Clinical Trials

Incentivizing healthy lifestyle behaviors to reduce cardiovascular risk in people with serious mental illness: An equipoise randomized controlled trial of the wellness incentives program Publication date: June 2019 Source: Contemporary Clinical Trials, Volume 81 Author(s): Sarah I. Pratt, Mary F. Brunette, Rosemarie Wolfe, Emily A. Scherer, Haiyi Xie, Stephen Bartels, Joelle C. Ferron, Kelley Capuchino Abstract Background Medicaid recipients with serious mental illness die 25–30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy disparity. The current study evaluated the impact of incentives on participation in weight management programming (for overweight and obese adults) and smoking cessation treatment (for regular smokers). Methods Participants were Medicaid recipients with disabling mental illness receiving services at any one of 10 community mental health centers across New Hampshire. Using an equipoise stratified randomized design, n = 1348 were enrolled and assigned to one of four weight management programs (Healthy Choices Healthy Changes: HCHC) and n = 661 were enrolled and assigned to one of three smoking cessation interventions (Breathe Well Live Well: BWLW). Following assignment to an intervention, participants were randomized to receive financial incentives (to attend weight management programs, or to achieve abstinence from smoking) or not. Data were collected at baseline and every 3 months for 12 months. Discussion New Hampshire's HCHC and BWLW programs were designed to address serious and preventable health disparities by providing incentivized health promotion programs to overweight/obese and/or tobacco-smoking Medicaid beneficiaries with mental illness. This study was an unprecedented opportunity to evaluate an innovative statewide implementation of incentivized health promotion targeting the most at-risk and costly beneficiaries. If proven effective, this program has the potential to serve as a national model for widespread implementation.

Proactive text messaging (GetReady2Quit) and nicotine replacement therapy to promote smoking cessation among smokers in primary care: A pilot randomized trial protocol Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): G.R. Kruse, E. Park, J.E. Haberer, L. Abroms, N.N. Shahid, S.E. Howard, Y. Chang, J.S. Haas, N.A. Rigotti Abstract Introduction Most smokers see a physician each year, but few use any assistance when they try to quit. Text messaging programs improve smoking cessation in community and school settings; however, their efficacy in a primary care setting is unclear. The current trial assesses the feasibility and preliminary clinical outcomes of text messaging and mailed nicotine replacement therapy (NRT) among smokers in primary care. Methods In this single-center pilot randomized trial, eligible smokers in primary care are offered brief advice by phone and randomly assigned to one of four interventions: (1) Brief advice only, (2) text messages targeted to primary care patients and tailored to quit readiness, (3) a 2-week supply of nicotine patches and/or lozenges (NRT), and (4) both text messaging and NRT. Randomization is stratified by practice and intention to quit. The text messages (up to 5/day) encourage those not ready to quit to practice a quit attempt, assist those with a quit date through a quit attempt, and promote NRT use. The 2-week supply of NRT is mailed to patients' homes. Results Feasibility outcomes include recruitment rates, study retention, and treatment adherence. Clinical outcomes are assessed at 1, 2, 6, and 12-weeks post-enrollment. The primary outcome is ≥1self-reported quit attempt(s). Secondary clinical outcomes include self-reported past 7- and 30-day abstinence, days not smoked, NRT adherence, and exhaled carbon monoxide. Conclusions This pilot assesses text messaging plus NRT, as a proactively offered intervention for smoking cessation support in smokers receiving primary care and will inform full-scale randomized trial planning. Trial registration ClinicalTrials.govNCT03174158.

Specialized tobacco quitline and basic needs navigation interventions to increase cessation among low income smokers: Study protocol for a randomized controlled trial Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Amy McQueen, Christina Roberts, Rachel Garg, Charlene Caburnay, Qiang Fu, Jacob Gordon, Terry Bush, Robin Pokojski, Tess Thompson, Matthew Kreuter Abstract Smoking in the United States follows a clear socioeconomic gradient: low-income Americans smoke more and quit less than those with more education and income. Evidence-based interventions like tobacco quitlines are designed to make effective cessation services available on a population basis to all smokers. However, these interventions do not address many of the unique challenges faced by low-income smokers, including unmet basic needs like food, housing, personal safety and money for necessities that often supersede health needs. Research is needed to maximize the use and effectiveness of tobacco quitlines in low-income populations. This paper details the rationale, design and methods for a 2 × 2 randomized controlled trial currently underway comparing the effects of Standard and Specialized Tobacco Quitlines with and without Basic Needs Navigation on intervention engagement and smoking cessation among low-income smokers. Smokers are recruited from United Way 2-1-1 in Missouri and all participants receive tobacco quitline services from Optum. Quitline and navigation services are provided for 3 months. Participants complete telephone surveys at baseline, 3- and 6-month follow up. The primary study outcome is self-reported 7-day point prevalence abstinence at 6-month follow up. Embedding the study in practice agencies will accelerate dissemination and scalability should our findings demonstrate intervention effectiveness.

Dose-response analysis of ranibizumab as-needed regimens for visual improvement in patients with diabetic macular edema using a modelling approach Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Yuan Xiong, Etienne Pigeolet, Zufar Mulyukov, Philippe Margaron, Amy Racine, Andreas Clemens Abstract Background Ranibizumab and aflibercept are anti-vascular endothelial growth factor therapies for diabetic macular edema (DME) but have only been directly compared in one study: the Protocol T study, a 24-month randomized controlled trial which compared the safety and efficacy of three anti-VEGF agents (ranibizumab 0.3 mg, aflibercept 2.0 mg and bevacizumab 1.25 mg). The ranibizumab dose used in Protocol T is not licensed for use outside of the US, where a higher ranibizumab dose of 0.5 mg is approved. Therefore, the relevance of the head-to-head Protocol T study findings to healthcare providers in Europe is limited. The purpose of this research was to predict the visual outcomes that may have been achieved in Protocol T with ranibizumab 0.5 mg. Methods A simplified dose-response model was constructed to describe the relationship between average monthly dose and one-year best corrected visual acuity (BCVA) change from baseline. A linear mixed effects model was evaluated and Bayesian Monte-Carlo Markov chains method was used to estimate the model parameters. Results If ranibizumab 0.5 mg PRN had been studied in Protocol T, it would have resulted in a BCVA gain of 14–15 early treatment diabetic retinopathy study (ETDRS) letters; 3–4 letters more than the actual BCVA gain reported with ranibizumab 0.3 mg PRN. In Protocol T patients with poor baseline BCVA (<69 letters), a similar additional letter gain would have been achieved. Conclusion The relevance of the Protocol T study findings are limited due to the use of ranibizumab 0.3 mg PRN which, based on the modelling approach reported herein, resulted in sub-optimal visual gains.

Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Terri Blackwell, Dana R. Kriesel, Eric Vittinghoff, Conor S. O'Brien, Jason P. Sullivan, Natalie C. Viyaran, Shadab A. Rahman, Steven W. Lockley, Laura K. Barger, Ann C. Halbower, Sue E. Poynter, Kenneth P. Wright, Pearl L. Yu, Phyllis C. Zee, Christopher P. Landrigan, Charles A. Czeisler, Katie L. Stone, for the ROSTERS Study Group Abstract Introduction While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs). Methods ROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers. The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm. Secondary aims were to assess the relationship of the study arm to resident-physician sleep duration, work hours and neurobehavioral performance. Results The study involved 6577 patients with a total of 38,821 patient days (n = 18,749 EDWR, n = 20,072 RCWR). There were 413 resident-physician rotations included in the study (n = 203 EDWR, n = 210 RCWR). Resident-physician questionnaire data were over 95% complete. Conclusions Results from data collected in the ROSTERS study will be evaluated for the impact of resident-physician schedule roster on patient safety outcomes in PICUs, and will allow for examination of a number of secondary outcome measures. ClinicalTrials.gov Identifier: NCT02134847

Evaluation of worldwide clinical trials by gender: An FDA perspective Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Emily Ayuso, Ruth J. Geller, Junyang Wang, John Whyte, Marjorie Jenkins Abstract Introduction The US Food and Drug Administration (FDA) has undertaken efforts to promote representation of women in clinical trials. The objectives of this research are to assess women's participation in clinical trials from a global perspective and to analyze the demographic characteristics of clinical trial participants. Methods FDA's Center for Drug Evaluation and Research-Professional Affairs and Stakeholder Engagement (CDER/PASE) and Office of Women's Health (OWH) collaborated to evaluate demographic data (race, ethnicity, gender, and age) of pivotal trials of New Molecular Entities (NMEs) approved in 2015–2016 by geographic location. One hundred fifty-four pivotal clinical trials supporting 66 NMEs were identified, and the research team analyzed demographic characteristics of 131,749 participants from 70 countries. Results U.S. sites contributed 31% of the 131,749 study participants. On the country level, the United States contributed the largest number of participants and other individual countries contributed 5% or less of the total trial population. Overall, 43% (n = 56,272) of the 131,747 clinical trial participants were women. Of the 40,833 U.S. participants, 49% were women as compared to 40% of the 90,914 non-U.S. participants. Similar levels of participation were seen after the exclusion of sex-specific drug indications, and by therapeutic area for U.S. and non-U.S. sites. Conclusions Clinical trials are becoming increasingly multi-national, and the increasing representation of women across countries is promising. FDA approval processes ensure that global data used in the drug approval process meets regulatory standards and that data can be generalized to the U.S. population.

Care partner problem solving training (CP-PST) for care partners of adults with traumatic brain injury during inpatient rehabilitation: Study protocol for a multisite, randomized, single-blind clinical feasibility trial Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Shannon B. Juengst, Valeria Silva, Yelena Goldin, Keith Cicerone, Jean Lengenfelder, Nancy Chiaravalloti, Simon Driver, David Mellick, Georgianna Dart, Chung Lin Kew, Andrew Nabasny, Kathleen R. Bell Abstract Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and quality of life of care partners and individuals with TBI under their care. Equipping care partners with problem-solving skills could facilitate and sustain their transition into this supportive role. Problem-solving training (PST) has demonstrated efficacy for providing such skills to care partners of individuals with TBI after discharge from inpatient rehabilitation. We propose that PST delivered to care partners during inpatient rehabilitation of individuals with TBI will provide care partners with the skills to manage their caregiving roles across the transition from hospital to home. Herein, we describe the methodology of a current randomized controlled trial that examines the feasibility and efficacy of PST plus TBI education compared to TBI education alone to improve care partner burden, emotional distress, and adaptive coping when delivered during the inpatient rehabilitation stay of individuals with moderate-severe TBI.

Design and patient characteristics of the randomized controlled trial TExT-MED + FANS A test of mHealth augmented social support added to a patient-focused text-messaging intervention for emergency department patients with poorly controlled diabetes Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Elizabeth Burner, Janisse Mercado, Antonio Hernandez-Saenz, Anne Peters, Lourdes Baezconde-Garbanati, Sanjay Arora, Shinyi Wu Abstract Although diabetes is a nationwide epidemic, US Latinos are a particularly vulnerable population. Culturally appropriate interventions can combat this disparity, especially those that increase social support. However, these interventions face significant cost and time barriers, which mHealth (mobile health) may overcome. This trial examines the benefit of adding social support to an existing text-message based, patient-focused mHealth intervention for emergency department patients with poorly controlled diabetes. Family members and friends of patients were randomized to mHealth augmented social support training (daily text-messages that synchronize with the patient messages) or a pamphlet based training (the same content mailed to their house.) We hypothesize that patients who received mHealth augmented social support will have a larger improvement in diabetes management (glycosylated hemoglobin or A1C) than those receiving standard support at six-months, and that improvement will be sustained at twelve-months. Secondary patient outcomes are clinical (weight, blood pressure), behavioral (medication adherence, self-care activities) and psychosocial (general and diabetes-specific social support, self-efficacy, diabetes-related distress, depression, fatalism and quality of life). We screened 2004 patients and enrolled 166 patient/supporter dyads. 70% of patients are Spanish-speaking, 51% female, with a mean A1C of 10.8. We employed innovative measures to remotely enroll family members and support a bilingual population, which will assist other investigators in design of similar trials. The findings of our trial will have real-world applicability for clinicians, health system administrators, health educators and mHealth developers who aim to improve the health of this vulnerable population.

Social incentives to encourage physical activity and understand predictors (STEP UP): Design and rationale of a randomized trial among overweight and obese adults across the United States Publication date: May 2019 Source: Contemporary Clinical Trials, Volume 80 Author(s): Joseph D. Harrison, Jeremy M. Jones, Dylan S. Small, Charles A.L. Rareshide, Gregory Szwartz, David Steier, James Guszcza, Pameljit Kalra, Brian Torio, Gregory Reh, Victoria Hilbert, Mitesh S. Patel Abstract Background Less than half of adults in the United States (US) obtain the recommended level of physical activity. Social incentives, the influences that impact individuals to adjust their behaviors based on social ties or connections, are ubiquitous and could be leveraged within gamification interventions to provide a scalable, low-cost approach to increase engagement. Gamification, or the use of game design in non-game situations, is commonly used in the real world, but in most cases has not appropriately leveraged principles from theories of health behavior. Methods We are conducting a four-arm, randomized, controlled trial of 602 overweight and obese adults to evaluate the effectiveness of gamification interventions that leverage insights from behavioral economics to enhance either supportive, competitive, or collaborative social incentives. Daily step counts are monitored using wearable devices that transmit data to the study platform. Participants established a baseline step count, selected a step goal increase, and then were randomly assigned to control or one of three interventions for a 24-week intervention and 12-week follow-up period. To understand predictors of strong or poor performance, we had participants complete validated questionnaires on a range of areas including their personality, risk preferences, social network, and habits relating to physical activity, eating, and sleep. Trial enrollment was conducted in partnership with Deloitte Consulting and included employees from 40 states across the US. Conclusion The STEP UP Trial represents a scalable model and interventions found to be effective could be deployed more broadly to increase physical activity. Trial registration Clinicaltrials.gov Identifier: NCT03311230

Effectiveness of shortened time interval to postpartum visit in improving postpartum attendance: Design and rationale for a randomized controlled trial Publication date: Available online 18 April 2019 Source: Contemporary Clinical Trials Author(s): Saba W. Masho, Timothy O. Ihongbe, Wen Wan, Whitney C. Graves, Nicole Karjane, Pamela Dillon, Gloria Bazzoli, Elizabeth McGee Abstract Background/Aims Recent evidence suggests that there are numerous benefits to scheduling postpartum visits as early as 3 weeks post-delivery. However, findings are not conclusive due to methodological limitations. This report discusses the unique aspects of a randomized controlled trial's (RCT) design, intervention, and strategies to maintain participant retention. Methods This study was a four-year, prospective, open-label RCT conducted at the Virginia Commonwealth University Medical Center. Women who recently delivered a healthy, full-term baby vaginally, were randomized to receive a 3–4 or 6–8 weeks postpartum appointment and were followed for 18 months. Results A total of 364 women participated in this study. A large proportion of women were retained in the study as demonstrated by the high completion rates at the 18-month follow-up interview (Total sample: 87.6%; 3–4 weeks group: 88.0%; 6–8 weeks group: 87.3%). Similarly, high adherence to the protocol-directed postpartum visit schedule was reported in the overall study sample (79.7%), as well as in the 3–4 (70.5%) and 6–8 (90.0%) week postpartum groups. Conclusion The study design offered unique features which ensured excellent participant completion and adherence rates, despite the presence of hard-to-track women who typically do not return for their postpartum visits.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00306932607174,00302841026182,alsfakia@gmail.com