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Smartphone-facilitated Asthma Control (SNAPP)

2020年11月11日 更新者:Donald H Arnold、Vanderbilt University Medical Center

Smartphone-facilitated Medication Notification for Asthma Control in Pediatric Patients (SNAPP) Pilot Study

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.

研究概览

详细说明

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.

研究类型

介入性

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 11年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  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:

  • 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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:控制
控制组
Asthma teaching
其他名称:
  • Asthma teaching
实验性的:Smartphone Asthma Control
Asthma teaching
其他名称:
  • Asthma teaching
Smartphone Asthma Control
其他名称:
  • SNAPP

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Childhood asthma control test
大体时间:6 months
Measurement of change of C-ACT at 6 months.
6 months

次要结果测量

结果测量
措施说明
大体时间
Fractional excretion of exhaled nitric oxide
大体时间:6 months
Measurement of change of FeNO at 6 months.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Donald H Arnold, MD, MPH、Vanderbilt University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年12月3日

初级完成 (预期的)

2025年3月1日

研究完成 (预期的)

2025年4月1日

研究注册日期

首次提交

2014年7月28日

首先提交符合 QC 标准的

2014年7月30日

首次发布 (估计)

2014年7月31日

研究记录更新

最后更新发布 (实际的)

2020年11月13日

上次提交的符合 QC 标准的更新

2020年11月11日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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