Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Rate of Asthma Exacerbations
研究概览
简要总结
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Rate of Asthma Exacerbations
时间窗: baseline to week 13
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
次要结局
- Change in Asthma Control(baseline, 13 weeks)
- Change in Pulmonary Function Tests(baseline, 13 weeks)
- Number of Emergency Department and Hospitalization Visits(13 weeks)
- Change in Asthma Symptoms(baseline, 13 weeks)