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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: ASTHMAXcel mobile application; Other: Outpatient primary care

• Registration Number: NCT03847142
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Study Start: 2020-03-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASTHMAXcel arm	ASTHMAXcel mobile application	The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma.
Usual care arm	Outpatient primary care	This arm represents usual care delivered in the outpatient primary care setting at the study sites.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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