About this trial
The objective of this study is to conduct a randomized controlled trial (RCT) to compare the adapted and refined ASTHMAXcel Voice platform to usual care (UC). It is hypothesized by the investigator team that ASTHMAXcel Voice will be associated with improved clinical and process outcomes, asthma quality of life (QOL), medication adherence, and self-efficacy as compared to UC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Persistent asthma (diagnosed by a healthcare provider) on a daily controller medication
Able to provide informed consent
Smartphone access (iOS or Android) with data plan
Disqualifiers
Pregnancy
Severe psychiatric or cognitive problems that would prohibit completion of protocol
Trial design
Parallel
Treatments tested in this trial
ASTHMAXcel Voice platform
Other interventionASTHMAXcel Voice is a mobile health application with a multi-level approach to address barriers with intervention components and facilitate health behavior change through the use of push notifications and interactive educational content.
Treatment groups
Trial outcomes
Primary outcomes
Change in Asthma Control
Change in asthma control will be assessed and measured using the Asthma Control Test (ACT). The ACT is a 5-item questionnaire administered to assess asthma control. Participants will score each item on the ACT based on a 5-point Likert scale ranging from 1 (poor control) to 5 (excellent control) yielding an overall possible scoring range of 5-25, such that higher overall scores are associated with increased levels of asthma control. Change in ACT scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to compare ACT scores between baseline and 2 months and baseline and 6 months within each arm.
Secondary outcomes
Change in Asthma Control
Change in asthma control will be assessed and measured using the Asthma Control Test (ACT). The ACT is a 5-item questionnaire administered to assess asthma control. Participants will score each item on the ACT based on a 5-point Likert scale ranging from 1 (poor control) to 5 (excellent control) yielding an overall possible scoring range of 5-25, such that higher overall scores are associated with increased levels of asthma control. Change in ACT scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to compare ACT scores between baseline and 2 months and baseline and 6 months within each arm.
Change in User Acceptance of ASTHMAXcel Voice Application
Change in user acceptance of the application will be assessed using the Unified Theory of Acceptance and User of Technology (UTAUT) Questionnaire. The UTAUT considers 4 constructs: performance expectancy (PE), effort expectancy (EE), social influence (SI), and facilitating conditions (FC), as most influential in determining technology acceptance and adoption behavior. Each of the 4 constructs consists of 4 statements which are evaluated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with higher scores indicating a greater likelihood of technology acceptance and use, reflecting stronger perceptions of PE, EE, SI, and FC. Scores for all items are summed and then the total score is divided by 16 to calculate a mean or average score. Scores will be summarized by using basic descriptive statistics. Paired t-tests will also be used to assess changes in user acceptance between baseline and 2 months and baseline and 6 months within the arm.
Change in User Satisfaction of Interaction with the ASTHMAXcel Voice application
Change in User satisfaction of Interaction with the application will be assessed using Version 7 of the Questionnaire for User Interface Satisfaction (QUIS). The QUIS is a measurement tool designed to assess a computer user's subjective satisfaction with specific aspects of the human-computer interface. QUIS measures specific interface factors such as screen visibility, terminology and system information, learning factors, system capabilities, usability and user interface, and system clutter, across 32 questions. Each QUIS question is measured on an ascending scale ranging from 0-9, wherein higher scores are associated with more favorable user impression of aspects of the interface. Scores for all items are summed and divided by the number of items answered to calculate a mean or average score. Scores will be summarized by using basic descriptive statistics. Paired t-tests will also be used to assess changes between baseline and 2 months and baseline and 6 months within the arm.
ASTHMAXcel Voice application Usage
ASTHMAXcel Voice application usage will be evaluated using analytics within the "Admin Panel" of the application. Specifically, the number of logins to ASTHMAXcel Voice will be determined and considered as a proxy for usage. Usage will be summarized using basic descriptive statistics.
Sponsors and contacts
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Montefiore Medical Center
Lead sponsor
Yeshiva University
Collaborator
Agency for Healthcare Research and Quality (AHRQ)
Collaborator