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

Tracking Information

• First Submitted Date: February 15, 2019
• First Posted Date: February 20, 2019
• Last Update Posted Date: February 8, 2022
• Actual Study Start Date: March 1, 2020
• Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 18, 2019)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 19, 2019)

• 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
• 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
• 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
• 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
• 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
• 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
• Number of asthma emergency department visits [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
  Number of asthma emergency department visits
• Number of asthma hospitalizations [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
  Number of asthma hospitalizations

Original Secondary Outcome Measures (submitted: February 18, 2019)

• 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
• 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
• 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
• 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
• 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
• 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
• Asthma emergency department visits [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
  Asthma emergency department visits
• Asthma hospitalizations [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
  Asthma hospitalizations

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
• Official Title: Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Asthma

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 18, 2019): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2022
• Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03847142
• Other Study ID Numbers: 2018-9027; R18HS025645 ( U.S. AHRQ Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Responsible Party: Sunit P. Jariwala, Montefiore Medical Center
• Study Sponsor: Montefiore Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sunit Jariwala; Montefiore Medical Center

• PRS Account: Montefiore Medical Center
• Verification Date: February 2022