Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)
Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents
調査の概要
詳細な説明
Asthma that has persisted in adolescents is likely to persist into adulthood. For 25-30% of Americans, adolescence is also the period at which they experience their greatest weight gain, particularly as they approach the final stages of puberty. Asthma management may be more of a challenge in the overweight adolescent compared to a normal weight youth. Asthma related morbidity is increased in overweight patients, reflected in higher health care utilization for this subgroup. Little guidance is given to physicians caring for obese adolescents with asthma, but findings suggest that interventions designated to achieve control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g. low self-esteem, depression and low quality of life) successful interventions should incorporate a patient-centered approach.
Patient-centered care (or patient focused care) involves a partnership between the patient and the physician, shared discussion making, as well as productive communication and health promotion. The objective of this project is to collect the information necessary to develop a tailored discussion guide for use by the physician caring for the obese teen with asthma. Project results will provide an evidence base for the development and evaluation of additional patient-centered health interventions for obese adolescents with asthma. The investigators will conduct this study among patients whom eligibility can be determined using the electronic medical record (EMR). The specific aims of this proposal are to:
Qualitatively collect information on outcomes important to obese adolescents with asthma:
Create a tailored discussion guide that incorporates patient preferences and treatment goals that can be used by providers caring for overweight adolescents with asthma:
Conduct a randomized trial to determine if patient-centered and clinical outcomes improve for patients whose physicians use the tailored discussion guide compared to those who do not.
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
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford 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:
- BMI >85th Percentile & Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:
- At least one emergency department visit with a principal diagnosis of asthma, or
- At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or
- At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or
- At least four asthma medications dispensed in the last 12 month
Exclusion Criteria:
- Does not meet eligibility criteria for weight and/or asthma;
- Currently enrolled in another investigational asthma management /education/weight management trial.
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 |
|---|---|
|
他の：Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.
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Teens in the control group will receive standard or usual care as provided by their physician.
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他の：Intervention
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
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Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
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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 |
|---|---|---|
|
Asthma Control Test
時間枠：12 months of enrollment
|
A validated measure of asthma control
|
12 months of enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Mass Index (BMI)
時間枠：12 months of enrollment
|
changes in participant weight
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12 months of enrollment
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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
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。
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