AMAZE™ Asthma Implementation QI Study
- Conditions
- Asthma
- Interventions
- Device: AMAZE™ Disease Management Platform
- Registration Number
- NCT04901260
- Lead Sponsor
- AstraZeneca
- 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 patients throughout their patient 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- >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
- 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™
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Quality Initiative AMAZE™ Disease Management Platform 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.
- Primary Outcome Measures
Name Time Method Clinician Dashboard Usage Up to 6 months 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.
Symptoms and Triggers Up to 6 months 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.
Patient App Usage Up to 6 months 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.
Self-Reported Rescue Medication usage Up to 6 months 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.
Daily Asthma status Up to 6 months 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.
- Secondary Outcome Measures
Name Time Method ER visits and Hospitalization avoidance Up to 6 months The impact of AMAZE™ on ER and hospitalizations will be measured as the frequency of patients who report "agree" or "strongly agree" with the item "The visit helped avoid an ER or Urgent Care center visit or hospitalization" from the patient visit experience survey
Patient Perception of Usability and Design of Mobile app Up to 6 months The usability of the AMAZE™ app will be measured by the frequency of patients who rate the app excellent (SUS score \>80.3), good (68-80.3), okay (68), poor (51-68), or awful (\<51) at months 1 and 6
Clinical Staff Perception of Usability and Design of Dashboard Up to 6 months The usability of the AMAZE™ dashboard will be measured by the frequency of clinical staff who rate the app excellent (SUS score \>80.3), good (68-80.3), okay (68), poor (51-68), or awful (\<51) at months 1 and 6
Evaluate ease of implementation of AMAZE™ in clinical setting Up to 6 months The ease of implementation of AMAZE™ will be measured by the frequency of clinical staff who report "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 month 6.
Evaluate Perceived Benefit of AMAZE™ in clinical setting Up to 6 months The perceived benefit of AMAZE™ will be evaluated by the frequency of clinical staff who endorse different perceived benefits based on the item "what did you find the most useful about the AMAZE™ platform?" in the post-study survey at month 6.
Impact of AMAZE™ on patient visits Up to 6 months The impact of AMAZE™ on patient visits will be measured as the frequency of patients who select "agree" or "strongly agree" in response to the 9-items in the patient visit experience survey.
Evaluate Perceived Disadvantages of AMAZE™ in clinical setting Up to 6 months The perceived disadvantages of AMAZE™ will be evaluated by the frequency of clinical staff who endorse different perceived disadvantages based on the item "what did you find the least useful or cumbersome about the AMAZE™ platform?" in the post-study survey at month 6.
Evaluate patient satisfaction with healthcare experience Up to 6 months Patient satisfaction with their healthcare experience will be evaluated using the PSQ-18 items and subscale scores (General Satisfaction, Technical Quality, Interpersonal Manner, Communication, Financial Aspects, Time Spent with Doctor, Accessibility and Convenience) at Month 6.
Patient Perception of Appointment Discussions and Taking Part in Asthma Decisions Up to 6 months The impact of AMAZE™ on improved patient communication with their provider will be measured as the frequency of patients who report "agree" or "strongly agree" with the items "the app helped me discuss my asthma with my healthcare provider(s) during my most recent visit" and "I was included in making decisions about my asthma treatment during my most recent visit" on the patient visit experience survey.
Evaluate impact of AMAZE™ on managing patients Up to 6 months The impact of AMAZE™ on managing patients will be measured by the frequency of clinical staff who report "moderately" or "very well" to the question "Did the AMAZE™ help you manage your patients?" in the post-study survey at month 6.
Evaluate patient satisfaction with app Up to 6 months Satisfaction with the app features will be measured by the frequency of patients who report satisfaction on a scale of 1 (lowest satisfaction) to 5 (highest satisfaction) at months 1, 3, and 6.
Trial Locations
- Locations (1)
Research Site
🇺🇸Austin, Texas, United States