Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02205723
Study type Interventional
Source Vanderbilt University Medical Center
Contact
Status Withdrawn
Phase N/A
Start date December 3, 2021
Completion date April 2025

See also
  Status Clinical Trial Phase
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT05066841 - Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children N/A
Not yet recruiting NCT05105386 - The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing
Completed NCT01450774 - Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children Phase 3
Completed NCT05390554 - Using Buteyko Breathing Technique to Control Asthma in School-Age Children N/A
Active, not recruiting NCT04089085 - STRONGer Together: A Small Group Intervention for Children With Asthma and Anxiety/Depression N/A
Completed NCT03304067 - Asthma Control Study N/A
Completed NCT02451709 - STudy of Asthma Adherence Reminders N/A
Withdrawn NCT01451944 - Effect of Home Health Case Management on Asthma Morbidity N/A
Completed NCT00204828 - T Regulatory and Childhood Asthma
Completed NCT01472471 - Urinary 8-isoprostane is Elevated in Acute Childhood Asthma N/A
Completed NCT03278561 - General Risk Factors and Inflammatory Determinants in Older Patients With Asthma
Completed NCT02702687 - Childhood Asthma Perception Study N/A
Completed NCT03514485 - West Philadelphia Controls Asthma N/A
Not yet recruiting NCT02678949 - Changes in the Lung Clearance Index in Pediatric Patients With Asthma N/A
Completed NCT02404103 - Flunisolide HFA in Children With Small Airway Disease N/A
Completed NCT02341573 - Experienced Chinese Herbal Formulas on Pediatric Asthma N/A
Completed NCT03481673 - COPE for Children With Asthma: Intervention for Children With Asthma N/A
Recruiting NCT04250779 - Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence Early Phase 1
Completed NCT03696602 - More Relaxation by Deep Breath on Methacholine