Air Quality Index (AQI) and Childhood Asthma: an Intervention
Phase: NA
Conditions: Asthma, Asthma in Children
Sponsor: University of Pittsburgh

PROTOCOL & STATISTICAL PLAN 
Title: Air Quality Index (AQI) and Childhood Asthma: an intervention 
NCT: 004454125 
Date: March 17th, 2020 
Note: The protocol and statistical plan were IRB approved on 03_17_2020. The 
following changes were made on 03_18_2022 prior to uploading to 
ClinicalTrials.gov: the protocol and statistical plan were combined and the 
protocol background and significance section were removed.  

 
2 
 
2. STUDY DESIGN:  
 
Longitudinal (6 month) intervention trial, simple randomized 1:1 with stratification based on age 
(8-12 years, 13-17 years), non-blinded, to determine if adding the AQI to asthma action plans 
(AAP) reduces asthma exacerbations, and improves asthma control and quality of life (Figure 
3).  
 
Both groups will receive basic 
education about the AQI including 
what the AQI is, where to find it, 
how to use it, and behavioral 
recommendations by category. In 
our practice, discussion of the AQI 
varies by practitioner and patients. 
While true routine care is likely 
absence of discussion of the AQI, 
this was determined to be 
inappropriate for this study. First, 
consenting children to the study 
would result in some discussion of 
the AQI and therefore bias any true 
“routine care”. Second, we did not 
wish to withhold potentially vital 
asthma self-management to 
participants. Therefore, all children 
in the study will receive AQI 
education. The routine group will receive written AAP only, and the intervention group will 
receive AAP + AQI written plan. Additionally, the intervention group will be required to 
download the app onto their or their parent’s smartphone (available both for iPhone or android 
phones) or demonstrate the ability to navigate to the airnow.gov website to obtain the AQI at 
their location. Participants will be followed at monthly intervals for 6 months.  
 
The goal of the AQI is to familiarize persons to their own sensitivities to air pollution and 
encourage self-modification as needed for personal symptom control. Additionally, there is a 
goal to prevent discouraging physical activity as most US persons do not meet current daily 
recommendations.  
 
2.1 Hypothesis and Specific Aims 
We hypothesize that the addition of the AQI to AAP will (A) reduce asthma exacerbations, and 
(B) improve symptom control & quality of life in children with asthma. To test these 
hypotheses, in this study we will pursue the following specific aims: 
• Aim 1:  To recruit a pilot cohort of 40 children with asthma. For proof of concept, we will 
recruit 40 children with asthma from Children’s Hospital of Pittsburgh, the only 
children’s hospital serving southwest Pennsylvania (metropolitan area >2.6 million 
people). Baseline knowledge about the AQI including familiarity, usage, and prior 
healthcare provider discussion will be assessed.  
 
Figure 3: Proposed cohort flow chart  
 
AAP= asthma action plan; AQI= Air Quality Index 

 
3 
• Aim 2: To evaluate if the addition of the AQI to AAP reduces asthma exacerbations in a 
pilot study of children. Participating children (Aim 1) will be randomized to one of two 
groups. All participants/caregivers will receive an AAP and verbal AQI education. The 
intervention group will additionally demonstrate the ability to check the AQI, and AQI 
recommendations will be incorporated onto their written AAP. Children will be followed 
monthly for 6 months to evaluate adherence to AQI recommendations and assess the 
frequency of asthma exacerbations, defined per ATS guidelines.  Other known factors 
contributing to asthma exacerbations, such as asthma severity, viral illnesses, allergic 
triggers will also be monitored.  
 
• Aim 3: To examine whether the addition of the AQI to AAP improves asthma symptom 
control and quality of life in a pilot study of children Asthma symptom control will be 
measured in participating children monthly, and quality of life will be assessed before 
randomization and at 6 months. Symptom control and quality of life will be evaluated 
within (before/after intervention) and between groups.  
 
2.2 Outcome Measures 
 
• Asthma exacerbations will be defined by ATS guidelines as:  
(1) Severe:  
a) requiring 3 or more days of systemic corticosteroids  
or  
b) ED visit/hospitalization for asthma treated with systemic steroids (any 
duration) 
 
(2) Moderate: 
a) asthma symptoms + increased rescue medication both for at least 2 days50  
or  
b) a visit to ED/urgent care/doctor office or clinic for which sick care was sought 
for asthma but no systemic steroids were given 
 
(note: Inclusion of urgent care/doctor office or clinic for acute asthma care is interpretation 
of PI and not explicitly stated in ATS guidelines, this does not include routine visits) 
 
• Asthma control will be defined used validated asthma control tests: ACT for children 
12 years and older and CACT for children 8-11 years.  
 
• Asthma quality of life will be assessed via the validated pediatric asthma quality of 
life questionnaire (PAQLQ(S)).  
 
2.3 Questionnaires 
7 questionnaires will be administered to the parents and children of study participants (see 
Figure 4).  (1) Intake Questionnaire: this is a respiratory/general health questionnaire used 
by the VitD Kids Asthma Study.  (2) Tobacco Questionnaire- this is a short questionnaire 
from questions used on the National Youth Tobacco Survey. (3) AQI intake & follow up: 
Intake: there are no existing questionnaires evaluating what parents know about the AQI 
as pertains to their children with asthma. This questionnaire contains questions from 
NHANES and BRFSS with modifications. The AQI intake has a section to be completed by 
the parent to understand the parent’s knowledge and practices regarding the AQI. The 

 
4 
intake questionnaire additionally contains a section for the child to complete, which is the 
AQI follow up questionnaire. The follow up questionnaire was developed by the PI to 
assess usage of the AQI. (4) Asthma Control Test (ACT)51 and Childhood Asthma Control 
Test (C-ACT)52  are validated questionnaires to assess asthma control in the last 4 weeks. 
(5) Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))© is validated questionnaire 
that will be interviewer-administered53. (6) Physical activity questionnaire contains modified 
questions from NHANES and The Physical Activity Questionnaire for older children and 
adolescents. (7) Shortened respiratory questionnaire (sRHQ): this is a short questionnaire 
that has been modified from the VitD Kids Asthma study. It is designed to capture asthma 
exacerbations.  
 
The order of the questionnaires is important. The AQI intake form will be completed by the 
parent/guardian and the child participant prior to AQI education/intervention.  
 
2.4 Lung Function Tests: Spirometry and fractional exhaled nitric oxide (FeNO)  
will be obtained at entrance and exit visit as secondary measures of control (e.g. forced vital 
capacity (FVC), forced expiratory volume in 1 sec (FEV1), and FEV1/FVC).  
 
2.5 Anthropometric measures: Height and weight will be obtained at the baseline and exit 
visit, to assess if adherence to AQI potentially alters weight/BMI by increased sedentarism.    
 
2.6 Urine collection: as an ancillary to this study, will collect urine for cotinine measurement 
(nicotine metabolites) and store.   
 
2.7 Nasal epithelial cells (NEC): as an ancillary to this study, NEC will be collected and 
stored for future studies aimed at understanding the effects of outdoor air pollution on 
epigenetic changes and how a behavioral intervention could alter impacts.   
 
3. FUNDING: 
 
The study is funded by the American Thoracic Society Foundation (ATSF) unrestricted 
pulmonary grant.  
 
4. ORGANIZATION & LEADERSHIP: 
Figure 4: Proposed cohort timeline by visit: 
 

 
5 
 
The study’s principal investigator is Franziska Rosser, MD MPH. Dr. Rosser is an assistant 
professor in the Department of Pediatrics, Division of Pulmonary Medicine. She is involved in 
clinical and research activities at UPMC Children’s Hospital of Pittsburgh and recently served 
as a Co-Investigator on the VitD Kids Asthma Study.  
Dr. Rosser is responsible for the study and will supervise training of study personnel, data 
collection, data collection quality, transition of study personnel, and human subjects protection. 
She will lead study meetings.  
 
5. STUDY POPULATION: 
 
The study will be recruited from and conducted at UPMC Children’s Hospital of Pittsburgh 
(single site). Recruitment will be from pediatric pulmonology and pediatric asthma registry. 
Preference from asthma registry will be pediatric pulmonology clinic patients.  
 
5.1 Inclusion Criteria:  
Child participant:  
1. Physician diagnosed persistent asthma (mild, moderate, or severe).  
2. Aged 8-17 years old (at time of consent) 
3. Family home internet access or smartphone access + willingness to download 
AirNow app on phone 
 
Parent/guardian participant:  
1.  Parent or guardian of the child participant 
 
5.2 Exclusion Criteria:  
Child participant:  
1. Diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary 
dysplasia, etc.) 
2. Immunodeficiency- acquired or congenital 
3. Neuromuscular disease 
4. Disability affecting ambulation (e.g. spastic quadriplegia) 
5. Cyanotic congenital heart disease 
6. Plans to move out of Pittsburgh area in next 6 months  
7. Only 1 participant per household is eligible 
 
Parental/guardian exclusion criteria: none 

 
6 
 
6. STUDY INTERVENTION:  
All children will receive an asthma 
action plan (AAP). The asthma 
action plan lists the participant’s 
daily asthma controller medications 
and informs patients/families what 
to do if asthma symptoms. All 
children will receive the same AQI 
education, however the intervention 
group will receive an AAP that has 
the reviewed AQI material printed 
on the back (Figure 5). In addition, 
the intervention group will 
demonstrate to research 
coordinator that (1) they can 
navigate to the airnow.gov website 
to check the local AQI or (2) they 
can navigate the AirNow phone 
app to check local AQI. (see AQI 
education form) 
 
As mentioned above in Section 2, 
all patients will receive education 
about the AQI as we do not wish to 
withhold potentially valuable 
information and the consenting 
process will result in discussion of the AQI. However, the intervention group will be provided 
the AQI on the back of their AAP whereas the control group will not.  
 
7. POTENTIAL BENEFITS: 
 
This protocol will help to determine if improved education and usage of an already publicly 
available intervention (AQI) reduces asthma exacerbations, improves asthma control and 
asthma quality of life. If this intervention is effective there will be benefits for pediatric patients 
with asthma.  
  
Parents and participants will be provided with an asthma action. All participants should already 
have an asthma action plan as part of their care, however there may be an additional benefit of 
providing the plan. The results of spirometry or FeNO may be shared with the participant’s 
primary care physician or asthma specialist (per parental request/approval).  
 
8. RISKS AND DISCOMFORTS: 
 
8.1. Procedures 
 
 
 
 
Figure 5: Back of AAP + AQI 
 

 
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Table 1: Study Procedures 
VISIT LOCATION QUESTIONNAIRE 
EMR 
MEASURES 
SPECIMENS 
1 
In-person, 
PCTRC 
Intake, AQI intake, 
PA, ACT or CACT, 
PAQLQ, tobacco 
intake 
Confirm asthma 
controller 
medications, IgE, 
allergen testing, 
eosinophila, BAL or 
sputum eosionphils 
Spirometry, 
FeNO, height, 
weight 
Nasal epithelial 
cells, urine 
2 
Telephone 
sRQ, AQI_f/u, PA, 
ACT or CACT. 
- 
- 
- 
3 
Telephone 
sRQ, AQI_f/u, PA, 
ACT or CACT., 
- 
- 
- 
4 
Telephone 
sRQ, AQI_f/u, PA, 
ACT or CACT. 
- 
- 
- 
5 
Telephone 
sRQ, AQI_f/u, PA, 
ACT or CACT. 
- 
- 
- 
6 
Telephone 
sRQ, AQI_f/u, PA, 
ACT or CACT. 
- 
- 
- 
7 
In-person, 
PCTRC 
sRQ, AQI_f/u, PA, 
ACT or CACT. 
- 
Spirometry, 
FeNO, height, 
weight 
Nasal epithelial 
cells, urine 
Intake questionnaire (completed by parent); AQI intake- includes parent portion (completed by 
parent) + AQI follow up (completed by participant); PA=physical activity (parent and/or 
participant), ACT=asthma control test ages 12 and older (completed by participant); 
CACT=childhood asthma control test for ages 8-11 (completed by parent and participant); 
PAQLQ(s)-pediatric asthma quality of life questionnaire (completed by participant); participant 
tobacco intake form (completed by participant); sRQ= shortened respiratory questionnaire 
(completed by parent); AQI_f/u=AQI follow up questionnaire (completed by participant).  
 
8.1a Questionnaires: the risks from questionnaire administration involves social-psychological 
risk resulting from inadvertent disclosure of medical information and/or questions may create 
discomfort. Participants and parents do not have to answer any question that they do not wish 
to answer.   
 
8.1b Spirometry: The risks of spirometry are minimal and include temporary lightheadedness 
from repeated spirometry maneuvers and there is a small risk (rare) of wheezing and 
shortness of breath and increased cough when performing spirometry. If the participant has 
had a pneumothorax (a.k.a collapsed lung, air leak), open thoracic surgery (a.k.a open chest 
surgery), myocardial infarction (a.k.a heart attack), or hemoptysis (a.k.a coughing up blood) in 
the last 2 months they should not undergo spirometry.  
 
8.1c Fractional Exhaled Nitric Oxide (FeNO): The risks of FeNO are similar to spirometry in 
that they are minimal may include temporary lightheadedness.  If the participant has had a 
pneumothorax (a.k.a collapsed lung, air leak), open thoracic surgery (a.k.a open chest 
surgery), myocardial infarction (a.k.a heart attack), or hemoptysis (a.k.a coughing up blood) in 
the last 2 months they should not undergo FeNO.  
 
8.1d Nasal epithelial collection: The main risk of the nasal sample is discomfort and nose 
bleeding. Additional risks include watery eyes and sneezing. There is also the rare possibility 
of a tear at the brushing site and infection from this procedure.  We will place a small amount 
of lidocaine (~1cc) into the participants nose to reduce discomfort. Lidocaine will not be 
injected with a needle (no needles will be used). Lidocaine sometimes cause an unpleasant 
taste in the mouth and may cause temporary redness, stinging, and swelling at the application 

 
8 
site. If the participant has a bleeding disorder (coagulopathy) they should not undergo nasal 
cell collection.  
 
8.1e Urine collection: the risks of urine collection are minimal and may include discomfort 
with providing a sample.  
 
8.1f Measures of height and weight: possible participant discomfort with having weight 
obtained. The risks are minimal.  
 
8.2 Break of confidentiality: participant data will be identified by a unique study number 
assigned to each child. The unique study number will be used as identification and not 
participant identifying information (ex. first name, last name, DOB) will be kept with research 
information. The link between study ID and participant will be kept in a secure and locked 
location.  
 
8.3 Genetic testing: Genetic testing carries the potential for breach of confidentiality that could 
have a potential impact on future reproduction plans, insurability, employability, or could have 
a negative impact on family relationships, and/or result in paternity suits or stigmatization. 
Information about the child’s participation and results will not be placed in the medical record. 
Participants will not be informed about an individual genetic data to be obtained from the study. 
Genetic information will never be labeled with a participant’s identifying information such as 
name, date of birth, etc.  
 
8.4 Study intervention:  
There are no known risks associated with the AQI.  
 
9. INFORMED CONSENT: 
 
There is one consent form for both the parent participant and the child participant. Informed 
consent and child assent will be obtained after thorough discussion of the potential risks and 
benefits.  
 
10. ADVERSE EVENTS: 
 
10.1 Adverse events  
The risk for adverse events related to the study intervention are minimal. An adverse event will 
be defined as an unexpected accident, experience, or outcome that is unexpected (in terms of 
nature, severity, or frequency), is related or possibly related to the subject’s participation in the 
research, and places subjects or others at a greater harm (including physical, psychological, 
economic, or social harm) than was previously known or recognized. Such events will be 
recorded as per 45 CFR part 46. Unexpected adverse events of moderate severity will be 
reported to the IRB within 10 working days of the investigator learning of the event.   
 
As asthma is a chronic lung disease with waxing and waning impairment and risk, asthma 
exacerbations (both severe & moderate) and loss of control are not unexpected. We will 
consider an increased severity or frequency of such events as adverse events, although these 
will not meet the definition required for reporting to IRB as these such events are not 
anticipated to be related or possibly related to the research.   
 

 
9 
Specific examples of these are below. While these will not require reporting to the IRB, they 
will be captured as adverse events and safety procedures will be implemented as below:  
  
1. If a participant has more than 3 severe asthma exacerbations during the study 
2. If a participant has 3 consecutive ACT or C-ACT scores ≤19. 
3. If a participant has an FEV1 < 80% at either V1 or V7 
 
These events will be recorded, parent or guardian/participant will be notified of possible poorly 
controlled asthma and will be encouraged to follow up with managing asthma specialist. With 
parental permission, PI or RC will reach out to managing asthma specialist to alert to 
concerns.  
 
10.2 Serious Adverse Event 
 
A serious adverse event will be defined as an event that is fatal, life-threatening, inpatient 
hospitalization or prolongation of hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions.   
 
As we anticipate learning of such events (e.g. hospitalization for asthma exacerbation) 
retrospectively (thru questionnaire) we will inquire about whether the participant has been seen 
by managing asthma specialist since event. If the answer is no, we will encourage 
family/participant to contact asthma specialist and with permission, PI or RC will alert 
managing asthma specialist.  
 
Serious adverse events will be reported to the IRB within 24 hours of learning of any 
unexpected serious adverse event associated with the research intervention.  
 
11. CLINICAL MANAGEMENT AND DATA COLLECTION: 
 
Table 2: Summary of Study Protocol 
VISIT LOCATION 
TIMING 
QUESTIONNAIRE 
MEASURES SPECIMENS 
V1 
In-person, 
PCTRC 
Start 
AQI intake*, Intake, PA, 
ACT or CACT, PAQLQ, 
tobacco intake 
Spirometry, 
FeNO, ht, wt 
NEC, urine 
V2 
Telephone 
W4, 4 wks post V3 
(+/- 7d) 
sRQ, AQI_f/u, PA, ACT or 
CACT. 
- 
- 
V3 
Telephone 
W8, 4 wks post V3 
(+/- 7d) 
sRQ, AQI_f/u, PA, ACT or 
CACT., 
- 
- 
V4 
Telephone 
W12, 4 wks post V3 
(+/- 7d) 
sRQ, AQI_f/u, PA, ACT or 
CACT. 
- 
- 
V5 
Telephone 
W16, 4 wks post V3 
(+/- 7d) 
sRQ, AQI_f/u, PA, ACT or 
CACT. 
- 
- 
V6 
Telephone 
W20, 4 wks post V3 
(+/- 7d) 
sRQ, AQI_f/u, PA, ACT or 
CACT. 
- 
- 
7V 
In-person, 
PCTRC 
W24, 4 wks post V3 
(+/- 7d) 
sRQ, AQI_f/u, PA, ACT or 
CACT. 
Spirometry, 
FeNO, ht, wt 
NEC, urine 
Intake questionnaire (completed by parent); AQI intake- includes parent portion (completed by parent) + AQI follow up (completed by participant); 
PA=physical activity (parent and/or participant), ACT=asthma control test ages 12 and older (completed by participant); CACT=childhood asthma 
control test for ages 8-11 (completed by parent and participant); PAQLQ(s)-pediatric asthma quality of life questionnaire (completed by 
participant); participant tobacco intake form (completed by participant); sRQ= shortened respiratory questionnaire (completed by parent); 
AQI_f/u=AQI follow up questionnaire (completed by participant).  
Ht=height, wt=weight, NEC=nasal epithelial cells 
*AQI intake form should be completed prior to AQI education/intervention.  

 
10 
 
11.1 Recruitment 
 
Recruitment will occur at UPMC Children’s Hospital of Pittsburgh Pediatric Pulmonology and 
from Pediatric Asthma Registry. A referral log will be used to track the age and gender of every 
child whose family is approached about the study but declines or who is not eligible because of 
lack of home internet or smart phone access. The research coordinator will determine eligibility 
criteria (as much is possible) prior to reaching out to family about study.  
 
11.2 Eligibility and Randomization (Visit 1) 
 
Once the family and participant have indicated willingness to participate and have scheduled a 
V1, the research coordinator will notify PI. PI will review medical record (granted permission by 
Asthma Registry patients and allowable access as part of regular duties) to confirm asthma 
controller medications. PI will prepare AAP for research coordinators to distribute. In the event 
of a discrepancy between parental reported controller medication and medical record 
medication, the PI will reach out (with participant parent permission) to healthcare provider 
managing asthma to confirm asthma controller medications.  
 
After informed consent has been obtained, participant’s will be randomized 1:1 by age group. 
The RC assign random group at time of intervention. Eligibility for lung function tests and/or 
NEC will be assessed prior to study procedures. Questionnaires will be administered, height 
and weight will be obtained, lung function tests will be obtained (if eligible), specimens will be 
collected (if applicable), and AQI education will be provided. For the intervention group only, 
the AAP containing the AQI information will be provided. The intervention group will 
demonstrate ability to navigate to either airnow website or airnow app on smart phone. For the 
control group, an AAP will be provided (containing no AQI information) Both the participants, 
parents, and research coordinator will know randomization assignment. V1 should not be done 
if child participant has been sick with respiratory infection in prior 7 days or currently has 
respiratory symptoms.  
 
If a participant’s spirometry demonstrates an FEV1 <80%, the family and participant’s 
managing asthma healthcare provider will be notified. Per family permission, spirometry will be 
shared with managing asthma healthcare provider. If a participant’s FeNO is above 20ppb, 
with family permission, FeNO will be shared with managing asthma healthcare provider.  
 
11.3 Trial Phase (Visits 2-6) 
 
The participants will be followed monthly (every 4 weeks, +/- 7 days) with interval follow up 
telephone calls. Questionnaires will be administered during the telephone calls. Throughout 
the trial, participants will be reminded that participation in the research study does not replace 
clinical care. Moderate and severe asthma exacerbations will be asked about on monthly 
questionnaires. If a participant reports 3 severe asthma exacerbations (so defined by ATS 
criteria as an event requiring 3 or more days of systemic steroid treatment for asthma or an ED 
visit/hospitalization during which a steroid was prescribed), the participant’s managing asthma 
healthcare provider will be notified. Additionally, if a participant has more 3 consecutive ACT or 
CACT scores that are equal to or less than 19, which is the threshold concerning for asthma 
control, the participant’s managing healthcare provider will be notified. 
 

 
11 
11.4 Exit visit (Visit 7) 
 
Visit 7 will be conducted in person. Eligibility for lung function tests and/or NEC will be 
assessed prior to study procedures. Questionnaires will be administered, height and weight will 
be obtained, lung function tests will be obtained (if eligible), and specimens will be collected (if 
applicable).  
 
If a participant’s spirometry demonstrates an FEV1 <80%, the family and participant’s 
managing asthma healthcare provider will be notified. Per family permission, spirometry will be 
shared with managing asthma healthcare provider. If a participant’s FeNO is above 20ppb, 
with family permission, FeNO will be shared with managing asthma healthcare provider.  
 
11.5 Protocol Violations 
 
Protocol violations are defined as departures from accepted clinical research practices, study 
protocol, and/or study procedures that pose a risk to participant safety, adversely affect data 
quality and the integrity of the major scientific goals of the study, and/or involve a significant 
and repeated breach of participants’ privacy. Protocol violations include (but are not limited to):  
• Failure to obtain informed consent appropriately 
• Enrollment and/or randomization of ineligible participants 
• Incorrect intervention provided to participant 
• Failure to follow the protocol safety monitoring plan 
• Breaches of confidentiality resulting from lost, misplaced, or stolen study documents.  
 
By the nature of their definition protocol violations are considered the most serious class of 
departure from the study protocol.  
 
11.6 Protocol Deviations 
 
Protocol deviations are defined as departures from a study protocol or methods of a procedure 
that do not pose a risk to subject safety, do not adversely affect the integrity of the major 
scientific goals of the study, and do not involve a significant and repeated breach of participant 
privacy. Protocol deviations include (but are not limited to):  
• Mistimed procedures 
• Omission of protocol and/or procedure elements that do not impact participant safety 
• Failure to carry out study procedures in the appropriate order, when applicable 
• Submission or an outdated version of a data collection form 
 
All protocol violations and deviations will be reported at the time of discovery to the PI. PD 
reports will be reviewed at regular meetings, no less than monthly.  
 
12. SPECIMEN HANDLING 
If applicable, NEC and urine will be obtained at Visit 1 and 7. NEC will be processed and 
stored in the laboratory of Dr. Juan Celedón located in Rangos Research Building. Urine will 
be stored and processed in the laboratory of Dr. Juan Celedón.  
 
13. DATA MANAGEMENT 
 
13.1 Electronic Data Entry 

 
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Research coordinators will endeavor to enter all information into redcap at time of visits. If 
paper forms are used, they will not contain personal identifiers and should be entered 
immediately into redcap as soon as possible.  
 
13.2 Data Quality 
 
All data should be entered into Redcap. Questions will be labeled as required as to trigger an 
alert to the research coordinator upon saving if there are missing questions. Participants may 
choose not to answer any question.  
 
13.3 Privacy and Data Security 
Procedures will be implemented to maintain the security and confidentiality of participant data, 
including assigning unique study identifiers rather than using names or other identifying 
information.  
 
Participant records will kept in accordance with IRB-approved consent procedures, and 
thereafter destroyed leaving available only de-identified data for use in publications, 
presentations, etc. 
 
14. DATA SAFETY AND MONITORING: 
 
Dr. Rosser will oversee this clinical study thru close contact with research coordinators and 
close monitoring of data. Dr. Rosser will review recruitment, enrollment and study visit data.. 
Study procedures will be reviewed and monitored by PI. All deviations/violations will be 
reported as per IRB specifications.  
 
The risks of this study are minimal. 
 
Please refer to adverse event section regarding reporting to the IRB. As noted in prior section, 
children with asthma are expected to have asthma exacerbations and loss of control. Should 
such events be deemed to be outside frequency or severity, contact will be made with 
participant’s parent/guardian and with permission, PI or RC will reach out to asthma managing 
specialist to alert to potential concerns. Participants/families will be reminded at each visit that 
participation in this study does not replace clinical asthma care. All concerns about asthma 
control or management will be encouraged to be discussed with the participant’s asthma care 
provider.  
 
 
 
 
 
 
 
 
 
 
 
 

 
13 
STATISTICAL PLAN:  
 
Statistical Analysis: Data will be analyzed using SAS (SAS 9.4, Cary, N.C.). Baseline statistics 
per treatment group will be obtained. Bivariate analysis of covariates (age, sex, race/ethnicity, asthma 
severity, phenotype (i.e. atopic), socioeconomic status (SES), exposure to primary or secondary 
tobacco smoke, FeNO, use of controller medication, etc) between groups will be conducted using 
student t-test or Wilcoxon rank sum and Fisher’s exact or Chi-square (where appropriate and based on 
distribution). Variables with significant differences between groups (P<0.05) will be considered for 
inclusion in multivariate model selection. The effects of physical activity on the outcomes will be 
compared between groups. Baseline knowledge and usage of AQI will be assessed. Adherence to AQI 
will also be assessed and compared between groups, with potential stratification by AQI usage. 
Additionally, differences in weight and BMI will be assessed to evaluate if adherence to AQI promotes 
sedentarism and leads to increased weight gain. We will evaluate our outcomes (Aims 2 and 3) in three 
ways. First, we will evaluate the average difference (overall mean) between groups for our primary 
outcomes using T test or chi-square (where appropriate). Additionally, we will test the average mean 
difference between each treatment group by multivariate regression (linear for PAQLQ and ACT or 
CACT, and/or Poisson or logistic regression for mean asthma exacerbations depending on distribution) 
to allow for covariate adjustment. Second, we will use paired t-tests (or matched Wilcoxon signed-rank) 
to evaluate the within group effects (6 month mean – baseline) for each primary outcome. Third, to 
assess the effects over time in our intervention study (correlated repeat measures data), we anticipate 
analyzing our primary outcomes by generalized linear mixed models (GLMM). For these models, we 
will first evaluate the distribution of our primary outcome and determine the most appropriate link (e.g. 
for severe asthma exacerbations: logistic link if there are overall a high proportion of participants with 
none, or Poisson link if more consistent with count data). A stepwise approach will be used to build all 
multivariable models. All final models will include age, sex, race/ethnicity, SES, and tobacco smoke 
exposure. Additionally, the above outcomes will be stratified by age group (8-12y, 13-17y) to determine 
if the effects are greater in older children for whom the AQI recommendations may be better self-
incorporated into outdoor physical activities, vs the younger group who will likely be more reliant on 
parental checking and activity modification. 
 
 
Power calculations: Power calculations were conducted using G*Power 354 and SAS (SAS 9.4, 
Cary, N.C.) using proc glmpower. For mean difference between treatment groups (routine vs. 
intervention) with sample size of 20 participants per group, two-tailed test, alpha 0.05, we will have 
≥90% power to detect a mean difference of 1.05 between groups for mean asthma exacerbations, ACT 
and C-CACT, and PAQLQ. Our study will provide ≥80% power to detect a mean difference of 0.91. As 
the clinical difference for ACT is 2-3 points, we anticipate adequate power to detect a clinical difference. 
The estimated clinically meaningful difference in PAQLQ is 0.5, and our study may be underpowered to 
detect this small of difference with this analysis. For comparison within each treatment group, 
comparing the matched difference (end of study- baseline), using the same assumptions above, we will 
have ≥90% power to detect a mean difference of 0.76, and ≥80% power to detect a mean difference of 
0.66. Therefore, we expect better ability to detect changes in PAQLQ within the groups then between 
them. For repeat measures, we estimated our power using proc glmpower using F test based on 
Hotelling-Lawley trace. We estimated a study allocation of 1:1, alpha 0.05, repeated measures at 1, 2, 
3, 4, 5 months, lear correlation structure with base correlation 0.85 & decay rate of 1, with an estimated 
mean difference of 2, standard deviation of 2, which provides a ≥90% power for a treatment group size 
of 12 for overall mean and n=26 for time*treatment.