Smartphone-facilitated Asthma Control (SNAPP)
Smartphone-facilitated Medication Notification for Asthma Control in Pediatric Patients (SNAPP) Pilot Study
調査の概要
詳細な説明
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.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt Children's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- TennCare Medicaid insurance, and an acute exacerbation (45% of our ED patients with acute asthma, section C.11.)
- 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.
- 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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:コントロール
対照群
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Asthma teaching
他の名前:
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実験的:Smartphone Asthma Control
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Asthma teaching
他の名前:
Smartphone Asthma Control
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Childhood asthma control test
時間枠:6 months
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Measurement of change of C-ACT at 6 months.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fractional excretion of exhaled nitric oxide
時間枠:6 months
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Measurement of change of FeNO at 6 months.
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6 months
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協力者と研究者
協力者
捜査官
- 主任研究者:Donald H Arnold, MD, MPH、Vanderbilt University
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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