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A Randomized Controlled Trial of AppS to Home Monitor Your Asthma (ASTHMA)

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: NCT04401332
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
RAND

Brief Summary:
The objective of this study is to design, implement, and evaluate the impact of an adapted health information technology(IT)-enabled practice model for asthma symptom monitoring using patient-reported outcomes (PROs) in a primary care setting. Adults over 18 years of age with asthma will be recruited at four primary care clinics and randomized to either 1) asthma symptom monitoring via the mobile health (mHealth) app; or 2) usual care. The investigators will collect data on patient-reported asthma quality of life and asthma-related healthcare utilization. We will also study barriers and facilitators to implementation of the mHealth app and health IT-enabled practice model.

Condition or disease Intervention/treatment Phase
Asthma Other: mobile health app Not Applicable

Detailed Description:

The specific aims of this study are:

  1. Adapt our existing health IT-enabled practice model for asthma symptom monitoring using PROs to a primary care population. The health IT-enabled practice model is comprised of the following: an mHealth app that can be installed on patients' smartphones that integrates into clinical workflow; and an asthma PRO dashboard in the electronic health record (EHR) for clinicians.
  2. Implement the adapted health IT-enabled practice model in 4 primary care community clinics, identify a cohort of eligible asthma patients to participate, and train clinicians and clinical staff.
  3. Rigorously evaluate the impact of this new health IT-enabled practice model using a randomized controlled trial study in which we enroll 500 asthma patients (250 intervention, 250 usual care) by primary care clinician. We will measure patient-reported asthma quality of life and asthma-related healthcare utilization (defined as urgent care and emergency room visits and hospitalizations) as our primary and secondary outcomes, respectively. We will use mixed methods to identify barriers and facilitators to implementation and factors that affect sustainable spread and scale as per the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Intervention Other: mobile health app
asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones

No Intervention: Usual Care



Primary Outcome Measures :
  1. Asthma-related patient-reported quality of life [ Time Frame: 6 months from enrollment ]
    Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)

  2. Asthma-related patient-reported quality of life [ Time Frame: 12 months from enrollment ]
    Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)


Secondary Outcome Measures :
  1. Asthma-related healthcare utilization [ Time Frame: 12 months from enrollment ]
    Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.



Information from the National Library of Medicine

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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
  • 18 years of age
  • Regularly uses (most days) a compatible smartphone (iOS or Android)
  • Able to provide consent
  • Seen for primary care within the last 12 months at one of the outpatient primary care clinics that are part of the Brigham & Women's Hospital (BWH)/ Brigham & Women's Faulkner Hospital (BWFH) practice-based research network.
  • At least one visit coded for asthma within 12 months prior to screening, including inpatient, emergency department, urgent care/walk-in, and specialist visits.

Exclusion Criteria:

  • Deemed inappropriate for study, per judgment of the BWH/ BWFH primary care provider
  • Unable to provide consent

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): NCT04401332


Contacts
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Contact: Robert S Rudin, PhD (617) 338-2059 ext 8636 rrudin@rand.org
Contact: Jessica L Sousa, MSW, MPH (617) 338-2059 ext 8604 jsousa@rand.org

Locations
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United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Anuj K Dalal, MD    617-525-8891    adalal1@partners.org   
Contact: Sofia Perez    (617) 732-5091    sperez11@bwh.harvard.edu   
Sponsors and Collaborators
RAND
Brigham and Women's Hospital
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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT04401332    
Other Study ID Numbers: 2019-0038
2018P002394 ( Other Identifier: Partners HealthCare )
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020

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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 RAND:
patient-reported outcomes (PROs)
mobile health (mHealth) apps
asthma
electronic health record (EHR)
health information technology
implementation research
mobile phone
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