Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial.

BACKGROUND: Acute viral bronchiolitis is the most common reason for hospitalization of infants in the USA. Infants hospitalized for bronchiolitis are at high risk for recurrent respiratory symptoms and wheeze in the subsequent year, and longer-term adverse respiratory outcomes such as persistent childhood asthma. There are no effective secondary prevention strategies. Multiple factors, including air pollutant exposure, contribute to risk of adverse respiratory outcomes in these infants. Improvement in indoor air quality following hospitalization for bronchiolitis may be a prevention opportunity to reduce symptom burden. Use of stand-alone high efficiency particulate air (HEPA) filtration units is a simple method to reduce particulate matter ≤ 2.5 µm in diameter (PM2.5), a common component of household air pollution that is strongly linked to health effects. METHODS: BREATHE is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children < 12 months of age hospitalized for the first time with bronchiolitis will participate. Children will be randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child's sleep space and a common room) or to a control group with units that do not contain HEPA and carbon filters. The primary objective is to determine if use of HEPA filtration units reduces respiratory symptom burden for 24 weeks compared to use of control units. Secondary objectives are to assess the efficacy of the HEPA intervention relative to control on (1) number of unscheduled healthcare visits for respiratory complaints, (2) child quality of life, and (3) average PM2.5 levels in the home. DISCUSSION: We propose to test the use of HEPA filtration to improve indoor air quality as a strategy to reduce post-bronchiolitis respiratory symptom burden in at-risk infants with severe bronchiolitis. If the intervention proves successful, this trial will support use of HEPA filtration for children with bronchiolitis to reduce respiratory symptom burden following hospitalization. TRIAL REGISTRATION: NCT05615870. Registered on November 14, 2022.

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUP): a randomized, controlled trial.

Background: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. Methods: Custodial parents/caregivers with ≥1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. Discussion: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine-uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. Clinical Trials Registration: Name of the registry: clinicaltrials.gov Trial registration number: NCT05386355 Date of registration: May 23, 2022 URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT05386355.

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial.

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. METHODS: Custodial parents/caregivers with ≥ 1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥ 1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. DISCUSSION: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT05386355 . Registered on May 23, 2022.

Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures.

Background/Objective: Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods: The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation. Results: All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources. Conclusion: Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.

Analysis of Professional Competencies for the Clinical Research Data Management Profession.

OBJECTIVE: This job analysis was conducted to compare, assess and refine the competencies of the clinical research data management profession. MATERIALS AND METHODS: Two questionnaires were administered in 2015 and 2018 to collect information from data managers on professional competencies, types of data managed, types of studies supported, and necessary foundational knowledge. RESULTS: In 2018 survey, 67 professional competencies were identified. Job tasks differed between early- to mid-career and mid- to late-career practitioners. A large variation in the types of studies conducted and variation in the data managed by the participants was observed. DISCUSSION: Clinical research data managers managed different types of data with variety of research settings, which indicated a need for training in methods and concepts that could be applied across therapeutic areas and types of data. CONCLUSION: The competency survey reported here serves as the foundation for the upcoming revision of the Certified Clinical Data Manager (CCDMTM) exam.