PackHealth: Asthma Engagement Tool
Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
調査の概要
詳細な説明
Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.
The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials
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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North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke Asthma Allergy and Airway Center
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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:
- Patients with a physician diagnosis of asthma for at least the previous 12 months.
- Asthma that is not well controlled by NAEPP guidelines.
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
- Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
- A diagnosis of cancer with ongoing treatment.
- Any terminal illness or conditions that results in a life expectancy less than one year.
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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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他の：Asthma Patients
Patient engagement toolkit
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Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients.
These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care
|
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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Rate of Asthma Exacerbations
時間枠：12 weeks prior to baseline
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The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
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12 weeks prior to baseline
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Rate of Asthma Exacerbations
時間枠：baseline to week 13
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The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
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baseline to week 13
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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 |
|---|---|---|
|
Change in Asthma Control
時間枠：baseline, 13 weeks
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Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma.
The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
5 items with 4-week recall.
The score range is 5-25 with >19 representing good control and <18 representing poor control.
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baseline, 13 weeks
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Change in Asthma Symptoms
時間枠：baseline, 13 weeks
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Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall. Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09 |
baseline, 13 weeks
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Change in Pulmonary Function Tests
時間枠：baseline, 13 weeks
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Measured by spirometry.
We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters.
FEV1 is a measure of airflow obstruction.
The change in lung function is the change in these measurements compared to baseline.
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baseline, 13 weeks
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Number of Emergency Department and Hospitalization Visits
時間枠：Prior Year
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Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
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Prior Year
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Number of Emergency Department and Hospitalization Visits
時間枠：13 weeks
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Number of emergency department and hospitalization visits will be recorded
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13 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Njira Lugogo, MD、Duke University
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。
Patient engagement toolkitの臨床試験
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University of BaselNational Cancer Center, Korea; University Hospital, Geneva; Swiss National Science Foundation; University... と他の協力者完了
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Jewish General HospitalUniversity of Manitoba; McGill University Health Centre/Research Institute of the McGill University... と他の協力者完了
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Chinese University of Hong Kongまだ募集していません
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University of MichiganThe Craig H. Neilsen Foundation完了
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Imperial College Healthcare NHS Trust完了
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VU University of AmsterdamUniversity of Copenhagen; University Hospital Heidelberg; World Health Organization募集