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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28104470/a-cluster-randomized-trial-of-a-primary-palliative-care-intervention-connect-for-patients-with-advanced-cancer-protocol-and-key-design-considerations
#1
Claire L Becker, Robert M Arnold, Seo Young Park, Margaret Rosenzweig, Thomas J Smith, Douglas B White, Kenneth J Smith, Yael Schenker
BACKGROUND: The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care specialists-is an alternative approach that has not been rigorously evaluated. METHODS: A cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania...
January 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28104469/culturally-grounded-diabetes-prevention-program-for-obese-latino-youth-rationale-design-and-methods
#2
A N Williams, Y P Konopken, C S Keller, F G Castro, K Arcoleo, E Barraza, D L Patrick, M L Olson, G Q Shaibi
BACKGROUND: Type 2 diabetes (T2D) disproportionately impacts Latino youth yet few diabetes prevention programs address this important source of health disparities. OBJECTIVES: To address this knowledge gap, we describe the rationale, design, and methodology underpinning a culturally-grounded T2D prevention program for obese Latino youth. The study aims to: 1) to test the efficacy of the intervention for reducing T2D risk, 2) explore potential mediators and moderators of changes in health behaviors and health outcomes and, 3) examine the incremental cost-effectiveness for reducing T2D risk...
January 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28089764/promoting-weight-maintenance-with-electronic-health-record-tools-in-a-primary-care-setting-baseline-results-from-the-maintain-pc-trial
#3
Molly B Conroy, Cindy L Bryce, Kathleen M McTigue, Dana Tudorascu, Bethany Barone Gibbs, Diane Comer, Rachel Hess, Kimberly Huber, Laurey R Simkin-Silverman, Gary S Fischer
Maintaining weight loss is a significant challenge in combating obesity. The goal of Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) is to evaluate the use of tools delivered through an electronic health record (EHR) and patient portal, with or without health coach support, to help primary care patients maintain weight loss. EHR tools include flowsheets, standardized surveys, and secure patient messaging. Inclusion criteria were age 18-75years, voluntary 5% weight loss in the past 2years with prior BMI≥25kg/m(2), and no bariatric procedures in past 5years...
January 12, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28089763/comparison-of-multi-arm-multi-stage-design-and-adaptive-randomization-in-platform-clinical-trials
#4
REVIEW
Jianchang Lin, Veronica Bunn
Platforms trials are clinical trials that allow for concurrent evaluations of multiple treatments, thus allowing for more efficient and ethical studies compared to traditional two-arm trials. Conventional group-sequential multi-arm multi-stage (MAMS) designs use pre-specified stopping boundaries and treatment selection rules to determine if experimental treatments should be dropped. Flexible MAMS designs allow for interim modifications to the design plan without compromising error rates. Bayesian response adaptive randomization (BRAR) designs increase patient allocation to treatment arms that are performing well during the course of the trial...
January 12, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28088514/assessing-the-feasibility-acceptability-and-potential-effectiveness-of-an-integrated-approach-to-smoking-cessation-for-new-and-expectant-fathers-the-dads-in-gear-study-protocol
#5
Joan L Bottorff, John L Oliffe, Gayl Sarbit, Cristina Caperchione, Marianne Clark, Anima Anand, Kym Howay
BACKGROUND: Evidence related to the effects of tobacco exposure in pregnancy and on infant and child health have focused on women's smoking cessation. Less often addressed is men's smoking, which when continued in fatherhood, reduces the chances of female partners' cessation and can negatively impact children's health as well as men's health. Dads in Gear (DIG) is an innovative program designed specifically for new fathers who want to reduce and quit smoking that includes three components: smoking cessation, fathering, and physical activity...
January 11, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28064028/resilient-empowered-active-living-with-diabetes-real-diabetes-study-methodology-and-baseline-characteristics-of-a-randomized-controlled-trial-evaluating-an-occupation-based-diabetes-management-intervention-for-young-adults
#6
Elizabeth A Pyatak, Kristine Carandang, Cheryl Vigen, Jeanine Blanchard, Paola A Sequeira, Jamie R Wood, Donna Spruijt-Metz, Robin Whittemore, Anne L Peters
OVERVIEW: This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist...
January 5, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28064029/improving-precision-by-adjusting-for-prognostic-baseline-variables-in-randomized-trials-with-binary-outcomes-without-regression-model%C3%A2-assumptions
#7
Jon Arni Steingrimsson, Daniel F Hanley, Michael Rosenblum
In randomized clinical trials with baseline variables that are prognostic for the primary outcome, there is potential to improve precision and reduce sample size by appropriately adjusting for these variables. A major challenge is that there are multiple statistical methods to adjust for baseline variables, but little guidance on which is best to use in a given context. The choice of method can have important consequences. For example, one commonly used method leads to uninterpretable estimates if there is any treatment effect heterogeneity, which would jeopardize the validity of trial conclusions...
January 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28042054/design-and-rationale-of-heart-and-lung-failure-pediatric-insulin-titration-trial-half-pint-a-randomized-clinical-trial-of-tight-glycemic-control-in-hyperglycemic-critically-ill-children
#8
Michael Sd Agus, Ellie Hirshberg, Vijay Srinivasan, Edward Vincent Faustino, Peter M Luckett, Martha Aq Curley, Jamin Alexander, Lisa A Asaro, Kerry Coughlin-Wells, Donna Duva, Jaclyn French, Natalie Hasbani, Martha T Sisko, Carmen L Soto-Rivera, Garry Steil, David Wypij, Vinay M Nadkarni
OBJECTIVES: Test whether hyperglycemic critically ill children with cardiovascular and/or respiratory failure experience more ICU-free days when assigned to tight glycemic control with a normoglycemic versus hyperglycemic blood glucose target range. DESIGN: Multi-center randomized clinical trial. SETTING: Pediatric ICUs at 35 academic hospitals. PATIENTS: Children aged 2weeks to 17years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients...
December 30, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28039022/a-single-blind-randomized-control-trial-of-adjunctive-transcranial-direct-current-stimulation-tdcs-for-chronic-pain-among-patients-receiving-specialized-inpatient-multimodal-pain-management
#9
G Janice Jimenez-Torres, Benjamin L Weinstein, Cory R Walker, J Christopher Fowler, Philippa Ashford, Jeffrey J Borckardt, Alok Madan
Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a minimally-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience METHODS AND DESIGN: Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial...
December 27, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28034686/letter-to-the-editor-in-response-to-o-m-bautista-a-luxembourg-deconstructing-the-measure-of-vaccine-efficacy-against-disease-irrespective-of-hpv-in-hpv-vaccine-clinical-trials-contemporary-clinical-trials-47-2016-254-258
#10
LETTER
Nicolas Folschweiller, Valérie Berlaimont, S Rachel Skinner, Cosette M Wheeler, Naveen Karkada, Frank Struyf, Martin Ryser
No abstract text is available yet for this article.
December 26, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28027950/dietfits-study-diet-intervention-examining-the-factors-interacting-with-treatment-success-study-design-and-methods
#11
Michael V Stanton, Jennifer L Robinson, Susan M Kirkpatrick, Sarah Farzinkhou, Erin C Avery, Joseph Rigdon, Lisa C Offringa, John F Trepanowski, Michelle E Hauser, Jennifer C Hartle, Rise J Cherin, Abby C King, John P A Ioannidis, Manisha Desai, Christopher D Gardner
Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between-subject differences in weight loss within any given diet group (e.g., ~25kg weight loss to ~5kg weight gain). The primary objective of this study was to identify predisposing individual factors at baseline that help explain differential weight loss achieved by individuals assigned to the same diet, particularly a pre-determined multi-locus genotype pattern and insulin resistance status...
December 24, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28017907/phone-delivered-mindfulness-training-to-promote-medication-adherence-and-reduce-sexual-risk-behavior-among-persons-living-with-hiv-design-and-methods
#12
Elena Salmoirago-Blotcher, Carla Rich, Rochelle K Rosen, Shira Dunsiger, Aadia Rana, Michael P Carey
INTRODUCTION: Two-thirds of people living with HIV (PLWH) show sub-optimal adherence to antiretroviral therapy (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been associated with emotional distress and impulsivity. To allay distress and lessen impulsivity, mindfulness training (MT) can be helpful. In this trial, we will investigate the utility of phone-delivered MT for PWLH. The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as well as on their hypothesized antecedents...
December 23, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28011388/dietary-intervention-for-glucose-tolerance-in-teens-dig-it-protocol-of-a-randomized-controlled-trial-using-health-coaching-to-prevent-youth-onset-type-2-diabetes
#13
Kelly A Wagner, Ethan Braun, Seth M Armah, Diarmuid Horan, Lisa G Smith, Julie Pike, Wanzhu Tu, Marc T Hamilton, Edward J Delp, Wayne W Campbell, Carol J Boushey, Tamara S Hannon, Nana Gletsu-Miller
BACKGROUND: Youth-onset type 2 diabetes (T2D) is a disease that is newly emerging and behavioral strategies for its prevention are limited. Interventions that target the lifestyle behaviors of adolescents, to improve poor dietary quality and reduce excessive sedentariness, promise to reduce the risk of developing T2D. Health coaching is effective for promoting healthy behaviors in patients who have chronic disease, but few experimental studies are in adolescents. This randomized controlled trial, in adolescents with prediabetes, will determine the effectiveness of a health coaching intervention to facilitate adoption of healthy diet and activity behaviors that delay or prevent development of T2D...
December 21, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28011389/extended-release-naltrexone-for-pre-release-prisoners-a-randomized-trial-of-medical-mobile-treatment
#14
Michael S Gordon, Frank J Vocci, Terrence T Fitzgerald, Kevin E O'Grady, Charles P O'Brien
BACKGROUND: Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases has been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment. METHODS: Male and female prisoners (240) with pre-incarceration histories of opioid use disorder who are within one month of release from prison will be enrolled in this randomized clinical trial...
December 20, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28011387/the-kidney-and-periodontal-disease-kapd-study-a-pilot-randomized-controlled-trial-testing-the-effect-of-non-surgical-periodontal-therapy-on-chronic-kidney-disease
#15
Vanessa Grubbs, Faviola Garcia, Bonnie L Jue, Eric Vittinghoff, Mark Ryder, David Lovett, Jacqueline Carrillo, Steven Offenbacher, Peter Ganz, Kirsten Bibbins-Domingo, Neil R Powe
INTRODUCTION: Chronic kidney disease (CKD) remains a prevalent public health problem that disproportionately affects minorities and the poor, despite intense efforts targeting traditional risk factors. Periodontal diseases are common bacterial plaque-induced inflammatory conditions that can respond to treatment and have been implicated as a CKD risk factor. However there is limited evidence that treatment of periodontal disease slows the progression of CKD. METHODS/DESIGN: We describe the protocol of the Kidney and Periodontal Disease (KAPD) study, a 12-month un-blinded, randomized, controlled pilot trial with two intent-to-treat treatment arms: 1...
December 20, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28007635/pharmaid-study-protocol-randomized-controlled-trial-to-assess-the-impact-of-integrated-pharmaceutical-care-at-a-psychosocial-intervention-on-caregiver-s-burden-in-alzheimer-s-disease-or-related-diseases
#16
T Novais, C Moutet, F Delphin-Combe, V Dauphinot, C Colin, P Krolak-Salmon, C Mouchoux
INTRODUCTION: Alzheimer's Disease and Related Diseases (ADRD) are associated with a caregiver burden that increases with the progression of the disease. Psychosocial interventions reported a moderate improvement on caregivers' burden. Patients with ADRD and their older caregivers are also exposed to a higher risk of developing drug-related problems. The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of caregivers...
December 19, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28007634/2gether-the-dual-protection-project-design-and-rationale-of-a-randomized-controlled-trial-to-increase-dual-protection-strategy-selection-and-adherence-among-african-american-adolescent-females
#17
Alexander C Ewing, Melissa J Kottke, Joan Marie Kraft, Jessica M Sales, Jennifer L Brown, Peggy Goedken, Jeffrey Wiener, Athena P Kourtis
BACKGROUND: African American adolescent females are at elevated risk for unintended pregnancy and sexually transmitted infections (STIs). Dual protection (DP) is defined as concurrent prevention of pregnancy and STIs. This can be achieved by abstinence, consistent condom use, or the dual methods of condoms plus an effective non-barrier contraceptive. Previous clinic-based interventions showed short-term effects on increasing dual method use, but evidence of sustained effects on dual method use and decreased incident pregnancies and STIs are lacking...
December 19, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28007633/the-go-actiwe-randomized-controlled-trial-an-interdisciplinary-study-designed-to-investigate-the-health-effects-of-active-commuting-and-leisure-time-physical-activity
#18
Mads Rosenkilde, Martin Bæk Petersen, Anne Sofie Gram, Jonas Salling Quist, Jonas Winther, Simon Due Kamronn, Desirée Hornbæk Milling, Jakob Eg Larsen, Astrid Pernille Jespersen, Bente Stallknecht
Regular physical activity is efficacious for improving metabolic health in overweight and obese individuals, yet, many adults lead sedentary lives. Most exercise interventions have targeted leisure time, but physical activity also takes place in other domains of everyday life. Active commuting represents a promising alternative to increase physical activity, but it has yet to be established whether active commuting conveys health benefits on par with leisure time physical activity (LTPA). A 6-month randomized controlled trial was designed to investigate the effects of increased physical activity in transport (bicycling) or leisure time domains (moderate or vigorous intensity endurance exercise)...
December 19, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27979754/design-of-the-integrative-medical-group-visits-randomized-control-trial-for-underserved-patients-with-chronic-pain-and-depression
#19
Paula Gardiner, Anna Sophia Lestoquoy, Katherine Gergen-Barnett, Brian Penti, Laura F White, Robert Saper, Lisa Fredman, Sarah Stillman, N Lily Negash, Pamela Adelstein, Ivy Brackup, Christine Farrell-Riley, Karim Kabbara, Lance Laird, Suzanne Mitchell, Timothy Bickmore, Ameneh Shamekhi, Jane M Liebschutz
BACKGROUND: Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. METHODS: This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits...
December 13, 2016: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/27979755/effects-of-non-nutritive-sweetened-beverages-on-appetite-during-active-weight-loss-switch-protocol-for-a-randomized-controlled-trial-assessing-the-effects-of-non-nutritive-sweetened-beverages-compared-to-water-during-a-12-week-weight-loss-period-and-a-follow
#20
U Masic, J A Harrold, P Christiansen, D J Cuthbertson, C A Hardman, E Robinson, J C G Halford
BACKGROUND: Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. METHODS/DESIGN: A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants...
December 12, 2016: Contemporary Clinical Trials
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