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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.
Utilizing a feasibility and pilot randomized controlled trial (RCT) design, the objective of the
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.
Recruitment and data collection began in May 2017 and were completed in October 2018.
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.
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Asthma affects over 10 million children and adolescents in the United States [
Given that most WAAPs consist of densely presented text typically written at a seventh- to ninth-grade reading level [
Visual tools for communicating health-related information (eg, details about a diagnosis and instructions for treatment) can improve comprehension, satisfaction with information, self-management, and provider-patient engagement [
This protocol describes the final phase in a 2-phase study, called the
Assessing feasibility and acceptability of interventions in health care settings will ensure that important factors related to intervention design and study procedures are explored and optimized before implementing a definitive randomized controlled trial (RCT) [
A mixed-methods approach to data collection and analysis will be used based on the current guidelines for the development of effective behavior change interventions [
The study protocol, personnel, and materials have been reviewed and approved by the Institutional Review Board at West Virginia University (WVU).
This study is taking place in subspecialty clinics (asthma/allergy/pulmonology) across 3 locations affiliated with WVU Medicine, Department of Pediatrics. A sample of 60 children and adolescents with asthma (aged 8-17 years) and parents or caregivers or legal guardian (hereon referred to as
The inclusion criteria for the participants are as follows: (1) aged 8-17 years, (2) have a clinical diagnosis of persistent asthma, (3) have a prescription for a daily controller inhaler compatible with an adherence monitoring electronic sensor (ie, Qvar HFA (TEVA), Dulera HFA (Merck), Advair [HFA and Diskus] (GSK), or Flovent [HFA and Diskus] (GSK), (4) have never received an AAP in the past, and (5) do not have a disability or cognitive impairment that would prevent them from completing the study procedures. Eligible participants must also match at least one of the following supplemental criteria: (1) newly diagnosed with persistent asthma, (2) asthma control is suboptimal (eg, child is using his or her rescue inhaler often), or (3) physician plans to make a change to the patient’s asthma treatment plan.
Potentially eligible families will be identified through 2 pathways: (1) clinic staff will identify potential participants through the electronic medical record (EMR) system and share clinic appointment details with the research team or (2) through a filter based on eligibility criteria applied to EMR lists associated with clinics. Families identified this way will receive a brief email message through the EMR system, introducing them to the study and providing contact details for the research team. Families who do not have an active email account as part of the EMR system will receive a phone call. Interested families who are not already receiving care in one of the study’s allergy or asthma specialty clinics can be referred by their physician if a referral is deemed appropriate.
A research team member will call all families in advance of their clinic appointment to introduce or reintroduce the study so that they can plan to have enough time to stay to complete the baseline appointment, which lasts approximately 90 min.
The TAAC intervention involves an individually tailored AAP (WAAP or PAAP) summarizing each participant’s asthma treatment plan. On the basis of the National Health, Lung & Blood Institute (NHLBI) guidelines for managing persistent asthma [
The PAAP software is designed to enable providers to quickly and easily generate a PAAP that is tailored to the characteristics (ie, gender and ethnicity) and asthma treatment plans (eg, daily controller inhaler type) of each participant. Physicians will generate the PAAP by responding to questions organized by zone (green, yellow, and red), and each question is followed by a drop-down menu of options. PAAPs comprise 3 horizontal banners for the green, yellow, and red zone treatment instructions (see
Physician training to generate AAPs using the PAAP software will occur over a 30-minute session with the project coordinator. During these sessions, a written step-by-step guide will be provided to the physicians and they will be introduced to the software, several sample PAAPs will be generated, and issues or questions will be discussed.
Example of personalized pictorial asthma action plan.
The NHLBI WAAP template [
The TAAC intervention comprises 5 behavior change techniques (BCTs), as defined in the BCT Taxonomy version 1 [
Behavior change techniques within the Take Action for Asthma Control intervention (pictorial asthma action plan and written asthma action plan).
Behavior change techniques | Definition | Operationalization |
Action planning | To prompt detailed planning of performance of the behavior (must include at least one of the following: context, frequency, duration, and intensity) | The AAPa provides step-by step details of prescription for asthma medications (eg, 2 puffs twice a day) and help-seeking steps (eg, call physician). |
Habit formation | To prompt rehearsal and repetition of the behavior in the same context repeatedly so that the context elicits the behavior | The AAP prompts taking medication in the morning and evening, before exercise (green zone), or in response to certain symptoms in the yellow and red zones. It also prompts to call the clinic or hospital or 911 in response to lack of symptom improvement. |
Adding objects to the environment | To add objects to the environment to facilitate performance of the behavior (more than an information booklet) | The intervention adds an AAP to the family’s home environment. Families are encouraged to place the AAP somewhere easily visible. |
Goal setting (behavior) | To set or agree on a goal defined in terms of the behavior to be achieved | The AAP provides step-by step details of prescription for asthma medication and help-seeking steps to follow for daily asthma management. |
Credible source | To present verbal or visual communication from a credible source in favor of or against the behavior | In both the written asthma action plan and pictorial asthma action plan groups, the physician reviews the AAP during the clinic appointment. |
aAAP: asthma action plan.
Physicians will assess families for study eligibility during their consultation and invite a researcher to discuss the study further with interested families. Families who agree to participate will provide informed consent (parent) and assent (child) and be randomized to the PAAP or WAAP groups. Group assignment will then be communicated to the physician, who will generate a WAAP or a PAAP and deliver the AAP review session with the family.
Following the AAP review session, the participant and parent will separately complete brief structured interviews to assess their comprehension of the new AAP. Participants and parents will complete a number of questionnaires (see
Summary of study appointment procedures.
Appointment information | Baseline | 1 month | 3 month | 6 month |
Location | Clinic | Telephone | Clinic | Clinic |
Duration (min) | 90 | 30 | 45 | 60 |
Gift card value | US $30 | US $20 | US $30 | US $45 |
Participant information | ✓a | —b | — | — |
Asthma Control Test | ✓ | ✓ | ✓ | ✓ |
Spirometry | ✓ | — | ✓ | ✓ |
Reading comprehension and health literacy | ✓ | — | — | — |
AAPc knowledge | ✓ | — | ✓ | ✓ |
AAP satisfaction | — | ✓ | — | ✓ |
Daily controller adherenced | ✓ | ✓ | ✓ | ✓ |
aIndicates time points at which data were collected.
bIndicates time points at which data were not collected in relation to a variable, eg, spirometry was not measured at 1 month follow-up as that appointment was conducted by phone.
cAAP: asthma action plan.
dDaily controller inhaler adherence is monitored continuously through the sensor attached to each participant’s inhaler. Syncing of adherence data with the sensor dashboard will be checked at 4 time points, but the data will only be discussed with families at the 6-month follow-up appointment.
To enable the collection of objective adherence data for daily controller medication, a small electronic sensor will be fitted to the participant’s inhaler. The sensor is connected to an app that is downloaded to the participant’s or their parent’s cell phone or to a device called a hub that can be plugged in at the family’s home, with individual participant data transferred to a Web-based dashboard that will be monitored by the research team. A complimentary canister or diskus (circular, rather than cylindrical inhaler device) of their daily controller inhaler will be provided to each participant to allow the research team to fit the sensor onto the inhaler and to show the family how this is done for refill medication.
To address aims 1 and 3 of this study, validated measures of health literacy (Short Test of Functional Health Literacy in Adults [S-TOFHLA]) and numeracy (Asthma Numeracy Questionnaire [ANQ]), reading comprehension (Wechsler Individual Achievement Test-III [WIAT-III]), and asthma symptom control (Asthma Control Test [ACT]) will be used. Details of the quantitative measurement tools that will be used are summarized in
Overview of quantitative measures.
Measure | Length | Validation status | Cronbach alpha according to previous research | Response options | Range possible | Respondents | ||
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Short Test of Functional Health Literacy in Adults | 36 items | Validated for use with young people and adults aged 13+ | Youth=.90-.92; adults=.97 | Fill in the blanks to complete sentences | 0-36 | Parents and participants aged 13-17 years | |
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Asthma Numeracy Questionnaire | 4 items | Validated for use with adults | .57a | Question-specific; free text or list of possible answers | 0-4 | Parents | |
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Wechsler Individual Achievement Test-III | Varies by grade | Validated for use based on current grade | >.08 | —b | Varies by grade | Youth | |
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— | Validated for use with ages 4-11 years and >12 | — | Version and question specific, for example, 4-point Likert scale from very bad to very good | — | — | |
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Age 4-11 years version | 7 items | — | .76 | — | 0-27 | Parent and youth | |
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Age >12 years version | 5 items | — | .84 | — | 5-25 | Youth |
aFor measures with less than 10 items, an alpha value greater than .05 indicates satisfactory reliability.
b—: not applicable.
The S-TOFHLA [
The ANQ [
The Wechsler Individual Achievement Test-III [
The ACT [
A structured interview
Devised for this study, the
Pulmonary function will be assessed using spirometry, administered by a trained member of the research team during clinic-based appointments. After maximal inhalation, spirometry measures the volume of air exhaled during a forceful and complete exhalation, as well as the flow of air at different time points. The 4 primary endpoints derived and focused on for the purposes of this study will be (1) the total exhaled volume known as forced vital capacity (FVC; both absolute and percentage of predicted values), (2) the volume exhaled in the first second known as forced expiratory volume in 1 second (FEV1; both absolute and percentage of predicted values), (3) their ratio (FEV1/FVC), and (4) the forced expiratory flow between 25% and 75% of the forced vital capacity (FEF 25-75; percentage of predicted values), which may provide information regarding the small airways.
Objective adherence data will be collected using an electronic sensor provided by Propeller Health (Madison, WI), a company specializing in mobile self-management technology for respiratory conditions, including asthma. The Propeller Health sensor provides a reliable and objective record of each actuated dose from participants’ inhaler [
The sensor contains a battery that can last up to 18 months and can hold up to 1000 pieces of data. Therefore, if the sensor and app or hub through which it communicates with the Propeller Health dashboard are not in close proximity for several days, a sync between the sensor and app or hub will effectively bring the adherence data up to date. As a result, time away from home for participants (eg, during vacations or intermittent issues with Wi-Fi connection) will not detrimentally affect the accurate collection of adherence data. Once it is time to replace or refill their inhaler prescription, the family will transfer the sensor to the participant’s next daily controller inhaler. This transfer can occur without any disruption to the collection of adherence data. Before each study visit, the adherence monitoring dashboard will be checked, and the family will be asked to sync their sensor with their smartphone app or hub if a sync has not occurred in recent days.
Families will be asked to have their child use only the inhaler with the device attached for the duration of the study and that this device will track particular aspects of medication use. Reactive effects, if they occur, should be equally distributed across groups. The outcome of mean daily adherence will be calculated as the total number of puffs actuated divided by the total number of puffs prescribed and multiplied by 100. Episodes of 10 or more actuations in less than a minute will be classified as
To assess the feasibility and acceptability of this pilot RCT, qualitative data will be collected by reviewing study records, through interviews with service providers involved in the study and via exit interviews with a subgroup of participants and parents. Interviews will be conducted with providers involved in the study at the beginning and toward the end of the course of the pilot RCT, either face-to-face or by telephone. Finally, semistructured interviews will be conducted with a subgroup of participants and parents following completion of their involvement in the study. Exit interviews will be conducted either face-to-face or by telephone, depending on the availability and preferences of the interviewees.
The interviews will be conducted by a member of the research team who is not involved with the day-to-day running of the study to facilitate openness among the families and providers to share their study experiences and feedback.
Feasibility and acceptability outcomes and data collection plan.
Variable | Data collection method | Schedule | |
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Provider engagement (eg, facilitating and participating in study meetings) | Study records and provider interviews | Ongoing and 3-month intervals |
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Recruitment and retention rates | Study records and interviews with providers and families | Ongoing and 3-month intervals |
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Fit of study activities within clinic workflow | Provider interviews | 3-month intervals |
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Integrity of data collection (eg, missing data) | Study records | Ongoing |
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Family views of study activities (eg, schedule, time involved, and types of measures) | Interviews with families | Exit interview |
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Adequacy of participant payments | Interviews with families | Exit interview |
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Perceptions of value added to consultations and asthma management | Interviews with providers and families | Providers: 3-month intervals; Families: 1-month phone interview and exit interview |
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Adequacy of PAAP (eg, accessibility, clarity, usability, tailoring, liking, and influence) | Interviews with providers and families | Providers: 3-month intervals; Families: exit interview |
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Impact of group assignment on retention | Interviews with providers and families | Providers: 3-month intervals; Families: exit interview |
aPAAP: pictorial asthma action plan.
The aims of the primary quantitative analyses in this pilot RCT are to assess initial evidence for the efficacy of PAAPs in comparison with WAAPs for improving pediatric asthma management and outcomes and to produce robust effect size estimates ahead of a future definitive RCT. A power analysis was run for the primary outcome of the ACT using PASS software version 13 (NCSS, 2019) [
On the basis of our previous research of similar duration, we anticipate a<20% attrition rate. Thus, we will recruit up to 60 participants from the specialist asthma and pulmonology clinics within WVU Medicine, with sufficient power to test for equivalence even with attrition and not accounting for missing data. In the event of a lower-than-anticipated attrition rate or data missing completely at random, a sample size of 50 (25 per group) will maintain high power for detecting equivalence.
Preliminary evidence of between-group differences will be examined in relation to the following outcome variables: AAP knowledge, AAP satisfaction, ACT scores, mean adherence to daily controller medication, and pulmonary function using spirometry. The hypothesis tests of interest will involve the fixed effects of the time-by-group interaction for all study outcomes, with covariates included provided they are significant and improve model fit. Specifically, to account for the correlation among the repeated measurements on each participant, general linear mixed models will be the main tools of analysis for the primary outcomes. These models are designed to model correlations among observations on subjects (over time and within groups) and are valid in the presence of missing at random (MAR) data [
Given our power to estimate effect sizes for a subsequent definitive RCT, we will demonstrate the overall stability of the effect of the treatment response utilizing the
SPSS version 24 will be used for data management and basic analyses; SAS version 9.4 (primarily PROC MIXED) will be used for all advanced statistical analyses. Every attempt will be made to minimize attrition and missing data; however, we recognize that some degree of missing data is inevitable. The REML method involved in mixed modeling is generally appropriate for use under the MAR assumption. Moreover, we will carry out models under missing not at random assumptions to assess the sensitivity of our conclusions to the missing data (eg, via selection models or pattern-mixture models, as needed or appropriate).
Thematic analysis will be used to organize and analyze the qualitative data gathered from providers, participants, and parents, including AAP satisfaction survey and exit interview data [
In this study, a theoretical thematic analysis will be conducted with the aim of addressing the research questions related to the feasibility and acceptability of the TAAC intervention and study procedures, as opposed to approaching the data with a more exploratory aim. Analysis will progress through the phases recommended by Braun and Clarke [
Recruitment and data collection began in May 2017 and were completed in October 2018. Results are expected by March 2019.
According to the literature, many barriers exist to asthma self-management among young people, including inadequate asthma education and knowledge [
Notable strengths of this protocol include the mixed-methods approach to data collection and analysis; integration of technology in the intervention; use of objective outcomes measures; identification of BCTs; and the approach of adapting the standard WAAP, an existing guideline-based tool. The findings of this study will inform the design of the next phase of this research, which will be a definitive RCT. Potential limitations of the protocol are mainly a function of the pilot nature of the study, including data collection from a small number of sites, implementation of the intervention by a small number of physicians, and reliance on Wi-Fi in a rural location in the United States. Nevertheless, this study will produce valuable pilot data for a future large-scale definitive trial that will aim to recruit a large sample from multiple sites and have substantial potential for national application.
The planned feasibility and pilot trial, as part of a larger program of research, builds on a growing body of innovative AAP literature [
asthma action plan
Asthma Control Test
Asthma Numeracy Questionnaire
behavior change techniques
electronic medical record
forced expiratory flow between 25% and 75% of the forced vital capacity
forced expiratory volume in 1 second
Forced Vital Capacity
Health and Human Services
Health Resources and Services Administration
missing at random
pictorial asthma action plan
randomized controlled trial
residual maximum likelihood
Short Test of Functional Health Literacy in Adults
Take Action for Asthma Control
written asthma action plan
Wechsler Individual Achievement Test-III
West Virginia University
The authors would like to acknowledge the participation of the families involved in this study as well as the clinical teams supporting the research. The authors also acknowledge the work of BeHealth Solutions, who designed the PAAP software and will continue to work with this research group on software updates. This project is supported by the Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) under grant number R40MC28320, R40 Maternal and Child Health Field-initiated Innovative Research Studies Program. This information or content and conclusions are those of the authors and should not be construed as the official position or policy of HRSA, HHS, or the US government, nor should any endorsements be inferred by HRSA, HHS, or the US government.
None declared.