Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)
Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
調査の概要
状態
条件
詳細な説明
Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).
The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Health System
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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:
- 13-19 years of age
- Must be able to provide electronic assent and have consent from a parent/guardian if applicable
Diagnosis of asthma by meeting one of the following criteria within the last 12 months:
- At least one emergency department diagnosis of asthma or
- At least one acute inpatient encounter with asthma as the principal diagnosis or
- At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
- At least four asthma medications dispensed
Exclusion Criteria:
- Inability to provide informed consent/assent
- Lack of physician diagnosis of asthma
- Other co-morbidities that make it impossible for the individual to participate.
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：他の
- 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 |
|---|---|
|
実験的：Tailored asthma management program
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
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Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.
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アクティブコンパレータ：Control
Teens in the control group will receive generic, web-based asthma education.
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Web-based, generic asthma management intervention delivered in 4 sessions.
|
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 |
|---|---|---|
|
Asthma Control Test (ACT)
時間枠：12 Months
|
Comparison of ACT scores at 12 months after the randomization
|
12 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Asthma Exacerbations/Functional Status
時間枠：12 Months
|
Comparison of asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing)and functional status(e.g.
self report of symptom-days, symptom nights, days of restricted activity, school/work days missed) at 12 months after randomization.
|
12 Months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Cost
時間枠：Up to 12 months
|
The cost of study intervention will be evaluated: The cost for participant enrollment with Electronic Medical Record (EMR) initiation; data collection and management with/o EMR initiation including assessing the reliability of EMR clinical outcomes/primary endpoints, compared to chart abstraction.
|
Up to 12 months
|
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The Cost Effectiveness
時間枠：Up to 12 months
|
The cost effectiveness of Puff City intervention compared to controls without study intervention.
|
Up to 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Christine Joseph, PhD、Henry Ford Health System
- 主任研究者：Mei Lu, PhD、Henry Ford Health System
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。