Trial Outcomes & Findings for A Randomized Controlled Trial of AppS to Home Monitor Your Asthma (NCT NCT04401332)
NCT ID: NCT04401332
Last Updated: 2026-04-08
Results Overview
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).
COMPLETED
NA
413 participants
Baseline to 12 months
2026-04-08
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
Usual Care
Usual care group patients received an email with general asthma advice
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
202
|
|
Overall Study
COMPLETED
|
176
|
190
|
|
Overall Study
NOT COMPLETED
|
35
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of AppS to Home Monitor Your Asthma
Baseline characteristics by cohort
| Measure |
Intervention
n=211 Participants
Intervention group patients were asked to download and use the study app on their smartphone (available in English and Spanish)
|
Control (Usual Care)
n=202 Participants
Usual care group patients received an email with general asthma advice
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 Years
STANDARD_DEVIATION 15.5 • n=527 Participants
|
52.6 Years
STANDARD_DEVIATION 15.4 • n=527 Participants
|
52.2 Years
STANDARD_DEVIATION 15.4 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=527 Participants
|
164 Participants
n=527 Participants
|
321 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=527 Participants
|
38 Participants
n=527 Participants
|
92 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Black
|
37 Participants
n=527 Participants
|
45 Participants
n=527 Participants
|
82 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
42 Participants
n=527 Participants
|
35 Participants
n=527 Participants
|
77 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=527 Participants
|
110 Participants
n=527 Participants
|
226 Participants
n=1054 Participants
|
|
Race/Ethnicity, Customized
Other or missing
|
16 Participants
n=527 Participants
|
12 Participants
n=527 Participants
|
28 Participants
n=1054 Participants
|
|
Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score
|
5.18 Score on a scale
STANDARD_DEVIATION 1.21 • n=527 Participants
|
5.04 Score on a scale
STANDARD_DEVIATION 1.27 • n=527 Participants
|
5.11 Score on a scale
STANDARD_DEVIATION 1.24 • n=1054 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Includes participants who completed the 12-month MiniAQLQ questionnaire.
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).
Outcome measures
| Measure |
Intervention
n=176 Participants
Intervention group patients were asked to download and use the study app on their smartphone (available in English and Spanish)
|
Control (Usual Care)
n=190 Participants
Usual care group patients received an email with general asthma advice
|
|---|---|---|
|
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 12 Months
|
0.34 Change in units on a scale
95% Confidence Interval 1.16 • Interval 0.19 to 0.49
|
0.11 Change in units on a scale
95% Confidence Interval 1.28 • Interval -0.11 to 0.33
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Includes participants who completed the 6-month Mini Asthma Quality of Life Questionnaire (MiniAQLQ).
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).
Outcome measures
| Measure |
Intervention
n=141 Participants
Intervention group patients were asked to download and use the study app on their smartphone (available in English and Spanish)
|
Control (Usual Care)
n=146 Participants
Usual care group patients received an email with general asthma advice
|
|---|---|---|
|
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 6 Months
|
0.22 Change in units on a scale
Interval 0.1 to 0.35
|
-0.10 Change in units on a scale
Interval -0.22 to 0.03
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsMean 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.
Outcome measures
| Measure |
Intervention
n=211 Participants
Intervention group patients were asked to download and use the study app on their smartphone (available in English and Spanish)
|
Control (Usual Care)
n=202 Participants
Usual care group patients received an email with general asthma advice
|
|---|---|---|
|
Asthma-related Healthcare Utilization
|
0.59 Encounters per participant
Interval 0.42 to 0.77
|
0.76 Encounters per participant
Interval 0.55 to 0.96
|
Adverse Events
Intervention
Control (Usual Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place