Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma
Phase: NA
Conditions: Asthma
Sponsor: Children's Hospital Medical Center, Cincinnati

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 1 of 34 
Revised:  August 16, 2023  
PROTOCOL TITLE: 
Using Technology- Assisted Stepped Care Intervention to Improve Adherence in 
Adolescents with Asthma  
PRINCIPAL INVESTIGATOR: 
Rachelle R. Ramsey 
Behavioral Medicine and Clinical Psychology 
513-803-8348 
Rachelle.ramsey@cchmc.org 
VERSION NUMBER/DATE: 
Version 10.0/ August 17, 2023  
REVISION HISTORY 
 
Revision 
#
Version Date 
Summary of Changes 
Consent 
Change?
1 
6/4/2019 
The data safety monitoring plan was added to 
the appendix of the protocol. In addition, a 
reference was added. 
Yes 
2 
8/7/2019 
Language about participants being paid during 
the Step 2 intervention was added. Information 
about when the CEQ questionnaire was 
completed was edited. Finally, the Perceived 
Characteristics of Intervention Scale was 
added. 
Yes 
3 
10/17/19 
The time period for baseline was extended to 2 
months. One exclusionary criteria item was 
added.
Yes 
4 
3/18/2020 
Information about the measures and procedures 
completed during recruitment and at the 
baseline visit was adapted to allow for remote 
visits.
No 
5 
4/2/2020 
Study procedures for the telehealth sessions 
were revised to allow for food delivery.
No 
6 
5/22/2020 
Electronic consent was modified to allow for 
the use of REDCap. 
No 
7 
12/09/2020 
A short questionnaire was added with questions 
regarding how COVID-19 has impacted 
learning. 
No 
8 
11/23/2022 
Protocol was updated to include a new 
company that will be providing inhaler sensor 
caps.  In addition, the name of a specific 
asthma management app was made generic.
No 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 2 of 34 
Revised:  August 16, 2023  
9 
8/16/2023 
Protocol was updated to change sample size 
from 70 to 80 participants 
No 
 
 
 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 3 of 34 
Revised:  August 16, 2023  
Table of Contents 
1.0 
Study Summary ...................................................................................................... 43 
2.0 
Objectives .............................................................................................................. 54 
3.0 
Background ............................................................................................................ 54 
4.0 
Study Endpoints ....................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved................................................................................................. 7 
7.0 
Data and Specimen Banking .................................................................................. 13 
8.0 
Sharing of Results with Subjects ........................................................................... 13 
9.0 
Study Timelines ..................................................................................................... 13 
10.0 Inclusion and Exclusion Criteria ............................................................................ 13 
11.0 Vulnerable Populations .......................................................................................... 14 
12.0 Local Number of Subjects ..................................................................................... 14 
13.0 Recruitment Methods ............................................................................................. 14 
14.0 Withdrawal of Subjects .......................................................................................... 15 
15.0 Risks to Subjects .................................................................................................... 15 
16.0 Potential Benefits to Subjects ................................................................................ 16 
17.0 Data Management and Confidentiality .................................................................. 16 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 19 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 19 
20.0 Compensation for Research-Related Injury ........................................................... 19 
21.0 Economic Burden to Subjects ................................................................................ 19 
22.0 Consent Process ..................................................................................................... 20 
23.0 Process to Document Consent in Writing .............................................................. 20 
24.0 Setting .................................................................................................................... 20 
25.0 Resources Available............................................................................................... 21 
26.0 Multi-Site Research ............................................................................................... 21 
27.0    References………………………………………………………………………...21 
28.0    Appendix………………………………………………………………………….27 
 
 
 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 4 of 34 
Revised:  August 16, 2023  
1.0 
Study Summary 
 
Study Title 
Using Technology- Assisted Stepped Care Intervention to 
Improve Adherence in Adolescents with Asthma  
Study Design
Randomized Controlled Trial
Primary Objective 
To test the preliminary efficacy of the TASC adherence-
promotion intervention for adolescents with asthma in a 
feasibility randomized controlled trial compared to treatment as 
usual control arm.
Secondary 
Objective(s) 
To assess the implementation of the TASC adherence-
promotion intervention for adolescents with asthma through 
a process evaluation.
Research 
Intervention(s)/ 
Investigational 
Agent(s) 
Behavioral adherence-promotion intervention delivered via 
technology.  
IND/IDE #  
Not applicable
Study Population
12-18 year olds with moderate or severe persistent asthma
Sample Size
80 
Study Duration for 
individual 
participants
6 months 
Study Specific 
Abbreviations/ 
Definitions  
Technology Assisted Stepped Care (TASC)  
 
 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 5 of 34 
Revised:  August 16, 2023  
2.0 
Objectives 
Aim 1: To test the preliminary efficacy of the TASC adherence-promotion intervention 
for adolescents with asthma in a feasibility randomized controlled trial compared to 
treatment as usual control arm. Based on preliminary development studies (ORBIT Phase 
I (IRB#2017-7166) and II (IRB#2018-0727)) TASC will include a stepped collection of 
interventions: 1) electronic educational materials, 2) utilization of an inhaler adherence 
monitoring device and tailored text message feedback, and 3) a telehealth problem-
solving intervention. 
 Hypothesis 1: The TASC adherence-promotion intervention will result in 
improved adherence to daily inhaled corticosteroids as measured by electronic 
monitoring compared to a treatment as usual control arm.  
 Hypothesis 2: The TASC adherence-promotion intervention will result in 
improved disease severity as measured by the Composite Asthma Severity Index75 
combining symptoms, treatment, exacerbations compared to a treatment as usual 
control arm, and lung function as measured by mobile spirometry. 
Aim 2: To assess the implementation of the TASC adherence-promotion intervention for 
adolescents with asthma through a process evaluation.  
 Hypothesis 3: The TASC adherence-promotion intervention implementation will 
be successful as evidenced by high levels of reach, acceptability, usability, and 
sustainability. 
Exploratory Aim: Examine clinical, demographic, and behavioral predictors of 
attendance, acceptance, and improvement in medication adherence and health within each 
intervention step.  
Successful completion of this project is expected to have a substantial impact on public 
health, as the TASC intervention will result in a novel system for delivering personalized 
adherence-promotion intervention content to adolescents with asthma via technology to 
maximize reach, and as a result offer an innovative approach to improving health 
outcomes and decreasing health care utilization in this at-risk population.  
 
3.0 
Background 
Pediatric nonadherence is a significant contributor to the public health burden of asthma. 
Nearly 2.4 million adolescents in the United States have asthma.35 Although asthma can 
typically be controlled with daily inhaled corticosteroids, 10 Americans die each day 
from asthma.36 In addition to substantial morbidity, asthma presents a significant public 
health burden because of the emotional impact, and annual $56 billion costs of care.1 One 
major contributor to the significant public health burden of asthma is nonadherence to 
prescribed medical treatment.4,37-39 Rates of nonadherence in children and adolescents 
with asthma range from 30-70%.2,3,5-15,40,41 Nonadherence often leads to treatment failure, 
increased frequency and severity of asthma symptoms and exacerbations, variability in 
pulmonary function, school absenteeism, and increased expenses from medications, 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 6 of 34 
Revised:  August 16, 2023  
additional lab tests, and health care utilization.9,42-48  Adolescents are at particularly high 
risk for nonadherence49 and morbidity, with death rates twice as high for 11-17 year olds 
compared to 0-10 year olds.50-52 Although developmental factors (e.g., complacency, 
sense of invincibility) are barriers to adherence during adolescence,53 adolescence is also 
the time when lifelong patterns of health behaviors and self-management skills are 
established, presenting a unique window of opportunity for intervention delivery.31,54-56 
Thus, adolescents are a critical target population to improve long-term asthma outcomes. 
Behavioral interventions can improve adherence and asthma symptoms in adolescents. A 
recent systematic review of behavioral interventions to improve asthma management 
outcomes for adolescents57 documented improvements in medication adherence,32,34,54,58 
knowledge,59,60 quality of life,24,32,33,58,61 proper use of mediations,61 asthma 
symptoms,16,33,58,61-63 asthma control,16,34,64 lung function,16,32,34 and health care 
utilization.61 Promising approaches to improving adherence to daily controller 
medications included self-monitoring of medication use, objective monitoring of inhaled 
corticosteroid adherence, feedback on medication-taking behavior, increasing asthma 
self-management skills, goal-setting, problem-solving skills-training, and school nurse-
observed therapy.32-34,65 Broadly, these effective interventions include components 
consistent with the Information-Motivation-Behavioral skills model (IBM).66 
Unfortunately, the majority of these interventions require families with poor medical 
appointment attendance to attend at least 6 additional hours of outpatient visits and bear 
the burden and costs associated with traveling to the intervention.  
Despite efficacious interventions, nonadherence in adolescents with asthma remains a 
significant public health concern due to inaccessibility and a lack of individualized 
tailoring. One reason for the persistence of nonadherence in adolescents with asthma is 
that efficacious interventions are not being disseminated or implemented in settings 
outside of the original study in which it is being conducted. When behavioral 
interventions are available, treatment session attendance is a significant barrier for 
adolescents and treatment content, intensity, timing, and delivery system are not 
personally tailored in a systematic way. Often when adherence interventions are delivered 
they are provided as a “one size fits all” intervention during a consultation, rather than in 
a self-correcting model that allows for assessment of critical outcomes at structured time 
points and an increase in the content, intensity, timing, and delivery of the intervention 
based on the patients’ needs. 
Use of a technology-assisted stepped-care (TASC) intervention allows for increased 
access, tailoring, and dissemination of an adherence-promotion intervention for 
adolescents. Recent interventions have included technology to promote intervention 
delivery such as web-based tailored asthma education sessions,17-22,67,68 tailored text 
messages,24,25,27,69 and electronic monitoring combined with feedback.28,30,70 A stepped-
care intervention system delivered via technology allows for the delivery of the ideal care 
to the right patient at the right time using a delivery system (mobile phone) that is 
engaging for adolescents. The TASC intervention will utilize the least burdensome (both 
in terms of cost and personal inconvenience for the patient and the amount of time 
required of the interventionist) interventions while still providing significant health 
improvements and reserving high intensity treatment for patients who do not benefit from 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 7 of 34 
Revised:  August 16, 2023  
simpler treatments.39 Based on the technology-based adherence intervention literature and 
previously collected qualitative data (see preliminary studies (IRB #2017-7166; 
IRB#2018-0727)), this TASC intervention will be most effective and engaging for 
adolescent patients if it includes an information component, motivation component, and 
behavioral component.66 Specifically, the TASC adherence-promotion intervention will 
include the following three steps: 1) Information: asthma management app, 2) 
Motivation: Inhaler adherence monitoring and feedback via text messaging, and 3) 
Behavior: Problem-solving and behavior skills training via telehealth. With the TASC 
intervention, a patient whose adherence improves as a result of utilizing the asthma 
management app (Step 1) will continue to receive only this strategy while an adolescent 
whose adherence does not improve will receive the more intensive treatment of 
personalized adherence feedback via text messaging).  
Combining a stepped-care adherence-promotion intervention with the use of technology 
to deliver intervention content and obtain real-time adherence monitoring creates a 
system that is self-correcting. Adherence results will be systematically assessed so that 
treatment provision changes can be made if current treatments are not achieving 
significant improvement. This allows children to receive optimal treatment content, 
intensity, timing, and delivery while also allowing clinicians to intervene with as many 
patients as possible, therefore saving time and money because patients are only receiving 
the level of care that they need. Although medical care is often provided in a stepped-care 
fashion, there have been no adherence-promotion interventions to date for adolescents 
with asthma that are administered in a stepped-care framework. TASC will be a novel 
and engaging intervention that leverages adolescent use of technology to increase 
adherence to treatment and improve health outcomes. 
4.0 
Study Endpoints 
The primary study end point is post-treatment. 
5.0 
Study Intervention/Investigational Agent 
 
The TASC intervention will be delivered using technology so that participants do not 
need any resources to travel to appointments. Step 1 (Information) will include electronic 
educational information via an asthma management app related to asthma symptoms and 
triggers, attacks, self-monitoring, treatments, action plans, and automated text message 
medication reminders. Step 1 will be provided to all adolescents. Adherence will be 
electronically monitored, but feedback will not be provided. Step 2 (Motivation) will 
include electronic monitoring of adherence and personally tailored feedback via text 
messages. Adolescents will be given access to the adherence tracking smartphone app 
and graphs of their inhaler adherence. Adolescents will also receive brief, personalized 
text messages that provide supportive motivation and directive, tangible actions. Step 3 
(Behavioral) will include problem-solving telehealth intervention with a trained clinician. 
Four telehealth sessions individually tailored to the unique needs and barriers of the 
adolescent will be provided. These will be based on a functional analysis via objective 
adherence data, graphical feedback, and discussion of adherence patterns allowing for a 
comprehensive understanding of specific behavioral factors interfering with adherence. 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 8 of 34 
Revised:  August 16, 2023  
Behavioral treatment plans will be modified based on a patient’s progress in treatment 
and ability to achieve short-term adherence goals. Patients will also be contacted via text 
messaging to assess success with specific adherence plans between sessions based on 
objective data. This telehealth intervention will be delivered to adolescents’ cell phones 
via video conferencing software. For each telehealth session, adolescents will also place a 
food order with their interventionist, which will be delivered to the participant via food 
delivery service (e.g., restaurant delivery, Uber Eats, GrubHub, DoorDash, etc.).  
 
 
 
6.0 
Procedures Involved 
The current study involving human subjects consists of a Randomized Controlled Trial to 
test the feasibility, effectiveness, and implementation of the TASC intervention as 
compared to a treatment as usual group. A total of up to 80 adolescents with moderate or 
severe persistent asthma between the ages of 12-18 years will be randomized to TASC 
(n=35) or treatment as usual (n = 35). After adolescent participants have met inclusion 
criteria, completed baseline assessments, and have been enrolled in the feasibility RCT, 
they will be randomized to either TASC or Treatment As Usual (TAU). The statistician 
will make the randomization schedule and the principle investigator will maintain 
randomization schedule. Outcomes measures (adherence and disease severity) will be 
assessed at baseline, monthly during active treatment, and at post-treatment, with the 
primary endpoint being post-treatment. 
Participants will be enrolled in the study for a duration of six months. First, participants 
will complete baseline questionnaires related to demographic, and clinical predictors of 
adherence and asthma. Participants will be randomized following completion of baseline 
measures. A smart phone prepared by the CCHMC IT team with a data plan will be 
provided to participants who do not have their own cellphone. Propeller or FindAir 
adherence caps will also be provided to all participants and utilized for 2 months without 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 9 of 34 
Revised:  August 16, 2023  
feedback to obtain baseline adherence. If the participant did not bring their inhalers to the 
appointment, a coordinator will follow up with the patient to ensure that the Propeller or 
FindAir sensors are properly attached to the patients’ inhalers. In addition, all participants 
receive a mobile spirometer (Spirobank Smart) to track their lung function throughout the 
study. The spirometer connects to an app (Propeller or FindAir) via Bluetooth. This app 
allows the participant to perform pulmonary function tests (PFTs) and view the results of 
these tests, such as their forced expiratory volume (FEV1) as well as other lung function 
parameters. Participants will be asked to use the spirometer at least once a month when 
completing study visits over the phone with a study team member. Following the baseline 
visit, a 8 week run-in phase will be completed to assess baseline adherence using 
electronic inhaler monitoring. After 4 weeks in baseline, the coordinator will call the 
participants in TASC and TAU for their first monthly phone call. After obtaining 8 weeks 
of baseline adherence data, the coordinator will call the participants in TASC and TAU 
for their second monthly phone call. The coordinator will calculate baseline adherence 
and obtain data for the Composite Asthma Severity Index (CASI) and the Asthma 
Control Test (ACT) for TASC and TAU participants. For TASC participants only, the 
coordinator will introduce Step 1 of the intervention for all participants. Adherence 
checks will continue to occur every four weeks for the duration of the study for all 
participants and adherence <68% will prompt movement from one level of treatment to 
the next for TASC participants only. The study coordinator will calculate the 
participant’s adherence percentage prior to the monthly telephone call. During the call, 
the coordinator will tell the participant if they will get moved up to the next step and 
explain what they will be doing during that step. TASC participants may remain at a 
treatment level for more than four weeks and may complete 1, 2, or 3 interventions steps 
during the 5 month study depending on the adolescent’s adherence. 
Brief measures will be completed by patients online via REDCap. Participant specific 
data such as asthma severity, lung function, and adherence will be collected through the 
Propeller Health or FindAir mobile phone application, TreatSmart web portal, and via 
telephone. Clinical chart reviews will be conducted by study staff to provide an accurate 
estimate of lung function and disease severity from the date of consent to the end of study 
date.  
Adherence Assessment: 
Medical chart reviews will be conducted by study personnel to obtain information on 
medication regimen. 
 
 Electronic Monitoring: The Propeller Health or FindAir monitoring system includes 
a Bluetooth enabled sensor that attaches to the patient’s inhaler. This sensor records 
every dose, or “puff”, the patient takes and sends it to a corresponding online 
database that is accessible to study staff. All participants will be given this sensor at 
baseline. Patients will not receive medication adherence feedback during the first 
month of the study as baseline inhaler adherence data will be collected during this 
time.  TASC participants who move into Step 2 of the intervention will have access to 
their adherence via the Propeller Health or FindAir application. Study staff will have 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 10 of 34 
Revised:  August 16, 2023  
access the patient’s adherence from a daily, weekly, and monthly standpoint through 
the Propeller Health or FindAir provider portal. 
 Adolescent Barriers to Medication Scales (AMBS): The AMBS is an 18-item 
validated measure of perceived barriers to medication adherence in adolescents. The 
wording will be modified slightly to match asthma treatment regimens. Good internal 
consistency and construct validity have been documented. The participant’s AMBS 
score will be obtained at the baseline visit via REDCap questionnaire and again via 
phone at the end of the study.    
 Asthma Responsibility Questionnaire (ARQ): A brief validated measure that assess 
patterns of family responsibility for asthma management and the division of family 
responsibility for 10 asthma management tasks. Good internal consistent and 
convergent validity have been documented84. Participants will complete the ARQ at 
the baseline visit via REDCap and again at the end of the study via phone.  
 COVID-19 and Learning Questionnaire: A brief set of questions that assesses the 
current learning environment and its consistency to evaluate the impact on adherence. 
The participants’ responses will be obtained verbally and recorded in an excel 
database. At each of the subsequent study visits, the study coordinator will check-in 
with participants to see if there have been any changes to their school schedule since 
their previous visit.  
 
Lung Function Assessment: 
 
 MIR Spirobank Smart ™: The mobile spirometer records multiple parameters of 
the patient’s lung function including FEV1 (forced expiratory volume), PEF (peak 
expiratory flow), FVC (forced vital capacity), FEV1/FVC ratio, FEV6, and FEF2575 
(forced expiratory flow). The spirometer sends the FEV1, PEF, FVC, FEV1/FVC, 
FEV6, and FEF2575 values to the corresponding mobile phone application, Propeller 
Health or FindAir, which is directly accessible to the patient. Other values will be 
accessible to study staff through a secured database. Participants will be able to view 
their previous lung function data as well as adherence data within the phone 
application. Participants will also be asked to use their spirometer while on the phone 
with the study coordinator during their monthly visits.  
 
Disease Severity Assessment: 
 
 Composite Asthma Severity Index (CASI): The participants’ CASI score will be 
calculated through the TreatSmart program on a CCHMC secured laptop. The 
TreatSmart software web-based program, developed at CCHMC and hosted on a 
CCHMC secure server, will be used to determine the participant’s symptom burden, 
health care utilization, systemic corticosteroid use, and current medication use to 
determine the level of asthma severity/control the participant has. The study 
coordinator will collect this information from the participant at baseline and then once 
a month during the study telephone call and will enter the data into the program. The 
program also makes an initial treatment recommendation based on the National 
Asthma Education and Prevention Program (NAEPP asthma guidelines) if the 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 11 of 34 
Revised:  August 16, 2023  
participant’s asthma meets the definition of persistent asthma and if their treatment 
dose should remain the same or be changed based on their level of control. This 
program will also produce a visit summary and asthma action plan. The CASI and 
Treat Smart have both been validated by ICAC.  
 
 Asthma Control Test (ACT). The ACT will be used as a measure of disease severity 
in this study. The ACT is a 5-question scoring tool designed for patients with asthma 
who are 12 years and older. The questions ask the patient to rate their asthma 
severity, symptom frequency, control, and inhaler use on a scale of 1-5. The total 
score is calculated by the sum of each response, which determines how well-
controlled the patient’s asthma is on a scale from 5-25. The survey will be conducted 
at the initial visit and then via telephone (once a month throughout the study) and the 
ACT scores will be recorded in a password-protected database within a secured 
CCHMC server.  
 
Behavioral Assessment: 
 
 Behavior Assessment System for Children-Third Edition, Self-report of 
Personality (BASC-3-SRP-A)74: The BASC-3 is a widely used, reliable (α= 0.94 – 
0.96 , test-retest r= 0.81 –0.82), and valid inventory to assess emotional and 
behavioral symptoms in adolescents and young adults (ages 13-21). Different forms 
are available for children and adolescents, based on age. This self-report version is 
completed by adolescents. The BASC questionnaire will be completed at the baseline 
visit and again at the end of the study via phone. Data collected from the 
questionnaires will be stored in a password-protected database within a secured 
CCHMC server.  
 
Asthma Knowledge Assessment: 
 
 Knowledge Questionnaire: A 13-item questionnaire assessing individual’s 
knowledge of asthma symptoms, triggers, and medications. Participants rate their 
level of agreement to each statement on a scale from ‘Strongly Agree’ to ‘Strongly 
Disagree.’ This questionnaire will be completed at the baseline visit.  
 
Hardship Assessment:  
 
 Hardship Questionnaire: A 19-item validated questionnaire assessing the financial 
strain of individuals within a household. 80, 81, 82, 83 Participants will complete this 
measure at their baseline visit.  
 
Technology Use Assessment:  
The technology use measures will be completed either at baseline via REDCap or at the 
secondly monthly study visit via phone.  
 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 12 of 34 
Revised:  August 16, 2023  
 Autonomy and Competence in Technology Adoption Questionnaire (ACTA): A 
10-item measure of why people adopt use of a technology (i.e. download an app, 
register with a website, purchase a wearable device, etc.). The ACTA is based on the 
Self-Regulation Questionnaire scales used to measure behavior in other settings, 
including exercise, learning, and health care. Participants respond to self-regulation 
statements on a scale of 1 to 5, 1 being ‘not at all true’ and 5 being ‘very true.’ Based 
on the SRQ scales, the responses on the autonomous items are averaged to form the 
autonomous regulation score for the target behavior and the responses on the 
controlled items are averaged to form the controlled regulation score for the target 
behavior. Participants will fill out the ACTA questionnaire at their baseline visit via 
REDCap.  
 Technology-based Experience of Need Satisfaction- Task questionnaire (TENS- 
Task): An 8-item measure of participant’s competence, autonomy, and relatedness in 
managing their asthma using technology. Participants rate their level of agreement to 
each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree). 
Participants will complete this questionnaire at the baseline visit and again via 
telephone during their second monthly phone call. Responses will be entered into 
REDCap. 
 Technology-based Experience of Need Satisfaction- Interface questionnaire 
(TENS-Interface):  A 15- item measure of participant’s competence, autonomy, and 
relatedness in using technology. Participants rate their level of agreement to each 
statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree). 
Participants will complete this questionnaire via telephone during their second 
monthly phone call and answers will be entered into REDCap.  
 Technology Effects on Need Satisfaction in Life (TENS- Life): The TENS-Life is a 
10- item measure of the extent to which a user perceives that the use of a particular 
technology has had an influence on the satisfaction of basic psychological needs in 
their life. It is based on the validated Basic Psychological Need Satisfaction and 
Frustration Scale (Chen, Vansteenkiste, et al., 2015).79  Participants rate their level of 
agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly 
Agree). Participants will complete this questionnaire via telephone during their 
second monthly phone call.  
 
Feasibility: 
 
 Attendance/participation rates: Participation rates will be measured different ways 
for each step. The first measure will be how often participants accessed the electronic 
material (asthma management app, FindAir, and/or Propeller Health app), the second 
measure will be how many responses to directive text messaging were received, and 
the third measure will be attendance to the telehealth sessions.  
 Feasibility/Acceptability Questionnaire: A 5-31 item measure of format, content, 
length, skills and acceptability of the intervention will be given to participants in the 
form of a questionnaire at the end of each step and the end of the study.  

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 13 of 34 
Revised:  August 16, 2023  
 System Usability Scale (83): A 10 item, Likert scale giving a global view of 
usability will be given to participants in the form of a questionnaire at the end of each 
step and the end of the study. 
 Acceptability of Intervention Measure (AIM): A 4 item measure of participants’ 
belief that the intervention is acceptable will be given at the end of the study.  
 Intervention Appropriateness Measure (IAM):  A 4 item measure of participants’ 
perception that the intervention is appropriate will be given at the end of the study.  
 Feasibility of Intervention Measure (FIM): A 4 item measure of participants’ belief 
that the intervention is feasible will be given at the end of the study.  
 Credibility/Expectancy Questionnaire (CEQ): A brief, 6-item validated measure of 
treatment credibility and outcome expectancy. The wording of the items will be 
modified slightly for the current intervention, but the format and response options 
will remain the same. Internal consistency and test-retest reliability of the CEQ range 
from .75- .8585. Participants will complete the CEQ via phone at their second visit.  
 
Implementation: 
 
 Implementation: Treatment fidelity and time needed for the intervention will be 
assessed. Treatment fidelity will be assessed through fidelity checklists created 
specifically for each intervention session. Sessions will be timed and the number of 
weeks to complete the session will be tracked to determine the average length of time 
needed for the intervention. 
 Reach: Enrollment rate of high-risk or underserved individuals, reasons for declining 
participation, and representativeness of the sample will be assessed and monitored 
 Potential for Sustainability: Process evaluation regarding the facilitators/barriers to 
delivering TASC intervention, possible facilitators and barriers for sustaining 
intervention after study completion, and feedback regarding intervention changes that 
could improve adoption or sustainability. 
 Perceived Characteristics of Intervention Scale (PCIS): 19 item measure of 
interventionist’s views toward the study intervention. This questionnaire will be 
completed at the end of the study.  
 
 
 
Baseline 
(in 
person 
or via 
phone)
Follow 
up (via 
phone) 
Follow 
Up (via 
phone)  
Follow 
Up (via 
phone) 
Follow 
Up (via 
phone) 
Follow 
Up (via 
phone) 
Final 
Visit   
(via 
phone)  
Measures 
Visit 1 
Visit 2 
(1 
month)
Visit 3 
(2 
months)
Visit 4 
(3 
months) 
Visit 5 
(4 
months) 
Visit 6 
(5 
months)
Visit 7 
(6 
months) 
Electronic 
Monitoring 
X 
X 
X 
X 
X 
X 
X 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 14 of 34 
Revised:  August 16, 2023  
AMBS
X
X
ARQ
X
X
COVID 
Questionnaire
X 
X 
X 
X 
X 
X 
X 
Mobile 
Spirometry
X 
X 
X 
X 
X 
X 
X 
CASI
X
X
X
X
X
X
X
ACT
X
X
X
X
X
X
X
BASC-3
X
X
Knowledge 
Questionnaire
X 
 
 
 
 
 
 
Hardship 
Questionnaire
X 
 
 
 
 
 
 
ACTA
X
TENS-Task
X
X
TENS- 
Interface
X 
 
 
X 
 
 
 
TENS- Life
X
X
Feasibility 
Step 1
 
 
 
X 
 
 
 
Feasibility 
Step 2*
 
 
 
 
X 
X 
X 
Feasibility 
Step 3*
 
 
 
 
 
X 
X 
Acceptability 
Questionnaire
 
 
 
 
 
 
X 
SUS*
X
X
X
X
AIM
X
IAM
X
FIM
X
CEQ
X
*Depending on when or if the participant is moved into Step 2 and Step 3 of the 
intervention, they will complete these questionnaires when they finish the step or they 
may not complete these questionnaires.  
These questionnaires will be filled out by TASC participants only.  
 
7.0 
Data and Specimen Banking 
 
Not applicable.  
 
8.0 
Sharing of Results with Subjects 
The results will not be shared with the participant’s primary care physicians.  
9.0 
Study Timelines 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 15 of 34 
Revised:  August 16, 2023  
 
Participants will be enrolled in the study for a duration of 6 months. It is anticipated that 
all participants will be enrolled at the end of the 5th year of the study. It is anticipated that 
primary data analyses will be completed a year after study enrollment is complete. 
 
10.0 Inclusion and Exclusion Criteria 
Eligible adolescents will be identified through electronic medical records and recruited 
during outpatient medical visits or via telephone. Adolescents with a history of 
nonadherence per physician report will be targeted. 
 Inclusion Criteria: 
 Patient age between 12-18 years 
 Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP 
asthma guidelines 
 Patient is prescribed at least one daily inhaled controller medication or a daily 
combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist 
bronchodilator 
 English fluency for patient, caregiver, and clinician 
 
Exclusion Criteria: 
 Significant cognitive deficits that may interfere with comprehension per medical team 
or chart review 
 Diagnosis of serious mental illness (e.g., schizophrenia)  
 Diagnosis of pervasive developmental disorder   
 Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis, 
pulmonary hypertension, and moderate or severe tracheomalacia)  
 Patient receives school administered daily controller medication at the time of the 
enrollment visit 
 
11.0 Vulnerable Populations 
This study includes vulnerable subjects (children). Our research team has extensive 
experience with the unique needs of this population, thus this study presents minimal risk 
to patients, no greater than those encountered in routine behavioral assessment and 
clinical care. There are no medical risks. The assessments are similar to tasks conducted 
in our outpatient clinics. Intervention sessions will utilize evidence-based strategies 
similar to those conducted clinically in outpatient clinics. It is possible that participants 
may feel uncomfortable responding to questions about their adherence, social support, 
medication knowledge, problem-solving or barriers to adherence, asthma responsibility, 
or behavioral difficulties. All participants will be reminded that they can decline to 
answer any questions if they choose without negative repercussions. The PI, Rachelle 
Ramsey, PhD is a licensed Clinical Psychologist and will be available to participants at 
any time during study participation. Consistent with HHS regulations for minimal risk 
studies, adolescent assent and parental consent will be obtained. Trained study staff will 
obtain-age appropriate written information consent/assent. All pertinent aspects of 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 16 of 34 
Revised:  August 16, 2023  
consent/assent will be reviewed verbally and in writing including study purpose, 
risks/benefits, confidentiality, and right to withdraw. Patients will be informed that their 
care at CCHMC will not be affected whether they choose to participate in the study and 
that they are able to withdraw at any time. Study staff will address all questions and 
concerns. No assessment procedures will occur until after parent consent and adolescent 
consent or assent are obtained. 
12.0 Local Number of Subjects 
Up to 80 adolescents will be enrolled in the current study. 
13.0 Recruitment Methods 
 
Adolescents will be recruited through the CCHMC Asthma Center, which conducts 4500 
patient visits each year. Eligible adolescents will be identified through electronic medical 
records and approached during outpatient medical visits. Adolescents with a history of 
nonadherence per physician report will be targeted. Study staff will meet with interested 
adolescents and parents to confirm eligibility and obtain written consent/assent. 
Adolescents may also be recruited via telephone. For the patients study staff plan to 
recruit via phone, a recruitment letter will be mailed or emailed to eligible families with 
upcoming pulmonary appointments, which will describe the study briefly and include an 
“opt out” phone number to call if they do not wish to be contacted about the study. Two 
weeks after sending the letters, study staff will call potential participants to discuss the 
study more thoroughly. Reasons for decline and sample composition will be tracked 
throughout the study to ensure accurate representation and to examine the reach of the 
intervention based on the enrollment rate of high-risk or underserved individuals. 
 
Participants will be compensated for their participation in the amount of $50 for the 
baseline assessment, $20 at the end of month 1, $20 at the end of month 2, $25 at the end 
of month 3, $30 at the end of month 4, $40 at the end of month 5, $75 at the end of the 
study. In addition, participants will be paid $10 a week for syncing their Propeller or 
FindAir caps in conjunction with the Step 2 texting intervention, allowing the 
interventionists to obtain the data needed to complete the intervention. Participants who 
qualify for behavioral intervention sessions will be paid $15 per session for up to four 
sessions. In the event that a study phone is not returned, we will attempt via phone and 
email to reach the family and set up a way to retrieve it in person or via mail. Given the 
high cost of the phones, if, after several months it is still not returned, we may offer an 
incentive of $50 for the safe return of the working mobile device, no questions asked. 
 
Families will be compensated using a reloadable debit card (ClinCard). The ClinCard 
will be given to families at the initial visit and compensation will be loaded once their 
initial visit is complete. In addition, families will receive a handout with instructions on 
how to use the debit card (Appendix 19.B - ClinCard Debit Card handout). Families are 
encouraged to keep their debit card for future visits but, should they need another card, it 
will be provided to them at no cost. Cards will be loaded by research coordinators 
immediately after a visit is completed.  
 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 17 of 34 
Revised:  August 16, 2023  
14.0 Withdrawal of Subjects 
Participants may withdraw from the study at any time and will be informed of this 
right verbally and in writing during the consent process. The principle investigator 
may remove participants from the study for abuse of CCHMC device privileges 
(see cell phone contract).  
15.0 Risks to Subjects 
 
This is a minimal risk study. All behavioral assessments and questionnaires have been 
used in research without any reported negative effects; rarely, participants experience 
mild temporary distress related to completion of behavioral measures. The adherence 
trackers (Propeller Health or FindAir) that will be provided to participants are registered 
with the FDA as a Class 1 Medical Device and therefore only pose minimal risk. Families 
also might be slightly inconvenienced by participating over a short period of time. 
 
Several precautions will be taken to minimize the risk, discomforts, and inconveniences 
associated with this protocol. First, the PI is a licensed clinical psychologist and will 
oversee all study components. Thus, in the unlikely event of psychological distress 
resulting from questionnaires or assessment components, appropriate treatment and/or 
referrals can be easily made. All assessment components will be completed online or in 
conjunction with a pulmonary clinic appointment to lessen the burden of time and travel 
for families. 
 
Knowledge gained in this study has the potential to improve treatment of pediatric 
asthma by enhancing disease management skills that, consequently, would improve 
treatment outcome in this population. The minimal risk posed to participants by this study 
is acceptable given that the knowledge that reasonably may be expected to result is 
substantial to the overall treatment of these patients and their families.  
 
16.0 Potential Benefits to Subjects 
 
Data from this project will inform clinical treatment of asthma through the empirical 
testing of an adherence-promotion intervention for adolescents with asthma. There is no 
guarantee of direct benefit to study participants. It is anticipated that at least some of the 
participants in this trial will benefit from the services provided. It is also anticipated that 
the pilot trial will provide important findings relative to the large-scale dissemination and 
implementation of the TASC intervention, ultimately benefitting additional patients with 
asthma. 
 
Knowledge gained in this study has the potential to improve medication adherence in 
adolescents with asthma through the use of a technology-assisted empirically-supported 
behavioral intervention that is ready for dissemination. Despite existing adherence-
promotion interventions for adolescents with asthma, nonadherence remains high and no 
technology-assisted interventions that can be easily disseminated are available. If this 
pilot trial is successful, there are pragmatic public health and clinical practice changes 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 18 of 34 
Revised:  August 16, 2023  
that might emanate from this research. The study has the potential to advance existing 
adherence-promotion intervention science by shedding light on specific processes of 
change targeted by feedback and problem-solving based interventions. Our proposed 
examination of demographic factors may also help to explain why interventions work for 
some adolescents with asthma, but not others. The degree of risk to which study 
participants will be exposed in the proposed protocol is low. By contrast, the potential 
and probable benefits to be derived are substantial, insofar as the results will be used to 
enhance existing treatment or develop new interventions for this population. When 
considering the minimal risks entailed with participation and the extensive efforts 
proposed to limit/eliminate these risks, we feel that the potential benefits to the research 
community and future interventions far outweigh the potential minimal risks.  
 
17.0 Data Management and Confidentiality 
 
The primary outcome measure for Aim 1 at post-treatment is percent change in adherence 
to daily inhaled corticosteroids as measured by electronic monitoring devices compared 
to a treatment as usual control group. The secondary outcome measure is change in CASI 
scores. The expectation is that the TASC group will have an increased change in 
adherence and a decreased change on the CASI.  
 
For Aim 2, the outcome measures are reach, acceptability, usability, and sustainability.  
 
The exploratory outcome measures are clinical, demographic, and behavioral predictors 
of attendance, acceptance, and improvement in medication adherence and health within 
each intervention step.  
 
 
Aim 1: To test the preliminary efficacy of the TASC adherence-promotion 
intervention for adolescents with asthma in a feasibility randomized controlled trial 
compared to treatment as usual control arm.
 Hypothesis 1 (H1): The TASC adherence-promotion intervention will result in 
improved adherence to daily inhaled corticosteroids as measured by electronic 
monitoring compared to a treatment as usual control arm. 
 Hypothesis 2 (H2): The TASC adherence-promotion intervention will result in 
improved disease severity as measured by the Composite Asthma Severity Index 
combining symptoms, treatment, and exacerbations30 compared to a treatment as usual 
control group.
The statistical test of choice for H1 and H2 will be an analysis of covariance 
(ANCOVA). Percent change in adherence is the primary clinical outcome of interest and 
change in CASI is the secondary outcome of interest. Seasonality will be controlled by 
recruitment of participants in waves and ensuring balanced enrollment across the study 
period. In the event that distributional assumptions are not amenable for analysis, 
nonparametric tests will be considered, as appropriate.  
Aim 2: To assess the implementation of the TASC adherence-promotion intervention 
for adolescents with asthma through a process evaluation.

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 19 of 34 
Revised:  August 16, 2023  
 Hypothesis 3 (H3): The TASC adherence-promotion intervention implementation will 
be successful as evidenced by high levels of acceptability, usability, reach, and 
sustainability.
For H3 acceptability, descriptive statistics of participant-reported and provider-
reported satisfaction with intervention structure, length, convenience, and perceived 
impact on outcomes will be assessed86. For usability, the statistical test of choice will be 
one-sample t-test tested at the nominal α2-tailed = 0.05 level. Usability will be evaluated 
using the SUS and a comparison score of 71 indicating good usability.87 For reach, 
representativeness of the sample and enrollment rate of underserved individuals will be 
assessed. For sustainability, facilitators and barriers to delivering the intervention will be 
assessed.  
Exploratory Aim: Examine clinical, demographic, and behavioral predictors of 
attendance, acceptance, and improvement in medication adherence and health within 
each intervention step.
Mediation and moderation of treatment effects will be examined using strategies 
outlined by Barron and Kenny88, Holmbeck and colleagues89,90 using candidate covariates 
believed to be in the causal chain, including but not limited to, demographic 
characteristics, asthma symptoms, clinical presentation, treatment outcome expectancy 
(CEQ), and externalizing and internalizing problems (BASC). 
 
A total of 60 participants will be needed for Hypothesis 1 analyses. Monte Carlo 
simulations in Mplus (version 8.1) were conducted to estimate statistical power 
assuming: 1) baseline adherence, asthma exacerbations, and race/ethnicity could explain 
between (R2 = 0.20-0.40) 20%-40% of response variable noise variance, 2) participant 
attrition could range between 0%-20%, 3) alpha = .05, and 4) pre-post correlations 
similar to those reported in both the intervention literature and observed in our lab. The 
power analysis question involved identifying the smallest d effect size difference under 
these assumptions. Assuming proper handling of missing data, results showed power will 
be > 0.80 for d >0.72. Effect sizes larger than the one proposed have been documented in 
published studies12,91, however, if statistical significance is not achieved, effect size 
estimates would inform design and power considerations for subsequent efficacy studies 
to further evaluate the TASC intervention. Up to 80 participants will be recruited to 
account for attrition. 
 
Many procedures are in place to guard against missing or unusable data; however, 
missing data are almost inevitable in clinical research. The strategy for accommodating 
missing values is to first investigate and identify patterns of missingness, by group and 
variable, by using established pattern identification techniques. To the extent possible, 
potential mechanisms of missingness will be identified, including values deemed to be 
missing at random, completely at random, or not random at all. If substantial missing data 
are observed, parameter estimation using multiple imputation methods will be computed 
to estimate the missing values, and relevant predictors related to missingness will be 
added to our models. Sensitivity analyses will be conducted, with and without 
outliers/extreme values, and with and without imputed values to test the stability of our 
models under alternative conditions. 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 20 of 34 
Revised:  August 16, 2023  
 
All data will be de-identified with the use of unique assigned study identifier codes. All 
electronic data will be stored on a CCHMC network server with built-in security. 
Treatsmart program data and web-based databases are located on a CCHMC secure 
server. Propeller Health or FindAir adherence data is located on their HIPAA-compliant 
servers and will be transferred securely to the CCHMC investigators at the end of the 
study for data analysis. Smartphones provided by CCHMC for use by the participants in 
the clinical study will be loaded with a security software program, Air Watch. Air Watch 
is a mobile device management technology that enables IT to deploy, configure, manage, 
support, and secure mobile devices from afar to provide remote configuration, trouble-
shooting, and lock and wipe security. Air Watch will not be loaded on participants’ 
personal cell phones.     
 
Propeller Health, FindAir, Treatsmart, asthma management app, and REDCap data will 
be stored on a secure, HIPAA compliant server and only approved study personnel will 
have access to the server (MAP) and data contained within the server. Informed 
consent/assent documents, and W-9 tax forms will be stored on a secure network drive 
with limited access. Any de-identified data will be confidentially protected with the use 
of unique assigned study identifier codes, and a master key linking identifying patient 
information (e.g., MR#) with the study ID code will be secured in a different locked file. 
The key, used for data entry purposes, will be destroyed as soon as possible after the 
completion of the study. Data will be retained until final data analyses are completed; all 
de-identified data will then be destroyed (e.g., shredded). Weekly audits to confirm 
access to database repositories and web application server environments will be 
conducted to ensure that it is limited to the appropriate user group. In addition, private 
conference rooms are available at CCHMC to ensure confidentiality during telehealth 
visits 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
This study involves minimal risk to participants. Study personnel at CCHMC will 
monitor data collection, progress through treatment, any technical difficulties that may 
arise, adverse events, and completion of study procedures. Any adverse events (i.e., 
breach of confidentiality or events that are unexpected and related to the intervention) 
will be reported to the IRB within 48 hours. Participation will be discontinued at parent 
or patient request or if the investigators deem that it is in the best interest of the patient’s 
health. The study team will provide referrals as appropriate for treatment needs resulting 
from any adverse events. The IRB requires yearly renewal of study protocols, which 
provides additional monitoring of participant safety. All other adverse events that happen 
in the course of the study procedures as well as minor deviations from protocol will be 
reported in table form at the next yearly continuing IRB review. The PI will review study 
data with her primary mentor at weekly meetings to ensure safety compliance and proper 
reporting to the IRB. In addition, the PI will have quarterly meetings with her mentorship 
team to monitor the progress of the study, the integrity of the treatment, discuss the need 
for any protocol refinements, and conduct regular safety monitoring checks of adverse 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 21 of 34 
Revised:  August 16, 2023  
events. The PI will report any significant study related or unanticipated adverse events to 
not only the IRB, but also to the study sponsor based upon institutional and sponsor 
guidelines. Given that this pilot study is using evidence-based intervention, we believe 
that monitoring at the level of the PI, her mentors and research team, with oversight from 
the IRB and study sponsor is sufficient.  
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
 
All research staff will participate in data safety and monitoring by reporting any 
emotional distress reactions or adverse events to the study PI. Participation in the study 
will be discontinued at parent or patient request, or if the parent or patient experiences a 
significant adverse event. The PI will immediately report any adverse events to the IRB. 
In the unlikely event of a participant necessitating medical or psychological treatment due 
to adverse effects of participating in a study, a member of the investigative team will 
make appropriate referrals and/or hospitalization within the appropriate study site.  
 
It is possible that situations will arise in which research staff will be provided information 
by participants which they are legally and ethically obligated to disclose (e.g. suicidal or 
homicidal intent, sexual/physical abuse). In these instances, the appropriate report and/or 
referral for psychological intervention will be arranged and the PI, Rachelle Ramsey, 
PhD, will be immediately notified. All exceptions to confidentiality will be clearly 
outlined to the participant during informed consent.  
 
20.0 Compensation for Research-Related Injury 
 
Not applicable.  
 
21.0 Economic Burden to Subjects 
 
There is no cost for participating in the study, only time and minimal cell phone use. 
Study procedures will be completed online or in conjunction with pulmonary clinic 
appointments to lessen the burden of travel. All study components (i.e. cellular phone and 
data plan, inhaler attachment, and mobile spirometer) will be supplied to participants at 
no cost if they do not have the necessary cellular device. Families will continue to be 
responsible for usual costs associated with their medical care.  
 
22.0 Consent Process 
 
Potential participants will be consented by telephone or in person. For telephone 
recruitment, the consent form will be sent to families for review and a phone call will be 
utilized for study staff to thoroughly review the form with the family. This will allow 
caregivers and patients ample time to review the document and get answers to any 
questions. Once all questions are answered, patients and caregivers will sign the 
consent/assent form. Assent and parental permission will be obtained from at least one 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 22 of 34 
Revised:  August 16, 2023  
legal guardian for individuals under the age of 18 years old. Forms can be returned to 
study staff by mail, email, or fax, or can be signed electronically using REDCap or 
SignNow, a cloud-based electronic signature platform that allows companies and 
individuals to sign documents from their computer, iPhone, iPad, or Android device. 
Each page of the consent form will be uploaded into REDcap so that the patient and 
caregiver can view the form. There are spaces in the REDCap form for the research 
participant to indicate their date of birth, whether or not they consent to the study, as well 
an area to type their name, sign, and date. If the research participant is under 18, there is 
also a space in REDCap for the caregiver or legally authorized representative to sign and 
date, as well an area for the legally authorized representative to provide a description of 
their authority. Study staff will sign and date accordingly on the signature page or in a 
designated space in the REDCap form corresponding to the date the forms were received, 
not necessarily reviewed with the family. The method used to obtain participant consent 
will also be written on the Informed Consent Process Note. Reasons for decline and 
sample composition will be tracked throughout the study to ensure accurate 
representation. 
 
Participants may also be consented in person at their appointment in the Pulmonary 
Clinic. Study staff will thoroughly review the form with the family and caregivers and 
patients will be given ample time to review the document and get answers to any 
questions. Once all questions are answered, patients and caregivers will sign the 
consent/assent form. Forms can also be signed electronically via REDCap or the 
SignNow platform in person, using either the coordinator’s CCHMC laptop or the 
participant’s smartphone.  
 
23.0 Process to Document Consent in Writing 
 
In compliance with CCHMC SOP Number 41-1.6, study staff will sign and date 
accordingly on the signature page of each form or in a designated spaced in REDCap 
corresponding to the date the forms were received, not necessarily reviewed with the 
family. The method used to obtain participant consent will also be written on the 
Informed Consent Process Note. Signed consents will not be sent to Health Information 
Management due to the minimal risk nature of the study. 
 
24.0 Setting 
Research will be conducted at Cincinnati Children’s Hospital Medical Center and 
satellite locations, including Green Township and Liberty Campus. Potential 
participants will be identified through electronic medical records and approached 
during outpatient medical visits or via phone following a two- week “opt out” 
period. Research procedures will be performed at Cincinnati Children’s main 
campus, the satellite locations listed above for the baseline visits, or via phone.  
25.0 Resources Available 
 

PROTOCOL TITLE: Using Technology- Assisted Stepped Care Intervention to Improve 
Adherence in Adolescents with Asthma  
 
 
Page 23 of 34 
Revised:  August 16, 2023  
Adolescents will be recruited through the CCHMC Asthma Center, which conducts 4500 
patient visits each year. We will start by contacting patients in the Asthma Center, but 
will recruit from other clinics within pulmonary and allergy if necessary. 
 
26.0 Multi-Site Research 
Not applicable.  
 
27.0 References 
 
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6. 
Baum D, Creer TL. Medication compliance in children with asthma. Journal of 
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7. 
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Gibson NA, Ferguson AE, Aitchison TC, Paton JY. Compliance with inhaled 
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Burgess SW, Sly PD, Morawska A, Devadason SG. Assessing adherence and 
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15. 
Sherman JM, Baumstein S, Hendeles L. Intervention strategies for children poorly 
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16. 
Guendelman S, Meade K, Benson M, Chen YQ, Samuels S. Improving asthma 
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17. 
Rikkers‐Mutsaerts E, Winters A, Bakker M, et al. Internet‐based self‐management 
compared with usual care in adolescents with asthma: A randomized controlled 
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18. 
Chan DS, Callahan CW, Hatch-Pigott VB, et al. Internet-based home monitoring 
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Krishna S, Francisco BD, Balas EA, Konig P, Graff GR, Madsen RW. Internet-
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Kouba J, Velsor-Friedrich B, Militello L, et al. Efficacy of the I Can Control 
Asthma and Nutrition Now (ICAN) pilot program on health outcomes in high 
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21. 
Homer C, Susskind O, Alpert HR, et al. An evaluation of an innovative 
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Hughes M, Murphy M. Evaluation of a pilot national online asthma E-learning 
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23. 
Jan RL, Wang JY, Huang MC, Tseng SM, Su HJ, Liu LF. An internet-based 
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Seid M, D'Amico EJ, Varni JW, et al. The in vivo adherence intervention for at 
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Ostojic V, Cvoriscec B, Ostojic SB, Reznikoff D, Stipic-Markovic A, Tudjman Z. 
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Dayer L, Heldenbrand S, Anderson P, Gubbins PO, Martin BC. Smartphone 
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27. 
Park LG, Howie‐Esquivel J, Dracup K. A quantitative systematic review of the 
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28. 
Spaulding SA, Devine KA, Duncan CL, et al. Electronic monitoring and feedback 
to improve adherence in pediatric asthma. Journal of pediatric psychology. 
2012;37(1):64-74. 
29. 
Chan AHY, Stewart AW, Harrison J, Camargo CA, Black PN, Mitchell EA. The 
effect of an electronic monitoring device with audiovisual reminder function on 
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28.0  Appendix 
 
Data Safety And Monitoring Plan 
 
The purpose of this K23 is to test the preliminary efficacy of a technology-assisted 
stepped-care (TASC) adherence-promotion intervention for 12-18 year old adolescents 
with asthma in a pilot RCT. Following a two month baseline period, adherence will be 
assessed monthly and adolescents will be provided with the appropriate intervention step 
based on their adherence to daily inhaled corticosteroids. Preliminary efficacy will be 
demonstrated by improved adherence to daily inhaled corticosteroids as measured by 
electronic monitoring devices compared to a treatment as usual (TAU) control group. 
Secondary outcomes include disease severity as measured by the Composite Asthma 
Severity Index combining symptoms, treatment, and exacerbations compared to TAU and 
an assessment of TASC implementation through a process evaluation assessing reach, 
usability, and sustainability. 
 
This study involves no more than minimal risk to participants. The PI, her mentoring 
team, and study personnel at CCHMC will monitor recruitment, retention, data 
collection, progress through treatment, any technical difficulties that may arise, adverse 
events, and completion of study procedures. Any adverse events will be reported to the 
IRB within 48 hours. Participation will be discontinued at parent or patient request or if 
the investigators deem that it is in the best interest of the patient’s health. The study team 
will provide referrals as appropriate for treatment needs resulting from any adverse 
events. The IRB requires yearly renewal of study protocols, which provides additional 
monitoring of participant safety. All other adverse events that happen in the course of the 
study procedures as well as minor deviations from protocol will be reported in table form 
at the next yearly continuing IRB review. The PI will review study data with her primary 
mentor at weekly meetings to ensure safety compliance and proper reporting to the IRB. 
In addition, the PI will have quarterly meetings with her mentorship team to monitor the 
progress of the study, the integrity of the treatment, discuss the need for any protocol 
refinements, and conduct regular safety monitoring checks of adverse events. The PI will 
report any significant study related or unanticipated adverse events to not only the IRB, 

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Adherence in Adolescents with Asthma  
 
 
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but also to the study sponsor based upon institutional and sponsor guidelines. Given that 
this pilot study is using evidence-based intervention, we believe that monitoring at the 
level of the PI, her mentors and research team, with oversight from the IRB and study 
sponsor is sufficient.  
 
All data will be de-identified with the use of unique assigned study identifier codes. All 
electronic data will be stored on a CCHMC network server with built-in security. 
Treatsmart program data and web-based databases are located on a CCHMC secure 
server. Propeller Health or FindAir adherence data is located on their HIPAA-compliant 
servers and will be transferred securely to the CCHMC investigators for data analysis. 
CCHMC smartphones used by the participants in the clinical study will be loaded with a 
security software program, Air Watch. Air Watch is a mobile device management 
technology that enables IT to deploy, configure, manage, support, and secure mobile 
devices from afar to provide remote configuration, trouble-shooting, and lock and wipe 
security.     
 
Computer files will only contain study identifier codes and will be password protected. 
Paper records will be stored in locked file cabinets accessible only to the PI and 
authorized study team members. Access to all data and subject identities will be limited 
to the research team. Informed consent documents will be stored in a locked location 
separate from study data. Medical chart data will be collected under the supervision of 
the PI. Summaries of these data will remain secure under the supervision of the PI and 
study coordinator. Private conference rooms are available at CCHMC to ensure 
confidentiality during telehealth visits. These risk protection methods have been used 
effectively by Dr. Ramsey and her mentors in previous studies. 
 
Procedures for monitoring study safety, minimizing research-associated risk, and 
protecting the confidentiality of participant data 
 
Adolescents and parents will be approached during outpatient medical visits or via 
telephone. Study staff will meet, in person or over the phone, with interested adolescents 
and parent(s) to confirm eligibility and obtain written consent/assent. The coordinator 
will explain the purpose of the study, what participation entails, risks and benefits of 
participation, data to be collected, confidentiality, privacy, procedure for discontinuation 
of participation, reimbursement, and contact information for study personnel. For consent 
obtained over the phone, the consent will be provided electronically to the patient and 
family ahead of time in offer to allow for time to review. Participants and parents will be 
explicitly told that their child’s medical care will not be affected whether they choose to 
participate in the study or decline participation. Once any questions from the parent or 
adolescent have been answered, parents will sign the consent from and adolescents will 
sign the assent form on the same parent consent documents, which includes HIPAA 
authorization. A copy of the signed combined consent/assent form will be provided to the 
parent. Names and phone numbers of the PI and the Institutional Review Board will be 
provided on these consent forms. Participants and parents will also be told that they may 
decline to answer any questions that make them feel uncomfortable and will be reminded 

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Adherence in Adolescents with Asthma  
 
 
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of this prior to measure completion. Participants may also withdraw from the study at any 
time and will be informed of this right verbally and in writing during the consent process.  
 
In the unlikely event that the content of the questionnaires causes emotional or 
psychological distress, the Principal Investigator, Rachelle Ramsey, PhD, a licensed 
Clinical Psychologist at CCHMC, or a qualified designee will be contacted immediately 
to assess the patient and provide appropriate referrals and/or treatment. If the matter is 
assessed as urgent, the PI or a qualified designate will recommend that child seek 
emergency medical care (e.g., go to the nearest emergency room). In situations that are 
not urgent, the PI or a qualified designate will provide the individual with referral 
information for obtaining psychological services.  
 
We will attempt to alleviate all issues of confidentiality breaches. Confidentiality will be 
protected by assigning a numerical code to each research participant for data collection. 
Study identifier codes will be used in the web interface for data entry and adherence 
electronic monitor data download. No other identifying data such as date of birth, 
address, phone numbers, social security number, or zip code will be entered in the web 
interface. All exported data files will only identify participants via study identifier codes. 
All data will be kept in password protected electronic files on the CCHMC hard drives. 
All passwords will only be known to study staff directly involved in the administration 
and oversight of the data collection. All information collected as part of this study will be 
accessible only to study staff, who will complete CCHMC human subjects training to 
ensure familiarity with rights of research participants and protection of confidentiality. 
Electronic data stored on CCHMC’s network is backed up nightly. The server is 
maintained and all backups are conducted by the Division of Information Services. 
Access to data and subject identities will be limited to study team members.  
 
Informed consent/assent documents will be maintained in a locked location at CCHMC. 
Consents will be kept separate from participant’s data. Only the study investigative team 
will have access to these materials. Medical chart data will be collected by trained study 
staff under the supervision of the PI. These risk protection methods have been effectively 
used by the PI and her mentors for numerous studies.  
 
It is possible that situations will arise in which research staff will be provided information 
by participants which they are legally and ethically obligated to disclose (e.g. suicidal or 
homicidal intent, sexual/physical abuse). In these instances, the appropriate report and/or 
referral for psychological intervention will be arranged and the PI, Rachelle Ramsey, 
PhD, will be immediately notified. All exceptions to confidentiality will be clearly 
outlined to the participant during informed consent.  
 
We will be using technology for the intervention; thus, it is possible that privacy can be 
lost when using the internet, cell phones, computers, or tablets. Parents/legal guardians 
will be advised about this potential loss of privacy. For study purposes, we will continue 
to code everything to a participant number or use language that minimizes identification 
of a particular participant by name or HIPAA-based information.  

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Adherence in Adolescents with Asthma  
 
 
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Security for web-based applications is provided through a Secured Socket Layer 
certificate allowing for 128-bit encryption between client and server transactions as well 
as the secured demilitarized zone (DZD) network. Participant responses will be stored on 
the secured SQL server database. All data will be stored and accessed in accordance with 
the HCFA’s Internet Security Policy and HIPAA. 
 
Data will be stored in the secured data repository on CCHMC’s internal network drive 
and automatically backed up and managed by the administrator. The guidelines from the 
Society of Clinical Data Management will be followed for security at various steps of 
development. Weekly audits to confirm access to database repositories and web 
application server environments will be conducted to ensure that it is limited to the 
appropriate user group 
 
Finally, because this research study involves payment for participation, we are required 
by Internal Revenue Service (IRS) rules to collect and use their social security number 
(SSN) or taxpayer identification number (TIN) in order to track the amount of money that 
we pay them.  Unless they have given specific permission for another use of their SSN or 
TIN related to this research study, we will only use their SSN or TIN to keep track of 
how much money we pay them, and their SSN or TIN will not be used as part of this 
research study. 
 
Additional Protections for Vulnerable Subjects, Children 
Consistent with HHS regulations for minimal risk studies, adolescent assent and parental 
consent will be obtained. Further, the minimal risk posed by this project to participants is 
reasonable given the resulting novel adherence-promotion intervention.  
 
In the unlikely event that the content of the interviews, questionnaires, or intervention 
causes emotional or psychological distress, the PI, Rachelle Ramsey PhD, a licensed 
clinical Psychologist at CCHMC or a qualified designee will be contacted immediately to 
assess the situation and provide appropriate referrals and/or treatment.  
 
Adolescence is a unique development period marked by significant changes in academic 
and occupational roles, social relationships, responsibilities and independence. Accurate 
assessment of the efficacy of TASC and identification of predictors of adherence relevant 
to this age group requires the inclusion of children ages 12-18 years. Our team’s 
specialized training and expertise in adolescents will allow us to be sensitive to the 
unique needs of our study participants. We will listen carefully to any information and 
concerns reported by both adolescent participants and their parent/caregiver.  
 
Procedures for handling endorsement of intent to self-harm 
A question related to intent to self-harm is included in the current protocol on the 
Behavior Assessment Scale for Children Form. QUESTION 124 says “My life isn’t 
worth living.” If the adolescent responds with ‘often’ or ‘always’ to QUESTION 124, the 
PI, Rachelle Ramsey PhD, a licensed clinical psychologist with training in suicide risk 
and assessment or a qualified designee, will be contacted to assess the situation, including 

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Adherence in Adolescents with Asthma  
 
 
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an assessment of risk. If it is determined that there is no immediate risk or concern, the 
parent/legal guardian will be provided with information regarding what to do if the risk 
status changes at home, how to keep the child safe (e.g., removal of weapons or material 
that can be used for self-harm), as well as procedures to go to the local Emergency Room 
if risk is elevated. The adolescent will also be provided with the National Suicide 
Prevention Lifeline (1-800-273-TALK) hotline. If the adolescent is at risk for self-harm 
and has intent and means, the adolescent and their parent will be directed to go to the an 
emergency room for further assessment (e.g., need for a 72 hour hold, inpatient 
psychiatry). Regardless of the level of concern, such risks will be documented as they 
occur and the IRB will be notified during the continuing review. These are considered 
adverse events because they are expected in this population as approximately 45% of 
youth with asthma report depression symptoms and the suicide attempt rate has been 
shown to be twice the national population rates.92 These procedures have been 
successfully used in prior behavioral adherence trials conducted by the PI and her 
mentors.  
 
These procedures will also be followed should concerns arise regarding abuse or neglect. 
If, during the course of the study, research staff become aware of mistreatment of neglect 
of a child under the age of 18 by a parent/legal guardian, his/her partner, a relative or 
someone living in the home, a caretaker (e.g., babysitter, day care worker), or any person 
responsible for the child’s welfare, we are mandated by law to contact the appropriate 
person or agency. If this occurs, the PI or a designee will be contacted. If abuse/neglect is 
suspected, a report will be initiated immediately to child protective services based on the 
local reporting requirements. This would be considered a serious adverse event. Such an 
event would be reported by the PI to NHLBI and the IRB immediately and during 
continuing review. Patients and caregivers will be made aware that any information 
obtained during their participation that suggests the potential for harm to self or others 
will be immediately disclosed to the appropriate individual in order to protect the patient. 
 
Study safety monitoring schedule 
The PI and mentoring team will randomly review 10% of all participant research files on 
an annual basis for: compliance with IRB requirements (including proper completion of 
all consent documents), compliance with informed consent requirements, data quality and 
integrity, and research assistant compliance with the study protocol.  
 
The research team will monitor for safety and adverse events at each study visit. In the 
context of this study, adverse events are defined as “any untoward or unfavorable medical 
occurrence in a human participant, including any abnormal sign, symptom, or disease, 
temporally associated with the subject’s participation in the research, whether or not 
considered related to the subject’s participation in the research” 
(http://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-
problems/index.html). Given this definition, adverse events such as suicidal ideation and 
hospitalizations and emergency room visits due to asthma would be expected in this 
patient population but it would be very unlikely for an adverse event such as this to occur 
as a result of study participation. We will record suicidal ideation, hospitalizations and 

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Adherence in Adolescents with Asthma  
 
 
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emergency room visits and report these as regular adverse events during the yearly 
continuing review.  
 
A serious adverse event is defined as any event that could be considered life-threatening, 
requires an emergency room visit or hospitalization, or may jeopardize the child’s health 
(http://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-
problems/index.html). All serious adverse events (such as reports of abuse/neglect) will 
be reported immediately (in less than 48 hours) to NHLBI and to the IRB. Such reports 
will include the date on which the event occurred, a detailed description of the event, a 
detailed accounting of the response to the event, whether the event was related or 
unrelated to the study, and a log of which monitoring entities were contacted.