Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot and Feasibility Randomized Controlled Trial

Abstract

Background Asthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use. However, WAAPs are typically written at a seventh- to ninth-grade reading level, which can be a barrier to young people in understanding their treatment, having confidence in using a WAAP, and engaging with asthma education. Objective Utilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the Take Action for Asthma Control study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in comparison with a standard WAAP and assess the feasibility and acceptability of the asthma action plan (AAP) intervention and study procedures. The study has 3 aims: (1) estimate the effect sizes of PAAPs compared with WAAPs on outcomes (eg, AAP knowledge and medication adherence), (2) evaluate feasibility and acceptability of AAP intervention and RCT procedures from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. Methods This feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6 months in duration. At baseline, participants will be randomly assigned to receive a PAAP or WAAP generated for them and reviewed with them by their asthma physician. Study procedures will take place over 4 separate time points: a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point, data will be collected related to the main outcomes: AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up to 60 participants (aged 8-17 years) will be recruited. Feasibility and acceptability data will be collected via one-to-one qualitative interviews with providers involved in the study and a subgroup of families that participate in the study. Results Recruitment and data collection began in May 2017 and were completed in October 2018. Conclusions This pilot and feasibility study will test the potential efficacy, feasibility, and acceptability of an AAP intervention and study procedures. The findings will inform the design and delivery of a future definitive trial to assess the efficacy of PAAPs versus WAAPs in supporting asthma self-management among children and adolescents. International Registered Report Identifier (IRRID) DERR1-10.2196/11733

Implementation of a Pictorial Asthma Action Plan (PAAP) in a Special Population

“…This project aimed to implement the PAAP and curriculum to increase control and self-management of asthma among children in an underserved population [11,20,31,56,69]. Asthma Action Plans vary depending on the provider, but several point out the green, yellow and red zones of asthma and what measures the participant should take in terms of care for each zone [24,30,58,65,86]. The "Iggy and the Inhalers" curriculum has been implemented and studied in various ways, including in-school studies, camp studies, and hospital studies [13,42,78].…”

“…Research shows that pictograms are an excellent educational gateway beyond disparities such as language and literacy barriers [10,20,23,30,33,36,38,63,64]. The evidence establishes Pictograms, as evidenced by research, are an excellent educational tool for bridging disparities such as language and literacy barriers [57].…”