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

• ClinicalTrials.gov Identifier: NCT03847142
• Recruitment Status: Recruiting
• First Posted: February 20, 2019
• Last Update Posted: February 8, 2022
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Sunit P. Jariwala, Montefiore Medical Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Asthma	Other: ASTHMAXcel mobile application; Other: Outpatient primary care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
• Actual Study Start Date: March 1, 2020
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline asthma quality of life to 2, 6, and 12 months [ Time Frame: 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 :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Sunit Jariwala, MD; 8666338255; sjariwal@montefiore.org

Contact: Emine Cosar; 8666338255; ecosar@montefiore.org

Locations

United States, New York

Montefiore Medical Center; Recruiting

Bronx, New York, United States, 10467

Contact: Sunit Jariwala 866-633-8255 sjariwal@montefiore.org

Sponsors and Collaborators

Montefiore Medical Center

Investigators

• Principal Investigator: Sunit Jariwala; Montefiore Medical Center

More Information

• Responsible Party: Sunit P. Jariwala, Associate Professor (Medicine), Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03847142
• Other Study ID Numbers: 2018-9027; R18HS025645 ( U.S. AHRQ Grant/Contract )
• First Posted: February 20, 2019
• Last Update Posted: February 8, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sunit P. Jariwala, Montefiore Medical Center:

informatics; asthma

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases