JMIR Publications

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  Non-randomized Protocols and Methods...

  Jun 24, 2019

  Protocol for the Development of a Behavioral Family Lifestyle Intervention Supported by Mobile Health to Improve Weight Self-Management in Children With...

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  Authors List:

  • David Fedele  
  • Robert Lucero  
  • David Janicke  
  • Mutasim Abu-Hasan  
  • Elizabeth McQuaid  
  • Jon Moon  
  • Andrea Fidler  
  • Tanya Wallace-Farquharson  
  • David Lindberg  

  Abstract:

  Background: Asthma is the most common chronic childhood illness and is a leading cause of emergency department visits in the United States. Obesity increases the risk of poor health outcomes, reduced quality of life, and increased health care expenditures among youth with asthma. Weight loss is crucial for improving asthma outcomes in children with obesity. Our study team developed the Childhood Health and Asthma Management Program (CHAMP), a 16-session behavioral family lifestyle intervention (BFI) for school-age children with asthma and obesity and evaluated CHAMP in a randomized controlled trial compared with attention control. There were medium effect sizes favoring CHAMP for changes in body mass index z-scores, asthma control, and lung function among completers (ie, those who attended ≥9 of 16 sessions). Despite high rates of satisfaction reported by families, attendance and trial attrition were suboptimal, which raised concerns regarding the feasibility of CHAMP. Qualitative feedback from participants indicated 3 areas for refinement: (1) a less burdensome intervention modality, (2) a more individually tailored intervention experience, and (3) that interventionists can better answer health-related questions. Objective: We propose to improve upon our pilot intervention by developing the Mobile Childhood Health and Asthma Management Program (mCHAMP), a nurse-delivered BFI, delivered to individual families, and supported by a mobile health (mHealth) app. This study aims to (1) identify structural components of mCHAMP and (2) develop and test the usability of our mCHAMP app. Methods: Participants will be recruited from an outpatient pediatric pulmonary clinic. We will identify the structural components of mCHAMP by conducting a needs assessment with parents of children with asthma and obesity. Subsequently, we will develop and test our mCHAMP app using an iterative process that includes usability testing with target users and pediatric nurses. Results: This study was funded in 2018; 13 parents of children with asthma and obesity participated in the needs assessment. Preliminary themes from focus groups and individual meetings included barriers to engaging in health-promoting behaviors, perceived relationships between asthma and obesity, facilitators to behavior change, and intervention preferences. Participatory design sessions and usability testing are expected to conclude in late 2019. Conclusions: Outcomes from this study are expected to include an mHealth app designed with direct participation from the target audience and usability data from stakeholders as well as potential end users. International Registered Report Identifier (IRRID): DERR1-10.2196/13549

  • JMIR Res Protoc 2019;8(6):e13549

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  Grant Proposals (eHealth, funded)

  Jun 24, 2019

  Web-Based Self-Management Guide for Kidney Transplant Recipients (The Getting on With Your Life With a Transplanted Kidney Study): Protocol for Development...

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  Authors List:

  • Daniela Massierer  
  • Ruth Sapir-Pichhadze  
  • Vanessa Bouchard  
  • Kaberi Dasgupta  
  • Nicolas Fernandez  
  • Deborah da Costa  
  • Sara Ahmed  
  • Marie-Chantal Fortin  
  • Rosalie Langevin  
  • Nancy Mayo  
  • Tania Janaudis-Ferreira  

  Abstract:

  Background: Although it is well known that compared with dialysis, kidney transplantation improves the quality of life (QoL) of patients with end-stage renal disease, posttransplant recovery of physical health and other aspects of QoL remain well below age- and sex-matched norms. In addition, most transplant recipients are not physically active even years after the transplant and face several barriers to engaging in physical activity (PA). This is of concern as low levels of PA in transplant recipients has been associated with increased risk of mortality and poor graft function. Optimization of QoL needs a team approach involving the patients and the members of the health care team. While members of the health care team are focused on optimizing the biological responses to transplant, patients may have few or no tools at their disposal to engage in behaviors that optimize QoL. To accomplish the need of supporting these patients in the self-management of their condition and to facilitate engagement with PA, new tools tailored to this population are required. Objective: The aim of this protocol study is to develop a Web-based, patient-centered self-management intervention to promote a healthy lifestyle, increase daily PA, and improve QoL in kidney transplant recipients. Methods: We will use the Obesity-Related Behavioral Intervention Trials model for developing behavioral treatments for chronic diseases to guide the proposed project. We will follow a modified version of the iterative 10-step process that was used to develop educational material for people with multiple sclerosis. The development of the intervention will occur in partnership with patients and a multidisciplinary team of clinicians and researchers. A comprehensive needs assessment including data from our pilot study, literature review, and focus groups will be conducted. The focus groups will be conducted with 6 to 10 participants for each type of stakeholders: patients and professional experts to identify areas of concerns of kidney transplant recipients that are appropriate to address through self-management. The areas of concern identified through the assessment needs will be included in the website. Results: This study has received funding from the Kidney Foundation of Canada for 2 years (2018-2020) and was recently granted ethics approval. Investigators have begun conducting the needs assessment described in step 1 of the study. The study is expected to be completed by the end of 2020. Conclusions: This will be the first comprehensive, evidence- and experience-based self-management program for kidney transplant recipients. Once the intervention is developed, we anticipate improvements in patient experience, shared decision making, daily PA, QoL, and, in future studies, improvements in health outcomes and demonstrations of cost savings in posttransplant care. International Registered Report Identifier (IRRID): PRR1-10.2196/13420

  • JMIR Res Protoc 2019;8(6):e13420

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  RCTs - Protocols/Proposals (funded,...

  Jun 21, 2019

  “Smartphone Medication Adherence Saves Kidneys” for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial

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  Authors List:

  • John McGillicuddy  
  • Jessica Chandler  
  • Luke Sox  
  • Martina Mueller  
  • Lynne Nemeth  
  • Prabhakar Baliga  
  • Frank Treiber  

  Abstract:

  Background: Kidney transplant recipients’ poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK). Objective: Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care. Methods: This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT. Results: The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants. Conclusions: This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care. International Registered Report Identifier (IRRID): DERR1-10.2196/13351

  • JMIR Res Protoc 2019;8(6):e13351

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  RCTs - Protocols/Proposals (eHealth)

  Jun 21, 2019

  The Effects of the Digital Platform Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) for People With Mild Cognitive Impairment and...

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  Authors List:

  • Peter Anderberg  
  • Pilar Barnestein-Fonseca  
  • Jose Guzman-Parra  
  • Maite Garolera  
  • María Quintana  
  • Fermin Mayoral-Cleries  
  • Evi Lemmens  
  • Johan Sanmartin Berglund  

  Abstract:

  Background: Many countries are witnessing a trend of growth in the number and proportion of older adults within the total population. In Europe, population aging has had and will continue to have major social and economic consequences. This is a fundamentally positive development where the added life span is of great benefit for both the individual and the society. Yet, the risk for the individual to contract noncommunicable diseases and disability increases with age. This may adversely affect the individual’s ability to live his or her life in the way that is desired. Cognitive conditions constitute a group of chronic diseases that predominantly affects older people. Recent technology advancements can help support the day-to-day living activities at home for people with cognitive impairments. Objective: A digital platform (Support Monitoring and Reminder for Mild Dementia; SMART4MD) is created to improve or maintain the quality of life for people with mild cognitive impairment (PwMCI) and their carers. The platform will provide reminders, information, and memory support in everyday life, with the purpose of giving structure and lowering stress. In the trial, we will include participants with a diagnosed neurocognitive disorder as well as persons with an undiagnosed subjective memory problem and cognitive impairment, that is, 20 to 28 points on the Mini-Mental State Examination. Methods: A pragmatic, multicenter RCT is being conducted in Spain, Sweden, and Belgium. The targets for recruitment are 1200 dyads—split into an intervention group and a control group that are in usual care. Intervention group participants will be provided with a data-enabled computer tablet with the SMART4MD app. Its core functionalities, intended to be used daily at home, are based on reminders, cognitive supporting activities, and sharing health information. Results: Inclusion of participants started in December 2017, and recruitment is expected to end in February 2019. Furthermore, there will be 3 follow-up visits at 6, 12, and 18 months after the baseline visit. Conclusions: This RCT is expected to offer benefits at several levels including in-depth knowledge of the possibilities of introducing a holistic multilayered information and communication technology solution for this group. SMART4MD has been developed in a process involving the structured participation of PwMCI, their informal carers, and clinicians. The adoption of SMART4MD faces the challenge of this age group’s relative unfamiliarity with digital devices and services. However, this challenge can also be an opportunity for developing a digital device tailored to a group at risk of digital exclusion. This research responds to the wider call for the development of digital devices which are accessible and affordable to older people and this full scale RCT can hopefully serve as a model for further studies in this field. Trial Registration: ClinicalTrials.gov NCT03325699; https://clinicaltrials.gov/ct2/show/NCT03325699 International Registered Report Identifier (IRRID): DERR1-10.2196/13711

  • JMIR Res Protoc 2019;8(6):e13711

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  Non-Randomized Study Protocols and...

  Jun 19, 2019

  Diet-Induced Alteration of Microbiota and Development of Obesity, Nonalcoholic Fatty Liver Disease, and Diabetes: Study Protocol of a Prospective Study

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  Authors List:

  • Martine Uittenbogaart  
  • Wouter KG Leclercq  
  • Danielle Bonouvrie  
  • Marleen M Romeijn  
  • Arijan APM Luijten  
  • Steven WM Olde Damink  
  • Francois MH van Dielen  
  • Sander S Rensen  

  Abstract:

  Background: Development of obesity and obesity-related diseases, such as type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD), is associated with altered gut microbiota composition. The aim of this study is to investigate associations among dietary compounds, intestinal cell function, and gut microbiota composition. We hypothesize that dietary lipid intake is associated with Paneth cell and goblet cell properties that affect gut microbiota composition. Objective: The primary objective of this study is to determine whether a difference in dietary intake is associated with a difference in intestinal mucin-2 expression and gut microbiota composition. Methods: This is a single-center prospective study, including 1 obese group undergoing laparoscopic Roux-en-y gastric bypass and 2 lean control groups undergoing either laparoscopic cholecystectomy or upper gastrointestinal endoscopy (n=228). During laparoscopy, biopsies will be taken of visceral fat (omentum majus), liver, muscle tissue of the abdominal wall, and subcutaneous fat. In the obese group, a small segment of the jejunum will be collected for analysis, which will be compared with an endoscopically derived jejunal biopsy from the upper gastrointestinal endoscopy control group. Stool samples for microbiota profiling will be collected at baseline and 1 year after surgery. Primary outcomes are fecal microbiota composition and mucus characteristics. Secondary outcomes include Paneth cell phenotype, body weight, diet composition, glucose tolerance, resolution of comorbidities, and weight loss 1 year after surgery. Results: This trial is currently open for recruitment. The anticipated completion date is December 2019. Conclusions: The Diet-Induced Alteration of Microbiota and Development of Obesity, NAFLD, and Diabetes study will improve insight into the pathophysiology of obesity and its associated metabolic disorders. Better understanding of weight loss failure and weight regain following bariatric surgery might also behold new therapeutic opportunities for obesity and obesity-related comorbidities. Trial Registration: Netherlands Trial Register NTR5660; https://www.trialregister.nl/trial/5540 (Archived by WebCite at http://www.webcitation.org/78l7jOZre) International Registered Report Identifier (IRRID): DERR1-10.2196/11553

  • JMIR Res Protoc 2019;8(6):e11553

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  Non-randomized Protocols and Methods...

  Jun 18, 2019

  Web-Based Eligibility Quizzes to Verify Opioid Use and County Residence Among Rural Young Adults: Eligibility Screening Results from a Feasibility Study

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  Authors List:

  • April M Ballard  
  • Hannah LF Cooper  
  • April M Young  

  Abstract:

  Background: Web-based methods can be used to collect data from hidden populations, including people who use drugs (PWUD). These methods might be especially advantageous among PWUD in rural areas, where transportation barriers are prevalent, stigma may heighten concerns about confidentiality, and internet access is improving. However, Web-based research with PWUD can be challenging, especially in verifying eligibility. Administering quizzes to verify residential and substance use eligibility could prove valuable in online research among PWUD, yet the utility of this approach is currently unknown. Objective: This study describes the implementation of online eligibility quizzes about the local community to verify residence in the target study area along with drug dose, appearance, and price to verify opioid misuse. Methods: To be eligible, individuals had to live in 1 of 5 eastern Kentucky counties, report using opioids to get high in the past 30 days, and be 18 to 35 years old. Participants recruited from August 2017 to July 2018 were asked questions about their opioid use followed by a quiz about drug dose, appearance, and price to verify substance use eligibility. Residential eligibility was verified with 5-question quizzes assessing knowledge of the county where they reported living. Questions tested knowledge about towns, festivals, and landmarks; local school mascots and colors; and presence of certain retail stores, restaurants, and facilities (eg, jails). A subsample that reported using opioids in the past 24 hours was randomly selected to complete urine drug testing (UDT). Nonparametric tests were performed to explore differences across demographic subgroups. Results: Of the 410 entries assessed for eligibility, 39.3% (161/410) were ineligible as they reported no substance use, being outside the age range, or living outside the study area. Of the remaining 249 who met the eligibility criteria based on age, residency, and opioid misuse, 94.0% (234/249) passed the eligibility quizzes. Among those who passed the heroin quiz, 99.4% (167/168) recognized the image of powdered heroin, 94.6% (159/168) answered the cap size (ie, the purchase unit) question correctly, and 97.0% (163/168) answered the street price question correctly. Among those who passed the drug quiz for prescription opioids, 95% (36/38) answered the dose question correctly, and 82% (31/38) selected the correct image. In a random sample of participants who completed UDT within 3 days of their online screening, 74% (25/34) tested positive for an opioid. Conclusions: This study demonstrated the utility of using online eligibility screening quizzes to verify opioid misuse and residence. Participants accurately recognized heroin and prescription opioid doses, prices, and images and correctly answered questions about features of their county. Online quizzes to screen and enroll PWUD hold promise for future research as an alternative to more time- and resource-intensive approaches that could offset the advantages of Web-based methods. International Registered Report Identifier (IRRID): RR1-10.2196/12984

  • JMIR Res Protoc 2019;8(6):e12984

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  RCTs - Protocols/Proposals (funded,...

  Jun 17, 2019

  Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot...

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  Authors List:

  • Lisa Hynes  
  • Kristine Durkin  
  • Desireé N Williford  
  • Hope Smith  
  • David Skoner  
  • Christa Lilly  
  • Viral Dilip Kothari  
  • Jenny Mc Sharry  
  • Christina L Duncan  

  Abstract:

  Background: Asthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use. However, WAAPs are typically written at a seventh- to ninth-grade reading level, which can be a barrier to young people in understanding their treatment, having confidence in using a WAAP, and engaging with asthma education. Objective: Utilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the Take Action for Asthma Control study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in comparison with a standard WAAP and assess the feasibility and acceptability of the asthma action plan (AAP) intervention and study procedures. The study has 3 aims: (1) estimate the effect sizes of PAAPs compared with WAAPs on outcomes (eg, AAP knowledge and medication adherence), (2) evaluate feasibility and acceptability of AAP intervention and RCT procedures from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. Methods: This feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6 months in duration. At baseline, participants will be randomly assigned to receive a PAAP or WAAP generated for them and reviewed with them by their asthma physician. Study procedures will take place over 4 separate time points: a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point, data will be collected related to the main outcomes: AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up to 60 participants (aged 8-17 years) will be recruited. Feasibility and acceptability data will be collected via one-to-one qualitative interviews with providers involved in the study and a subgroup of families that participate in the study. Results: Recruitment and data collection began in May 2017 and were completed in October 2018. Conclusions: This pilot and feasibility study will test the potential efficacy, feasibility, and acceptability of an AAP intervention and study procedures. The findings will inform the design and delivery of a future definitive trial to assess the efficacy of PAAPs versus WAAPs in supporting asthma self-management among children and adolescents. International Registered Report Identifier (IRRID): DERR1-10.2196/11733

  • JMIR Res Protoc 2019;8(6):e11733

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  Non-Randomized Studies (funded,...

  Jun 13, 2019

  Uniform Noting for International Application of the Tumor-Stroma Ratio as an Easy Diagnostic Tool: Protocol for a Multicenter Prospective Cohort Study

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  Authors List:

  • Marloes Smit  
  • Gabi van Pelt  
  • Annet Roodvoets  
  • Elma Meershoek-Klein Kranenbarg  
  • Hein Putter  
  • Rob Tollenaar  
  • J Han van Krieken  
  • Wilma Mesker  

  Abstract:

  Background: Colon cancer treatment is dependent on the stage at diagnosis. The current Tumor-Node-Metastasis (TNM) staging for the selection of patients for adjuvant chemotherapy needs additional prognostic and predictive biomarkers. Better decision making for chemotherapy will result in reducing over- and undertreatment. We developed a new, easy-to-apply, practice-changing method to select colon cancer patients for adjuvant chemotherapy: the tumor-stroma ratio (TSR). The TSR distinguishes within stage II-III patients who will likely benefit from adjuvant chemotherapy and those who will not. Objective: The aim of the study was to add, in addition to the TNM classification, the TSR to current routine pathology evaluation. Pathologists will be instructed for scoring the TSR in combination with a quality assessment program. An international multicenter study will validate the parameter prospectively. Methods: The study is designed for future implementation of the TSR to the current TNM guidelines, using routinely Haematoxylin- and Eosin-stained tumor tissue sections. In part 1 of the study, an electronic learning (e-learning) module with a quality assessment program using the European Society of Pathology framework will be developed. This module will be used to assess the reliability and reproducibility of the TSR, conducted by national and international pathologists. Part 2 will involve the validation of the TSR in a prospective cohort of colon cancer p-stage II-III patients in a multicenter setting. In total, 1500 patients will be included. Results: The results of part 1 will be expected in the first half of 2019. For part 2, the inclusion of patients in the prospective study, which started at the end of 2018, will take 3 years with an additional follow-up after another 3 years. Conclusions: The main endpoints of this study are as follows: in part 1, trained (international) pathologists who are able to reliably score the TSR, resulting in low intra- and interobserver variation; in part 2, confirmation of significant survival differences for patients with a stroma-high tumor versus patients with a stroma-low tumor. On the basis of these findings, a modification in current treatment guidelines will be suggested. Trial Registration: Netherlands Trial Register NTR7270; https://www.trialregister.nl/trial/7072 International Registered Report Identifier (IRRID): DERR1-10.2196/13464

  • JMIR Res Protoc 2019;8(6):e13464

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  Non-Randomized Study Protocols and...

  Jun 13, 2019

  Aims, Study Design, and Enrollment Results From the Assessing Predictors of Infant Respiratory Syncytial Virus Effects and Severity Study

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  Authors List:

  • Edward E Walsh  
  • Thomas J Mariani  
  • ChinYi Chu  
  • Alex Grier  
  • Steven R Gill  
  • Xing Qiu  
  • Lu Wang  
  • Jeanne Holden-Wiltse  
  • Anthony Corbett  
  • Juilee Thakar  
  • Lauren Benoodt  
  • Matthew N. McCall  
  • David J Topham  
  • Ann R Falsey  
  • Mary T Caserta  

  Abstract:

  Background: The majority of infants hospitalized with primary respiratory syncytial virus (RSV) infection have no obvious risk factors for severe disease. Objective: The aim of this study (Assessing Predictors of Infant RSV Effects and Severity, AsPIRES) was to identify factors associated with severe disease in full-term healthy infants younger than 10 months with primary RSV infection. Methods: RSV infected infants were enrolled from 3 cohorts during consecutive winters from August 2012 to April 2016 in Rochester, New York. A birth cohort was prospectively enrolled and followed through their first winter for development of RSV infection. An outpatient supplemental cohort was enrolled in the emergency department or pediatric offices, and a hospital cohort was enrolled on admission with RSV infection. RSV was diagnosed by reverse transcriptase-polymerase chain reaction. Demographic and clinical data were recorded and samples collected for assays: buccal swab (cytomegalovirus polymerase chain reaction, PCR), nasal swab (RSV qualitative PCR, complete viral gene sequence, 16S ribosomal ribonucleic acid [RNA] amplicon microbiota analysis), nasal wash (chemokine and cytokine assays), nasal brush (nasal respiratory epithelial cell gene expression using RNA sequencing [RNAseq]), and 2 to 3 ml of heparinized blood (flow cytometry, RNAseq analysis of purified cluster of differentiation [CD]4+, CD8+, B cells and natural killer cells, and RSV-specific antibody). Cord blood (RSV-specific antibody) was also collected for the birth cohort. Univariate and multivariate logistic regression will be used for analysis of data using a continuous Global Respiratory Severity Score (GRSS) as the outcome variable. Novel statistical methods will be developed for integration of the large complex datasets. Results: A total of 453 infants were enrolled into the 3 cohorts; 226 in the birth cohort, 60 in the supplemental cohort, and 78 in the hospital cohort. A total of 126 birth cohort infants remained in the study and were evaluated for 150 respiratory illnesses. Of the 60 RSV positive infants in the supplemental cohort, 42 completed the study, whereas all 78 of the RSV positive hospital cohort infants completed the study. A GRSS was calculated for each RSV-infected infant and is being used to analyze each of the complex datasets by correlation with disease severity in univariate and multivariate methods. Conclusions: The AsPIRES study will provide insights into the complex pathogenesis of RSV infection in healthy full-term infants with primary RSV infection. The analysis will allow assessment of multiple factors potentially influencing the severity of RSV infection including the level of RSV specific antibodies, the innate immune response of nasal epithelial cells, the adaptive response by various lymphocyte subsets, the resident airway microbiota, and viral factors. Results of this study will inform disease interventions such as vaccines and antiviral therapies.

  • JMIR Res Protoc 2019;8(6):e12907

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  RCTs - Protocols/Proposals (eHealth)

  Jun 13, 2019

  The Notijoves Project: Protocol for a Randomized Controlled Trial About New Communication Technologies and Gamification to Promote Partner Notification of...

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  Authors List:

  • Dolors Carnicer-Pont  
  • Eva Loureiro-Varela  
  • Josep Mª Manresa  
  • Montse Martinez  
  • Àngels Avecilla-Palau  
  • Laura Montero-Pons  
  • Gemma Falguera-Puig  

  Abstract:

  Background: An increase in sexually transmitted infections (STIs) as well as an increase in the use of new information and communication technologies among young people in Catalonia is the inspiration behind the idea of designing a smartphone app to promote partner notification of STIs. Objective: The main objective of this study is to design a Web-based tool adapted to smartphones for partner notification of STIs among youth who are 16 to 24 years old. Additionally, the objective is to evaluate the Web-based tool’s role in increasing the patient referral partner notification. Methods: This is a multicenter randomized controlled trial with a proportional stratification of the sample by center and random allocation of participants to the 3 arms of the study (simple Web-based intervention, game Web-based intervention, and control). This study is being conducted by midwives, gynecologists, and physicians in the sexual and reproductive areas of the primary health care centers. Results: The primary outcome measure is the number and proportion of partner notifications. Additional outcome measures are the yield of early diagnosis and treatment of those exposed and infected, acceptability, barriers, and preferences for partner notification. Expected results include an increase in the yield of partner notification, early diagnosis and treatment among youth using Web-based interventions compared with those receiving the traditional advice to notify, and a description of sexual networks among those participating in the study. Conclusions: The Notijoves is expected to have a sustainable positive impact in the partner notification practice among youth and contribute to increasing the awareness of STI prevention. International Registered Report Identifier (IRRID): DERR1-10.2196/12896

  • JMIR Res Protoc 2019;8(6):e12896

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  Usage Data and Process Outcomes in...

  Jun 12, 2019

  A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design,...

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  Authors List:

  • Elaine C Khoong  
  • Leah Karliner  
  • Lowell Lo  
  • Marilyn Stebbins  
  • Andrew Robinson  
  • Sarita Pathak  
  • Jasmine Santoyo-Olsson  
  • Rebecca Scherzer  
  • Carmen A Peralta  

  Abstract:

  Background: The diagnosis of chronic kidney disease (CKD) is based on laboratory results easily extracted from electronic health records; therefore, CKD identification and management is an ideal area for targeted electronic decision support efforts. Early CKD management frequently occurs in primary care settings where primary care providers (PCPs) may not implement all the best practices to prevent CKD-related complications. Few previous studies have employed randomized trials to assess a CKD electronic clinical decision support system (eCDSS) that provided recommendations to PCPs tailored to each patient based on laboratory results. Objective: The aim of this study was to report the trial design and implementation experience of a CKD eCDSS in primary care. Methods: This was a 3-arm pragmatic cluster-randomized trial at an academic general internal medicine practice. Eligible patients had 2 previous estimated-glomerular-filtration-rates by serum creatinine (eGFRCr) <60 mL/min/1.73m2 at least 90 days apart. Randomization occurred at the PCP level. For patients of PCPs in either of the 2 intervention arms, the research team ordered triple-marker testing (serum creatinine, serum cystatin-c, and urine albumin-creatinine-ratio) at the beginning of the study period, to be completed when acquiring labs for regular clinical care. The eCDSS launched for PCPs and patients in the intervention arms during a regular PCP visit subsequent to completing the triple-marker testing. The eCDSS delivered individualized guidance on cardiovascular risk-reduction, potassium and proteinuria management, and patient education. Patients in the eCDSS+ arm also received a pharmacist phone call to reinforce CKD-related education. The primary clinical outcome is blood pressure change from baseline at 6 months after the end of the trial, and the main secondary outcome is provider awareness of CKD diagnosis. We also collected process, patient-centered, and implementation outcomes. Results: A multidisciplinary team (primary care internist, nephrologists, pharmacist, and informaticist) designed the eCDSS to integrate into the current clinical workflow. All 81 PCPs contacted agreed to participate and were randomized. Of 995 patients initially eligible by eGFRCr, 413 were excluded per protocol and 58 opted out or withdrew, resulting in 524 patient participants (188 usual care; 165 eCDSS; and 171 eCDSS+). During the 12-month intervention period, 53.0% (178/336) of intervention patient participants completed triple-marker labs. Among these, 138/178 (77.5%) had a PCP appointment after the triple-marker labs resulted; the eCDSS was opened for 73.9% (102/138), with orders or education signed for 81.4% (83/102). Conclusions: Successful integration of an eCDSS into primary care workflows and high eCDSS utilization rates at eligible visits suggest this tailored electronic approach is feasible and has the potential to improve guideline-concordant CKD care. Trial Registration: ClinicalTrials.gov NCT02925962; https://clinicaltrials.gov/ct2/show/NCT02925962 (Archived by WebCite at http://www.webcitation.org/78qpx1mjR) International Registered Report Identifier (IRRID): DERR1-10.2196/14022

  • JMIR Res Protoc 2019;8(6):e14022

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  Wet Lab Protocols and Methods

  Jun 12, 2019

  Stimulation of Nucleotide Oligomerization Domain and Toll-Like Receptors 2 to Enhance the Effect of Bacillus Calmette Guerin Immunization for Prevention of...

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  Authors List:

  • Michael Eisenhut  

  Abstract:

  Background: Bacillus calmette guerin (BCG) immunization has been associated with a reduction in Mycobacterium tuberculosis (MTB) infection. BCG immunization has been shown to enhance innate immunity. This effect of BCG can be explained by an enhancing effect on innate immunity. Objective: This study aimed to test the following hypotheses: (1) BCG immunization can prevent infection with MTB, (2) prevention of infection occurs via stimulation of NOD2 (nucleotide oligomerization domain) and toll-like receptors 2 (TLR2), and (3) the effect of BCG immunization on prevention of infection with MTB can be enhanced by giving stimulators of NOD2 and TLR2. Methods: To detect the influence of immunization on infection rates, the ultralow dose (ULD) infection model is used. The infection rate of mice vaccinated with BCG and exposed after 6 weeks to ULD of MTB and unvaccinated mice are compared via cultures of lung homogenates and interferon (IFN) gamma release assay. If a reduced infection rate by BCG immunization is confirmed, the experiment is repeated by giving BCG combined simultaneously or in time sequence with the enhancers of innate immunity murabutide or beta-glycan. The influence of murabutide or beta-glycan alone on infection rates is investigated. To quantify the contribution of innate immunity levels of tumor necrosis factor, IFN gamma expression, histone H3 K4me3 trimethylation, and concentrations of monocytes with features of activation of innate immunity as defined by the Ly6Chigh as well as CD11b positive phenotype in immunized versus unimmunized infected and uninfected mice in the various immunization protocols is compared. The experiments will be repeated with prior application of the inhibitors of epigenetic programming of innate immunity histone methyltransferase inhibitor 5’-deoxy-5’-methylthio-adenosine and histone acetyl transferase inhibitor epigallocatechin-3-gallate. The influence of BCG on innate immunity is further corroborated by a prospective observational study in human infants. Results: Investigations of derivatives of muramyl dipeptide (MDP) to enhance early immunity in the C57BL/6 mouse strain (mice aged 7 weeks) by another group used 300 micrograms per mouse of oil-associated 6-0-mycoloyl-N-acetylmuramyl-L-alanyl-D-isoglutamine (mycol-MDP) 50/50 mixed with Freund’s incomplete adjuvant. Comparison of colony-forming unit (CFU) count in the lungs 3 weeks after aerosol challenge with Mycobacterium bovis of groups (n=5) between groups receiving mycol-MDP in oil emulsion (see above) versus controls (n=5) showed a significantly lower CFU count of 94.5 x106 (SD 22.0) in cases versus controls with 204.0 X 106 (SD 77.6). It is important to note that after elimination of T-cells in this model, a reduction of CFU in lungs of mice treated with mycol-MDP persisted albeit without statistical significance, which was possibly related to the small number of animals used. Conclusions: Demonstration of a reduction of MTB infection by enhancement of innate immunity could show a new approach to improving vaccine efficacy against this pathogen. International Registered Report Identifier (IRRID): PRR1-10.2196/13045

  • JMIR Res Protoc 2019;8(6):e13045

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