Asthma
Conditions
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.
Interventions
DEVICEAMAZE™ Application
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.
DEVICEAMAZE™ Dashboard
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.
Sponsors
Massachusetts General Hospital
Evidera
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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™.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 6 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participants and Clinical Site Staff never opened App | 1 | 0 |
| Overall Study | Participants and Clinical Site Staff terminated early | 3 | 1 |
Baseline characteristics
| Characteristic | Massachusetts General Hospital (MGH) Participants | Total | Massachusetts General Hospital (MGH) Clinical Site Staff |
|---|---|---|---|
| Age, Continuous | 24.5 Years STANDARD_DEVIATION 12 | 24.5 Years STANDARD_DEVIATION 12 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 7 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 30 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | — |
| Race (NIH/OMB) White | 33 Participants | 33 Participants | — |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: End of Study (Month 6)
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (End of Study) | Excellent | 1 Participants | 25 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (End of Study) | Good | 1 Participants | 25 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (End of Study) | Okay | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (End of Study) | Poor | 1 Participants | 25 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (End of Study) | Awful | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (End of Study) | Skipped | 1 Participants | 25 |
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.
Time frame: Month 1
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (Month 1) | Poor | 1 Participants | 20 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (Month 1) | Excellent | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (Month 1) | Good | 4 Participants | 80 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (Month 1) | Okay | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (Month 1) | Awful | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Clinical Site Staff-Reported SUS (Month 1) | Skipped | 0 Participants | 0 |
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.
Time frame: End of Study (Month 6)
Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study) | Strongly agree | 2 Participants |
| Massachusetts General Hospital (MGH) Participants | Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study) | Agree | 1 Participants |
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).
Time frame: End of Study (Month 6)
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study) | Very easy | 4 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study) | Somewhat easy | 0 Participants |
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).
Time frame: End of Study (Month 6)
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Evaluate Impact of AMAZE™ App on Managing Participants (End of Study) | Moderately | 2 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Impact of AMAZE™ App on Managing Participants (End of Study) | Very well | 0 Participants |
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'.
Time frame: End of Study (Month 6)
Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Evaluate Participant Satisfaction With the AMAZE™ App (End of Study) | Very unsatisfied | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Participant Satisfaction With the AMAZE™ App (End of Study) | Unsatisfied | 0 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Participant Satisfaction With the AMAZE™ App (End of Study) | Neutral | 3 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Participant Satisfaction With the AMAZE™ App (End of Study) | Satisfied | 12 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Participant Satisfaction With the AMAZE™ App (End of Study) | Very satisfied | 6 Participants |
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).
Time frame: End of Study (Month 6)
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study) | Ability to track symptoms | 2 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study) | Ability to track asthma triggers | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study) | Ability to track reliever medication use | 2 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study) | Ability track ER visits/ hospitalizations | 0 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study) | Integration of AMAZE™ platform with electronic health records | 2 Participants |
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).
Time frame: End of Study (Month 6).
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study) | Ability to track air flow measurements | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study) | Participant-HCP messaging feature | 2 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study) | Ability to assign another healthcare provider to a participant | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study) | Ability to track level of impairment through ACT™ scores | 1 Participants |
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.
Time frame: Day 1 through End of Study (Month 6)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Impact of AMAZE™ App on Participants Clinic Visits | Strongly agree | 2 Participants |
| Massachusetts General Hospital (MGH) Participants | Impact of AMAZE™ App on Participants Clinic Visits | Agree | 0 Participants |
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.
Time frame: Weeks 13 to 16
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 13 to 16) | 5.8 Days | Standard Deviation 6.5 |
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.
Time frame: Weeks 17 to 20
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 17 to 20) | 5.6 Days | Standard Deviation 6.5 |
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.
Time frame: Weeks 1 to 4
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 1 to 4) | 8.3 Days | Standard Deviation 6.7 |
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.
Time frame: Weeks 21 to 24
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 21 to 24) | 6.7 Days | Standard Deviation 4.9 |
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.
Time frame: Weeks 5 to 8
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 5 to 8) | 5.8 Days | Standard Deviation 6.1 |
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.
Time frame: Weeks 9 to 12
Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 9 to 12) | 6.6 Days | Standard Deviation 6.1 |
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.
Time frame: Weeks 13 to 16
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Home | 12.6 Days | Standard Deviation 8.2 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Daily asthma log | 12.1 Days | Standard Deviation 8.1 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Air quality | 1.0 Days | Standard Deviation 0 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | My plan | 1.1 Days | Standard Deviation 0.3 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Trends | 1.1 Days | Standard Deviation 0.3 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Appointments | 1.2 Days | Standard Deviation 0.4 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Educational material | 1.0 Days | Standard Deviation 0 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Messages | 1.3 Days | Standard Deviation 0.6 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) | Notifications | 1.0 Days | Standard Deviation 0 |
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.
Time frame: Weeks 17 to 20
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Home | 9.3 Days | Standard Deviation 7.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Daily asthma log | 8.9 Days | Standard Deviation 7.2 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Air quality | 1.0 Days | — |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | My plan | 1.2 Days | Standard Deviation 0.4 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Trends | 1.2 Days | Standard Deviation 0.4 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Appointments | 1.5 Days | Standard Deviation 0.7 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Educational material | 1.0 Days | — |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Messages | 1.3 Days | Standard Deviation 0.8 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) | Notifications | 1.0 Days | Standard Deviation 0 |
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.
Time frame: Weeks 1 to 4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Home | 16.8 Days | Standard Deviation 7.1 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Daily asthma log | 16.5 Days | Standard Deviation 6.8 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Air quality | 2.3 Days | Standard Deviation 1.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | My plan | 2.2 Days | Standard Deviation 1.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Trends | 2.8 Days | Standard Deviation 3 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Appointments | 1.3 Days | Standard Deviation 0.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Educational material | 1.0 Days | Standard Deviation 0 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Messages | 2.3 Days | Standard Deviation 2.4 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) | Notifications | 1.3 Days | Standard Deviation 0.5 |
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.
Time frame: Weeks 21 to 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) | Home | 7.6 Days | Standard Deviation 7.2 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) | Daily asthma log | 7.8 Days | Standard Deviation 7.3 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) | My plan | 1.2 Days | Standard Deviation 0.4 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) | Trends | 1.0 Days | Standard Deviation 0 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) | Appointments | 3.0 Days | — |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) | Messages | 1.3 Days | Standard Deviation 0.5 |
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.
Time frame: Weeks 5 to 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Home | 12.5 Days | Standard Deviation 8.6 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Daily asthma log | 12.1 Days | Standard Deviation 8.6 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Air quality | 1.5 Days | Standard Deviation 0.7 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | My plan | 1.6 Days | Standard Deviation 0.8 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Trends | 1.6 Days | Standard Deviation 0.8 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Appointments | 1.3 Days | Standard Deviation 0.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Educational material | 1.0 Days | Standard Deviation 0 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Messages | 1.8 Days | Standard Deviation 1.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) | Notifications | 1.0 Days | Standard Deviation 0 |
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.
Time frame: Weeks 9 to 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Daily asthma log | 11.2 Days | Standard Deviation 7.8 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Air quality | 1.0 Days | Standard Deviation 0 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Home | 11.4 Days | Standard Deviation 8.1 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | My plan | 1.5 Days | Standard Deviation 1 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Trends | 1.4 Days | Standard Deviation 0.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Appointments | 1.3 Days | Standard Deviation 0.6 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Educational material | 1.0 Days | — |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Messages | 1.4 Days | Standard Deviation 0.5 |
| Massachusetts General Hospital (MGH) Participants | Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) | Notifications | 1.0 Days | Standard Deviation 0 |
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.
Time frame: Weeks 13 to 16
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16) | High | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16) | Very low | 0 Participants |
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.
Time frame: Weeks 17 to 20
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20) | High | 0 Participants |
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20) | Very low | 1 Participants |
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.
Time frame: Weeks 1 to 4
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4) | High | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4) | Very low | 0 Participants |
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.
Time frame: Weeks 21 to 24
Population: No participant completed at least one daily asthma log during the specified time frame (Weeks 21 to 24), so no data was reported.
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.
Time frame: Weeks 5 to 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8) | High | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8) | Very low | 0 Participants |
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.
Time frame: Weeks 9 to 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12) | High | 1 Participants |
| Massachusetts General Hospital (MGH) Participants | Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12) | Very low | 0 Participants |
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.
Time frame: End of Study (Month 6)
Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) | Asthma discussions-Strongly Agree | 3 Participants |
| Massachusetts General Hospital (MGH) Participants | Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) | Asthma Discussions-Agree | 5 Participants |
| Massachusetts General Hospital (MGH) Participants | Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) | To take appointment smoothly-Strongly agree | 3 Participants |
| Massachusetts General Hospital (MGH) Participants | Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) | To take appointment smoothly-Agree | 3 Participants |
| Massachusetts General Hospital (MGH) Participants | Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) | Asthma treatment decision-Strongly agree | 14 Participants |
| Massachusetts General Hospital (MGH) Participants | Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) | Asthma treatment decision-Agree | 4 Participants |
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).
Time frame: End of Study (Month 6)
Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Patient-Reported SUS (End of Study) | Poor | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported SUS (End of Study) | Excellent | 14 Participants | 63.6 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported SUS (End of Study) | Good | 6 Participants | 27.3 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported SUS (End of Study) | Okay | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported SUS (End of Study) | Awful | 2 Participants | 9.1 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported SUS (End of Study) | Skipped | 0 Participants | 0 |
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.
Time frame: Month 1
Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Patient-Reported System Usability Scale (SUS) (Month 1) | Excellent | 17 Participants | 56.7 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported System Usability Scale (SUS) (Month 1) | Good | 9 Participants | 30 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported System Usability Scale (SUS) (Month 1) | Okay | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported System Usability Scale (SUS) (Month 1) | Poor | 3 Participants | 10 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported System Usability Scale (SUS) (Month 1) | Awful | 0 Participants | 0 |
| Massachusetts General Hospital (MGH) Participants | Patient-Reported System Usability Scale (SUS) (Month 1) | Skipped | 1 Participants | 3.3 |
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.
Time frame: End of study (Month 6)
Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | General satisfaction | 4.1 Scores on a Scale | Standard Deviation 0.86 |
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | Technical quality | 4.3 Scores on a Scale | Standard Deviation 0.61 |
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | Interpersonal manner | 4.3 Scores on a Scale | Standard Deviation 0.57 |
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | Communication | 4.2 Scores on a Scale | Standard Deviation 0.77 |
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | Financial aspects | 4.0 Scores on a Scale | Standard Deviation 0.91 |
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | Time spent with doctor | 3.8 Scores on a Scale | Standard Deviation 0.95 |
| Massachusetts General Hospital (MGH) Participants | Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) | Accessibility and convenience | 3.6 Scores on a Scale | Standard Deviation 0.89 |