Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02205723 |
| Other study ID # |
IRB 140934 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2021 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
November 2020 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
