The objective of this protocol is to pilot an innovative approach to medication adherence to determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence, a critical gap in improving the health of children with asthma. SNAPP incorporates monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS medication adherence and that the investigators believe will influence the child's future independence and chronic disease-management skills.
Full Title of Study: “Smartphone-facilitated Medication Notification for Asthma Control in Pediatric Patients (SNAPP) Pilot Study”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: March 2025
The objective of this protocol is to pilot an innovative approach to medication adherence to determine if such an approach will improve inhaled corticosteroid (ICS) medication adherence, a critical gap in improving the health of children with asthma.
Acute asthma exacerbations occur yearly in almost 60% of children with asthma. They are the most frequent reason for childhood hospitalization and the most expensive component of pediatric asthma care in the U.S. Exacerbations impair quality of life and disproportionately affect African-American children, children with Medicaid insurance, and the poor. Up to 70% of exacerbations are preventable if guideline-recommended inhaled corticosteroid (ICS) medication adherence is achieved. However, ICS medication adherence in children with persistent asthma is dismal at only 11 – 18%. Amongst children with Medicaid insurance prescribed ICS, 63% discontinue the medication within 90 days. As a healthcare system, investigators have been unable to meaningfully improve ICS medication adherence in a cost-efficient way for patients with asthma, and particularly for the high-risk, highest-potential population of children with moderate or severe persistent asthma. These children suffer the greatest morbidity and mortality from asthma yet have highest-potential to benefit from improved ICS medication adherence. There is an urgent need for an efficacious adherence intervention for this population because, without it, these children will continue to experience impaired health and disproportionate morbidity.
The investigators' long-term objective is to identify and disseminate an intervention that will minimize the occurrence and severity of exacerbations in this population. The overall objective of this pilot study is to test the feasibility of Smartphone-facilitated medication Notification for Asthma Control in Pediatric Patients (SNAPP) using a wireless medication monitor (WMM) and smartphone application that provides parents reminders for administration of ICS medication, real-time feedback on preventive and controller medication adherence, and wireless upload of this data to a secure online database. The central hypothesis is that for children in this population, SNAPP will result in >=25% improved Asthma Control Test (ACT) scores in comparison with usual management. Secondary hypotheses are that the intervention will result in a >= 30% decrease in FeNO in comparison with usual care at 6 months and >=40% increase in ICS medication adherence at 6 months. The central hypothesis has been formulated on the basis of reports that parents of children with acute exacerbations continue to have insufficient knowledge of asthma self-management yet are motivated to do what is best for their child. SNAPP incorporates monitoring, reminders, and dynamic feedback through a smartphone that will improve ICS medication adherence and that will influence the child's future independence and chronic disease-management skills. Importantly, the investigators will use wireless medication monitors to accurately and objectively ascertain ICS medication adherence without patient effort. Parents are facile with and use wireless technology to organize their daily activities and for communicating. Incorporating this technology into health care and medication adherence is a logical next-step.
The investigators propose to test the hypotheses through the following Aim: To determine whether SNAPP meaningfully improves 6-month asthma control measured with the Asthma Control Test, airway inflammation measured using exhaled nitric oxide and ICS adherence compared with usual care, in an RCT of children with moderate or severe persistent asthma.
- Behavioral: Asthma teaching in ER
- Asthma teaching
- Behavioral: Smartphone Asthma Control
- Smartphone Asthma Control
Arms, Groups and Cohorts
- Experimental: Smartphone Asthma Control
- Smartphone Asthma Control
- Active Comparator: Control
- Control group
Clinical Trial Outcome Measures
- Childhood asthma control test
- Time Frame: 6 months
- Measurement of change of C-ACT at 6 months.
- Fractional excretion of exhaled nitric oxide
- Time Frame: 6 months
- Measurement of change of FeNO at 6 months.
Participating in This Clinical Trial
1. TennCare Medicaid insurance, and an acute exacerbation (45% of our ED patients with acute asthma, section C.11.)
2. Parent has a smartphone and wireless account that they agree to use for this study (if randomized to intervention group), anticipated residence in the Nashville Metropolitan Service Area for at least 12 months, willingness to participate in phone-based (wireless or landline) ACT-scoring monthly, and willingness to return at 3, 6 and 12 months for FeNO testing.
3. The participant's PCP agrees that patient has moderate or severe persistent asthma and should be on ICS for at least the subsequent 12 months in accordance with NIH-NAEPP expert panel guidelines.87,88
Exclusion criteria include prior study enrollment, other medical condition contributing to respiratory distress (e.g., pneumonia, cystic fibrosis) or other diseases that may necessitate treatment with systemic corticosteroid (CCS; e.g., nephrotic syndrome).
Gender Eligibility: All
Minimum Age: 4 Years
Maximum Age: 11 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Vanderbilt University Medical Center
- Aerocrine AB
- Provider of Information About this Clinical Study
- Principal Investigator: Donald H Arnold, Associate Professor of Pediatrics and Emergency Medicine – Vanderbilt University Medical Center
- Overall Official(s)
- Donald H Arnold, MD, MPH, Principal Investigator, Vanderbilt University
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