telehealth (VTH) delivery of ERP is warranted...
January 16, 2024: Contemporary Clinical Trials
Keisuke Hanada, Junji Moriya, Masahiro Kojima
The restricted mean survival time provides a straightforward clinical measure that dispenses with the need for proportional hazards assumptions. We focus on two strategies to directly model the survival time and adjust covariates. Firstly, pseudo-survival time is calculated for each subject using a leave-one-out approach, followed by a model analysis that adjusts for covariates using all pseudo-values. This method is used to reflect information of censored subjects in the model analysis. The second approach adjusts for covariates for those subjects with observed time-to-event while incorporating censored subjects using inverse probability of censoring weighting (IPCW)...
January 14, 2024: Contemporary Clinical Trials
Claudia K Fox, David M Vock, Nancy E Sherwood, Amy C Gross, Justin R Ryder, Megan O Bensignor, Eric M Bomberg, Muna Sunni, Carolyn T Bramante, Nina Jacobs, Sarah J Raatz, Aaron S Kelly
BACKGROUND: Severe obesity is a complex, chronic disease affecting nearly 9% of adolescents in the U.S. Although the current mainstay of treatment is lifestyle therapy, pediatric clinical practice guidelines recommend the addition of adjunct anti-obesity medication (AOM), such as phentermine and topiramate. However, guidance regarding when adjunct AOM should be started and how AOM should be used is unclear. Furthermore, an inherent limitation of current treatment guidelines is their "one-size-fits-all" approach, which does not account for the heterogeneous nature of obesity and high degree of patient variability in response to all interventions...
January 12, 2024: Contemporary Clinical Trials
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