AMAZE™ Asthma Implementation QI Study

Asthma Clinical Trial

Official title:

AMAZE™ Asthma Implementation Quality Improvement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901260
• Other study ID #: N3566000000
• Status: Completed
• Start date: November 25, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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™

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• AMAZE™ Disease Management Platform
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.

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Austin	Texas

Sponsors (3)

Lead Sponsor	Collaborator
AstraZeneca	Evidera, Inc., Greater Austin Allergy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluating change in medication	Medication changes from baseline to six-month will be evaluated.	Up to 6 months
Other	Evaluating clinician-reported asthma control	Asthma control was assessed by a clinician completed single item; asthma control at baseline will be evaluated.	Up to 6 months
Other	Evaluating patient-reported asthma control	The impact of AMAZE™ on asthma control will be measured as the frequency of patients considered to be poorly controlled (ACT scores =15), not well-controlled (ACT scores 16-19, and well-controlled (ACT scores =20) from Month 1 through Month 6.	Up to 6 months
Other	Changes in asthma symptoms before clinical visit	Frequency of symptoms reported in the patient daily log up to a week proceeding a clinical visit during the study period will be evaluated to assess trends in symptoms that may have triggered a visit.	Up to 6 months
Other	Changes in medication after clinical visit	Following a clinical visit any time during the study period, medication changes will be monitored to determine if any changes were prompted by the visit.	Up to 6 months
Other	Characteristics of Patients Most Likely to Benefit from AMAZE™	Demographic information reported by the patient and clinical information reported by the clinical staff will be used and stratified by subgroups, including age, asthma severity, education, and ethnicity, to evaluate characteristics of patients most likely to benefit from AMAZE™	Up to 6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Impact of AMAZE™ on patient visits	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.	Up to 6 months
Secondary	ER visits and Hospitalization avoidance	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	Up to 6 months
Secondary	Patient Perception of Appointment Discussions and Taking Part in Asthma Decisions	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.	Up to 6 months
Secondary	Patient Perception of Usability and Design of Mobile app	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	Up to 6 months
Secondary	Clinical Staff Perception of Usability and Design of Dashboard	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	Up to 6 months
Secondary	Evaluate ease of implementation of AMAZE™ in clinical setting	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.	Up to 6 months
Secondary	Evaluate impact of AMAZE™ on managing patients	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.	Up to 6 months
Secondary	Evaluate Perceived Benefit of AMAZE™ in clinical setting	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.	Up to 6 months
Secondary	Evaluate Perceived Disadvantages of AMAZE™ in clinical setting	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.	Up to 6 months
Secondary	Evaluate patient satisfaction with healthcare experience	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.	Up to 6 months
Secondary	Evaluate patient satisfaction with app	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.	Up to 6 months

External Links

•   Redacted CSR synopsis