Asthma, Asthma in Children
Conditions
Keywords
Air Quality Index (AQI), Childhood asthma exacerbations
Brief summary
This is a small pilot prospective intervention trial in children with asthma who will be randomized to receive either (A) Air Quality Index (AQI) education + an asthma action plan (control) or (B) AQI education + an asthma action plan which contains AQI behavioral recommendations + demonstrate ability to navigate to AirNow either online or on smartphone app (intervention).
Detailed description
Over 3 million US children with asthma reported at least one attack in the prior year. Poorly controlled asthma is a major cause of suffering, school absences, loss of caregiver productivity, and healthcare costs (estimated as \ $80 billion/year). Over half of children on controller medication are not well controlled, due to environmental exposures, non-adherence, or true non-response to treatment. Outdoor air pollution is a known trigger of asthma. Although sound health policies are the best long-term approaches to reduce the harmful effects of air pollution, exposure avoidance is needed until clean air is ensured through effective legislation. Despite this, healthcare providers infrequently provide pollution exposure advice to children with asthma. The Environmental Protection Agency (EPA) monitors air pollution and reports a daily Air Quality Index (AQI) that is easy to use and available in most metropolitan areas. Practical recommendations regarding outdoor activity can be based on AQI levels. Despite this, AQI-based recommendations are rarely addressed in asthma action plans (AAP). No pediatric study has assessed the addition of the AQI to AAP to reduce asthma morbidity. This proposal seeks to recruit a pilot cohort of 40 children with asthma. Using this cohort, the investigators will test the hypotheses that (1) the addition of the AQI to AAP will reduce asthma exacerbations and (2) the addition of the AQI to AAP will improve asthma symptom control & quality of life in children with asthma. The inclusion of the AQI onto asthma action plans is novel in clinical asthma care; its wide availability would make large-scale implementation feasible. The investigators expect this low-cost and low-tech intervention will have a positive impact in reducing asthma morbidity. Given that 1 out of every 12 children in the U.S. has asthma, this is relevant to health care professionals, parents, and public health practitioners. Optional, the investigators will collect nasal epithelial cells for use in future genomic/epigenetic studies. Additionally, 40 parents/guardians of the children were also recruited to complete a baseline parental knowledge and usage of the AQI questionnaire administered at the randomization visit. This was originally listed as a secondary outcome however was removed during reporting of results as parental knowledge is not a true clinical trial outcome. Also, the secondary outcome of baseline child AQI usage (checking AQI) was changed to reflect this was a measure collected at all study visits and the secondary measure of physical activity was added.
Interventions
BEHAVIORALAQI intervention
The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
OTHERRoutine care
The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
Sponsors
American Thoracic Society
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unblinded
Intervention model description
40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Child Inclusion criteria includes: 1. physician diagnosis of persistent asthma- either mild, moderate, or severe; 2. family home internet access and/or smartphone access + willingness to download AirNow app on phone; 3. age 8-17 years. Parent/guardian inclusion: parent or guardian of the child participant, of whom has met inclusion criteria.
Exclusion criteria
* Child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time | Over study duration (up to 6 months) | Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria. |
| Mean Change in Asthma Control Over Time | Over study duration (up to 6 months) | Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of \<=19 concerning for poor asthma control; \<=15 concerning for very poorly controlled). CACT (min=0, max=27, score of \<=19 concerning for poor asthma control; \<=12 concerning for very poorly controlled) |
| Mean Change in Pediatric Asthma Quality of Life Over Time | Baseline, 6 months | Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active | Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit. | Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No. |
| Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI | Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit. | Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time. |
| Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week | Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit. | Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Routine Care Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information. | 20 |
| AQI Intervention AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app). | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Total | AQI Intervention | Routine Care |
|---|---|---|---|
| Age, Categorical <=18 years | 40 Participants | 20 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.5 years STANDARD_DEVIATION 2.7 | 12.5 years STANDARD_DEVIATION 2.9 | 12.5 years STANDARD_DEVIATION 2.6 |
| Asthma Control Test (ACT) | 21.0 score on a scale STANDARD_DEVIATION 3.8 | 21.2 score on a scale STANDARD_DEVIATION 3 | 20.9 score on a scale STANDARD_DEVIATION 4.6 |
| At least one severe asthma exacerbation in the past 12 months, yes | 24 Participants | 13 Participants | 11 Participants |
| Body Mass Index z-score (BMIz) | 1.27 z score STANDARD_DEVIATION 1.29 | 1.03 z score STANDARD_DEVIATION 1.22 | 1.51 z score STANDARD_DEVIATION 1.35 |
| Childhood Asthma Control Test (CACT) | 21.6 score on a scale STANDARD_DEVIATION 5.8 | 20.7 score on a scale STANDARD_DEVIATION 8.3 | 22.6 score on a scale STANDARD_DEVIATION 1.3 |
| Pediatric Asthma Quality of Life Questionnaire | 6.03 score on a scale STANDARD_DEVIATION 0.93 | 6.11 score on a scale STANDARD_DEVIATION 0.84 | 5.96 score on a scale STANDARD_DEVIATION 1.02 |
| Race/Ethnicity, Customized Black | 15 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized More than 1 race | 7 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 10 Participants | 8 Participants |
| Region of Enrollment United States | 40 Participants | 20 Participants | 20 Participants |
| Reported any change in outdoor activity because of the AQI, yes | 8 Participants | 3 Participants | 5 Participants |
| Reported checking the AQI prior to going outside to be active, yes | 4 Participants | 2 Participants | 2 Participants |
| Reported moderate or vigorous activity for at least 10 minutes outside in a typical week, yes | 32 Participants | 18 Participants | 14 Participants |
| Sex: Female, Male Female | 20 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 20 Participants | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 3 / 20 | 4 / 20 |
| serious Total, serious adverse events | 2 / 20 | 1 / 20 |
Outcome results
Primary
Mean Change in Asthma Control Over Time
Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of \<=19 concerning for poor asthma control; \<=15 concerning for very poorly controlled). CACT (min=0, max=27, score of \<=19 concerning for poor asthma control; \<=12 concerning for very poorly controlled)
Time frame: Over study duration (up to 6 months)
Population: The mean change was obtained, via generalized linear modeling (glm), taking into account the correlation of repeat measures. The values are listed by group and contain all available time points averaged.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Routine Care | Mean Change in Asthma Control Over Time | Asthma Control Test | 0.17 score on a scale |
| Routine Care | Mean Change in Asthma Control Over Time | Childhood Asthma Control Test | -0.31 score on a scale |
| AQI Intervention | Mean Change in Asthma Control Over Time | Asthma Control Test | 2.02 score on a scale |
| AQI Intervention | Mean Change in Asthma Control Over Time | Childhood Asthma Control Test | 3.96 score on a scale |
Comparison: Outcome=Childhood Asthma Control Test Score. Obtained at all visits.p-value: 0.1495% CI: [-1.27, 9.2]generalized linear model, repeat measure
Comparison: Outcome=Childhood Asthma Control Test Scores.p-value: 0.1395% CI: [-1.19, 9.73]generalized linear model, repeat measure
Comparison: Outcome=Asthma Control Test Score. Obtained at all visits.p-value: 0.895% CI: [-1.17, 1.51]generalized linear model, repeat measure
Comparison: Outcome=Asthma Control Test Score. Obtained at all visits.p-value: 0.00195% CI: [0.88, 3.15]generalized linear model, repeat measure
Comparison: Outcome=Asthma Control Test Score. Obtained at all visits.p-value: 0.0495% CI: [0.09, 3.61]generalized linear model, repeat measure
Comparison: Outcome=Childhood Asthma Control Test Score. Obtained at all visits.p-value: 0.795% CI: [-1.87, 1.25]generalized linear model, repeat measure
Primary
Mean Change in Pediatric Asthma Quality of Life Over Time
Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)
Time frame: Baseline, 6 months
Population: 1 participant lost to follow up at exit visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Routine Care | Mean Change in Pediatric Asthma Quality of Life Over Time | 0.25 score on a scale |
| AQI Intervention | Mean Change in Pediatric Asthma Quality of Life Over Time | 0.54 score on a scale |
Comparison: Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).p-value: 0.1195% CI: [-0.06, 0.55]generalized linear model, repeat measure
Comparison: Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).p-value: 0.00295% CI: [0.2, 0.88]generalized linear model, repeat measure
Comparison: Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).p-value: 0.295% CI: [-0.16, 0.75]generalized linear model, repeat measure
Primary
Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.
Time frame: Over study duration (up to 6 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Routine Care | Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time | At least one severe asthma exacerbation during study, yes | 5 Participants |
| Routine Care | Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time | At least one moderate asthma exacerbation during study, yes | 13 Participants |
| AQI Intervention | Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time | At least one severe asthma exacerbation during study, yes | 4 Participants |
| AQI Intervention | Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time | At least one moderate asthma exacerbation during study, yes | 12 Participants |
Comparison: Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).p-value: 0.3295% CI: [0.23, 1.61]Generalized linear model, repeat measure
Comparison: Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).p-value: 0.2995% CI: [0.03, 2.76]generalized linear model, repeat measure
Comparison: Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).p-value: 0.5895% CI: [0.05, 5.68]generalized linear model, repeat measure
Comparison: Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).p-value: 0.0295% CI: [0.27, 0.91]generalized linear model, repeat measure
Comparison: Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).p-value: 0.0395% CI: [0.06, 0.86]generalized linear model, repeat measure
Comparison: Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).p-value: 0.395% CI: [0.11, 1.95]generalized linear model, repeat measure
Secondary
Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active
Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.
Time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Population: 1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Care | Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active | 3 Participants |
| AQI Intervention | Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active | 12 Participants |
Comparison: Outcome: Reported checking the AQI prior to going outside to be activep-value: 0.8795% CI: [0.45, 1.96]generalized linear model, repeat measure
Comparison: Outcome: Reported checking the AQI prior to going outside to be activep-value: 0.00495% CI: [1.85, 25.6]generalized linear model, repeat measure
Comparison: Outcome: Reported checking the AQI prior to going outside to be activep-value: 0.0195% CI: [1.62, 32.9]generalized linear model, repeat measure
Secondary
Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week
Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.
Time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Population: 1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Care | Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week | 9 Participants |
| AQI Intervention | Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week | 7 Participants |
Comparison: Obtained at all visitsp-value: 0.00495% CI: [0.24, 0.76]generalized linear model, repeat measure
Comparison: Obtained at all visits.p-value: <0.000195% CI: [0.05, 0.31]generalized linear model, repeat measure
Comparison: Obtained at all visits.p-value: 0.0395% CI: [0.1, 0.87]generalized linear model, repeat measure
Secondary
Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI
Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.
Time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Population: 1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Routine Care | Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI | 2 Participants |
| AQI Intervention | Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI | 7 Participants |
Comparison: Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.p-value: 0.1595% CI: [0.08, 1.47]generalized linear model, repeat measure
Comparison: Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.p-value: 0.9495% CI: [0.35, 2.68]generalized linear model, repeat measure
Comparison: Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.p-value: 0.2695% CI: [0.47, 16.5]generalized linear model, repeat measure