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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847142
• Other study ID #: 2018-9027
• Secondary ID: R18HS025645
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• ASTHMAXcel mobile application
ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.
• Outpatient primary care
Usual care delivered through the outpatient primary care setting

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of asthma emergency department visits	Number of asthma emergency department visits	Baseline, 2 months, 6 months, 12 months
Secondary	Number of asthma hospitalizations	Number of asthma hospitalizations	Baseline, 2 months, 6 months, 12 months