N/A
Completed N=49
Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform
Source: ClinicalTrials.gov NCT04868500 ↗Enrolled (actual)
49
Serious AEs
—
Results posted
Feb 2023
Primary outcomePrimary: Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) — 16.8; 16.5; 2.3; 2.2 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4) |
16.8; 16.5; 2.3; 2.2; 2.8; 1.3 | — |
| PRIMARY Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8) |
12.5; 12.1; 1.5; 1.6; 1.6; 1.3 | — |
| PRIMARY Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12) |
11.4; 11.2; 1.0; 1.5; 1.4; 1.3 | — |
| PRIMARY Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16) |
12.6; 12.1; 1.0; 1.1; 1.1; 1.2 | — |
| PRIMARY Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20) |
9.3; 8.9; 1.0; 1.2; 1.2; 1.5 | — |
| PRIMARY Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24) |
7.6; 7.8; 1.2; 1.0; 3.0; 1.3 | — |
| PRIMARY Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 1 to 4) |
8.3 | — |
| PRIMARY Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 5 to 8) |
5.8 | — |
| PRIMARY Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 9 to 12) |
6.6 | — |
| PRIMARY Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 13 to 16) |
5.8 | — |
| PRIMARY Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 17 to 20) |
5.6 | — |
| PRIMARY Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 21 to 24) |
6.7 | — |
| PRIMARY Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4) |
1; 0 | — |
| PRIMARY Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8) |
1; 0 | — |
| PRIMARY Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12) |
1; 0 | — |
| PRIMARY Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16) |
1; 0 | — |
| PRIMARY Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20) |
0; 1 | — |
| PRIMARY Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 21 to 24) |
— | — |
| PRIMARY Evaluate Participant Satisfaction With the AMAZE™ App (End of Study) |
1; 0; 3; 12; 6 | — |
| PRIMARY Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study) |
2; 1 | — |
| PRIMARY Impact of AMAZE™ App on Participants Clinic Visits |
2; 0 | — |
| PRIMARY Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study) |
3; 5; 3; 3; 14; 4 | — |
| PRIMARY Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study) |
4.1; 4.3; 4.3; 4.2; 4.0; 3.8 | — |
| PRIMARY Patient-Reported System Usability Scale (SUS) (Month 1) |
17; 9; 0; 3; 0; 1 | — |
| PRIMARY Patient-Reported SUS (End of Study) |
14; 6; 0; 0; 2; 0 | — |
| PRIMARY Clinical Site Staff-Reported SUS (Month 1) |
0; 4; 0; 1; 0; 0 | — |
| PRIMARY Clinical Site Staff-Reported SUS (End of Study) |
1; 1; 0; 1; 0; 1 | — |
| PRIMARY Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study) |
4; 0 | — |
| PRIMARY Evaluate Impact of AMAZE™ App on Managing Participants (End of Study) |
2; 0 | — |
| PRIMARY Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study) |
2; 1; 2; 0; 2 | — |
| PRIMARY Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study) |
1; 2; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- >18 years of age at the time of enrollment
- Clinically confirmed diagnosis of asthma
- Access to a smartphone with internet access with the following requirements: iOS (Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android (Operating System 8.0 or newer)
- Able to understand and speak English sufficiently to be able to use the AMAZE™ patient app
- Willingness to participate in a telephone interview and be audio-recorded
- Consenting to participate in the study
Exclusion Criteria
- Current diagnosis of active chronic obstructive pulmonary disease (COPD) or any pulmonary diagnosis other than asthma
- Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the ACT™.
Data sourced from ClinicalTrials.gov (NCT04868500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.