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

May 25, 2023 updated by: RAND

Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 7 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.

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English- or Spanish-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 7 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months from enrollment
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)
12 months from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Robert S Rudin, PhD, RAND
  • Principal Investigator: Anuj K Dalal, MD, Mass General Brigham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0038
  • 2018P002394 (Other Identifier: Mass General Brigham)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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