NCT04401332

A Randomized Controlled Trial of AppS to Home Monitor Your Asthma

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: RAND · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Mobile health app	Asthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones.

Timeline

• Start date: 2020-07-21
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-05-26
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

1 site across 1 country: United States