Clinical trial NCT04901260: AMAZE™ Asthma Implementation QI Study
Official title: AMAZE™ Asthma Implementation Quality Improvement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Greater Austin Allergy
name: Evidera, Inc.
First posted: 2021-05-25
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the GAA network, with approximately 120 patients ≥18 years old with a current diagnosis of asthma being enrolled. Participants will need to have access to a smartphone with internet.

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.

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™

Primary outcomes:
measure: Patient App Usage
timeFrame: Up to 6 months
measure: Clinician Dashboard Usage
timeFrame: Up to 6 months
measure: Daily Asthma status
timeFrame: Up to 6 months
measure: Symptoms and Triggers
timeFrame: Up to 6 months
measure: Self-Reported Rescue Medication usage
timeFrame: Up to 6 months
Secondary outcomes:
measure: Impact of AMAZE™ on patient visits
timeFrame: Up to 6 months
measure: ER visits and Hospitalization avoidance
timeFrame: Up to 6 months
measure: Patient Perception of Appointment Discussions and Taking Part in Asthma Decisions
timeFrame: Up to 6 months
measure: Patient Perception of Usability and Design of Mobile app
timeFrame: Up to 6 months
measure: Clinical Staff Perception of Usability and Design of Dashboard
timeFrame: Up to 6 months
measure: Evaluate ease of implementation of AMAZE™ in clinical setting
timeFrame: Up to 6 months
measure: Evaluate impact of AMAZE™ on managing patients
timeFrame: Up to 6 months
measure: Evaluate Perceived Benefit of AMAZE™ in clinical setting
timeFrame: Up to 6 months
measure: Evaluate Perceived Disadvantages of AMAZE™ in clinical setting
timeFrame: Up to 6 months
measure: Evaluate patient satisfaction with healthcare experience
timeFrame: Up to 6 months
measure: Evaluate patient satisfaction with app
timeFrame: Up to 6 months
Other outcomes:
measure: Evaluating change in medication
timeFrame: Up to 6 months
measure: Evaluating clinician-reported asthma control
timeFrame: Up to 6 months
measure: Evaluating patient-reported asthma control
timeFrame: Up to 6 months
measure: Changes in asthma symptoms before clinical visit
timeFrame: Up to 6 months
measure: Changes in medication after clinical visit
timeFrame: Up to 6 months
measure: Characteristics of Patients Most Likely to Benefit from AMAZE™
timeFrame: Up to 6 months
Locations:
city: Austin
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: GAA
name: Eric Schultz, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References: