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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Evidera | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMAZE™ Application | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39479373 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Massachusetts General Hospital (MGH) Participants | Participants used 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. |
| FG001 | Massachusetts General Hospital (MGH) Clinical Site Staff | Clinical site staff used 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All eligible participants who successfully enrolled in the implementation study were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Massachusetts General Hospital (MGH) Participants | Participants used 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. |
| BG001 | Massachusetts General Hospital (MGH) Clinical Site Staff |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not recorded for MGH Clinical Site Staff. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter. | Posted | Mean | Standard Deviation | Days | Weeks 1 to 4 |
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
This was an interventional study with no requirements to collect adverse events during the study since enrollment in the study was based on disease diagnosis and did not require the administration of a study drug. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Massachusetts General Hospital (MGH) Participants | Participants used 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. |
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This was an interventional study with no requirements to collect adverse events during the study since enrollment in the study was based on disease diagnosis and did not require the administration of a study drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca Clinical Study Information Center | +1-877-240-9479 | information.center@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2021 | Nov 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2021 | Nov 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| AMAZE™ Dashboard | Device | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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'. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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). | 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). | 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). | 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). | End of Study (Month 6). |
| Related Info | View source |
| Related Info | View source |
Clinical site staff used 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. |
| BG002 | Total | Total of all reporting groups |
Data only collected for MGH Participants arm for this baseline measure.
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Not recorded for MGH Clinical Site Staff. | Data only collected for MGH Participants arm for this baseline measure. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Not recorded for MGH Clinical Site Staff. | Data only collected for MGH Participants arm for this baseline measure. | Count of Participants | Participants |
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| Race (NIH/OMB) | Not recorded for MGH Clinical Site Staff. | Data only collected for MGH Participants arm for this baseline measure. | Count of Participants | Participants |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter. | Posted | Mean | Standard Deviation | Days | Weeks 5 to 8 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter. | Posted | Mean | Standard Deviation | Days | Weeks 9 to 12 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter. | Posted | Mean | Standard Deviation | Days | Weeks 13 to 16 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter. | Posted | Mean | Standard Deviation | Days | Weeks 17 to 20 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter. | Posted | Mean | Standard Deviation | Days | Weeks 21 to 24 |
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| Primary | 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. | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Mean | Standard Deviation | Days | Weeks 1 to 4 |
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| Primary | 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. | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Mean | Standard Deviation | Days | Weeks 5 to 8 |
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| Primary | 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. | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Mean | Standard Deviation | Days | Weeks 9 to 12 |
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| Primary | 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. | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Mean | Standard Deviation | Days | Weeks 13 to 16 |
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| Primary | 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. | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Mean | Standard Deviation | Days | Weeks 17 to 20 |
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| Primary | 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. | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Mean | Standard Deviation | Days | Weeks 21 to 24 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame. | Posted | Count of Participants | Participants | Weeks 1 to 4 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame. | Posted | Count of Participants | Participants | Weeks 5 to 8 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame. | Posted | Count of Participants | Participants | Weeks 9 to 12 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame. | Posted | Count of Participants | Participants | Weeks 13 to 16 |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame. | Posted | Count of Participants | Participants | Weeks 17 to 20 |
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| Primary | 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. | No participant completed at least one daily asthma log during the specified time frame (Weeks 21 to 24), so no data was reported. | Posted | Weeks 21 to 24 |
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| Primary | 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'. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame. | Posted | Count of Participants | Participants | Day 1 through End of Study (Month 6) |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6. | Posted | Mean | Standard Deviation | Scores on a Scale | End of study (Month 6) |
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| Primary | 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. | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 1. | Posted | Count of Participants | Participants | Month 1 |
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| Primary | 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). | All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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 who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Count of Participants | Participants | Month 1 |
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| Primary | 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). | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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). | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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). | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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). | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Count of Participants | Participants | End of Study (Month 6) |
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| Primary | 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). | Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure. | Posted | Count of Participants | Participants | End of Study (Month 6). |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Massachusetts General Hospital (MGH) Clinical Site Staff | Clinical site staff used 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. | 0 | 0 | 0 | 0 | 0 | 0 |
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Satisfied |
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| Very satisfied |
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| Title | Measurements |
|---|---|
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| To take appointment smoothly-Agree |
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| Asthma treatment decision-Strongly agree |
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| Asthma treatment decision-Agree |
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| Title | Measurements |
|---|---|
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| Communication |
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| Financial aspects |
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| Time spent with doctor |
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| Accessibility and convenience |
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| Title | Measurements |
|---|---|
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| Poor |
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| Awful |
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| Skipped |
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| Title | Measurements |
|---|---|
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| Poor |
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| Awful |
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| Skipped |
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| Title | Measurements |
|---|---|
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| Poor |
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| Awful |
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| Skipped |
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| Title | Measurements |
|---|---|
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| Poor |
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| Awful |
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| Skipped |
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| Title | Measurements |
|---|---|
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| Ability track ER visits/ hospitalizations |
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| Integration of AMAZE™ platform with electronic health records |
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| Title | Measurements |
|---|---|
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| Ability to track level of impairment through ACT™ scores |
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