Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform

NCT04868500 | Completed Results FDA Device

• 1 other identifier: N4280000000
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (31)

• 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.

  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).

Study Arms (2)

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.

Device: AMAZE™ Application

Massachusetts General Hospital (MGH) Clinical Site Staff

EXPERIMENTAL

Clinical site staff will use the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.

Device: AMAZE™ Dashboard

Interventions

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.

Massachusetts General Hospital (MGH) Participants

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.

Massachusetts General Hospital (MGH) Clinical Site Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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™.

Sponsors & Collaborators

• AstraZeneca: lead
• Massachusetts General Hospital: collaborator
• Evidera: collaborator

Study Sites (1)

Research Site

Boston, Massachusetts, 02114, United States

Location

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: 39479373 DERIVED

Related Links

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com

+1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: May 3, 2021
• Study Start: April 27, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

US (1)