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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847142
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sunit P. Jariwala, 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.

Condition or disease Intervention/treatment Phase
Asthma Other: ASTHMAXcel mobile application Other: Outpatient primary care Phase 2

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.

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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 : August 1, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847142


Contacts
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Contact: Sunit Jariwala, MD 8666338255 sjariwal@montefiore.org
Contact: Emine Cosar 8666338255 ecosar@montefiore.org

Locations
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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
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Principal Investigator: Sunit Jariwala Montefiore Medical Center
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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    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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