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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mobile health app
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring patient-reported outcomes (PROs), mobile health (mHealth) apps, asthma, electronic health record (EHR), health information technology, implementation research, mobile phone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham & Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Asthma-related healthcare utilization
Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.

Full Information

First Posted
May 20, 2020
Last Updated
May 25, 2023
Sponsor
RAND
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04401332
Brief Title
A Randomized Controlled Trial of AppS to Home Monitor Your Asthma
Acronym
ASTHMA
Official Title
Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
patient-reported outcomes (PROs), mobile health (mHealth) apps, asthma, electronic health record (EHR), health information technology, implementation research, mobile phone

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
445 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
mobile health app
Intervention Description
asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones
Primary Outcome Measure Information:
Title
Asthma-related patient-reported quality of life
Description
Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
Time Frame
6 months from enrollment
Title
Asthma-related patient-reported quality of life
Description
Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
Time Frame
12 months from enrollment
Secondary Outcome Measure Information:
Title
Asthma-related healthcare utilization
Description
Asthma-related healthcare utilization, defined as number of urgent care and emergency room visits, and number of hospitalizations.
Time Frame
12 months from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Rudin, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anuj K Dalal, MD
Organizational Affiliation
Mass General Brigham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Randomized Controlled Trial of AppS to Home Monitor Your Asthma

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