Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 9, 2018
Open Peer Review Period: Aug 9, 2018 - Aug 23, 2018
Date Accepted: Feb 10, 2019
(closed for review but you can still tweet)
Protocol of a pilot & feasibility Randomized Controlled Trial comparing written versus pictorial Asthma Action Plans to improve asthma management and health outcomes among children and adolescents.
ABSTRACT
Background:
Asthma is an important focal point for health-focused research as ineffective symptom management and control can lead to significant morbidity and mortality. Current treatment guidelines for asthma recommend the use of a written asthma action plan (WAAP) to include individualized instruction for daily care and medication use. However, WAAPs are typically written at a 7th to 9th grade reading level, which can be a barrier to patients understanding their treatment, having confidence in using a WAAP, and engaging in asthma education during clinic visits.
Objective:
Utilizing a feasibility and pilot Randomized Controlled Trial (RCT) design, the objective of the Take Action for Asthma Control (TAAC) study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in contrast to a standard WAAP, and assess the feasibility and acceptability of the AAP intervention and study procedures. The study has three primary aims: (1) estimate the effect sizes of PAAPs compared to WAAPs, (2) evaluate feasibility and acceptability 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 are randomly assigned to receive a PAAP or WAAP, which is generated for them and review with them by their asthma physician. Study procedures take place over four separate time points, including a baseline clinic appointment, 1-month telephone follow-up, and 3- and 6-month clinic-based follow-ups. At each time point date are collected related to the main outcomes of AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up 60 participants (ages 8-17 years) is being recruited. Feasibility and acceptability data are collected via one-to-one qualitative interviews with providers involved in the study, and a sub-group of families that participate in the study.
Results:
Recruitment for the current phase of the study began in May 2017. It is anticipated that recruitment will continue through May 2018. Full results will immediately follow follow-up data collection.
Conclusions:
An asthma action plan is an individualized, evidence-based strategy for patient education and asthma management. The standard WAAP, however, is dense and may be a barrier for families with lower literacy levels. Due to these concerns, many families are not prescribed a WAAP despite national guidelines encouraging its use. Moreover, pictorial asthma action plans (PAAPs) may be an acceptable and feasible alternative for these families. Clinical Trial: NCT03187119
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.