Clinical trial NCT04868500: Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform
Official title: Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform, A Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Evidera
First posted: 2021-05-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 participants throughout their participant 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: Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
timeFrame: Weeks 1 to 4
measure: Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
timeFrame: Weeks 5 to 8
measure: Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
timeFrame: Weeks 9 to 12
measure: Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
timeFrame: Weeks 13 to 16
measure: Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
timeFrame: Weeks 17 to 20
measure: Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
timeFrame: Weeks 21 to 24
measure: Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 1 to 4)
timeFrame: Weeks 1 to 4
measure: Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 5 to 8)
timeFrame: Weeks 5 to 8
measure: Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 9 to 12)
timeFrame: Weeks 9 to 12
measure: Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 13 to 16)
timeFrame: Weeks 13 to 16
measure: Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 17 to 20)
timeFrame: Weeks 17 to 20
measure: Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 21 to 24)
timeFrame: Weeks 21 to 24
measure: Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4)
timeFrame: Weeks 1 to 4
measure: Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8)
timeFrame: Weeks 5 to 8
measure: Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12)
timeFrame: Weeks 9 to 12
measure: Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16)
timeFrame: Weeks 13 to 16
measure: Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20)
timeFrame: Weeks 17 to 20
measure: Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 21 to 24)
timeFrame: Weeks 21 to 24
measure: Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
timeFrame: End of Study (Month 6)
measure: Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study)
timeFrame: End of Study (Month 6)
measure: Impact of AMAZE™ App on Participants Clinic Visits
timeFrame: Day 1 through End of Study (Month 6)
measure: Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
timeFrame: End of Study (Month 6)
measure: Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
timeFrame: End of study (Month 6)
measure: Patient-Reported System Usability Scale (SUS) (Month 1)
timeFrame: Month 1
measure: Patient-Reported SUS (End of Study)
timeFrame: End of Study (Month 6)
measure: Clinical Site Staff-Reported SUS (Month 1)
timeFrame: Month 1
measure: Clinical Site Staff-Reported SUS (End of Study)
timeFrame: End of Study (Month 6)
measure: Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study)
timeFrame: End of Study (Month 6)
measure: Evaluate Impact of AMAZE™ App on Managing Participants (End of Study)
timeFrame: End of Study (Month 6)
measure: Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
timeFrame: End of Study (Month 6)
measure: Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
timeFrame: End of Study (Month 6).
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
Study officials:
References: