ASTHMAXcel Voice Study

Not Applicable

Not yet recruiting

• Conditions: Asthma

• Registration Number: NCT06935084
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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.

Detailed Description

Poor outcomes for minority patients with asthma have been linked to poverty and other social determinants of health (SDOH), environmental exposures, and poor self-management. In a previous Agency for Healthcare Research and Quality (AHRQ)-funded study, the researchers developed and pilot tested ASTHMAXcel PRO, a mobile app that promotes self-management of asthma (NCT03847142). The app was optimized for outpatient settings and promoted asthma self-management through the collection of patient-reported outcomes (PROs), animated videos, goal setting, personalized algorithms, and push notifications. The use of the app led to significant decreases in the need for steroids, visits for asthma to the emergency department, and hospitalizations for asthma.

In this current research, ASTHMAXcel Voice, an app developed and refined during enhancement of ASTHMAXcel PRO, will make use of voice biomarkers to detect worsening symptoms. This technology uses machine learning to assess respiratory dysfunction, including asthma, based on a 6-second voice sample. From the sample, a Respiratory Symptoms Risk Score (RSRS) is calculated that correlates with the speaker's risk of respiratory impairment. The updated platform will calculate the patient's RSRS; facilitate shared decision making, screen for SDoH, and referrals; improve the ability of patients to self-manage; and allow for remote care coordination.

This program draws upon the Common Sense Model (CSM) of Self-Regulation which describes a cognitive processing system that includes situational stimuli (asthma symptoms), objective representation of the health threat (illness representations) with its treatment decision (controller medication use), and appraisal of outcomes (asthma control) for the success/failure of those treatment decisions. The model contains a feedback loop with illness representations changing over time as patients gain experience with asthma management. Social Determinants of Health (SDoH) may also affect the representation of the health threat, treatment decisions, and appraisal of outcomes. As an example, a patient with depression, a poor social support network, insecure housing, and financial stress may view asthma as an acute disease that is uncontrollable, which in turn leads to negative beliefs about medications and low self-efficacy towards asthma management. ASTHMAXcel Voice strives to shift illness representations away from the belief that asthma only exists when there are active symptoms and change behavior towards daily controller medication use over the long term to prevent asthma symptoms. Realtime feedback based on voice samples that yield a RSRS (voice biomarker) will help the patient to accurately detect perceived threats and manage asthma exacerbations during earlier stages. ASTHMAXcel Voice is also based on the SEM that addresses causes of poor asthma control across four interconnected domains: community, medical system, interpersonal, and individual level factors. ASTHMAXcel Voice is a multilevel approach to address these barriers with intervention components that are directly applied at each level.

There is growing recognition that mobile health interventions can be applied across all these levels to facilitate health behavior change through the use of push notifications and interactive educational content. ASTHMAXcel Voice works on the individual and interpersonal levels by providing targeted asthma education and push notifications to assist with medication adherence and asthma management. Worse outcomes assessed by PROs (asthma control) and voice biomarkers may heighten the perceived threat level of asthma and prompt Just-in-Time Adaptive Interventions (JITAIs) to seek out the educational content more frequently to improve asthma control. On the organizational (medical system) level, ASTHMAXcel Voice will facilitate shared decision-making and ongoing communication between the patient, Community Health Worker (CHW) or Social Worker (SW), and Health Care Provider (HCP). For example, a monthly visual dashboard display will increase HCP awareness of deteriorating trends assessed from PROs and voice biomarkers. On the community level, the CHW or SW will provide patients with SDoH relevant community resources (e.g., pest remediation services, smoking cessation programs, support groups, food pantries) to address SDoH concerns reported in the mobile platform. Finally, to inform more effective design and implementation of ASTHMAXcel Voice, the study team will use the Unified Theory of Acceptance and use of Technology (UTAUT) health IT framework in determining a user's technology acceptance and adoption behavior.

Study Timeline

• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Study Start: 2025-07
• Primary Completion: 2028-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy
• Severe psychiatric or cognitive problems that would prohibit completion of protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Asthma Control	Change from Baseline to 6 months after randomization	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 Outcome Measures

Name	Time	Method
Change in Asthma Control	Change from Baseline to 2 months after randomization	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	Baseline, 2 months, and 6 months after randomization	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	Baseline, 2 months, and 6 months after randomization	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	2 months and 6 months after randomization	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.
Change in Overall User Satisfaction	Baseline, 2 months, and 6 months after randomization	Overall User Satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a brief global measure of client satisfaction which contains four response choices (1-4), where "1" indicates the lowest degree of satisfaction and "4," the highest. Scores are summed across each item once. Responses to items 2, 4, 5, and 8 are reverse scored. Total overall scores range from 8-32, where in higher scores are indicative of greater overall user satisfaction. Scores will be summarized by using basic descriptive statistics. Paired t-tests will also be used to assess changes between post-refinement baseline and 2 months and baseline and 6 months within the arm.
Change in Shared Decision Making	Baseline to 2 months and 6 months after randomization	Patient-reported degree of shared decision making will be assessed using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). The SDM-Q-9 consists of 9 statements which asks the patient to assess the extent to which they agree or disagree with elements and perceptions of shared decision-making during clinical encounters. Each statement on the SDM-Q-9 is scored on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Scores are summed to yield an overall possible scoring range of 0-45, with higher values being indicative of greater perceived shared decision making. Scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to assess changes between post-refinement baseline and 2 months and 6 months within the arm
Change in Asthma-related Quality of Life	Baseline to 2 months and 6 months after randomization	Change in Asthma-related Quality of Life will be assessed using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ). The MiniAQLQ is a 15-item questionnaire that assesses asthma-related quality of life. Participants are asked to evaluate each of the questions/statements to describe how much (relative) time has been spent attending to symptoms of asthma or how much asthma has limited activities over the past 2 weeks. Each of the 15 items is scored on a 7-point Likert scale ranging from 1 (severe impairment) to 7 (no impairment), such that higher scores are associated with a better overall quality of life. Scores for the 15-items are summed and divided by 15 to express as a score out of 7 (mean or average score). Change in asthma quality of life scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to assess changes in asthma-related quality of life between baseline and 2 months and baseline and 6 months within each arm.
Asthma Healthcare Utilization - Emergency Department (ED) Visits	2 months and 6 months after randomization	The number of asthma-related ED visits at 2 months and 6-months post-randomization will be summarized by study arm using basic descriptive statistics.
Asthma Healthcare Utilization - Hospitalizations	2 months and 6 months after randomization	The number of asthma-related hospitalizations at 2 months and 6-months post-randomization will be summarized by study arm using basic descriptive statistics.
Change in Self-efficacy for managing chronic diseases	Baseline to 2 months and 6 months after randomization	Self-efficacy for managing chronic diseases will be evaluated using the Self-Efficacy for Managing Chronic Disease 6-Item (SEMCD-6) Scale. The SEMCD-6 assesses the level of confidence in managing six areas related to chronic disease: fatigue, physical discomfort/pain, emotional distress, other symptoms/health problems, tasks/activities needed to manage health conditions, and things other than just taking medication. Each question is rated on a 10-point scale ranging from 1 (not confident at all) to 10 (totally confident). Scores for all six items are summed, and then the total score is divided by six to calculate a mean or average score. Higher scores are associated with greater self-efficacy. Group scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to assess changes between post-refinement baseline and 2 months and 6 months within the arm.
Change in Self-reported Medication Adherence	Baseline to 2 months and 6 months after randomization	Medication Adherence will be evaluated using the 5-Item Medication Adherence Report Scale (MARS-5). The MARS-5 is a self-reported tool used to assess medication adherence and consists of 5 questions including items related to forgetting, changing dosage, stopping, skipping, and taking less medication. Each question is answered on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, and 5=never), resulting in an overall possible score of 5-25, with higher scores indicating a higher level of adherence. Group scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to assess changes between post-refinement baseline and 2 months and 6 months within the arm
SDoH Screening	2 months and 6 months after randomization	SDoH Screening will be determined by the number of SDoH positive screens over the prior month. Group scores will be summarized by study arm using basic descriptive statistics.
SDoH Referral	2 months and 6 months after randomization	SDoH Referral will be determined by the number of completed SDoH referrals over the prior month. Group scores will be summarized by study arm using basic descriptive statistics.
Referral Completion Rate	2 months and 6 months after randomization	SDoH Referral Completion Rate will be assessed by the number of SDoH referral completions over the prior month. Group scores will be summarized by study arm using basic descriptive statistics.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States