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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/29783091/mind-at-home-streamlined-study-protocol-for-a-randomized-trial-of-home-based-care-coordination-for-persons-with-dementia-and-their-caregivers
#1
Quincy M Samus, Betty Smith Black, Melissa Reuland, Jeannie-Marie S Leoutsakos, Laura Pizzi, Kevin D Frick, David L Roth, Laura N Gitlin, Constantine G Lyketsos, Deirdre Johnston
BACKGROUND: Dementia is associated with high health care costs, premature long-term care (LTC) placement, medical complications, reduced quality of life, and caregiver burden. Most health care providers and systems are not yet organized or equipped to provide comprehensive long-term care management for dementia, although a range of effective symptoms and supportive care approaches exist. The Maximizing Independence at Home-Streamlined (MIND-S) is a promising model of home-based dementia care coordination designed to efficiently improve person-centered outcomes, while reducing care costs...
May 18, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29777866/considerations-of-multiple-imputation-approaches-for-handling-missing-data-in-clinical-trials
#2
Hui Quan, Li Qi, Xiaodong Luo, Loic Darchy
Missing data exist in all clinical trials and missing data issue is a very serious issue in terms of the interpretability of the trial results. There is no universally applicable solution for all missing data problems. Methods used for handling missing data issue depend on the circumstances particularly the assumptions on missing data mechanisms. In recent years, if the missing at random mechanism cannot be assumed, conservative approaches such as the control-based and returning to baseline multiple imputation approaches are applied for dealing with the missing data issues...
May 16, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29777865/a-prospective-non-interventional-registry-study-of-patients-initiating-a-course-of-drug-therapy-for-overactive-bladder-perspective-rationale-design-and-methodology
#3
Eric S Rovner, Kevin V Carlson, Anna S Deal, Kavita V Nair, Eva E Oakkar, Julie Park, Eric Gemmen, Rita M Kristy, Katherine L Gooch, Carol R Schermer
INTRODUCTION: Pharmacotherapy of overactive bladder (OAB) typically involves treatment with an antimuscarinic or mirabegron, a β3-adrenoceptor agonist, but real-world evidence on their use, including treatment access, persistence, and switching, is limited. Here, we describe the design of a prospective, multicenter, non-interventional registry of patients beginning a new course of OAB pharmacological therapy in routine clinical practice. METHODS: Adults with an OAB diagnosis for at least 3 months who either initiated a new course of mirabegron or antimuscarinic, or who switched therapy were enrolled into PERSPECTIVE (A Prospective, Non-intErventional Registry Study of Patients Initiating a Course of Drug Therapy for OveractIVE Bladder)...
May 16, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29777864/effectiveness-on-maternal-and-offspring-metabolic-control-of-a-home-based-dietary-counseling-intervention-and-dha-supplementation-in-obese-overweight-pregnant-women-might-study-a-randomized-controlled-trial-study-protocol
#4
María Luisa Garmendia, Camila Corvalán, Paola Casanello, B Marcela Araya, Marcela Flores, Alfredo Bravo, Juan Pedro Kusanovic, Pablo Olmos, Ricardo Uauy
BACKGROUND: Lifestyle interventions are the primary prevention strategy for gestational diabetes (GDM) in obese/overweight women; however, these interventions have shown limited effectiveness. Omega-3 polyunsaturated fatty acids (PUFAs) intake has shown beneficial effects on glucose metabolism, lipid fractions and inflammatory factors in women who already have GDM. Combining PUFAs supplementation with a lifestyle intervention could achieve lower increase of glucose levels by improving insulin sensitivity...
May 16, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29763657/a-mhealth-based-care-model-for-improving-hypertension-control-in-stroke-survivors-pilot-rct
#5
Kamakshi Lakshminarayan, Sarah Westberg, Carin Northuis, Candace C Fuller, Farah Ikramuddin, Mustapha Ezzeddine, Julie Scherber, Stuart Speedie
PURPOSE: Hypertension (HTN) is significantly under-treated in stroke survivors. We examined usability and efficacy of a mHealth -based care model for improving post-stroke HTN control (Funding: AHRQ R21HS021794). METHODS: We used a RCT design. Planned study duration was 90 days. Intervention arm (IA) participants measured their BP daily using a smart phone and wireless BP monitor. This was transmitted automatically to the study database. Investigators (Physician + PharmD) made bi-weekly medication adjustments to achieve the BP goal...
May 12, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29747048/a-randomized-trial-examining-a-physical-activity-intervention-for-the-prevention-of-postpartum-depression-the-healthy-mom-trial
#6
Beth A Lewis, Katie Schuver, Shira Duniger, Lauren Samson, Amanda L Frayeh, Carrie A Terrell, Joe T Ciccolo, Melissa D Avery
Approximately 13-19% of women experience postpartum depression and approximately one-third of women who have a history of depression develop depression during the postpartum phase. Exercise is an efficacious intervention for depression among adults; however, few studies have examined the effect of exercise on postpartum depression. The purpose of this study was to conduct a randomized controlled trial examining the effect of exercise and wellness interventions on preventing postpartum depression among women at risk...
May 7, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29747047/a-randomized-controlled-trial-of-orthodontist-based-brief-advice-to-prevent-child-obesity
#7
Melbourne F Hovell, Katharine E Schmitz, Sandy Liles, Kristi Robusto, C Richard Hofstetter, Jeanne F Nichols, Cheryl L Rock, Veronica Irvin, Melanie S Parker, Santiago A Surillo, David Noel
OBJECTIVE: We conducted a randomized controlled trial to test whether brief exercise and diet advice provided during child patient visits to their orthodontic office could improve diet, physical activity, and age-and-gender-adjusted BMI. METHODS: We enrolled orthodontic offices in Southern California and Tijuana, Mexico, and recruited their patients aged 8-16 to participate in a two-year study. At each office visit, staff provided the children with "prescriptions" for improving diet and exercise behaviors...
May 7, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29733982/the-giving-parents-support-study-a-randomized-clinical-trial-of-a-parent-navigator-intervention-to-improve-outcomes-after-neonatal-intensive-care-unit-discharge
#8
Cara L Carty, Lamia M Soghier, Katherine I Kritikos, Lisa K Tuchman, Michelle Jiggetts, Penny Glass, Randi Streisand, Karen R Fratantoni
Parents of infants hospitalized in a neonatal intensive care unit (NICU) experience increased anxiety and stress, which may persist after discharge. The rationale and design of a randomized clinical trial assessing the impact of a 1-year, post-discharge, peer support intervention (parent navigation) on parental mental health and infant health care utilization is described. Qualitative methods guided the adaptation of an existing parent support program to target emotional and resource-related needs of NICU families...
May 4, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29730393/virtual-immersive-gaming-to-optimize-recovery-vigor-in-low-back-pain-a-phase-ii-randomized-controlled-trial
#9
Christopher R France, James S Thomas
The virtual immersive gaming to optimize recovery (VIGOR) study is a randomized controlled trial of the effects of virtual reality games to encourage lumbar spine flexion among individuals with chronic low back pain and fear of movement. Whereas traditional graded activity or graded exposure therapies for chronic low back pain have high attrition and poor long-term efficacy, we believe that virtual reality games have distinct advantages that can enhance adherence and clinical outcomes. First, they are engaging and enjoyable activities that can distract from pain and fear of harm...
May 3, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29698772/an-operations-partnered-evaluation-of-care-redesign-for-high-risk-patients-in-the-veterans-health-administration-vha-study-protocol-for-the-pact-intensive-management-pim-randomized-quality-improvement-evaluation
#10
Evelyn T Chang, Donna M Zulman, Steven M Asch, Susan E Stockdale, Jean Yoon, Michael K Ong, Martin Lee, Alissa Simon, David Atkins, Gordon Schectman, Susan R Kirsh, Lisa V Rubenstein
BACKGROUND: Patient-centered medical homes have made great strides providing comprehensive care for patients with chronic conditions, but may not provide sufficient support for patients at highest risk for acute care use. To address this, the Veterans Health Administration (VHA) initiated a five-site demonstration project to evaluate the effectiveness of augmenting the VA's Patient Aligned Care Team (PACT) medical home with PACT Intensive Management (PIM) teams for Veterans at highest risk for hospitalization...
April 23, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29684544/the-international-childhood-cardiovascular-cohort-i3c-consortium-outcomes-study-of-childhood-cardiovascular-risk-factors-and-adult-cardiovascular-morbidity-and-mortality-design-and-recruitment
#11
Alan R Sinaiko, David R Jacobs, Jessica G Woo, Lydia Bazzano, Trudy Burns, Tian Hu, Markus Juonala, Ronald Prineas, Olli Raitakari, Julia Steinberger, Elaine Urbina, Alison Venn, Cashell Jaquish, Terry Dwyer
Although it is widely thought that childhood levels of cardiovascular (CV) risk factors are related to adult CV disease, longitudinal data directly linking the two are lacking. This paper describes the design and organization of the International Childhood Cardiovascular Cohort Consortium Outcomes Study (i3C Outcomes), the first longitudinal cohort study designed to locate adults with detailed, repeated, childhood biological, physical, and socioeconomic measurements and a harmonized database. I3C Outcomes uses a Heart Health Survey (HHS) to obtain information on adult CV endpoints, using mail, email, telephone, and clinic visits in the United States (U...
April 20, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29680319/comrade-a-randomized-trial-of-an-individually-tailored-integrated-care-intervention-for-uncontrolled-type-2-diabetes-with-depression-and-or-distress-in-the-rural-southeastern-us
#12
Lesley D Lutes, Doyle M Cummings, Kerry Littlewood, Chelsey Solar, Marissa Carraway, Kari Kirian, Shivajirao Patil, Alyssa Adams, Stefanie Ciszewski, Bertha Hambidge
BACKGROUND: Emerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes. DESIGN: This prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care...
April 20, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29680318/using-a-randomized-controlled-trial-to-test-whether-modifications-to-contingency-management-improve-outcomes-for-heavy-drinkers-with-serious-mental-illness
#13
Oladunni Oluwoye, Jordan Skalisky, Ekaterina Burduli, Naomi S Chaytor, Sterling McPherson, Sean Murphy, Jalene Herron, Katherine Hirchak, Mason Burley, Richard K Ries, John M Roll, Michael G McDonell
BACKGROUND: In contingency management (CM), individuals receive rewards for alcohol abstinence. CM is associated with reduced alcohol use in adults with co-occurring serious mental illnesses (SMI). Pre-treatment urine ethyl glucuronide (uEtG) levels equivalent to daily heavy drinking (uEtG > 349 ng/mL) are associated with poor response to CM. Modifications to CM are needed to improve outcomes for non-responders. AIMS: To determine if pre-treatment heavy drinkers, defined by uEtG, with SMI achieve higher levels of alcohol abstinence when they receive an increased magnitude of reinforcement for abstinence (High-Magnitude CM) or reinforcers for reduced drinking, prior to receiving reinforcers for abstinence (Shaping CM), relative to those who receive typical low-magnitude abstinence based CM (Usual CM)...
April 19, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29680317/a-double-blind-placebo-controlled-phase-ii-randomised-cross-over-trial-investigating-the-use-of-duloxetine-for-the-treatment-of-chemotherapy-induced-peripheral-neuropathy
#14
Eva Battaglini, Susanna B Park, Elizabeth H Barnes, David Goldstein
BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant side effect of cancer treatment, potentially leading to early cessation of chemotherapy, enduring symptoms and long-lasting disability. Evidence from preclinical and clinical studies suggests that duloxetine, a serotonin-noradrenaline reuptake inhibitor, may be effective in the symptomatic treatment of CIPN. This double blind, placebo controlled, phase II randomised cross-over trial aims to determine whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment...
April 19, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29679670/mindfulness-based-relapse-prevention-combined-with-virtual-reality-cue-exposure-for-methamphetamine-addiction-study-protocol-for-a-randomized-controlled-trial
#15
XiJing Chen, Dongmei Wang, Lidan Zhou, Markus Winkler, Paul Pauli, Nan Sui, Yonghui Li
BACKGROUND: Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research shows that MBRP can effectively reduce negative emotions and craving in people with substance use disorders (SUDs). An important part of MBRP is to practice mindfulness meditation to cope with high-risk situations for relapse, such as stimuli and situations associated with drug taking. Virtual reality cue exposure (VRCE) may be a complementary approach to MBRP as it allows for controlled and graded presentations of various high-risk situations with distal and proximal drug cues...
April 18, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29655859/rescuing-cognitive-and-emotional-regulatory-skills-to-aid-smoking-prevention-in-at-risk-youth-a-randomized-trial
#16
Michael W Otto, Eugenia I Gorlin, David Rosenfield, Elijah A Patten, Warren K Bickel, Michael J Zvolensky, Stacey N Doan
Adolescence is a vulnerable period for smoking initiation, with disadvantaged teens particularly at risk. In addition, emotional and cognitive dysregulation is associated with an increased risk of smoking and makes it particularly challenging to benefit from standard substance use prevention interventions. The goal of the current study is to investigate the extent to which interventions designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory processes enhance the effectiveness of a standard smoking prevention informational intervention...
April 12, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29654929/a-randomized-controlled-trial-of-community-health-workers-using-patient-stories-to-support-hypertension-management-study-protocol
#17
J Lee Hargraves, Debra Bonollo, Sharina D Person, Warren Ferguson
BACKGROUND: Uncontrolled hypertension is a significant public health problem in the U.S. with about one half of people able to keep blood pressure (BP) under control. Uncontrolled hypertension leads to increased risk of stroke, heart attack, and death. Furthermore, the social and economic costs of poor hypertension control are staggering. People living with hypertension can benefit from additional educational outreach and support. METHODS: This randomized trial conducted at two Community Health Centers (CHCs) in Massachusetts assessed the effect of community health workers (CHWs) assisting patients with hypertension...
April 11, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29649631/simultaneous-risk-factor-control-using-telehealth-to-slow-progression-of-diabetic-kidney-disease-stop-dkd-study-protocol-and-baseline-characteristics-of-a-randomized-controlled-trial
#18
Clarissa J Diamantidis, Hayden B Bosworth, Megan M Oakes, Clemontina A Davenport, Jane F Pendergast, Sejal Patel, Jivan Moaddeb, Huiman X Barnhart, Peter D Merrill, Khaula Baloch, Matthew J Crowley, Uptal D Patel
Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care...
April 9, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29627621/the-optima-study-buprenorphine-naloxone-and-methadone-models-of-care-for-the-treatment-of-prescription-opioid-use-disorder-study-design-and-rationale
#19
M Eugenia Socias, Keith Ahamad, Bernard Le Foll, Ron Lim, Julie Bruneau, Benedikt Fischer, T Cameron Wild, Evan Wood, Didier Jutras-Aswad
BACKGROUND: Rates of non-medical use of opioids, and opioid use disorders (OUD) have been rising throughout North America. Methadone and buprenorphine/naloxone are the recommended first-line treatment options for OUD in Canada. Most studies to date have been conducted among heroin users, in controlled settings, and using similar strict dosing schedules (i.e., daily witnessed ingestion) despite buprenorphine/naloxone's superior safety profile, which allows a more flexible take-home dosing schedule...
April 5, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29627620/efficacy-safety-and-tolerability-of-lubiprostone-for-the-treatment-of-non-alcoholic-fatty-liver-disease-in-adult-patients-with-constipation-the-lubiprone-double-blind-randomised-placebo-controlled-study-design
#20
Takaomi Kessoku, Kento Imajo, Takashi Kobayashi, Yasushi Honda, Takayuki Kato, Yuji Ogawa, Wataru Tomeno, Shingo Kato, Takuma Higurashi, Masato Yoneda, Hiroyuki Kirikoshi, Kazuki Kubota, Masataka Taguri, Takeharu Yamanaka, Haruki Usuda, Koichiro Wada, Satoru Saito, Atsushi Nakajima
BACKGROUND: This paper reports the protocol of a randomised, double-blind, placebo-controlled study to test the efficacy, safety, and tolerability of lubiprostone (LUB) vs. placebo on suppressing gut permeability in non-alcoholic fatty liver disease (NAFLD) patients with constipation. NAFLD, including non-alcoholic steatohepatitis (NASH), is a common chronic liver disorder. Progression is associated with increased gut permeability and gut-derived endotoxins. Most NAFLD/NASH clinical trial drugs aim to improve liver function or systemic metabolism...
April 5, 2018: Contemporary Clinical Trials
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