NCT04401332

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
413

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

May 20, 2020

Results QC Date

February 6, 2026

Last Update Submit

March 19, 2026

Conditions

Asthma

Keywords

patient-reported outcomes (PROs)mobile health (mHealth) appsasthmaelectronic health record (EHR)health information technologyimplementation researchmobile phone

Outcome Measures

Primary Outcomes (2)

  • Change in Asthma-related Quality of Life (Mini AQLQ Score) - 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).

    Baseline to 12 months

  • Change in Asthma-related Quality of Life (Mini AQLQ Score) - 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).

    Baseline to 6 months

Secondary Outcomes (1)

  • Asthma-related Healthcare Utilization

    Baseline to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

All enrolled participants were assigned to a single study arm and received the intervention. The intervention consisted of a study smartphone application for asthma symptom monitoring (available in Spanish and English and downloadable for iOS and Android devices).

Other: Mobile health app

Usual Care

NO INTERVENTION

Usual care group patients received an email with general asthma advice

Interventions

Mobile health appOTHER

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English- or Spanish-speaking
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Rudin RS, Plombon S, Sulca Flores J, Sousa JL, Rodriguez J, Foer D, Lipsitz S, Edelen MO, Bates DW, Arcia A, Dalal AK. Between-Visit Asthma Symptom Monitoring With a Scalable Digital Intervention: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e256219. doi: 10.1001/jamanetworkopen.2025.6219.

    PMID: 40266619RESULT

  • Sulca Flores JA, Dalal AK, Sousa J, Foer D, Rodriguez JA, Plombon S, Bates DW, Arcia A, Rudin RS. Evaluation of a Primary Care-Integrated Mobile Health Intervention to Monitor between-Visit Asthma Symptoms. Appl Clin Inform. 2024 Aug;15(4):785-797. doi: 10.1055/s-0044-1788978. Epub 2024 Oct 2.

    PMID: 39357877RESULT

  • Rudin RS, Perez S, Rodriguez JA, Sousa J, Plombon S, Arcia A, Foer D, Bates DW, Dalal AK. User-centered design of a scalable, electronic health record-integrated remote symptom monitoring intervention for patients with asthma and providers in primary care. J Am Med Inform Assoc. 2021 Oct 12;28(11):2433-2444. doi: 10.1093/jamia/ocab157.

    PMID: 34406413RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

Please see attached outcomes paper for detail on study limitations

Results Point of Contact

Title
Robert S. Rudin, PhD
Organization
RAND
rrudin@rand.org
(617) 338-2059

Study Officials

  • Robert S Rudin, PhD

    RAND

    PRINCIPAL INVESTIGATOR

  • Anuj K Dalal, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 26, 2020

Study Start

July 21, 2020

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

April 8, 2026

Results First Posted

April 8, 2026

Record last verified: 2026-03

Locations

US(1)