AMAZE™ Asthma Implementation Quality Improvement Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Clinician Dashboard Usage
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>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
Exclusion Criteria
- •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™
Outcomes
Primary Outcomes
Clinician Dashboard Usage
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)