AMAZE™ Asthma Implementation Quality Improvement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Clinician Dashboard Usage
研究概览
简要总结
The primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the AMAZE™ platform into clinical practice.
详细描述
AstraZeneca has developed the AMAZE™ disease management platform to be used across multiple disease indications to provide a unified experience for the management of patients throughout their patient care journey. AMAZE™ integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. Implementation of AMAZE™ within clinical practice has not yet been evaluated. The results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •>18 years of age at the time of enrollment
- •Clinically confirmed diagnosis of asthma
- •Access to a smartphone with internet access with the following requirements: iOS (Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android (Operating System 8.0 or newer)
- •Able to understand and speak English sufficiently to be able to use the AMAZE™ patient App
- •Willingness to participate in a telephone interview and be audio-recorded
- •Consenting to participate in the study
排除标准
- •Current diagnosis of active chronic obstructive pulmonary disease (COPD) or any pulmonary diagnosis other than asthma;
- •Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the ACT™
结局指标
主要结局
Clinician Dashboard Usage
时间窗: Up to 6 months
Clinician dashboard usage will be measured as the mean number of days per week/month that the clinical site staff accessed the AMAZE™ dashboard over the 6-month period.
Symptoms and Triggers
时间窗: Up to 6 months
Frequency of symptoms and frequency of triggers (for those that reported symptoms) reported on the app will be described weekly during Months 1, and then per month from Month 1 through Month 6 pending availability of data after Month 1.
Patient App Usage
时间窗: Up to 6 months
Patient app usage will be measured as the number of days the patient engages (i.e., completes daily log, sends a message) with the app at least once a day during the study period.
Self-Reported Rescue Medication usage
时间窗: Up to 6 months
The number of times per month a patient used rescue medication as well as visited the emergency room or urgent care as reported on the app will be described from Month 1 through Month 6.
Daily Asthma status
时间窗: Up to 6 months
Patient daily asthma status (bad, okay, good) reported on the app will be described weekly during Month 1, and then per month from Month 1 through Month 6 pending availability of data after Month 1.
次要结局
- ER visits and Hospitalization avoidance(Up to 6 months)
- Patient Perception of Usability and Design of Mobile app(Up to 6 months)
- Clinical Staff Perception of Usability and Design of Dashboard(Up to 6 months)
- Evaluate ease of implementation of AMAZE™ in clinical setting(Up to 6 months)
- Evaluate Perceived Benefit of AMAZE™ in clinical setting(Up to 6 months)
- Impact of AMAZE™ on patient visits(Up to 6 months)
- Evaluate Perceived Disadvantages of AMAZE™ in clinical setting(Up to 6 months)
- Evaluate patient satisfaction with healthcare experience(Up to 6 months)
- Patient Perception of Appointment Discussions and Taking Part in Asthma Decisions(Up to 6 months)
- Evaluate impact of AMAZE™ on managing patients(Up to 6 months)
- Evaluate patient satisfaction with app(Up to 6 months)