AsthmaNCT04868500
Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform
A study testing AMAZE™ Application and AMAZE™ Dashboard in people with Asthma, run by AstraZeneca at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- AMAZE™ Application and AMAZE™ Dashboard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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™.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform, A Clinical Pilot Study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- AMAZE™ Application, AMAZE™ Dashboard
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMAZE™ ApplicationDevice
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.
AMAZE™ DashboardDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Experimental | 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. Receives: Device: AMAZE™ Application |
| Massachusetts General Hospital (MGH) Clinical Site Staff | Experimental | 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. Receives: Device: AMAZE™ Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1 to 4
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.
Measured: Weeks 5 to 8
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.
Measured: Weeks 9 to 12
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.
Measured: Weeks 13 to 16
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.
Measured: Weeks 17 to 20
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.
Measured: Weeks 21 to 24
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'.
Measured: End of Study (Month 6)
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.
Measured: End of Study (Month 6)
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.
Measured: Day 1 through End of Study (Month 6)
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.
Measured: End of Study (Month 6)
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.
Measured: End of study (Month 6)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: End of Study (Month 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start27 Apr 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Evidera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868500
- Sponsor's protocol ID
- N4280000000
- Status last verified
- Jan 2023
- First submitted
- 17 Mar 2021
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Alladina J, Moschovis PP, Gandhi HN, Carstens D, Bacci ED, Cutts K, Coyne KS, Goldsborough K, Jiang D, O'Brien C, Bernard Kinane T. Observational study of the Amaze asthma disease management platform. Digit Health. 2024 Oct 22;10:20552076241282380. doi: 10.1177/20552076241282380. eCollection 2024 Jan-Dec.
PubMed 39479373
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform, A Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT04868500
- Acronym / sponsor ID
- N4280000000
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Evidera
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Experimental | Device: AMAZE™ ApplicationParticipants 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. |
| Massachusetts General Hospital (MGH) Clinical Site Staff | Experimental | Device: AMAZE™ DashboardClinical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (2 listed)
- 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™.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMAZE™ ApplicationParticipants 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. | Device | Massachusetts General Hospital (MGH) Participants |
| AMAZE™ DashboardClinical 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. | Device | Massachusetts General Hospital (MGH) Clinical Site Staff |
Primary outcome
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: End of Study (Month 6)
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)
Time frame: End of Study (Month 6)
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
Time frame: Day 1 through End of Study (Month 6)
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)
Time frame: End of Study (Month 6)
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)
Time frame: End of study (Month 6)
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)
Time frame: 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)
Time frame: End of Study (Month 6)
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)
Time frame: 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)
Time frame: End of Study (Month 6)
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)
Time frame: End of Study (Month 6)
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)
Time frame: End of Study (Month 6)
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)
Time frame: End of Study (Month 6)
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)
Time frame: End of Study (Month 6).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39479373Alladina J, Moschovis PP, Gandhi HN, Carstens D, Bacci ED, Cutts K, Coyne KS, Goldsborough K, Jiang D, O'Brien C, Bernard Kinane T. Observational study of the Amaze asthma disease management platform. Digit Health. 2024 Oct 22;10:20552076241282380. doi: 10.1177/20552076241282380. eCollection 2024 Jan-Dec.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMAZE™ Application and AMAZE™ Dashboard in people with Asthma, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) (time frame: Weeks 1 to 4). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04868500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.