PackHealth: Asthma Engagement Tool
Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27705
- Duke Asthma Allergy and Airway Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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
|
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 |
|---|---|---|
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Rate of Asthma Exacerbations
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Asthma Control
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Njira Lugogo, MD、Duke University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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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