AsthmaASTHMANCT04401332
A Randomized Controlled Trial of AppS to Home Monitor Your Asthma
A study testing Mobile health app in people with Asthma, run by RAND at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mobile health app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Deemed inappropriate for study, per judgment of the BWH/ BWFH primary care provider
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Mobile health app
- Keywords
- patient-reported outcomes (PROs), mobile health (mHealth) apps, asthma, electronic health record (EHR), health information technology, implementation research, mobile phone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health appOther
Asthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Mobile health app |
| Usual Care | No intervention | Usual care group patients received an email with general asthma advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline to 6 months
Secondary outcomes (1)
Asthma-related Healthcare Utilization
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start21 Jul 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Robert S Rudin, PhD, Principal investigator, RANDAnuj K Dalal, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401332
- Sponsor's protocol ID
- 2019-0038
- Other IDs
- 2018P002394
- Acronym
- ASTHMA
- Status last verified
- Mar 2026
- First submitted
- 20 May 2020
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40266619Sulca 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.
PubMed 39357877Rudin 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.
PubMed 34406413
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits
- ClinicalTrials.gov ID
- NCT04401332
- Acronym / sponsor ID
- ASTHMA / 2019-0038
- Conditions
- Asthma
- Keywords
- patient-reported outcomes (PROs), mobile health (mHealth) apps, asthma, electronic health record (EHR), health information technology, implementation research, mobile phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Mobile health appAll 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). |
| Usual Care | No intervention | –Usual care group patients received an email with general asthma advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Deemed inappropriate for study, per judgment of the BWH/ BWFH primary care provider
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health appAsthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones. | Other | Intervention |
Primary outcome
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).
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).
1 secondary outcome
Asthma-related Healthcare Utilization
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40266619Rudin 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.
- Results publication: PubMed 39357877Sulca 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.
- Results publication: PubMed 34406413Rudin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Rudin, PhD principal investigator
RAND
Anuj K Dalal, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health app in people with Asthma, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 12 Months (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.