AMAZE™ Asthma Implementation QI Study
1 other identifier
observational
117
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2020
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 1, 2022
July 1, 2022
7 months
May 20, 2021
July 28, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Patient App Usage
Patient app usage will be measured as the number of days the patient engages (i.e., completes daily log, sends a message) with the app at least once a day during the study period.
Up to 6 months
Clinician Dashboard Usage
Clinician dashboard usage will be measured as the mean number of days per week/month that the clinical site staff accessed the AMAZE™ dashboard over the 6-month period.
Up to 6 months
Daily Asthma status
Patient daily asthma status (bad, okay, good) reported on the app will be described weekly during Month 1, and then per month from Month 1 through Month 6 pending availability of data after Month 1.
Up to 6 months
Symptoms and Triggers
Frequency of symptoms and frequency of triggers (for those that reported symptoms) reported on the app will be described weekly during Months 1, and then per month from Month 1 through Month 6 pending availability of data after Month 1.
Up to 6 months
Self-Reported Rescue Medication usage
The number of times per month a patient used rescue medication as well as visited the emergency room or urgent care as reported on the app will be described from Month 1 through Month 6.
Up to 6 months
Secondary Outcomes (11)
Impact of AMAZE™ on patient visits
Up to 6 months
ER visits and Hospitalization avoidance
Up to 6 months
Patient Perception of Appointment Discussions and Taking Part in Asthma Decisions
Up to 6 months
Patient Perception of Usability and Design of Mobile app
Up to 6 months
Clinical Staff Perception of Usability and Design of Dashboard
Up to 6 months
- +6 more secondary outcomes
Other Outcomes (6)
Evaluating change in medication
Up to 6 months
Evaluating clinician-reported asthma control
Up to 6 months
Evaluating patient-reported asthma control
Up to 6 months
- +3 more other outcomes
Study Arms (1)
Quality Initiative
Each participant will be asked to complete the symptoms log daily for up to 6 months. Additional surveys will be completed throughout the study by participants and GAA clinical staff.
Interventions
The disease management platform includes a patient mobile application where patients can enter daily symptoms, communicate with their healthcare providers, and access educational materials. Additionally, the healthcare providers will have access to a dashboard that is integrated with the EMR and patient app.
Eligibility Criteria
Participants will be recruited from the GAA network, with approximately 120 patients ≥18 years old with a current diagnosis of asthma being enrolled. Participants will need to have access to a smartphone with internet.
You may qualify if:
- \>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
You may not qualify if:
- 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™
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Greater Austin Allergycollaborator
- Evidera, Inc.collaborator
Study Sites (2)
Research Site
Austin, Texas, 78730, United States
Research Site
Austin, Texas, 78746, United States
Related Publications (1)
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.
PMID: 39479373DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Schultz, DO, MPH
GAA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 25, 2021
Study Start
November 25, 2020
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 1, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.