Take Action for Asthma Control Study - Pilot Randomized Controlled Trial of Pictorial Asthma Action Plans to Promote Self-management and Health in Rural Youth With Asthma
Phase: NA
Conditions: Asthma
Sponsor: West Virginia University

 
 
 
 
 
 
 
 
 
Take Action for Asthma Control Study - Developing pictorial asthma action plans to promote 
self-management and health in rural youth with asthma 
 
NCT03187119  
 
5/29/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
Title:  Take Action for Asthma Control Study - Developing pictorial asthma action plans to promote self-
management and health in rural youth with asthma  
Funding: US DHHS-HRSA-Maternal and Child Health Bureau (R40MC28320) for 2015-2018)  
Principal Investigator: Christina Duncan, PhD, Professor in Department of Psychology at West Virginia 
University; Office Phone:  304-293-1289; Email:  Christina.Duncan@mail.wvu.edu 
Background: Asthma, the most common chronic illness in children, is characterized by symptoms of 
wheezing, coughing, chest tightness, and shortness of breath. When poorly managed, asthma can be 
associated with negative social and health outcomes (Akinbami, Moorman, & Liu, 2011; Akinbami, & 
Schoendorf, 2002). Asthma action plans (AAPs) are individualized treatment plans, arranged in a 
stoplight format, that specify daily asthma care activities as well as instructions for adjusting medication 
or seeking emergency medical help in response to symptoms. Regular use of an AAP has been associated 
with improved outcomes such as adherence to daily inhaler use and fewer symptomatic days and nights 
(Bhogal, Zemek, & Ducharme, 2006). However, written AAPs are targeted at a 7th to 9th grade reading 
level and are dense with text, which significantly constrains their utility and may contribute to health 
disparities. Rural families with literacy issues are particularly at risk. A critical need exists to develop a 
simpler format for AAPs. 
 
Overall Aim: The overall aim of this pilot RCT is to develop a symptom-based, computer-generated 
pictorial AAP (PAAP) and to investigate acceptability and feasibility in a pilot randomized controlled 
trial (RCT). The PAAP will be comprised primarily of images, with minimal words or phrases, to direct 
the family regarding the child's asthma regimen. 
 
Specific Aim # 1 – Determine the relative  
 of pictorial & written AAPs. Our working hypothesis is that relative to usual care (Written 
AAP), Pictorial AAP will produce superior clinical and behavioral outcomes: (a) better treatment 
plan knowledge for caregiver and patient; (b) higher daily adherence rates to preventive 
medication (via electronic monitoring); and (c) better health outcomes (i.e., report of better 
asthma control & higher lung functioning or spirometry scores). This hypothesis is based in part 
on research findings indicating that use of pictures in health education markedly increases recall 
of information through simpler and more salient cues. 
 
Specific Aim # 2 – Evaluate provider and family acceptability of pictorial AAP. Based on 
existing literature, we expect that the Pictorial AAP will be easy and user-friendly for providers to 
offer as well as patients and families to use. Consequently, our working hypothesis is that patient 
and caregiver satisfaction (e.g., perceived ease of use, benefits) survey scores will be significantly 
higher for the Pictorial AAP than for the Written AAP group. 
 
Specific Aim # 3: Identify whether parent health literacy and youth literacy levels are 
associated with treatment outcome. Pearson (parametric) or Spearman (non-parametric) 
correlations will be used as appropriate to assess the association between parent health literacy 
and youth literacy to changes in knowledge, adherence, and health outcome, as well as caregiver 
and patient satisfaction, within and between AAP groups. Given that research suggests the use of 
graphics and images improves comprehension of medical information, it is anticipated that rural 
youth, particularly with lower literacy levels, will benefit significantly from a simpler, “image 
rich” pictorial AAP. 
 

Design: Pilot Randomized Controlled Trial  
 
Young people aged 8-17 were randomly assigned to one of two groups (pictorial vs. written AAP, i.e. 
usual care) for 6 months. The Written AAP (WAAP) group received a personalized, text-based AAP. The 
WAAP is consistent with national practice guidelines [5] and recommended as standard care for patients 
with asthma. The proposed study will use the written AAP published by the National Heart Lung and 
Blood Institute (NHLBI) (Available at: 
https://www.nhlbi.nih.gov/files/docs/public/lung/asthma_actplan.pdf). Providers (not researcher) 
completed the WAAP with the child’s prescribed medications and specific asthma care regimen. The 
provider reviewed the WAAP with the child and caregiver.  
 
The Pictorial AAP (PAAP) group received a largely pictorial version of their AAP (with only brief & 
simple text). Its content was personalized to their prescribed regimen and comparable to that of the 
written AAP (e.g., asthma regimen divided into stoplight-color zones); however, it used conventional 
pictures and symbols to represent what, when and how medications should be taken. Providers accessed 
the PAAP software program in clinic, after evaluating the patient, and selected options from dropdown 
menus to tailor the PAAP to the particular patient’s asthma regimen. The PAAP was provided to the 
participant, another was be saved in the participant’s online medical record, and a third was be kept in 
their research record. The provider reviewed the PAAP with the child and caregiver.  
It is hypothesized that the use of the PAAP will produce better AAP knowledge, higher objectively 
measured adherence rates to daily asthma medication, and better health outcomes, such as asthma control. 
Methods: 
This pilot RCT began data collection in May 2017 and continued through May 2018. A total of 45 youths 
and their families were recruited. Data was collected at four time points: baseline (recruitment), 1-month, 
3-months, and 6-months. At baseline, caregivers completed a general information form on demographics 
and medical history, as well as measures to assess health status (Asthma Control Test), and health literacy 
(S-TOFHLA and Asthma Numeracy Questionnaire). Patients completed measures to assess health status 
(Asthma Control Test), health literacy (S-TOFHLA) and reading comprehension (WIAT-III), and 
complete pulmonary function testing (spirometry). Qualitative methods were used to gather acceptability 
and feasibility data. Participants in both groups were provided with their first canister or diskus of 
medication in order to attach the electronic adherence monitor at baseline. Participants refilled with 
medications they purchase as needed for the remainder of the study. One month after initial visit, families 
were called to complete the Asthma Control Test and study-specific satisfaction survey. Three months 
after initial visit, families returned to clinic for follow up with the physician and to complete the Asthma 
Control Test, AAP knowledge interview, and pulmonary function testing (patient only).  Six months after 
initial visit, families returned to clinic for follow up with the physician and to complete the Asthma 
Control Test, AAP knowledge interview, satisfaction survey, spirometry (patient only), and to review 
adherence data and return the inhaler monitor. Six families completed follow up measures at 3 months 
due to time constraints. 
The findings of this study will be relevant to research and practice with rural youths with asthma, as well 
as families with significant literacy issues. A novel and innovative stakeholder-led approach was used in 
this study to develop a more accessible and effective approach to asthma education in pediatric settings. 
The process and findings of this study will be widely disseminated and guide improvements to the PAAP 
for use in future research and practice, including the possible development of an “app” version of the 
PAAP.  
 
 

Study Analysis Plan 
 
All analysis was conducted using SAS 9.4. Descriptive analysis was conducted on baseline measures for 
both the total sample, and by treatment group. Frequency and valid percentages were used to describe 
categorical data, means and standard deviations for continuous data, and medians and interquartile range 
for non-normal continuous data. Group differences were tested by chi-square, Fisher’s exact, Mann-
Whitney, or t-test as appropriate for variable type, with odds ratios (OR) and 95% CI of the OR, means by 
group and t-statistic, or mean score ranks and Z-statistic reported.  
 
Generalized linear mixed model (GLIMMIX) with multinomial response distribution and a cumulative 
logit link function were used to analyze the daily adherence data, in order to model the ordinal outcome 
measure (0%, 25%, 50%, 75%, and 100% adherence) over time. Multiple covariance structure models 
were tested, with an unstructured matrix best fitting by AIC. Because adherence changed depending on 
prescription, the models were tested by both interaction of prescription and by stratification. Sensitivity 
analysis was also run for 3 months or less data and compared to the full 6 month dataset. Fixed effects 
were reported. Generalized linear mixed model (GLIMMIX) with binary response distribution was also 
conducted for the binary outcome of ACT cut-off >= 19. 
 
Linear mixed models with restricted estimation maximum likelihood estimation and Kenward-Richardson 
adjustment for the degrees of freedom were used for the continuous outcome data. Pre-post analysis 
included combining 3 month and 6 month time points for outcome measures where the final time point 
was 3 instead of 6 months. Time was treated as categorical for these pre- post- time points; otherwise time 
was treated as continuous variable. Time, Group, and Time by Group interaction effects were included in 
the model. Random effects statement included the time, with participants listed by ID. Different 
covariance structures and intercept inclusion were tests; AIC was used to determine best model fit with 
the best fitting model including no intercept and an unstructured covariance matrix. Fixed effects are 
reported. Sensitivity analysis was also run by including days in the study for those post-outcomes where 
some participants have 3 months or less data and compared to the full 6 month dataset. 
 
Finally, equivalence testing was conducted for all continuous outcomes, assuming that results that fall 
within an SD unit difference would indicate that PAAP is as good as guideline-recommended care 
(WAAP) with sufficient power. The overall stability of the effect of the treatment response was 
demonstrated utilizing the F test for equivalence of the effect of psi-squared, a standardized measure of 
difference between groups/time point means and an overall (across groups and time points) mean. This 
was be assessed utilizing output from the best-fitting general linear mixed model and by testing whether 
this psi-squared effect size measure falls in the critical region [6]. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

References 
 
1. Akinbami, L. J., & Schoendorf, K. C. (2002). Trends in childhood asthma: Prevalence, health care 
utilization, and mortality. Pediatrics, 110(2), 315-322. 
2. Akinbami, L. J., Moorman, J. E., & Liu, X. (2011). Asthma prevalence, health care use, and 
mortality: United States, 2005-2009 (Report No. 32). Atlanta, GA: National Health Statitics Reports, 
Centers for Disease Control and Prevention; http://www.cdc.gov/nchs/data/nhsr/nhsr032.pdf. 
Updated January 12, 2011. Accessed May 4, 2014. 
3. Bhogal, S., Zemek, R., & Ducharme, F. M. (2006). Written action plans for asthma in children. 
Cochrane Database Systematic Reviews, 3, CD005306. 
4. Forbis, S. G., & Aligne, C. A. (2002). Poor readability of written asthma management plans found 
in national guidelines. Pediatrics, 109, e52. 
5. National Heart, Lung, and Blood Institute (2007). National Asthma Education and Prevention 
Program (NAEPP) Expert Panel Report 3, Guidelines for the Diagnosis and Management of 
Asthma (NIH Publication No. 08-4051).  
6. Wang, F., & Amrhein, J. (2016, April 18-21). Equivalence Tests. Paper presented at the Proceedings 
of the SAS®Global Forum 2016., Las Vegas, NV