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OpenTrials
Completed

NCT Number: NCT04401332

A Randomized Controlled Trial of AppS to Home Monitor Your Asthma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

The specific aims of this study are:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile health app

Other

Asthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones.

Primary outcomes

  1. Change in Asthma-related Quality of Life (Mini AQLQ Score) - 12 Months

    Time frame: Baseline to 12 months

    Mean change in asthma-related patient-reported quality of life from baseline to 12 months, assessed using the 15-item Mini Asthma Quality of Life Questionnaire (MiniAQLQ). MiniAQLQ scores range from 1 (worst quality of life) to 7 (best quality of life), with higher scores indicating better asthma-related quality of life. The MiniAQLQ score represents the mean of 15 items across four domains (symptoms, activity limitation, emotional function, and environmental stimuli).

  2. Change in Asthma-related Quality of Life (Mini AQLQ Score) - 6 Months

    Time frame: Baseline to 6 months

    Mean change in asthma-related patient-reported quality of life from baseline to 6 months, assessed using the 15-item Mini Asthma Quality of Life Questionnaire (MiniAQLQ). MiniAQLQ scores range from 1 (worst quality of life) to 7 (best quality of life), with higher scores indicating better asthma-related quality of life. The MiniAQLQ score represents the mean of 15 items across four domains (symptoms, activity limitation, emotional function, and environmental stimuli).

Secondary outcomes

  1. Asthma-related Healthcare Utilization

    Time frame: Baseline to 12 months

    Mean number of asthma-related healthcare encounters per participant during the study period, including nonroutine asthma-related emergency department visits, urgent care visits, and hospitalizations (with asthma listed as the primary or secondary diagnosis) at MGB-affiliated institutions.

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

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

Acronym: ASTHMA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 26, 2020
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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