search
Back to results

Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMAZE™ Application
AMAZE™ Dashboard
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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™.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Massachusetts General Hospital (MGH) Participants

Massachusetts General Hospital (MGH) Clinical Site Staff

Arm Description

Participants will use the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.

Clinical site staff will use the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.

Outcomes

Primary Outcome Measures

Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 1 to 4.
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 5 to 8.
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 9 to 12.
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 13 to 16.
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 17 to 20.
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 21 to 24.
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 1 to 4)
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 1 to 4.
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 5 to 8)
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 5 to 8.
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 9 to 12)
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 9 to 12.
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 13 to 16)
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 13 to 16.
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 17 to 20)
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 17 to 20.
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 21 to 24)
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 21 to 24.
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4)
Visit Survey Item 9 was 'The visit helped avoid an emergency room (ER) or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8)
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12)
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16)
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20)
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 21 to 24)
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Satisfaction with the AMAZE™ App features was measured by the number of participants who reported satisfaction on parameters of 'Very unsatisfied, Unsatisfied, Neutral, Satisfied, and Very satisfied'.
Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study)
The impact of AMAZE™ on ER, urgent care center visits, and hospitalizations was measured as the number of participants who reported "agree" or "strongly agree" with the question 'Since the start of the study, use of the AMAZE™ App helped me avoid ER or urgent care center visits or hospitalizations.' from the participant visit experience survey.
Impact of AMAZE™ App on Participants Clinic Visits
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' The impact of AMAZE™ on participant visits was measured as the number of participants who selected "agree" or "strongly agree" in response to the 9-items in the participant visit experience survey.
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
The impact of AMAZE™ on improved participant communication with their healthcare provider was measured as the number of participants who reported "agree" or "strongly agree" with the questions "The app helped me discuss my asthma with my healthcare providers during my most recent visit?", "App helped the appointment with my doctor go more smoothly?" and "I was included in making decisions about my asthma treatment during my most recent visit?" on the participant visit experience survey.
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Participant satisfaction with their healthcare experience was evaluated using the PSQ-18 items with subscale scores of 'General satisfaction, Technical quality, Interpersonal manner, Communication, Financial aspects, Time spent with doctor, Accessibility and convenience' at End of Study (Month 6). The PSQ-18 scores ranges from 1 to 5 and a higher score indicates greater satisfaction.
Patient-Reported System Usability Scale (SUS) (Month 1)
The usability of the AMAZE™ App was measured by the number of participants who rated the app as 'excellent, good, okay, poor, awful or skipped to report' at Month 1.
Patient-Reported SUS (End of Study)
The usability of the AMAZE™ App was measured by the number of participants who rated the app as 'excellent, good, okay, poor, awful or skipped to report' at End of Study (Month 6).
Clinical Site Staff-Reported SUS (Month 1)
The usability of the AMAZE™ dashboard was measured by the number of clinical staff who rated the App as 'excellent, good, okay, poor, awful or skipped to report' at Month 1.
Clinical Site Staff-Reported SUS (End of Study)
The usability of the AMAZE™ dashboard was measured by the number of clinical staff who rated the App as 'excellent, good, okay, poor, awful or skipped to report' at End of Study (Month 6).
Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study)
The ease of implementation of AMAZE™ was measured by the number of clinical staff who reported "very easy" or "somewhat easy" to the question "How would you rate the overall ease of implementing AMAZE™ on a platform into your clinical practice?" in the post-study survey at End of Study (Month 6).
Evaluate Impact of AMAZE™ App on Managing Participants (End of Study)
The impact of AMAZE™ on managing participants was measured by the number of clinical staff who reported "moderately" or "very well" to the question "Did the AMAZE™ help you manage your participants?" in the post-study survey at End of Study (Month 6).
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
The perceived benefit of AMAZE™ was evaluated by the number of clinical staff who endorsed different perceived benefits as "Ability to track symptoms, Ability to track asthma triggers, Ability to track reliever medication use, Ability track ER visits/ hospitalizations, and Integration of AMAZE™ platform with electronic health records" based on the item "What did you find the most useful about the AMAZE™ platform?" in the post-study survey at End of Study (Month 6).
Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
The perceived disadvantages of AMAZE™ were evaluated by the number of clinical site staff who endorsed different perceived disadvantages as "Ability to track air flow measurements, Participant-health care provides (HCP) messaging feature, Ability to assign another healthcare provider to a participant, Ability to track level of impairment through Asthma Control Test (ACT™) scores" based on the question "What did you find the least useful or cumbersome about the AMAZE™ platform?" in the post-study survey at End of Study (Month 6).

Secondary Outcome Measures

Full Information

First Posted
March 17, 2021
Last Updated
January 16, 2023
Sponsor
AstraZeneca
Collaborators
Massachusetts General Hospital, Evidera
search

1. Study Identification

Unique Protocol Identification Number
NCT04868500
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Massachusetts General Hospital, Evidera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massachusetts General Hospital (MGH) Participants
Arm Type
Experimental
Arm Description
Participants will use the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
Arm Title
Massachusetts General Hospital (MGH) Clinical Site Staff
Arm Type
Experimental
Arm Description
Clinical site staff will use the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.
Intervention Type
Device
Intervention Name(s)
AMAZE™ Application
Intervention Description
Participants will use the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
Intervention Type
Device
Intervention Name(s)
AMAZE™ Dashboard
Intervention Description
Clinical site staff will use the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.
Primary Outcome Measure Information:
Title
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Description
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 1 to 4.
Time Frame
Weeks 1 to 4
Title
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Description
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 5 to 8.
Time Frame
Weeks 5 to 8
Title
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Description
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 9 to 12.
Time Frame
Weeks 9 to 12
Title
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Description
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 13 to 16.
Time Frame
Weeks 13 to 16
Title
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Description
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 17 to 20.
Time Frame
Weeks 17 to 20
Title
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Description
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 21 to 24.
Time Frame
Weeks 21 to 24
Title
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 1 to 4)
Description
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 1 to 4.
Time Frame
Weeks 1 to 4
Title
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 5 to 8)
Description
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 5 to 8.
Time Frame
Weeks 5 to 8
Title
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 9 to 12)
Description
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 9 to 12.
Time Frame
Weeks 9 to 12
Title
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 13 to 16)
Description
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 13 to 16.
Time Frame
Weeks 13 to 16
Title
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 17 to 20)
Description
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 17 to 20.
Time Frame
Weeks 17 to 20
Title
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 21 to 24)
Description
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 21 to 24.
Time Frame
Weeks 21 to 24
Title
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4)
Description
Visit Survey Item 9 was 'The visit helped avoid an emergency room (ER) or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Time Frame
Weeks 1 to 4
Title
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8)
Description
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Time Frame
Weeks 5 to 8
Title
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12)
Description
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Time Frame
Weeks 9 to 12
Title
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16)
Description
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Time Frame
Weeks 13 to 16
Title
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20)
Description
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Time Frame
Weeks 17 to 20
Title
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 21 to 24)
Description
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Time Frame
Weeks 21 to 24
Title
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Description
Satisfaction with the AMAZE™ App features was measured by the number of participants who reported satisfaction on parameters of 'Very unsatisfied, Unsatisfied, Neutral, Satisfied, and Very satisfied'.
Time Frame
End of Study (Month 6)
Title
Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study)
Description
The impact of AMAZE™ on ER, urgent care center visits, and hospitalizations was measured as the number of participants who reported "agree" or "strongly agree" with the question 'Since the start of the study, use of the AMAZE™ App helped me avoid ER or urgent care center visits or hospitalizations.' from the participant visit experience survey.
Time Frame
End of Study (Month 6)
Title
Impact of AMAZE™ App on Participants Clinic Visits
Description
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' The impact of AMAZE™ on participant visits was measured as the number of participants who selected "agree" or "strongly agree" in response to the 9-items in the participant visit experience survey.
Time Frame
Day 1 through End of Study (Month 6)
Title
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
Description
The impact of AMAZE™ on improved participant communication with their healthcare provider was measured as the number of participants who reported "agree" or "strongly agree" with the questions "The app helped me discuss my asthma with my healthcare providers during my most recent visit?", "App helped the appointment with my doctor go more smoothly?" and "I was included in making decisions about my asthma treatment during my most recent visit?" on the participant visit experience survey.
Time Frame
End of Study (Month 6)
Title
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Description
Participant satisfaction with their healthcare experience was evaluated using the PSQ-18 items with subscale scores of 'General satisfaction, Technical quality, Interpersonal manner, Communication, Financial aspects, Time spent with doctor, Accessibility and convenience' at End of Study (Month 6). The PSQ-18 scores ranges from 1 to 5 and a higher score indicates greater satisfaction.
Time Frame
End of study (Month 6)
Title
Patient-Reported System Usability Scale (SUS) (Month 1)
Description
The usability of the AMAZE™ App was measured by the number of participants who rated the app as 'excellent, good, okay, poor, awful or skipped to report' at Month 1.
Time Frame
Month 1
Title
Patient-Reported SUS (End of Study)
Description
The usability of the AMAZE™ App was measured by the number of participants who rated the app as 'excellent, good, okay, poor, awful or skipped to report' at End of Study (Month 6).
Time Frame
End of Study (Month 6)
Title
Clinical Site Staff-Reported SUS (Month 1)
Description
The usability of the AMAZE™ dashboard was measured by the number of clinical staff who rated the App as 'excellent, good, okay, poor, awful or skipped to report' at Month 1.
Time Frame
Month 1
Title
Clinical Site Staff-Reported SUS (End of Study)
Description
The usability of the AMAZE™ dashboard was measured by the number of clinical staff who rated the App as 'excellent, good, okay, poor, awful or skipped to report' at End of Study (Month 6).
Time Frame
End of Study (Month 6)
Title
Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study)
Description
The ease of implementation of AMAZE™ was measured by the number of clinical staff who reported "very easy" or "somewhat easy" to the question "How would you rate the overall ease of implementing AMAZE™ on a platform into your clinical practice?" in the post-study survey at End of Study (Month 6).
Time Frame
End of Study (Month 6)
Title
Evaluate Impact of AMAZE™ App on Managing Participants (End of Study)
Description
The impact of AMAZE™ on managing participants was measured by the number of clinical staff who reported "moderately" or "very well" to the question "Did the AMAZE™ help you manage your participants?" in the post-study survey at End of Study (Month 6).
Time Frame
End of Study (Month 6)
Title
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
Description
The perceived benefit of AMAZE™ was evaluated by the number of clinical staff who endorsed different perceived benefits as "Ability to track symptoms, Ability to track asthma triggers, Ability to track reliever medication use, Ability track ER visits/ hospitalizations, and Integration of AMAZE™ platform with electronic health records" based on the item "What did you find the most useful about the AMAZE™ platform?" in the post-study survey at End of Study (Month 6).
Time Frame
End of Study (Month 6)
Title
Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
Description
The perceived disadvantages of AMAZE™ were evaluated by the number of clinical site staff who endorsed different perceived disadvantages as "Ability to track air flow measurements, Participant-health care provides (HCP) messaging feature, Ability to assign another healthcare provider to a participant, Ability to track level of impairment through Asthma Control Test (ACT™) scores" based on the question "What did you find the least useful or cumbersome about the AMAZE™ platform?" in the post-study survey at End of Study (Month 6).
Time Frame
End of Study (Month 6).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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™.
Facility Information:
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=N4280000000&attachmentIdentifier=68577816-6a4e-44ca-9d9d-5cc363bbd99f&fileName=EVA-28838_AMAZE_Redacted_Synopsis_20July2022_Clean_V2-v1.pdf&versionIdentifier=
Description
Related Info
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=N4280000000&attachmentIdentifier=1bde190a-9f41-4102-af15-b25bdbb9b4d7&fileName=1_clean_Asthma_Sponsor_Protocol_AZPulm_2021Aug10-Redacted.pdf&versionIdentifier=
Description
Related Info
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=N4280000000&attachmentIdentifier=f209dddf-4104-405b-983f-7c7e39d6d2ef&fileName=EVA-28838_AMAZE_DMP_SAP_v5.0_27July2021_FINAL-Redacted.pdf&versionIdentifier=
Description
Related Info

Learn more about this trial

Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform

We'll reach out to this number within 24 hrs