Caregiver Perceptions of Change in Pediatric Asthma Control During the COVID-19 Pandemic.

Purpose: Although several indicators suggest that pediatric asthma control in the United States improved early in the pandemic, other indicators suggest not. Missing are reports from caregivers of the experiences of their children with asthma early in the pandemic. Methods: Using the PP-ACT and other measures that we specifically constructed for our research, we conducted a cross-sectional national survey of US caregivers of children with asthma (N=595) to examine perceived change in their child's asthma control and changes in reports of ED visits and use of emergency relief medicine and controller medicine pre-pandemic (January to March 2020) versus early-pandemic (June to September 2020). Results: Caregivers fell into three groups: most caregivers perceived that their child's asthma control was improved (50.3%) or unchanged (41.2%), and few reported worse control (8.5%). Surprisingly, all three groups of caregivers reported similar frequencies of early-pandemic and pre-pandemic ED visits and use of emergency relief medicine. Also surprising, caregivers who perceived their child's asthma as more controlled (compared with the other two groups) reported more frequent ED visits and use of emergency relief medicine, yet also more use of controller medicine at both early-pandemic and pre-pandemic. Conclusion: The mismatch between caregivers' perceptions of their child's early-pandemic asthma control and their reports of ED visits and use of emergency relief medicine suggests that caregivers may rely on a gist (a global evaluation that can include nonbiomedical evidence) when estimating their child's asthma control. Caregivers and their families could benefit from help from clinicians in understanding the discrepancy between subjective asthma control and asthma control indicators and in understanding what well-controlled asthma looks and feels like.

AIM2ACT: Randomized controlled trial protocol for a mobile health intervention for early adolescents with asthma.

Early adolescents diagnosed with asthma have difficulties consistently performing disease self-management behaviors, placing them at-risk for poor asthma control, morbidity, and reduced quality of life. Helpful caregiver support is pivotal in determining whether early adolescents develop and master asthma self-management behaviors. We developed Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT), a mobile health intervention to facilitate helpful caregiver support in early adolescents (12-15 year-olds) with poorly controlled asthma. AIM2ACT is a dyadic smartphone intervention that contains three components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of skills training videos. This paper describes our plans to test the efficacy of AIM2ACT and evaluate long-term maintenance of treatment effects in a fully powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver. Families will be randomly assigned to receive AIM2ACT (n = 80) or a mHealth attention control condition (n = 80) that accounts for attention and novelty of a technology-based intervention for 6 months. Assessments will occur at baseline, post-intervention, and 3-, 6-, and 12-month follow-up time points. We will collect patient-reported and objectively monitored (e.g., spirometry, adherence) outcomes. Given the timing of the trial, a secondary exploratory goal is to evaluate the perceived impact of COVID-19 on family functioning and parental control of their adolescent's asthma in the context of our intervention.

A Stress and Pain Self-management mHealth App for Adult Outpatients With Sickle Cell Disease: Protocol for a Randomized Controlled Study.

BACKGROUND: This paper describes the research protocol for a randomized controlled trial of a self-management intervention for adults diagnosed with sickle cell disease (SCD). People living with SCD experience lifelong recurrent episodes of acute and chronic pain, which are exacerbated by stress. OBJECTIVE: This study aims to decrease stress and improve SCD pain control with reduced opioid use through an intervention with self-management relaxation exercises, named You Cope, We Support (YCWS). Building on our previous findings from formative studies, this study is designed to test the efficacy of YCWS on stress intensity, pain intensity, and opioid use in adults with SCD. METHODS: A randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on stress, pain, and opioid use will be conducted with 170 adults with SCD. Patients will be randomized based on 1:1 ratio (stratified on pain intensity [≤5 or >5]) to be either in the experimental (self-monitoring of outcomes, alerts or reminders, and use of YCWS [relaxation and distraction exercises and support]) or control (self-monitoring of outcomes and alerts or reminders) group. Patients will be asked to report outcomes daily. During weeks 1 to 8, patients in both groups will receive system-generated alerts or reminders via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the participant does not enter data after 24 hours, the study support staff will contact them for data entry troubleshooting (both groups) and YCWS use (experimental). We will time stamp and track patients' web-based activities to understand the study context and conduct exit interviews on the acceptability of system-generated and staff support. This study was approved by our institutional review board. RESULTS: This study was funded by the National Institute of Nursing Research of the National Institutes of Health in 2020. The study began in March 2021 and will be completed in June 2025. As of April 2022, we have enrolled 45.9% (78/170) of patients. We will analyze the data using mixed effects regression models (short term and long term) to account for the repeated measurements over time and use machine learning to construct and evaluate prediction models. Owing to the COVID-19 pandemic, the study was modified to allow for mail-in consent process, internet-based consent process via email or Zoom videoconference, devices delivered by FedEx, and training via Zoom videoconference. CONCLUSIONS: We expect the intervention group to report reductions in pain intensity (primary outcome; 0-10 scale) and in stress intensity (0-10 scale) and opioid use (Wisepill event medication monitoring system), which are secondary outcomes. Our study will contribute to advancing the use of nonopioid therapy such as guided relaxation and distraction techniques for managing SCD pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT04484272; https://clinicaltrials.gov/ct2/show/NCT04484272. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/33818.