JMIR Publications

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  RCTs - Protocols/Proposals (funded,...

  Feb 20, 2019

  Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol...

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  Authors List:

  • Ashley E Mason  
  • Laura Saslow  
  • Patricia J Moran  
  • Sarah Kim  
  • Hiba Abousleiman  
  • Alison Hartman  
  • Robert Richler  
  • Samantha Schleicher  
  • Wendy Hartogensis  
  • Elissa S Epel  
  • Frederick Hecht  

  Abstract:

  Background: Diet patterns have a profound influence on glycemic control for individuals with type 2 diabetes mellitus (T2DM), and craving-related eating is an important obstacle to dietary adherence. A growing body of research suggests that carbohydrate-restricted (CR) diets can improve glycemic control and reduce medication dependence in T2DM. However, limited data speak to the effects of long-term adherence to CR diets. Mindful eating training has been shown to reduce craving-related eating in overweight populations but has yet to be examined as a behavioral support for dietary adherence in T2DM. This trial examines behavioral mechanisms, particularly craving-related eating, through which mindful eating training might improve adherence to CR dietary recommendations in T2DM. This will clarify the importance of focusing on craving-related eating in the optimization of dietary adherence interventions. Objective: The aim of this trial is to determine whether providing training in mindful eating increases adherence to a CR dietary recommendation in T2DM. Methods: We are randomizing 60 participants to receive a CR diet with or without mindful eating training (12-week group intervention) and are following participants for 12 weeks after intervention completion. We hypothesize that participants who receive mindful eating training (relative to those who do not) will demonstrate greater adherence to the CR diet. Results: Our primary outcome is change in craving-related eating, as assessed using an ecological momentary assessment mobile phone–based platform. Secondary behavioral pathway outcomes include changes in stress-related eating, impulsivity, glycemic control, weight change, dietary adherence, and resumption of dietary adherence after dietary nonadherence. Conclusions: This theory-driven trial will shed light on the impact of mindfulness training on mechanisms that may impact dietary adherence in T2DM. Trial Registration: ClinicalTrials.gov NCT03207711; https://clinicaltrials.gov/ct2/show/NCT03207711 (Archived by WebCite at http://www.webcitation.org/73pXscwaU)  International Registered Report Identifier (IRRID): DERR1-10.2196/11002

  • JMIR Res Protoc 2019;8(2):e11002

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  RCTs - Pilots/Feasibility Studies...

  Feb 15, 2019

  Pilot Testing the Feasibility of a Game Intervention Aimed at Improving Help Seeking and Coping Among Sexual and Gender Minority Youth: Protocol for a...

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  Authors List:

  • Robert W S Coulter  
  • Jordan M Sang  
  • William Louth-Marquez  
  • Emmett R Henderson  
  • Dorothy Espelage  
  • Simon C Hunter  
  • Matthew DeLucas  
  • Kaleab Z Abebe  
  • Elizabeth Miller  
  • Brooke A Morrill  
  • Kimberly Hieftje  
  • Mark S Friedman  
  • James E Egan  

  Abstract:

  Background: Sexual and gender minority youth (SGMY; eg, lesbian, gay, bisexual, and transgender youth) experience myriad substance use and mental health disparities compared with their cisgender (nontransgender) heterosexual peers. Despite much research showing these disparities are driven by experiences of bullying and cyberbullying victimization, few interventions have aimed to improve the health of bullied SGMY. One possible way to improve the health of bullied SGMY is via a Web-accessible game intervention. Nevertheless, little research has examined the feasibility of using a Web-accessible game intervention with SGMY. Objective: This study aimed to describe the protocol for a randomized controlled trial (RCT) pilot, testing the feasibility and limited efficacy of a game-based intervention for increasing help-seeking–related knowledge, intentions, self-efficacy, behaviors, productive coping skills use, and coping flexibility and reducing health risk factors and behaviors among SGMY. Methods: We enrolled 240 SGMY aged 14 to 18 years residing in the United States into a 2-arm prospective RCT. The intervention is a theory-based, community-informed, computer-based, role playing game with 3 primary components: encouraging help-seeking behaviors, encouraging use of productive coping, and raising awareness of Web-based resources. SGMY randomized to both the intervention and control conditions will receive a list of SGMY-inclusive resources, covering a variety of health-related topics. Control condition participants received only the list of resources. Notably, all study procedures are conducted via the internet. We conveniently sampled SGMY using Web-based advertisements. Study assessments occur at enrollment, 1 month after enrollment, and 2 months after enrollment. The primary outcomes of this feasibility study include implementation procedures, game demand, and game acceptability. Secondary outcomes include help-seeking intentions, self-efficacy, and behaviors; productive coping strategies and coping flexibility; and knowledge and use of Web-based resources. Tertiary outcomes include bullying and cyberbullying victimization, loneliness, mental health issues, substance use, and internalized sexual and gender minority stigma. Results: From April to July 2018, 240 participants were enrolled and randomized. Half of the enrolled participants (n=120) were randomized into the intervention condition and half (n=120) into the control condition. At baseline, 52.1% (125/240) of the participants identified as gay or lesbian, 26.7% (64/240) as bisexual, 24.2% (58/240) as queer, and 11.7% (28/240) as another nonheterosexual identity. Nearly half (113/240) of participants were a gender minority: 36.7% (88/240) were cisgender boys, and 16.3% (39/240) were cisgender girls. There were no differences in demographic characteristics between intervention and control condition participants. Conclusions: Web-accessible game interventions overcome common impediments of face-to-face interventions and present a unique opportunity to reach SGMY and improve their health. This trial will provide data on feasibility and limited efficacy that can inform future Web-based studies and a larger RCT aimed at improving health equity for SGMY. Trial Registration: ClinicalTrials.gov NCT03501264; https://clinicaltrials.gov/ct2/show/NCT03501264 (Archived by WebCite at http://www.webcitation.org/72HpafarW) International Registered Report Identifier (IRRID): DERR1-10.2196/12164

  • JMIR Res Protoc 2019;8(2):e12164

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  RCTs - Protocols/Proposals (eHealth)

  Feb 15, 2019

  Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized...

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  Authors List:

  • Katriona Brooksbank  
  • Joanne O'Donnell  
  • Vicky Corbett  
  • Sarah Shield  
  • Rachel Ainsworth  
  • Ross Shearer  
  • Susan Montgomery  
  • Andrew Gallagher  
  • Hannah Duncan  
  • Lorna Hamilton  
  • Valerie Laszlo  
  • Rhonda Noone  
  • Anna Baxendale  
  • David Blane  
  • Jennifer Logue  

  Abstract:

  Background: Guidelines for the management of type 2 diabetes universally recommend that adults with type 2 diabetes and obesity be offered individualized interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the United Kingdom and where services are available, high attrition rates are often reported. In addition, individuals often fail to take up services, that is, after discussion with a general practitioner or practice nurse, individuals are referred to the service but do not attend for an appointment. Qualitative research has identified that the initial discussion raising the issue of weight, motivating the patient, and referring to services is crucial to a successful outcome from weight management. Objective: Our aim was to evaluate the effectiveness of an Internet-based training program and practice implementation toolkit with or without face-to-face training for primary care staff. The primary outcome is the change in referral rate of patients with type 2 diabetes to National Health Service adult weight management programs, 3 months pre- and postintervention. Methods: We used the Behavior Change Wheel to develop an intervention for staff in primary care consisting of a 1-hour Internet-based eLearning package covering the links between obesity, type 2 diabetes, and the benefits of weight management, the treatment of diabetes in patients with obesity, specific training in raising the issue of weight, local services and referral pathways, overview of weight management components/ evidence base, and the role of the referrer. The package also includes a patient pamphlet, a discussion tool, a practice implementation checklist, and an optional 2.5-hour face-to-face training session. We have randomly assigned 100 practices in a 1:1 ratio to either have immediate access to all the resources or have access delayed for 4 months. An intention-to-treat statistical analysis will be performed. Results: Recruitment to the study is now complete. We will finalize follow-up in 2018 and publish in early 2019. Conclusions: This protocol describes the development and randomized evaluation of the effectiveness of an intervention to improve referral and uptake rates of weight management programs for adults with type 2 diabetes. At a time when many new dietary and pharmacological weight management interventions are showing large clinical benefits for people with type 2 diabetes, it is vital that primary care practitioners are willing, skilled, and able to discuss weight and make appropriate referrals to services. Trial Registration: ClinicalTrials.gov NCT03360058; https://clinicaltrials.gov/ct2/show/NCT03360058 (Archived by WebCite at http://www.webcitation.org/74HI8ULfn) International Registered Report Identifier (IRRID): RR1-10.2196/12162

  • JMIR Res Protoc 2019;8(2):e12162

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  Non-Randomized Study Protocols and...

  Feb 14, 2019

  Determining Best Practices for Management of Bacteriuria in Spinal Cord Injury: Protocol for a Mixed-Methods Study

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  Authors List:

  • Felicia Skelton  
  • Lindsey Ann Martin  
  • Charlesnika T Evans  
  • Jennifer Kramer  
  • Larissa Grigoryan  
  • Pete Richardson  
  • Mark E Kunik  
  • Ivy Oiyee Poon  
  • S Ann Holmes  
  • Barbara W Trautner  

  Abstract:

  Background: Bacteriuria, either asymptomatic (ASB) or symptomatic, urinary tract infection (UTI), is common in persons with spinal cord injury (SCI). Current Veterans Health Administration (VHA) guidelines recommend a screening urinalysis and urine culture for every veteran with SCI during annual evaluation, even when asymptomatic, which is contrary to other national guidelines. Our preliminary data suggest that a positive urine culture (even without signs or symptoms of infection) drives antibiotic use. Objective: Through a series of innovative studies utilizing mixed methods, administrative databases, and focus groups, we will gain further knowledge about the attitudes driving current urine testing practices during the annual exam, as well as quantitative data on the clinical outcomes of these practices. Methods: Aim 1 will identify patient, provider, and facility factors driving bacteriuria testing and subsequent antibiotic use after the SCI annual evaluation through qualitative interviews and quantitative surveys. Aim 2 will use national VHA databases to identify the predictors of urine testing and subsequent antibiotic use during the annual examination and compare the clinical outcomes of those who received antibiotics with those who did not. Aim 3 will use the information gathered from the previous 2 aims to develop the Test Smart, Treat Smart intervention, a combination of patient and provider education and resources that will help stakeholders have informed conversations about urine testing and antibiotic use; feasibility will be tested at a single site. Results: This protocol received institutional review board and VHA Research and Development approval in July 2017, and Veterans Affairs Health Services Research and Development funding started on November 2017. As of submission of this manuscript, 10/15 (67%) of the target goal of provider interviews were complete, and 77/100 (77%) of the goal of surveys. With regard to patients, 5/15 (33%) of the target goal of interviews were complete, and 20/100 (20%) of the target goal of surveys had been completed. Preliminary analyses are ongoing; the study team plans to present these results in April 2019. Database analyses for aim 2 will begin in January 2019. Conclusions: The negative consequences of antibiotic overuse and antibiotic resistance are well-documented and have national and even global implications. This study will develop an intervention aimed to educate stakeholders on evidence-based management of ASB and UTI and guide antibiotic stewardship in this high-risk population. The next step will be to refine the intervention and test its feasibility and effectiveness at multiple sites as well as reform policy for management of this common but burdensome condition. International Registered Report Identifier (IRRID): DERR1-10.2196/12272

  • JMIR Res Protoc 2019;8(2):e12272

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  RCTs - Protocols/Proposals (non-eHealth)

  Feb 12, 2019

  Transforming Mental Health Delivery Through Behavioral Economics and Implementation Science: Protocol for Three Exploratory Projects

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  Authors List:

  • Rinad S Beidas  
  • Kevin G Volpp  
  • Alison N Buttenheim  
  • Steven C Marcus  
  • Mark Olfson  
  • Melanie Pellecchia  
  • Rebecca E Stewart  
  • Nathaniel J Williams  
  • Emily M Becker-Haimes  
  • Molly Candon  
  • Zuleyha Cidav  
  • Jessica Fishman  
  • Adina Lieberman  
  • Kelly Zentgraf  
  • David Mandell  

  Abstract:

  Background: Efficacious psychiatric treatments are not consistently deployed in community practice, and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus for mental health services research is to develop effective and cost-effective strategies that increase the use of evidence-based assessment, prevention, and treatment approaches in community settings. Objective: The goal of this program of research is to apply insights from behavioral economics and participatory design to advance the science and practice of implementing evidence-based practice (EBP) for individuals with psychiatric disorders across the life span. Methods: Project 1 (Assisting Depressed Adults in Primary care Treatment [ADAPT]) is patient-focused and leverages decision-making heuristics to compare ways to incentivize adherence to antidepressant medications in the first 6 weeks of treatment among adults newly diagnosed with depression. Project 2 (App for Strengthening Services In Specialized Therapeutic Support [ASSISTS]) is provider-focused and utilizes normative pressure and social status to increase data collection among community mental health workers treating children with autism. Project 3 (Motivating Outpatient Therapists to Implement: Valuing a Team Effort [MOTIVATE]) explores how participatory design can be used to design organizational-level implementation strategies to increase clinician use of EBPs. The projects are supported by a Methods Core that provides expertise in implementation science, behavioral economics, participatory design, measurement, and associated statistical approaches. Results: Enrollment for project ADAPT started in 2018; results are expected in 2020. Enrollment for project ASSISTS will begin in 2019; results are expected in 2021. Enrollment for project MOTIVATE started in 2018; results are expected in 2019. Data collection had begun for ADAPT and MOTIVATE when this protocol was submitted. Conclusions: This research will advance the science of implementation through efforts to improve implementation strategy design, measurement, and statistical methods. First, we will test and refine approaches to collaboratively design implementation strategies with stakeholders (eg, discrete choice experiments and innovation tournaments). Second, we will refine the measurement of mechanisms related to heuristics used in decision making. Third, we will develop new ways to test mechanisms in multilevel implementation trials. This trifecta, coupled with findings from our 3 exploratory projects, will lead to improvements in our knowledge of what causes successful implementation, what variables moderate and mediate the effects of those causal factors, and how best to leverage this knowledge to increase the quality of care for people with psychiatric disorders. Trial Registration: ClinicalTrials.gov NCT03441399; https://www.clinicaltrials.gov/ct2/show/NCT03441399 (Archived by WebCite at http://www.webcitation.org/74dRbonBD) International Registered Report Identifier (IRRID): DERR1-10.2196/12121

  • JMIR Res Protoc 2019;8(2):e12121

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  RCTs - Protocols/Proposals (eHealth)

  Feb 11, 2019

  A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized...

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  Authors List:

  • Akihiro Nomura  
  • Hiroki Tateno  
  • Katsunori Masaki  
  • Tomoyasu Muto  
  • Shin Suzuki  
  • Kohta Satake  
  • Eisuke Hida  
  • Koichi Fukunaga  

  Abstract:

  Background: Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment. Objective: This study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs. Methods: This will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52. Results: We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc. Conclusions: This is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000031589; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033555 International Registered Report Identifier (IRRID): DERR1-10.2196/12252

  • JMIR Res Protoc 2019;8(2):e12252

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  Systematic Review Protocols

  Feb 8, 2019

  Blockchain Implementation in Health Care: Protocol for a Systematic Review

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  Authors List:

  • Edward Meinert  
  • Abrar Alturkistani  
  • Kimberley A Foley  
  • Tasnime Osama  
  • Josip Car  
  • Azeem Majeed  
  • Michelle Van Velthoven  
  • Glenn Wells  
  • David Brindley  

  Abstract:

  Background: A blockchain is a digitized, decentralized, distributed public ledger that acts as a shared and synchronized database that records cryptocurrency transactions. Despite the shift toward digital platforms enabled by electronic medical records, demonstrating a will to reform the health care sector, health systems face issues including security, interoperability, data fragmentation, timely access to patient data, and silos. The application of health care blockchains could enable data interoperability, enhancement of precision medicine, and reduction in prescription frauds through implementing novel methods in access and patient consent. Objective: To summarize the evidence on the strategies and frameworks utilized to implement blockchains for patient data in health care to ensure privacy and improve interoperability and scalability. It is anticipated this review will assist in the development of recommendations that will assist key stakeholders in health care blockchain implementation, and we predict that the evidence generated will challenge the health care status quo, moving away from more traditional approaches and facilitating decision making of patients, health care providers, and researchers. Methods: A systematic search of MEDLINE/PubMed, Embase, Scopus, ProQuest Technology Collection and Engineering Index will be conducted. Two experienced independent reviewers will conduct titles and abstract screening followed by full-text reading to determine study eligibility. Data will then be extracted onto data extraction forms before using the Cochrane Collaboration Risk of Bias Tool to appraise the quality of included randomized studies and the Risk of Bias in nonrandomized studies of Interventions to assess the quality of nonrandomized studies. Data will then be analyzed and synthesized. Results: Database searches will be initiated in September 2018. We expect to complete the review in January 2019. Conclusions: This review will summarize the strategies and frameworks used to implement blockchains in health care to increase data privacy, interoperability, and scalability. This review will also help clarify if the strategies and frameworks required for the operationalization of blockchains in health care ensure the privacy of patient data while enabling efficiency, interoperability, and scalability.

  • JMIR Res Protoc 2019;8(2):e10994

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  Scoping Review Protocols

  Feb 7, 2019

  Digital Technology in Somatic and Gene Therapy Trials of Pediatric Patients With Ocular Diseases: Protocol for a Scoping Review

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  Authors List:

  • Edward Meinert  
  • Abrar Alturkistani  
  • Tasnime Osama  
  • Celine-Lea Halioua-Haubold  
  • Josip Car  
  • Azeem Majeed  
  • Glenn Wells  
  • Robert E MacLaren  
  • David Brindley  

  Abstract:

  Background: Pharmacogenomics suggests that diseases with similar symptomatic presentations often have varying genetic causes, affecting an individual patient’s response to a specific therapeutic strategy. Gene therapies and somatic cell therapies offer unique therapeutic pathways for ocular diseases and often depend on increased understanding of the genotype-phenotype relationship in disease presentation and progression. While demand for personalized medicine is increasing and the required molecular tools are available, its adoption within pediatric ophthalmology remains to be maximized in the postgenomic era. Objective: The objective of our study was to address the individual hurdles encountered in the field of genomic-related clinical trials and facilitate the uptake of personalized medicine, we propose to conduct a review that will examine and identify the digital technologies used to facilitate data analysis in somatic and gene therapy trials in pediatric patients with ocular diseases. Methods: This paper aims to present an outline for Healthcare Information Technology and Information and Communication Technology resources used in somatic and gene therapy clinical trials in children with ocular diseases. This review will enable authors to identify challenges and provide recommendations, facilitating the uptake of genetic and somatic therapies as therapeutic tools in pediatric ophthalmology. The review will also determine whether conducting a systematic review will be beneficial. Results: Database searches will be initiated in September 2018. We expect to complete the review in December 2019. Conclusions: Based on review findings, the authors will summarize methods used for facilitating IT integration in personalized medicine. Additionally, it will identify further research gaps and determine whether conducting further reviews will be beneficial. International Registered Report Identifier (IRRID): PRR1-10.2196/10705

  • JMIR Res Protoc 2019;8(2):e10705

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  RCTs - Protocols/Proposals (funded,...

  Feb 6, 2019

  Development of a Web-Based Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community: Protocol for a Pilot...

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  Authors List:

  • Marina B Wasilewski  
  • Mika Nonoyama  
  • Craig Dale  
  • Douglas A McKim  
  • Jeremy Road  
  • David Leasa  
  • Roger Goldstein  
  • Louise Rose  

  Abstract:

  Background: Across Europe, Canada, Australia, and the United States, the prevalence of home mechanical ventilation (HMV) prevalence is 6.6-12.9 per 100,000. At-home ventilator-assisted individuals (VAIs) are often vulnerable and highly comorbid, requiring complex care. In Canada, most VAI care is provided by family, leading to poor health-related quality of life and increased caregiver burden. No supportive interventions or peer support programs are tailored to VAI caregivers. Owing to the financial, geographic, and time limitations, Web-based support delivery may especially meet VAI family caregiver needs. We have developed a peer mentor training and Web-based peer support program for VAI caregivers including information-sharing, peer-to-peer communication, and peer mentorship. Objective: Study Stage 1 aims to (1) evaluate the face and content validity of the peer mentor training program and (2) investigate participant satisfaction. Study Stage 2 aims to evaluate (1) the feasibility of participant recruitment and Web-based program delivery; (2) acceptability, usability, and satisfactoriness; (3) experiences of caregivers and peer mentors with the Web-based peer support program; and (4) effect of the Web-based peer support program on caregiver health outcomes. Methods: Study Stage 1: We will train 7 caregivers to act as peer mentors for the Web-based peer support program trial; they will complete questionnaires rating the utility of individual training sessions and the training program overall. Study Stage 2: We will recruit 30 caregiver peers for a pilot randomized controlled trial of the 12-week Web-based peer support program using a waitlist control; the program includes private chat, a public discussion forum, and weekly moderated chats. Caregiver peers will be randomized to the intervention or waitlist control group using a 1:1 ratio using Randomize.net. Both groups will complete pre- and postintervention health outcome questionnaires (ie, caregiving impact, mastery, coping, personal gain, positive affect, and depression). Caregiver peers in the intervention arm will only complete a program evaluation and will be invited to participate in an interview to provide insight into their experience. Peer mentors will be invited to participate in a Web-based focus group to provide insight into their experience as mentors. We will judge the feasibility per the number of recruitment and program delivery goals met, use analysis of covariance to compare health outcomes between intervention and control groups, and analyze qualitative data thematically. Results: Peer mentor training was completed with 5 caregivers in July 2018. To date, 2 caregivers have beta-tested the website, and the Web-based peer support program trial will commence in September 2018. Results are expected by early 2019. Conclusions: This study will result in the production and initial evaluation of a rigorously developed, evidence- and stakeholder-informed Web-based peer training and peer support program for caregivers of VAIs residing at home. International Registered Report Identifier (IRRID): PRR1-10.2196/11827

  • JMIR Res Protoc 2019;8(2):e11827

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  RCTs - Protocols/Proposals (non-eHealth)

  Feb 6, 2019

  The Safety, Tolerability, and Effects on the Systemic Inflammatory Response and Renal Function of the Human Chorionic Gonadotropin Hormone-Derivative EA-230...

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  Authors List:

  • Roger van Groenendael  
  • Remi Beunders  
  • Jan Hofland  
  • Wim J Morshuis  
  • Matthijs Kox  
  • Lucas T van Eijk  
  • Peter Pickkers  

  Abstract:

  Background: The cardiac surgery–induced systemic inflammatory response may induce postoperative hemodynamic instability and impairment of renal function. EA-230, a linear tetrapeptide (A-Q-G-V), is derived from the beta chain of the human chorionic gonadotropin pregnancy hormone. It has shown immunomodulatory and renoprotective effects in several animal models of systemic inflammation. In phase 1 and phase 2a studies, these immunomodulatory effects were confirmed during human experimental endotoxemia, and EA-230 was found to have an excellent safety profile. Objective: The objective of this first in-patient study is to test the safety and tolerability as well as the immunomodulatory and renoprotective effects of EA-230 in a proof-of-principle design in patients with systemic inflammation following on-pump cardiac surgery. Methods: We describe a prospective, randomized, double-blind, placebo-controlled study in which 180 elective patients undergoing on-pump coronary artery bypass grafting, with or without concomitant valve surgery, are enrolled. Patients will be randomized in a 1:1 ratio and will receive either EA-230 (90 mg/kg/hour) or a placebo. These will be infused at the start of the surgical procedure until the end of the use of the cardiopulmonary bypass. The primary focus of this first-in-patient study will be on safety and tolerability of EA-230. The primary efficacy end point is the modulation of the inflammatory response by EA-230 quantified as the change in interleukin-6 plasma concentrations after surgery. The key secondary end point is the effect of EA-230 on renal function. The study will be conducted in 2 parts to enable an interim safety analysis by an independent data monitoring committee at a sample size of 60. An adaptive design is used to reassess statistical power halfway through the study. Results: This study has been approved by the independent competent authority and ethics committee and will be conducted in accordance with the ethical principles of the Declaration of Helsinki, guidelines of Good Clinical Practice, and European Directive 2001/20/CE regarding the conduct of clinical trials. Results of this study will be submitted for publication in a peer-reviewed scientific journal. Enrollment of this study commenced in July 2016, and results are expected at the end of 2018. Conclusions: This adaptive phase 2 clinical study is designed to test the safety and tolerability of EA-230 in patients undergoing cardiac surgery. In addition, efficacy end points focused on the effect of the systemic inflammatory response and renal function are investigated. Trial Registration: ClinicalTrials.gov NCT03145220; https://clinicaltrials.gov/ct2/show/NCT03145220 (Archived by WebCite at http://www.webcitation.org/74JPh8GNN) International Registered Report Identifier (IRRID): DERR1-10.2196/11441

  • JMIR Res Protoc 2019;8(2):e11441

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  RCTs - Protocols/Proposals (funded,...

  Feb 5, 2019

  Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP): Protocol for a Feasibility and Exploratory Efficacy Study in Men on Androgen...

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  Authors List:

  • Amit Algotar  
  • Chiu-Hsieh Hsu  
  • HH Sherry Chow  
  • Shona Dougherty  
  • Hani Babiker  
  • David Marrero  
  • Ivo Abraham  
  • Rachit Kumar  
  • Jennifer Ligibel  
  • Kerry S Courneya  
  • Cynthia Thomson  

  Abstract:

  Background: Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors. Objective: The Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP) is designed to address these gaps by using an intervention modeled on the Diabetes Prevention Program, a standardized multicomponent intervention with demonstrated effectiveness in reducing cardiometabolic risk factors that has been successfully adapted for multiple disease types including breast cancer. Methods: A single-arm unblinded clinical trial will be conducted to determine the feasibility of conducting a 24-week comprehensive lifestyle modification intervention that targets weight loss and increased physical activity modeled on the Diabetes Prevention Program in 30 men on ADT for prostate cancer. Secondary aims are to determine the effect of the intervention on cardiometabolic markers and quality of life. The tertiary aim is to determine the effect of the intervention on markers of inflammation and angiogenesis, important mechanisms for prostate cancer progression. Participants will be recruited from the University of Arizona Cancer Center and the surrounding community. The intervention will be delivered weekly in person and over the phone for 16 weeks. For Weeks 16-24, participants receive weekly phone calls from the study health coach to motivate them to continue their lifestyle modification. Questionnaire and biological data are collected at baseline, 12 weeks, and 24 weeks. Body composition using dual-energy x-ray absorptiometry scans will be performed at baseline and end of study. Results: Based on a sample size of 30, the two-sided 95% confidence interval will not be wider than 0.373 standard deviations for the adherence rate and will not be wider than 0.374 for the retention rate. In addition, the study will have a power of 80% to detect a change of 0.47 standard deviations from baseline for each of the markers investigated in the secondary and tertiary aims assuming a within-subject correlation of 0.20 at a significance level of 5%. The recruitment period is from October 2018 to April 2019. Conclusions: The aim of CLIPP is to determine the feasibility of conducting a Diabetes Prevention Program–style comprehensive lifestyle modification intervention in men with ADT for prostate cancer and its effects on cardiometabolic adverse effects, quality of life, as well as markers of inflammation and angiogenesis. Results will inform the development of future clinical trials in this population. International Registered Report Identifier (IRRID): DERR1-10.2196/12579

  • JMIR Res Protoc 2019;8(2):e12579

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  Non-Randomized Studies (funded, eHealth)

  Feb 4, 2019

  Rationale and Design of a Remote Web-Based Daily Diary Study Examining Sexual Minority Stress, Relationship Factors, and Alcohol Use in Same-Sex Female...

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  Authors List:

  • Kristin E Heron  
  • Robin J Lewis  
  • Alexander T Shappie  
  • Charlotte A Dawson  
  • Rachel Amerson  
  • Abby L Braitman  
  • Barbara A Winstead  
  • Michelle L Kelley  

  Abstract:

  Background: The Healthy People 2020 initiative aims to reduce health disparities, including alcohol use, among sexual minority women (SMW; eg, lesbian, bisexual, queer, and pansexual). Compared with heterosexual women, SMW engage in more hazardous drinking and report more alcohol-related problems. Sexual minority stress (ie, the unique experiences associated with stigmatization and marginalization) has been associated with alcohol use among SMW. Among heterosexuals, relationship factors (eg, partner violence and drinking apart vs together) have also been associated with alcohol use. Negative affect has also been identified as a contributor to alcohol use. To date, most studies examining alcohol use among SMW have used cross-sectional or longitudinal designs. Objective: Project Relate was designed to increase our understanding of alcohol use among young SMW who are at risk for alcohol problems. The primary objectives of this study are to identify daily factors, as well as potential person-level risk and protective factors, which may contribute to alcohol use in SMW. Secondary objectives include examining other physical and mental concerns in this sample (eg, other substance use, eating, physical activity, and stress). Methods: Both partners of a female same-sex couple (aged 18-35 years; n=150 couples) are being enrolled in the study following preliminary screening by a market research firm that specializes in recruiting sexual minority individuals. Web-based surveys are being used to collect information about the primary constructs of interest (daily experiences of alcohol use, sexual minority stress, relationship interactions, and mood) as well as secondary measures of other physical and mental health constructs. Data are collected entirely remotely from women across the United States. Each member of eligible couples completes a baseline survey and then 14 days of daily surveys each morning. Data will be analyzed using multilevel structural equation modeling. Results: To date, 208 women (ie, 104 couples) were successfully screened and enrolled into the study. In total, 164 women have completed the 14-day daily protocol. Compliance with completing the daily diaries has been excellent, with participants on average completing 92% of the daily diaries. Data collection will be completed in fall 2018, with results published as early as 2019 or 2020. Conclusions: Project Relate is designed to increase our understanding of between- and within-person processes underlying hazardous drinking in understudied, at-risk SMW. The study includes a remote daily diary methodology to provide insight into variables that may be associated with daily hazardous alcohol use. Before the development of programs that address hazardous alcohol use among young SMW, there is a need for better understanding of individual and dyadic variables that contribute to risk in this population. The unique challenges of recruiting and enrolling SMW from across the United States in a daily diary study are discussed. International Registered Report Identifier (IRRID): DERR1-10.2196/11718

  • JMIR Res Protoc 2019;8(2):e11718

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