A Randomized Controlled Trial of AppS to Home Monitor Your Asthma

Asthma Clinical Trial

— ASTHMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401332
• Other study ID #: 2019-0038
• Secondary ID: 2018P002394
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• mobile health app
asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma-related patient-reported quality of life	Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)	6 months from enrollment
Primary	Asthma-related patient-reported quality of life	Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)	12 months from enrollment
Secondary	Asthma-related healthcare utilization	Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.	12 months from enrollment