Transitioning a Research Protocol for Videosomnography to Assess Sleep and Nighttime Caregiving Activities in School-Aged Children With Developmental Disabilities During the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic significantly affected children with developmental disabilities (DDs)' sleep. Videosomnography is a noninvasive, portable time-lapse video recording system to objectively obtain a child's sleep-wake behaviors and parents' caregiving activities in a natural environment. METHOD: From September 2020 to February 2021, we conducted a feasibility study using actigraphy (in mothers) and videosomnography in children with DDs for seven consecutive nights to assess sleep and nighttime caregiving activities. Because of the pandemic, we developed and implemented alternative data collection strategies, such as delivering a "study package" with easy-to-follow written instructions and emailed video-recorded instructions on recording a child's sleep. RESULTS: We aimed to enroll 10 mothers and 10 school-aged children with DDs and achieved this goal. Nine out of 10 mothers completed video recordings of their child's sleep, with only 10% missing data for videosomnography. DISCUSSION: This paper shared adaptations to our videosomnography protocol and lessons learned.

Evaluation of the impact of COVID-19 in people coinfected with HIV and/or tuberculosis in low-income countries: study protocol for mixed methods research in Burkina Faso.

BACKGROUND: An issue of particular concern is the impact of the 2019 novel coronavirus (2019 nCOV) on the people coinfected with the Human Immuno-deficiency Virus (HIV) and/or tuberculosis (TB). Unfortunately, this interaction has not been well explored in African despite the large proportion of these risk populations living with HIV and/or patients and/or tuberculosis (TB) in the African region. This study aims to design a research protocol for assessment of the impact of coronavirus disease 2019 (COVID-19) on these risk populations in response to COVID-19 strategic plans in Burkina Faso by generating serological, epidemiological, virological, clinical and socio-anthropological evidence-based data. METHODS: A multidisciplinary research will be conducted in the city of Bobo-Dioulasso, Burkina Faso using mixed methods. Data will be collected from a cohort of people living with HIV and/or TB patients in the city (i) to determine the proportion of people with specific antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using retrospective data ; (ii) to determine the proportion of people infected with Covid-19 and the dynamics of viral loads and antibodies in these people based on prospective data; (iii) to identify circulating SARS-COV-2 variants and novel biomarkers using prospective data ; (iv) to analyze perceptions, community experiences and response strategies during the public health emergencies imposed by COVID-19 through a qualitative study. DISCUSSION: This study will generate factual and comprehensive data that will contribute in improving response strategies to COVID-19 and the other possible emerging diseases with keen interest on the risk populations living with HIV and/or TB infected patients.

Developing a toolkit to improve resident and family engagement in the safety of assisted living: Engage-A stakeholder-engaged research protocol.

Assisted living (AL) communities are experiencing rising levels of resident acuity, challenging efforts to balance person-centered care-which prioritizes personhood, autonomy, and relationship-based care practices-with efforts to keep residents safe. Safety is a broad-scale problem in AL that encompasses care concerns (e.g., abuse/neglect, medication errors, inadequate staffing, and infection management) as well as resident issues (e.g., falls, elopement, and medical emergencies). Person and family engagement (PFE) is one approach to achieving a balance between person-centered care and safety. In other settings, PFE interventions have improved patient care processes, outcomes, and experiences. In this paper, we describe the protocol for a multiple methods AHRQ-funded study (Engage) to develop a toolkit for increasing resident and family engagement in AL safety. The study aims are to engage AL residents and family caregivers, AL staff, and other AL stakeholders to (1) identify common AL safety problems; (2) prioritize safety problems and identify and evaluate existing PFE interventions with the potential to address safety problems in the AL setting; and (3) develop a testable toolkit to improve PFE in AL safety. We discuss our methods, including qualitative interviews, a scoping review of existing PFE interventions, and stakeholder panel meetings that involved a Delphi priority-setting exercise. In addition to describing the protocol, we detail how we modified the protocol to address the unique challenges of the COVID-19 pandemic. Study findings will result in a toolkit to improve resident and family engagement in the safety of AL that will be tested in future research.

Running an active gaming-based randomized controlled trial during the COVID-19 pandemic: Challenges, solutions and lessons learned.

Objectives: The COVID-19 pandemic has created significant obstacles for clinical trials and human subject research. This paper discusses the challenges our study team encountered while implementing an eHealth intervention during the pandemic, including: increased dropout, cancellation and rescheduling rates, increased mailing returns and delays, social distancing impediments, COVID-19 positive team members, and restricted training access. Study design: This is a short paper on research protocol for a six-month randomized controlled single-blind trial. Methods: N/A. Results: In response to these challenges, we changed the study protocol. We included multimodal communication models, amplified recruitment efforts, expanded our population's age range, increasingly utilized tracking labels, utilized external space for extra participants, and transitioned to a virtual RA training format. Conclusions: Sharing our experience and the adaptations required to run a clinical trial during the pandemic should provide useful and practical knowledge for institutions, funding agencies, and researchers. We believe that the lessons learned here would be applicable to future clinical trial research after the pandemic as well.

Constraints, effectiveness and solutions in using Google Classroom as a Learning Management System during Covid-19 pandemic: A systematic literature review

The purpose of this paper is to determine the impact of using Google Classroom as an educational tool during pandemic of Covid-19. This research is a meta-analysis study based on the search for several articles from newspapers and conferences that fit within the search string and the research protocol. From the selection and extraction of articles that fit within the research protocol, the accepted articles were classified considering the criteria of effectiveness, limitations and challenges and the solutions adopted by the educational stakeholders during the pandemic. Among the results found, we can highlight that the Google Classroom tool has good usability, the mobile application facilitates communication and interaction between hyperlinks. Among the limitations of the use of the tool during the pandemic, the internet quota or connection quality, or the impossibility of downloading large files, stand out. The solutions presented were to reduce the size of files and the good preparation of students and teachers in using this tool. © 2021 IEEE.

Clustered randomized controlled trial protocol of a Mobility-as-a-Service app for College campuses

This paper presents a protocol for a clustered, randomized controlled trial (RCT) in transportation planning. RCTs are still unusual in transportation planning, and this is the first RCT transportation protocol we are aware of seeking publication in a peer-reviewed journal. The trial tests a mobility-as-a-service app aimed at shifting mode choice to campus among an intervention student population while also tracking in parallel the mode choices of the control group. The concept behind the intervention is to leverage information and marketing to shift students' intentions relative to their travel to campus, following Azjen’s Theory of Planned Behavior. The app, which is custom developed under the guidance of the research team, facilitates students' trips to campus by transit, biking, walking, and ride-hailing. An intended secondary outcome of the intervention is improved academic outcomes among students in the intervention group. The research team developed the protocol through a literature review of campus-based travel demand management measures, then by vetting a draft protocol with an expert panel, and then through a series of survey pilots. The advent of COVID- 19 in the middle of the research project demonstrated the challenges of planning a real-world RCT where researchers have limited ability to control exogenous factors.

Heart up! RCT protocol to increase physical activity in cardiac patients who report hopelessness: Amended for the COVID-19 pandemic.

Hopelessness is associated with decreased physical activity (PA) and increased adverse events and death in patients with ischemic heart disease (IHD). Rates of PA in patients with IHD continue to be low in both hospital-based cardiac rehabilitation and home settings. While researchers have investigated strategies to increase PA among patients with IHD, interventions to promote PA specifically in IHD patients who report hopelessness are lacking. We describe the protocol for a NIH-funded randomized controlled trial designed to establish the effectiveness of a 6-week intervention (Heart Up!) to promote increased PA in IHD patients who report hopelessness. Participants (n = 225) are randomized to one of three groups: (1) motivational social support (MSS) from a nurse, (2) MSS from a nurse plus significant other support (SOS), or (3) attention control. Aims are to: (1) test the effectiveness of 6 weeks of MSS and MSS with SOS on increasing mean minutes per day of moderate to vigorous PA; (2) determine the effects of change in moderate to vigorous PA on hopelessness; and (3) determine if perceived social support and motivation (exercise self-regulation) mediate the effects of the intervention on PA. A total of 69 participants have been enrolled to date. The protocol has been consistently and accurately used by research personnel. We address the protocol challenges presented by the COVID-19 pandemic and steps taken to maintain fidelity to the intervention. Findings from this study could transform care for IHD patients who report hopelessness by promoting self-management of important PA goals that can contribute to better health outcomes.

Massachusetts Justice Community Opioid Innovation Network (MassJCOIN).

A major driver of the U.S. opioid crisis is limited access to effective medications for opioid use disorder (MOUD) that reduce overdose risks. Traditionally, jails and prisons in the U.S. have not initiated or maintained MOUD for incarcerated individuals with OUD prior to their return to the community, which places them at high risk for fatal overdose. A 2018 law (Chapter 208) made Massachusetts (MA) the first state to mandate that five county jails deliver all FDA-approved MOUDs (naltrexone [NTX], buprenorphine [BUP], and methadone). Chapter 208 established a 4-year pilot program to expand access to all FDA-approved forms of MOUD at five jails, with two more MA jails voluntarily joining this initiative. The law stipulates that MOUD be continued for individuals receiving it prior to detention and be initiated prior to release among sentenced individuals where appropriate. The jails must also facilitate continuation of MOUD in the community on release. The Massachusetts Justice Community Opioid Innovation Network (MassJCOIN) partnered with these seven diverse jails, the MA Department of Public Health, and community treatment providers to conduct a Type 1 hybrid effectiveness-implementation study of Chapter 208. We will: (1) Perform a longitudinal treatment outcome study among incarcerated individuals with OUD who receive NTX, BUP, methadone, or no MOUD in jail to examine postrelease MOUD initiation, engagement, and retention, as well as fatal and nonfatal opioid overdose and recidivism; (2) Conduct an implementation study to understand systemic and contextual factors that facilitate and impede delivery of MOUDs in jail and community care coordination, and strategies that optimize MOUD delivery in jail and for coordinating care with community partners; (3) Calculate the cost to the correctional system of implementing MOUD in jail, and conduct an economic evaluation from state policy-maker and societal perspectives to compare the value of MOUD prior to release from jail to no MOUD among matched controls. MassJCOIN made significant progress during its first six months until the COVID-19 pandemic began in March 2020. Participating jail sites restricted access for nonessential personnel, established other COVID-19 mitigation policies, and modified MOUD programming. MassJCOIN adapted research activities to this new reality in an effort to document and account for the impacts of COVID-19 in relation to each aim. The goal remains to produce findings with direct implications for policy and practice for OUD in criminal justice settings.