ASTHMAXcel Voice Study

ConditionAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ASTHMAXcel Voice platform

    Other intervention

    ASTHMAXcel 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

200 Participants
are divided into 2 treatment groups
Group A: ASTHMAXcelExperimental treatment 1 intervention
Group B: Usual Care (UC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from Baseline to 6 months after randomization

Secondary outcomes

1

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.

Time frame
Change from Baseline to 2 months after randomization
2

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.

Time frame
Baseline, 2 months, and 6 months after randomization
3

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.

Time frame
Baseline, 2 months, and 6 months after randomization
4

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.

Time frame
2 months and 6 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montefiore Medical Center

Lead sponsor

Yeshiva University

Collaborator

Agency for Healthcare Research and Quality (AHRQ)

Collaborator