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| ID | Type | Description | Link |
|---|---|---|---|
| 2018P002394 | Other Identifier | Mass General Brigham |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
The specific aims of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Usual Care | No Intervention | Usual care group patients received an email with general asthma advice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile health app | Other | Asthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Rudin, PhD | RAND | Principal Investigator |
| Anuj K Dalal, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40266619 | Result | 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. | |
| 39357877 | Result |
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Primary care clinicians participated in delivering usual clinical care and supporting the intervention but were not enrolled as research participants and are therefore not included in enrollment counts or study data reported in this record.
After providing informed consent and completing baseline questionnaires, 413 eligible patients were randomized to the intervention group (n = 211) or the usual care control group (n = 202).
Adults with a diagnosis of asthma who had a primary care provider at one of seven participating primary care clinics affiliated with a large academic health center in Boston, MA were identified and recruited between July 2020 and March 2022. Eligible patients completed screening and baseline questionnaires prior to enrollment.
Reported recruitment and pre-assignment details apply to patient participants only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intervention group patients were asked to download and use the study app on their smartphone. The app was available in Spanish and English and downloadable for iOS and Android devices. The app asked patients to complete weekly symptom questionnaires; showed their data in graph form; allowed them to enter notes, triggers and peak flow values; and provided educational videos such as how to use a rescue inhaler. For the weekly questionnaires, patients were prompted to complete an initial 5-item baseline Asthma Control Measure (ACM) questionnaire followed by similar weekly patient-reported outcome (PRO) questionnaires. If the PROs reflected problematic symptoms (defined as a 3-point worsening in the ACM compared to their baseline or prior week's score, or severest symptom on any one question), the app asked the patient if they wanted to request a call from a nurse. If the patient agreed, the app would send an electronic health record (EHR) inbox message to a triage nurse in the patient's primary care clinic. Patients also received reminders in the app prior to scheduled PCP visits to bring their smartphone and discuss their asthma data with their clinician. |
| FG001 | Usual Care | Usual care group patients received an email with general asthma advice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention group patients were asked to download and use the study app on their smartphone (available in English and Spanish) |
| BG001 | Control (Usual Care) | Usual care group patients received an email with general asthma advice |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Includes participants who completed the 12-month MiniAQLQ questionnaire. | Posted | Mean | 95% Confidence Interval | Change in units on a scale | Baseline to 12 months |
|
Not applicable (AEs not collected)
Adverse events were not systematically collected as part of this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Intervention group patients were asked to download and use the study app on their smartphone (available in English and Spanish) |
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Please see attached outcomes paper for detail on study limitations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert S. Rudin, PhD | RAND | (617) 338-2059 | 8636 | rrudin@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Jan 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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. |
| 34406413 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score | The Mini Asthma Quality of Life Questionnaire (MiniAQLQ) is a 15-item validated questionnaire assessing asthma-related quality of life across four domains (symptoms, activity limitations, emotional function, and environmental stimuli). Scores range from 1 (worst quality of life) to 7 (best quality of life). | Mean | Standard Deviation | Score on a scale |
|
| OG001 | Control (Usual Care) | Usual care group patients received an email with general asthma advice |
|
|
| Primary | 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). | Includes participants who completed the 6-month Mini Asthma Quality of Life Questionnaire (MiniAQLQ). | Posted | Mean | 95% Confidence Interval | Change in units on a scale | Baseline to 6 months |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Encounters per participant | Baseline to 12 months |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control (Usual Care) | Usual care group patients received an email with general asthma advice | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |