An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care

Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings

Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: ASTHMAXcel mobile application; Other: Outpatient primary care

Detailed Description

Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

English-speaking individuals >18 years with:

1. persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
2. able to give informed consent
3. Smartphone (iOS or Android) access

Exclusion Criteria:

1. use of oral corticosteroids in the 2 weeks prior to the baseline visit
2. pregnancy
3. severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
4. patients that previously received ASTHMAXcel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASTHMAXcel arm; The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma.	Other: ASTHMAXcel mobile application; ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.
Active Comparator: Usual care arm; This arm represents usual care delivered in the outpatient primary care setting at the study sites.	Other: Outpatient primary care; Usual care delivered through the outpatient primary care setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline asthma quality of life to 2, 6, and 12 months	Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)	Baseline, 2 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction measured by the Client Satisfaction Questionnaire-8	Patient satisfaction measured by the Client Satisfaction Questionnaire-8	Baseline, 2 months, 6 months, 12 months
Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire	Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire	Baseline, 2 months, 6 months, 12 months
Change from baseline asthma knowledge to 2 months, 6 months, and 12 months	Asthma knowledge as measured by the validated KASE asthma questionnaire	Baseline, 2 months, 6 months, 12 months
Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire	Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire	Baseline, 2 months, 6 months, 12 months
Change from baseline asthma control to 2, 6, and 12 months	Asthma symptom burden as measured by the Asthma Control Test	Baseline, 2 months, 6 months, 12 months
Depression as measured by the Patient Health Questionnaire-9	Depression as measured by the Patient Health Questionnaire-9	Baseline, 2 months, 6 months, 12 months
Number of asthma emergency department visits	Number of asthma emergency department visits	Baseline, 2 months, 6 months, 12 months
Number of asthma hospitalizations	Number of asthma hospitalizations	Baseline, 2 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Sunit Jariwala, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: asthma; informatics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2018-9027; R18HS025645 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No