Peer Led Asthma Self Management for Adolescents: PLASMA
Phase: PHASE2
Conditions: Asthma
Sponsor: University of Rochester

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University of Rochester RSRB Protocol 
Title – PLASMA: Peer led asthma self-management for adolescents 
Principal Investigator: Hyekyun Rhee, PhD, PNP 
       
 
 
University of Rochester Medical Center 
 
 
 
School of Nursing 
 
1. STUDY OVERVIEW – PURPOSE AND BACKGROUND 
Asthma, the most common pediatric chronic condition, is a serious problem for many adolescents. 1  In 
2010, nearly 11% of adolescents (2.7 million) ages 12 through 17 years in the US reported current 
asthma. 2  This age cohort suffers greater asthma-related morbidity and mortality than younger children. 
3, 4  Asthma disproportionately affects inner-city youth, where asthma severity has increased and 
achieving optimum asthma control has been elusive. 5  Several factors including poor socioeconomic 
conditions, life stresses, and environmental triggers have been found to be associated with poorly controlled 
asthma in inner-city children. 5 Programs targeting asthma in inner-city children have primarily focused on the 
modification of environmental factors 6 and addressing disparity in healthcare access. 7 Serious adverse 
outcomes requiring hospitalization, intubations and cardiopulmonary resuscitation are more 
common in adolescents than in younger children. 8  Moreover, asthma mortality among teens is 
approximately twice that of younger children. 3 Asthma results in decreased quality of life due to 
poor sleep quality and limited activity. 4, 9 The impact of asthma on daily activities is substantial: 
over 50% of teens with asthma reported some degree of activity limitations. 9, 10  
Limited intervention efforts have been directed to address high inner-city asthma morbidity specifically in 
adolescents by promoting adequate self-management. In adolescents, peers have the greatest influence 
over behaviors and psychosocial well-being, even in those with chronic illness. Peer support can increase 
adherence to disease self-management. 11-13 Adolescents with asthma highly value support from peers with 
asthma. 14, 15 Positive interactions between adolescents with asthma have been found to have positive 
impact on their asthma management, 16, 17 and overall psychosocial well-being. 13, 18, 19 Therefore, 
providing a context in which adolescents with asthma can interact with each other can be beneficial in 
implementing an asthma self-management program for this age group. Given the high prevalence, 
limited interventions and serious adverse outcomes of asthma and its impact on quality of life in 
adolescents, it is imperative to implement effective strategies to improve self-management and 
health outcomes in this population. Building on Dr. Rhee (PI) previous efficacy trial, the overall goal of 
the proposed study is to evaluate the effectiveness and generalizability of PLASMA, peer-led asthma self 
management for adolescents, in improving asthma outcomes in inner-city adolescents from three 
metropolitan cities in the Northern, Eastern and Southern US with distinctive historical and cultural 
backgrounds. Multisite studies have been advocated as an effective approach to strengthening 
external validity as such studies afford the opportunity to assess the extent to which treatment 
effects are generalizable to different settings. 20-22 Ascertaining generalizability across sites is 
important as it guides future translation of study findings into policy and practice. 22 This study will 
also determine long-term sustainability of PLASMA effects and estimate the economic impact of the 
intervention. This multi-site study is significant in that it will target the understudied population, inner-city 
adolescents with asthma in three cities in the US, who present serious challenges to optimum asthma 
management. 
Specific study aims are: 
1) To evaluate systematically the effectiveness of a peer-led asthma program in inner-city 
adolescents with persistent asthma. 

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Hypothesis: We hypothesize that: relative to the control group, the PLASMA group will report greater 
improvement over time in (H1) quality of life (primary outcome), and (H2) asthma knowledge, attitudes, 
outcome expectations, self-efficacy, self-management skills, and asthma control, FEV1 (exploratory 
outcomes). (H3) The post-PLASMA scores on outcome measures will be higher than pre-program 
scores from both treatment groups. 
2) To examine the mediating effects of the secondary outcomes (knowledge, attitudes, outcome 
expectations, self-efficacy, self-management skills, asthma control, and FEV1) on the primary outcome 
(quality of life) of the intervention. 
3) To examine the moderating effects of personal factors (e.g., age, sex, family support) on primary and 
secondary outcomes of the intervention. 
4) To evaluate the effects of PLASMA on primary and exploratory outcomes in peer leaders (16-20 
years).  
Hypothesis: We hypothesize that the peer leaders (n=42) will report significant improvement in quality of 
life (primary outcome) and secondary outcomes (knowledge, attitudes, outcome expectations, self-efficacy, 
self-management skills, asthma control and FEV1) over the course of 15 months. 
5) To determine the economic impact of the intervention. This aim will be accomplished by (5a) 
measuring the direct healthcare costs and total costs of the PLASMA program, as compared with the control 
group; (5b) performing net cost analyses for each type of costs; and (5c) estimating cost-effectiveness 
ratios of the PLASMA group compared with the control. 
Hypothesis: We hypothesize that the direct and overall costs per participant in the PLASMA group will be 
less than costs per participant in the control group, or cost neutral. 
 
2. CHARACTERISTICS OF STUDY POPULATION 
2.1 Subject Characteristics 
Asthma and its morbidity disproportionately affect minority children of low-income families in inner 
cities, where asthma severity has increased and poses serious challenges to achieving adequate 
asthma control. 5 Disparate burdens of asthma and its adverse outcomes among minority children 
have been consistently documented in the past 20 years. 4, 23-25 In 2010, asthma prevalence in 
black children under 18 years was twice that of white youths; children in families below the 
poverty threshold as defined by the US Census Bureau were 1.5 times more likely to report 
current asthma than those in families at or above 200% of the poverty line. 2 Compared with white 
youth, black inner-city children are 4 and 3 times more likely to have asthma-related ED visits and 
hospitalizations respectively. 4  The three cities where the study will take place, Buffalo, NY; Baltimore 
MD; Memphis TN demonstrate high rates of pediatric asthma, high health care utilization and high 
morbidity and mortality rates, thus this study will take place in these cities that are most likely to benefit 
from a proposed intervention.  
 
a) Number of Subjects:   
A total of 378 adolescents (12-17 years) and 42 adolescent peer leaders (16-20 years) will be 
recruited for this study. The sample size (N=378) is based on the power analysis using a novel 
method developed by Roy et al. 26 for a 3-level hierarchical longitudinal design based on the 
program "RMASS.” This method has the advantage of incorporating three levels from the sites 
and repeated-measures from each subject with random-effects of the time trends at both the 
subject- and site-level, which are assumed to be equivalent in terms of sampling proportions, 
number of groups and differential attrition rates over time. In this proposed study, quality of life, 
the primary outcome, was used to estimate the sample size. Using data from the previous study, 
27 the longitudinal trajectories of quality of life and its treatment-by-time interactions based on 
subject-level randomization were modeled: the estimated treatment*time interaction coefficient 
was 0.6 units, estimated SDs for error was 15, and the random-slope was 1.76. These estimated 
values with a Type-I error rate (alpha) of .05 yielded a total sample size of 276 that would detect a 

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time trend over eight time points (T1-T8) between groups with a power of .80. This sample size 
was estimated on the assumption that the analyses use multi-site hierarchical 3-level linear 
mixed-effects models. In the earlier study, the attrition rate of the inner-city subsample (n=55) was 
27% including those who failed to attend the camp program (n=13, 23%) and those lost to follow-
up (n=2, 4%). To compensate for a possible attrition rate of 27%, the total sample size was 
increased to 378 (126 for each site; 63 each of two groups). 
 
b)  Gender and Age of Subjects:   
Recruitment will not be limited on gender.  Based on epidemiological data, we will focus on 
adolescents from 12-17 years of age for campers and 16-20 years of age for peer leaders. 
Participants will be stratified by gender and age (younger 12-14 years, older 15-17 years), which 
emerged as influential covariates in the PI’s earlier study. Within each of four blocks generated by 
each combination of these two covariates, each subject will be randomly assigned to either group 
using a computer-generated randomization table. Stratified randomization will ensure a similar 
number of subjects representing each block in the two treatment groups, balancing the influence 
of age and gender. Stratified randomization will be done separately for each site, and centrally 
coordinated and managed. Within the treatment group, participants will be assigned to subgroups 
based on their age [younger (12-14 years) and older groups (15-17)] to allow the study team to 
adjust the levels of difficulty/complexity of program content delivered at the camp. In doing so, we 
will attempt to enhance participants’ understanding of the information covered in the program. In 
the previous study, we found no differences in study outcomes or camp satisfaction between 
gender-matched groups and co-ed groups, so subgroups will be gender-mixed.  
c) Racial and Ethnic Origin:   
Enrollment of participants will not be restricted to any racial or ethnic groups. By recruiting 
participants from three cities with high prevalence and incidence of pediatric asthma, (again 
based on epidemiological data) we anticipate the sample demographic to have a higher 
proportion of minority populations representative of the neighborhoods targeted (Buffalo, 
Baltimore and Memphis.)  
 
d) Vulnerable Subjects: 
This study will include inner city adolescents between ages 12-17 years. This study will evaluate the 
effectiveness and generalizability of the peer-led asthma self-management program in adolescents in three 
cities including Buffalo NY, Baltimore MD and Memphis TN.  The intervention has proved effective for inner-
city adolescents in Rochester, NY. 
 
2.2 Inclusion and Exclusion Criteria 
 
a) Inclusion Criteria: 
Eligibility criteria for adolescent participants (“campers”) include:  
(1) age between 12-17 years;  
(2) physician-diagnosed asthma that has required health service use (preventive or acute) within 
12 months prior to recruitment;  
(3) persistent asthma determined by current use of a control medication or presenting at least one 
of the following four symptom levels in the past 4 weeks, as defined by the NAEPP guidelines 28:  
(a) > 2 days/week of daytime symptoms, 
(b) >3-4 times of nighttime awakening,  
(c) >2 days/week of SABA use, or  
(d) any interference with normal activities due to asthma;  

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(4) no other chronic conditions requiring daily medication (e.g., diabetes, cancer, arthritis, etc.) 
and no severe mental illness (e.g., bipolar disorder, schizophrenia) or behavioral issues (e.g., 
criminal history) reported by parents or guardians;  
(5) primary residence located in the participating inner cities based on zip codes; and  
(6) ability to understand spoken and written English.  
Eligibility criteria for peer leaders include:  
(1) age between 16-20 years;  
(2) nomination from school teachers/nurses or healthcare providers for candidates’ exemplary 
asthma self-management, leadership, and emotional intelligence; and  
(3) fulfillment of eligibility criteria (2)-(6) prescribed for adolescent participants. 
 
 
b) Exclusion Criteria: 
1) Adolescents who are pregnant  
2) Have learning disabilities based on reports from teachers or clinicians will be excluded from 
the study because such conditions can confound the interpretation of findings.  
3) Those who have serious health (other than asthma) and emotional preconditions (e.g., 
severe depression, anxiety disorders, schizophrenia)  
4) Adolescents who become pregnant or incarcerated after enrollment will be withdrawn 
because these conditions can impact the study outcomes (e.g., quality of life) and limit the 
investigators’ capacity to follow up. 
 
3. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT 
3.1  Method of Subject Identification and Recruitment:  
Participants (peer leaders and camp participants) will be recruited from a variety of settings 
including clinical practices, community youth organizations, schools and/or churches in the three 
cities using clinician referrals, recruitment letters, flyers, or newspaper or website ads. Each 
clinical practice/school/church from which participants will be recruited will be informed of the 
eligibility criteria for peer leaders, and we will provide these recruitment sites with an information 
sheet that includes the eligibility criteria for peer leaders and instructs that referring adults would 
seek permission from the parents of teens (16-17 years) they wish to refer before referral. 
Referrals can be done by phone, email or written letter.  In their referral, referees will provide the 
study team with the contact numbers of the nominated teens and their parents. Then, the study 
team will contact the parent/teen to screen for the nominated teen’s qualification for enrollment as 
a peer leader. For older peer leaders (18-20 years), referees are not required to obtain parental 
permission prior to nomination. Older teens can also contact directly the study team responding to 
flyers, or newspaper or website ads to be considered as peer leaders.  Each site will choose 
recruitment strategies that are culturally appropriate and effective in its own community. No 
adolescents <18 years will be allowed to participate in the study without parental permission 
either as a peer leader or a camper.  
3.2  Process of Consent: 
Group assignment will be concealed from participants and data collectors. To ensure double 
blinding, data collectors will not participate in obtaining informed consent, nor any part of 
treatments. 
a) Informed Parent Permission/Consent. Consent will be obtained in a non-coercive fashion. Prior 
to obtaining consent, the site coordinator will provide parents/adolescents with detailed 
information regarding study participation. Parents and adolescents will be informed that their 
participation is strictly confidential, that they do not have to answer any questions they do not wish 

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to, and they are free to withdraw from the study at any time. The coordinator will solicit and 
answer any questions. When all questions have been answered, the coordinator will ask the 
subject a couple of questions pertaining to study procedure and the content of the consent to 
ensure the subject’s understanding. For Spanish-speaking parents, the consent form will be 
prepared in their language, and an RA who is fluent in Spanish will assist obtaining the consent 
following the procedure described above. A parent/guardian will be asked to sign two copies of 
the form, and the coordinator will also sign the consent form. One copy of the form will be kept; 
one copy will be given to the parent/guardian.  
Teen Assent. Assent will be obtained in a similar manner as the informed consent.  The assent 
form will be written using language that is developmentally appropriate. Adolescents will be told 
that they do not have to answer any questions they do not wish to, and they are free to stop being 
in the study at any time.  Adolescents will be asked to read the assent form silently while the 
coordinator reads the assent form to them.  
b) Vulnerable populations: The coordinator will solicit and answer questions. To make certain of 
their understanding of the assent consent, adolescents will be asked to explain back what they 
are being asked to do and clarification will be provided.  
 
4. METHODS AND STUDY PROCEDURES 
4.1 Study Procedures and Assessments 
Design: This study will use a two-group randomized controlled design implemented in three 
metropolitan cities: Buffalo, NY, Baltimore, MD, and Memphis, TN.  The project coordinator and a 
research assistant in each city who are not involved in direct patient care of teens with asthma will 
be responsible for recruitment and consent process taking place in each site. Peer leaders will 
attend a three-day intense training session that will take place prior to camps, lead small-group 
instructional activities at a one-day camp (PLASMA group) and follow up their group members 
bimonthly for 15 months. Camp participants from each site (n=126) will be randomly assigned to 
the peer-led (PLASMA) group or the adult-led (control) group. Upon enrollment, participants will 
be stratified by gender and age (younger 12-14 years, older 15-17 years), and randomly assigned 
to either group within each of four blocks generated by the combination of gender and age strata. 
Each group will attend a separate day camp where an asthma self-management program will be 
implemented either by peer leaders (intervention) or healthcare professionals (control). After the 
camp, the intervention group will receive peer-leader contacts bimonthly for 14 months using 
phone calls or other communication technologies (e.g., emails, or short-message system (e.g., 
texting) of teens’ choice. Adult instructors (healthcare professionals) will contact the control group 
bimonthly for 14 months using similar methods, but different contact topics.  
Both groups (intervention and control – more details below) will provide data at enrollment (T1), 3 
months later (T2), immediately following the camp (T3), and at 3-, 6-, 9-, 12-, and 15-months post-
camp (T4-T8).  
The intervention: The PLASMA program focuses on providing learning environments conducive to asthma 
self-management training. We will use adolescents with asthma as leaders to capitalize on peer dynamics, 
which are often a powerful force driving behavior changes in adolescents. PLASMA leverages teens’ 
receptiveness to peer influences while addressing their desire for independence by offering a teen-governed 
program format, thus increasing developmental relevance.  The Plasma program will be delivered in a 
camp settings. A camp setting also provides an informal environment in which participants become naturally 
acquainted and interact with peers with asthma while participating in learning and recreational activities. This 
setting can offer practical and scientific advantages as well, including allowing investigators to closely monitor 
multiple small group sessions to ensure fidelity and to provide immediate assistance to peer leaders.  We will 

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utilize a well developed and detailed training manual for adolescents (“Let’s Talk about Asthma”) that 
addresses four components of asthma self-management in adolescents, including symptom (1) prevention, 
(2) monitoring and (3) management; and (4) communication/psychosocial empowering. 29 The manual 
meticulously covers these four areas based on the National Asthma Education and Prevention 
Program (NAEPP) guidelines 28 and presents information in a way that increases developmental and 
contextual relevance to inner-city adolescents. Eligible peer leaders will be recruited via referrals or 
from local churches or colleges using newspaper ads or flyers. A total of 42 peer leaders (14 in each 
site) will be trained using a structured asthma self-management manual developed by the study team. 
Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. A certified 
asthma educator, who will be trained by the PI to be the peer leader trainer, will lead a 3-day training 
program (4 hours/day) for all three sites. Our previous study demonstrated the adequacy of the format, 
length and frequency of the training sessions to cover essential training components. Training content 
includes: Day 1: Asthma basics and prevention; Day 2: Asthma monitoring and management; Day 3: 
Communication/ psychosocial issue management/leadership training/hands-on practice in simulated 
peer-led group settings (role-play). Peer leader training will be offered no earlier than one month prior to 
the scheduled peer-led camp to maximize retention of acquired information and skills. Peer leaders 
will be evaluated using a combination of oral and written tests at the end of each session to ensure 
mastery and proficiency of covered content. If a trainee is absent from a session, she or he will attend an 
individual make-up session; anyone missing two days of training will be disqualified. In our earlier study, 30 
peer leaders’ knowledge, self-efficacy and other asthma outcomes showed declining trends 6-
months post-camp, suggesting the need for a booster training session. Booster training has been 
recommended due to its proven benefits for peer leaders. 31, 32 The peer leader trainer will offer a 
half-day booster session at 6-months post-camp at each site. 
Peer-led asthma camps: PLASMA will be implemented in small groups at a camp setting where paired 
peer-leaders will facilitate learning activities. The research team will oversee the group activities and 
provide assistance to peer leaders and campers as needed. Locations for camps will be selected based 
on their convenience for the majority of participants and community-based sites. Campers will be assigned 
to small groups of 8-10 teens, 3 younger groups (12-14 years) and 3 older groups (15-17). Younger 
leaders (13-17) will facilitate the younger groups, older leaders (18-20) the older groups. In the 
previous study, we found no differences in study outcomes or camp satisfaction between gender-matched 
groups and co-ed groups, so groups will be gender-mixed for simplicity in grouping. Group learning 
activities will closely align with the program manual (LTAA) that consists of three sessions: 1-Asthma 
basics and prevention; 2- Symptom monitoring and management; and 3-Communication and 
psychosocial issue management. Each session will last 45-75 minutes, and peer leaders will deliver the 
content and facilitate participant interactions and strategic thinking. Participants will also learn and practice 
skills in using the peak flow meter, spacer and inhaler, daily symptom diary and asthma action plan. The 
groups will compete in a game, “Asthma Jeopardy,” to review and apply acquired self-management 
information and skills in problem-solving. The younger and older groups will play separately. Besides 
instructional activities, participants will engage in recreational activities that each camp site can 
accommodate, such as dancing, arts-and-crafts, swimming, or rock climbing. 
Peer leader follow-ups: Long-term effects of self-management training can be reinforced by 
periodic follow-ups and continuous encouragement. 33, 34 Because the effects of asthma programs 
tend to erode over time, follow-ups after the program have been recommended. 35-37 In this study, 
peer leaders will follow up with their group members bimonthly, offering continuous peer support and 
encouragement. Peer leaders will use a contact checklist to guide and standardize their follow-up 
contacts. In our previous study, peer leaders found monthly contacts too frequent, and less than 50% were 
reached for monthly phone contacts, so here peer follow-ups will take place every two months using 
multiple contact methods such as emails, and text messaging in addition to phone calls. For peer contact 
months coinciding with data collection months (i.e., 6- and 12-months post-camp), data collections will be 

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done prior to peer contact. Research staff will keep a peer contact log to monitor and provide timely 
feedback and assistance to peer leaders. To reinforce peer contacts, we will award points for successful 
contacts, which become the basis for reward at the end of the study. For instance, peer leaders who 
successfully conduct >80% of peer contacts bimonthly will earn 10 points, with 70 points being the 
maximum possible points (10 points*7 bimonthly contacts). Gift cards loaded with varying amounts of money (a 
maximum of $50) will be offered based on accumulated points. 
Adult Led Asthma Self-Management (Control Group): The control group will attend a similar camp to the 
PLASMA group, which will take place within 2 weeks of the peer-led camp to minimize the history effect. 
Two local healthcare professionals selected by the site-PI will attend peer-leader training sessions to become 
familiar with the program content, then lead instructional activities. As in PLASMA, adult leaders will base their 
instruction on the program manual to ensure comparable program content. Campers will be divided into two 
age sub-groups (12-14, 15-17 years) for age-appropriate delivery of content. Adult leaders will adopt mainly a 
didactic format and skill demonstration. Each camper will receive the program manual. After the instructional 
sessions, campers will participate in “Asthma Jeopardy” and comparable recreational activities. To control for 
attention, the adult instructors will offer bimonthly contacts via similar contact methods to peer contacts, and 
will discuss topics unrelated to asthma. The study team will determine the non-asthma topics for each 
bimonthly follow-up to standardize interactions with participants. 
Intervention Fidelity: In a multisite study, ensuring consistent delivery of a program as planned across 
sites is of paramount importance to reach valid conclusions. PLASMA comprises three components: (1) 
peer leader training and a booster session at 6-months post-camp, (2) peer-led camps, and (3) 
bimonthly peer follow-ups. For each component, treatment content and pace will be evaluated using a 
rating scale. 38 (1) Peer leader (PL) training: The PL trainer, trained by the PI at the study center, will 
conduct PL training for all three sites based on a manualized curriculum. The PL trainer’s adherence to the 
training manual for each site will be evaluated by the site-PI, who will attend each training session, using 
a 3- point fidelity rating scale (1=delivered, 2=deviated (for inaccurate content), and 3=missed). The scale 
will also allow observers to assess time duration for each delivered content (1=adequate, 2=too short, 
3=too long) based on the length of time recommended by the study team. In addition, the PL training 
sessions will be audio-taped for review by the PI, who will independently assess them. The rating 
scales submitted by the PI and site PIs will be compared. The study team will revisit any items 
presenting notable discrepancies by replaying a recording until consensus is reached. A minimum of 
90% adherence will be required to assure treatment fidelity.  
The PI and site-PI will also conduct brief semi structured interviews with each PL to check the content 
and its adequacy for each session. The interviews will be audio-taped and transcribed verbatim for content 
analysis to assess fidelity from a PL’s perspective. (2) Peer-led camp: The camp program will be guided 
by the standardized manual used for PL training. Peer leaders’ adherence to program content and pace 
will be assessed. The research team will evaluate each session using a fidelity rating scale similar to that of 
PL training. All peer-led group sessions will be audio-taped, and the PI and site-PIs will later listen to the 
recordings and independently rate the extent of PLs’ adherence to the program manual using the fidelity 
rating scale. Any discrepancies in the ratings will be reconciled through the process described earlier. Ninety 
percent adherence will be required to assure treatment fidelity. Campers will also complete a checklist after 
each session to indicate covered training content and adequacy to assess fidelity from a participant’s 
perspective. (3) Bimonthly peer contacts: PLs will be required to keep contact logs in which they will record 
the date, time and duration of each contact, the method of contact and the number of attempts made for 
contact. PLs will use a checklist provided by the researchers to structure and standardize their interactions with 
participants. The contact logs and completed checklists for each bimonthly contact will be submitted to the study 
team, which will evaluate peer contact fidelity. PLs with inadequate adherence to the contact protocol (e.g., 
incomplete contact logs/checklist, delivery of <80% of content listed on the checklist) will be notified and 
counseled to ensure their adherence for subsequent peer contacts. 

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Procedures for control treatment fidelity: The study team will provide adult leaders with specific written 
guidelines that detail the elements to be covered and time lengths for each element. The PI and site-PIs 
will attend instructional sessions and independently rate the adult leaders’ adherence to the guidelines using 
the 3-point fidelity rating scale. Each session will be audio-taped to be evaluated by the investigator who 
did not observe it. Ratings from the raters will be compared, and any discrepancies reconciled using the same 
procedure as the PLASMA program. Ninety percent adherence will be required to ensure treatment fidelity. 
Campers will also complete a checklist after each session to indicate covered training content and adequacy 
to assess fidelity from a participant’s perspective. The RA, like peer leaders, will use a checklist for the 
bimonthly contacts and keep a contact log. The checklist and the log will be evaluated periodically to 
assure fidelity. Any RA with inadequate adherence to the contact protocol (e.g., incomplete contact 
log/checklist, <80% of successful contacts) will be notified and counseled to ensure her/his adherence for 
subsequent contacts. 
Involvement of Primary Care Providers (PCPs): The effects of asthma self-management in controlling 
and reducing the burdens of the disease can be augmented when self-management activities are 
coordinated in collaboration with a healthcare provider. Having recognized the important roles that 
the healthcare providers play in adolescents’ asthma self-management, we will attempt to 
incorporate the clinical system in our programs. For both groups, each subject’s primary care 
provider (PCP) will be informed of the teen patient’ study participation and training content in an 
introductory letter which will be either mailed or faxed to the office. The PCPs will also receive 
written bi-annual reports from the study team that summarizes the levels of asthma control and 
medication adherence of their teen patients in the past 6 months. In addition, we will communicate 
to the PCPs via letter or phone call when research data (e.g., FEV1 < 60% predicted, uncontrolled 
symptoms, consistent medication non-adherence, recent ED visit) warrant clinical attention. The 
timing and content of such reports provided to the PCPs (except for the introductory letter) will be 
documented and taken into consideration in analyzing and interpreting research data.  Subjects 
will be encouraged to communicate with their PCP about their asthma conditions learned through 
symptom monitoring (e.g., symptom diary, PEFR) during their scheduled or unscheduled office 
visits.  
Measures: Sources of research materials will include standardized questionnaires, demographic 
form, peak flow meters, spirometry, CMS/TennCare database and medical records. Data from 
these sources will be collected with parents’/participants’ consent and according to the standard 
procedure approved by the IRB. All data will be used for research purposes only and will be kept 
confidential and anonymous by using subject IDs without identifiers. Only the PI and authorized 
research staff will have access to these data. 
Primary Outcome:  
The Pediatric Asthma Quality of Life Questionnaire (PAQOL), a 23-item instrument, 39 
consists of three subdomains: activity limitation (5 items), emotional function (8 items), and 
symptoms (10 items). Higher scores indicate better levels of functioning. This scale has proved a 
valid and reliable measure of asthma-specific quality of life in adolescents. 39, 40 Longitudinal and 
cross-sectional construct validity of the scale has been supported. 41 Cronbach’s alphas of activity, 
emotion, and symptom subscales in our earlier study were .84, .93 and .95, respectively. 42 
Exploratory Outcomes:  
(a) Adolescent Asthma Knowledge Questionnaire (AAK): This 30-item instrument is a 
modification of the original 27-item questionnaire 43 measuring children’s knowledge of triggers 
and symptom identification and asthma management procedures. Cronbach’s alpha (α) in the PI’s 
previous study was .62. 42  

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(b) Attitude Toward Asthma Scale (ATA): This 13-item scale measures children’s attitudes 
toward their asthma on a 5-point Likert-type scale. 44 Sound psychometric properties were 
demonstrated in a study using 136 children with asthma. Construct validity was supported, and 
Cronbach’s α in the PI’s previous study was .85. 45  
 (c) Asthma Self-Efficacy (ASE): This 14-item scale measures a child’s confidence in attack 
prevention (e.g., learning asthma self-management skills, correct use of medication) and attack 
management (e.g., control symptoms, decide which medication to use). 46 Evidence of construct 
validity was demonstrated, 46 and Cronbach’s α was .83 in our earlier study. 42  
(d) Asthma Outcome Expectation Scale (AOE) measures a construct of “outcome 
expectations” derived from social cognitive theory. 47 This 15-item scale, developed for caregivers 
of children with asthma, showed acceptable reliability (α=.69-.72) and validity. 47 It will be revised 
for use with teens. 
 (e) Asthma Self-Management Skills (ASM): This instrument includes three self-management 
indices for adolescents including symptom prevention (11 items), symptom management (9 
items), and asthma self-efficacy (14 items) 48; in a recent high school study, the Cronbach’s α of 
each subscale was 0.71, 0.67, and 0.84 respectively. 49 Validity of the scale was established. 48  
(f) Medication Adherence-Self Report (AD-S): To assess medication adherence, we will use the 
Horne’s Medication adherence report scale, and also ask teens to report doses missed in the prior 
2 weeks. These self-repot measures will be administered for each assessment point. 
 (g) Medication Adherence-Objective (AD-O): to obtain objective adherence data, we will use 
dose counters that are integrated into medication canisters. Based on personal communication 
with a local healthcare provider, we learned that almost all inhaled steroids now include counters, 
and 99% of children used medication that included integrated counters. Participants will bring their 
medication canisters to an appointment with the study nurse, who will document the number of 
doses on the teens’ control medication inhaler (or count remaining pills for oral medications, i.e.; 
Singulair). Two weeks later, teens will use their mobile phone to take and send the picture of their 
inhaler displaying the counter number. For those without a mobile phone, in-person appointments 
or home visits will be arranged to re-measure the doses used. Based on the prescribed regimen, 
we will calculate adherence (#actuations / #prescribed) over the prior 2 weeks. Given the labor 
and time intensive nature of the assessment, we will obtain objective adherence data only twice, 
at baseline and 15-months assessments, which will provide the snapshot of adherence before 
and after study participation 
(h) Asthma Control Test (ACT), a 5-item clinical scale, assesses asthma control based on the 
frequency of daytime and nighttime symptoms, degree of activity limitation, and use of SABA in 
the past 4 weeks, per 2007 NHLBI Guidelines. Cronbach’s α was .71 in our previous study. 27 
Items will also be examined individually.  
(i) Asthma Exacerbation Checklist (AEC): This will assess the indicators of exacerbation 
including (1) systemic corticosteroids for asthma for at least 3 days; (2) asthma-specific hospital 
admission; and (3) asthma-specific ED visits. The self-report asthma exacerbation checklist will 
be used for all the assessment time points. 
(j) Peak Expiratory Flow Rate (PEFR): we will use commercial electronic peak flow meters 
(Piko-1™).  The Piko-1 (Ferraris Respiratory, Louisville, CO, USA) measures peak expiratory flow 
and FEV1, and it can store up to 96 measurements that are date- and time- stamped, Three color 
zones are visible on the display of the device: green for >80%, yellow for 50-80% and red for 
<50% of an individual’s best. Stored data in the Piko-1 can be downloaded to a computer. The 
device is powered by batteries, lasting about 2 years if used 6 times a day.  Values from the Piko-
1 have shown high correlations (r=0.93-0.95) with those from a reference spirometer, indicating 

Page 10 of 21 
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the acceptable accuracy of the device. 50, 51 The Piko-1 will be provided to 20 randomly selected 
participants from each site (10 from each treatment group) who will be instructed to use the 
device at least once a day. The RAs will make home visits every 3 months to download the stored 
data to a computer. For the rest of the sample, we will provide a manual peak flow meter with 
training on its use and instruct them to use it daily and record the values in a log as we proposed 
in the application, because this is part of self-management routines that we will attempt to 
reinforce through our training programs.  
 (k) Spirometry will be performed using a portable KoKo® spirometer (Pulmonary Data Service; 
Louisville, CO). Predicted values will be based on the equations of Polgar. The primary variables 
will be forced vital capacity (FVC) and FEV1, to be measured twice, at the camp and 15-months 
post-camp. Respiratory therapists at each site will be trained to perform the test in accordance 
with the ATS/ERS standardization of spirometry 52 prior to conducting the tests, and data will be 
interpreted in collaboration with a pulmonologist at the study center.  
Moderators: 
 (l) Perceived Family Support (PFS): We found that family support influenced quality of life and 
asthma control in adolescents. 53 This 20-item scale measures individuals’ perception of their 
family fulfilling their needs for support, information and feedback. Construct and criterion validity 
was demonstrated. 54 Cronbach’s α in our previous study was .85. (m) Sociodemographic Form 
(SDF) will be completed by parents to indicate adolescents’ race, age, sex, insurance type, 
parental education and annual family income.  
Table 1: Study measures for each assessment point  
 
PRIMARY 
OUTCOME 
EXPLORATORY OUTCOMES 
MODERATOR 
Cognitive factors 
Self-management 
Asthma control 
 
PAQL 
AA
AT
AS
AOE 
ASM 
AD-S 
AD-O 
FEF
ACT 
AEC 
FEV1 
SD
PFS 
T1  
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
 
√ 
√ 
T2 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
√ 
 
 
 
T3 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
√ 
√ 
 
 
T4 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
√ 
 
 
 
T5 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
√ 
 
 
 
T6 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
√ 
 
 
 
T7 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
√ 
√ 
√ 
 
 
 
T8 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
 
 
Measures for Cost-Effective Analysis: 
Health care utilization and costs associated with asthma will be assessed by (1) Medicaid claims, 
and (2) medical record reviews. We expect that a majority of participants will be enrolled in 
Medicaid as 90-95% of inner-city children/adolescents were in previous studies conducted in 
Rochester, Baltimore and Memphis. The Medicaid claims (to be purchased from the Centers for 
Medicaid & Medicare Services [CMS]: will provide the best source of data for Medicaid-covered 
services including office visits, ED visits, inpatient care, and prescribed medications. The 
Medicaid administrative data contain detailed individual-level information on treatment and 
procedure codes (ICD-9-CM or CPT codes), service dates and expenditures. For adolescents 
whose services are not available from CMS data, detailed data on service use and prescribed 
medications related to asthma will be collected through medical records from PCPs; HIPAA 
authorization will be obtained from parents. In all sites, medical record review was approved by 
supporting practices for participants lacking CMS data. In both cases, data will be collected 
between 3 months before enrollment and 3 months after completion of the 15-month follow-up. At 
each time point, teens and parents will report the number of missed school days due to asthma 
and the number of hours missed from parents’ gainful employment due to the teen’s asthma in 

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the past 3 months. 
Measures of Program Evaluation.  
(a) Camp Program Evaluation (CPE:7 items) will be administered at the camp to assess the 
campers’ perception about and overall satisfaction with the program. 
 (b) Overall Program Evaluation (OPE: 6 items) will be completed at 15-months follow-up to 
assess participants’ overall perceptions about the study. Each item will be examined individually.  
 (c) Peer Leaders Rating Scale (PLR: 8 items) 55, to be administered at the camp, will measure 
PLASMA teens’ perceptions of peer leaders’ characteristics (i.e., warmth, expertise, credibility) 
and “perceived similarity.” Cronbach’s α of the revised scale was .75 in our prior study. We will 
also examine items individually.  
 (d) Perceived Peer Leader Support Scale (PLS: 10 items) will be administered at 15-months 
follow-up to measure participants’ perceptions of peer-leader support. Cronbach’s α was .87 in 
the earlier study. Each item will be examined individually. 
4.3 Costs to the Subject 
There will be no direct cost to subjects to participate in the study.  
4.4 Payment for Participation 
Peer leaders will receive up to $530 total: $200 for attending 3 training sessions and one booster 
session (4 sessions at $50 each);  $100 for leading the camp program and maintaining bimonthly 
follow-ups . Peer leaders may receive varying additional amounts up to $50 in a gift card form for 
successfully completing >80% of bimonthly contacts during the study period. For both peer 
leaders and other adolescent participants, $30 will be provided at each time-point for completing 
baseline, 3-months pre-camp and 3-, 6-, 9-, and 12-months post-camp data (up to $180 total). To 
maximize participation and retention, the payment rate will increase to $50 for the camp and 15-
month follow-up (totaling $280 for regular/camp participants.) 
5. SUBJECT WITHDRAWALS 
Participants will be withdrawn from the study if they become pregnant or incarcerated as 
described above. In addition, those who do not show up at the camp or misses 3 or more 
assessment points in a row will be withdrawn from the study. For peer leaders, if they do not 
complete the three training sessions, they will become disqualified. Those disqualified peer 
leaders, however, can continue their participation as regular teen subjects (campers) if the are 16-
17 years, after re-consenting as a camper. 
6. REPORTABLE EVENTS 
Adverse events (AEs) are defined as physical and psychological discomfort (boredom, fatigue, 
stress) related to completing multiple questionnaires and participating in the day camp program, 
intense self-management training/program. AEs will also include physical injuries during 
recreational activities at the camp. Any breach of confidentiality would also be an adverse event. 
These events are believed to be possible but are not automatically expected. Procedures will be 
implemented in order to prevent and address AEs during the study  
Mechanism for Reporting Adverse Effects. The project staff will also periodically inquire about 
adolescents’ reactions or feelings throughout the study. The project staff will report any AEs 
observed in relation to study participation to the site-PI and PI immediately. Review of adverse 
events will include: (1) Adverse events in aggregate, by attribution (expected or unexpected) and 
relationship to study intervention, (2) Whether the study accrual pattern warrants 
continuation/action, and (3) potential protocol violations. The PI will also monitor study safety by 

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weekly reviews of randomly selected cases for research staff’s adherence to study procedure and 
IRB compliance (e.g., informed consent). The PI will continuously evaluate risks associated with 
research procedure and maintain subject confidentiality through weekly team meetings and 
conference calls with the project staff in other sites. The center coordinator will assist the PI in 
reviewing, capturing and reporting any adverse events and unanticipated problems to the IRB and 
NINR using interactive computer modules in the Clinical Data Management System. The PI will 
assess any external factors or relevant information that may impact the safety of participants or 
ethics of the study 
The research staff will report AEs to the PI and the site-PI immediately for each event. The PI will 
report to and discuss any identified AE with the Safety Management Committee (SMC). Decisions 
related to continued participation status of the subject will be reached within 10 working days by 
SMC consensus. The PI and site-PI will report the incident to the University of Rochester RSRB 
and relevant site IRB within 7 working days of each event. AEs identified during the camps will be 
recorded and discussed with the SMC immediately after the camps and reported to the UR RSRB 
and site IRB within 1-2 working days. AEs will be captured via the electronic system available for 
all three sites; the PI and center project coordinator will monitor and review these events weekly.  
7. RISK/BENEFIT ASSESSMENT 
Risks to Subjects 
Potential Risks: This study will present minimal potential risks to subjects. Data will be collected 
primarily using questionnaires and noninvasive physiological measures (peak flow meters and 
spirometer).  However, a small number of subjects may be stressed by having to complete 
multiple questionnaires every 3 months and monitor peak flow values daily during study 
participation. Due to the intensive nature of peer leader training and the camp education program, 
subjects may experience either fatigue and/or boredom. In addition, peer leaders may experience 
emotional distress potentially associated with their dealings with camp participants’ psychological 
and behavioral issues as well as any issues related to the illness during bimonthly contacts. Also, 
injuries may also occur during participation in camp recreational activities. The likelihood of risks 
associated with the camp program, however, is minimal given the sufficient number of trained 
adult volunteers and the study staff who will closely monitor the conditions and the safety of camp 
participants during the camp. 
Psychological/Physical Distress: To avoid worsening of physical or emotional preconditions, we 
will exclude those who have serious health (other than asthma) and emotional preconditions (e.g., 
severe depression, anxiety disorders, schizophrenia) as indicated in the eligibility criteria. Adult 
nominators (clinicians, teachers, etc.) of peer leaders will be informed of this eligibility criterion. 
For regular participants, the coordinator will confirm these criteria with parents. Adolescents and 
parents will be assured that, if the adolescent’s responses demonstrate a risk to themselves or 
others, the adolescent's primary care provider or the family will be notified immediately.  
This study involves minimal risk to participants as the study procedures are noninvasive in nature 
and do not require any changes in existing treatment regimens.  Should the research team 
identify any participant with serious asthma symptoms that have not received proper treatment, 
we will encourage the subject to seek medical attention immediately or refer the subject to his/her 
primary care provider if known. The research team will hold weekly multi-site standing meetings to 
review participants’ responses to the intervention and discuss any challenges or issues 
encountered in working with the participants.  
Peer leaders will be trained to identify and immediately report to the research team any unusual, 
alarming comments or concerning behavior that they noted during bimonthly contacts. The 
research team will provide peer leaders with examples of reportable comments and behaviors. 

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The study team will closely monitor peer leaders’ emotional distress potentially associated with 
their dealings with camp participants’ psychological and behavioral issues as well as issues 
associated with the illness during bimonthly contacts. Specifically, the peer leader trainer or the 
site study staff will provide each peer leader with ongoing and regularly scheduled supervision 
and support through brief informal interviews on the phone upon completion of each bimonthly 
contact period for early detection of peer leaders’ emotional burden. Any detected signs of 
distress will be reported immediately to the PI and site PI. All research staff will have a protocol to 
follow in instances of concerns: informing the family and the primary care provider and providing 
immediate referrals if indicated.  Any questionable conditions occurring during the study will be 
discussed in-depth during weekly project meetings for referral as well as a decision related to 
continuing study participation.   
The camps in Buffalo will be protected by liability and accident medical insurance provided by the 
University of Rochester in case of physical injury during camp participation. Non-UR sites 
(Baltimore and Memphis) will have subcontract with the UR, so will be subject to their own 
institutional terms and policies pertaining to research-related injuries. For each site, consent forms 
will contain specific statements describing how injuries resulted from study participation will be 
managed by the institution. Adult volunteers (primarily nursing students) will closely monitor and 
assist camp participants. The ratio of the volunteers and campers will be maintained at 1:6 to 
facilitate close surveillance. Each camp will be attended by a state-certified health practitioner 
(MD or NP) who will evaluate or treat asthma symptoms or minor injuries at the camp site. Each 
camp site will be equipped with medical supplies necessary to manage most medical emergency 
situations. Moreover, we will identify and contact a healthcare center with an ED facility located 
near the camp site prior to the scheduled camp date in order to ensure that the facility is prepared 
to manage any serious urgent health issues (e.g., asthma attack or severe physical injury) that 
may occur at the camp.   
Because the spirometry procedure requires forced expiration, some subjects may experience 
exacerbation of asthma symptoms. To address promptly this rare undesirable effect, participants 
will be instructed to bring their rescue medication (e.g., Albuterol) to the camp and the 15-month 
follow-up. Trained clinicians will be available for assistance if needed. Any subjects with known 
risk factors for spirometry-induced asthma exacerbation will be excluded from the procedure. 
These tests will be performed in a room that is equipped with a respiratory emergency treatment 
kit. 
Completing study questionnaires may cause boredom and fatigue in adolescents, although the 
PI’s earlier study indicated that teens ages 13-20 spent less than 20 minutes on average on this 
task. Subjects both peer leaders and campers may also experience boredom and tiredness as 
they participate in the lengthy peer leader training or the camp education program.  If the subjects 
express or present signs of boredom or fatigue, they will be allowed to take a short break during 
the administering of questionnaires. The electronic data capture system (REDCap) will be 
programmed in a way that it will permit multiple logins before completing questionnaires. 
Adolescents may also become physically and mentally exhausted during the peer leader training 
sessions and camp program. The research team will monitor any signs of discomfort shown by 
participants during peer leader training and the camp activities (instructional or recreational), and 
will be available to intervene in situations causing discomfort to the campers or peer leaders. 
Adolescents will be informed in the assent form and verbally that they do not have to respond to 
questions they do not wish to answer and that they are not obligated to attend the full camp 
program if they feel tired. In addition, adolescents will be encouraged to express any study-related 
questions or concerns at the time of contact or afterwards. 

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Confidentiality: To ensure confidentiality, subjects will be assigned an identification number, and 
they will be informed that all information will be held in confidence. Hardcopy data will be kept in a 
locked file cabinet in each site’s project office. Subject information connecting subject names with 
identification numbers will be locked in a separate file drawer in each site-PI’s office. Any printed 
subject information will be kept in the three site-PIs’ locked drawers and will be shredded 
immediately if not used. Subjects will be informed that their parents or guardians will not have 
access to their responses for any of the measures. Adolescents and parents will also be assured 
that forms will be destroyed safely upon completion of the study. Parents and adolescents will be 
informed that only the research team, University IRB members, grant sponsors and auditors from 
NIH will have access to their responses. All data from any parent or adolescent requesting 
withdrawal from the study will be destroyed at the time of the request. Only aggregated data 
without any personal identifiers will be reported in publications or presentations.  
Adolescents and parents will be informed that questionnaires will be completed online. The 
procedures to address privacy and confidentiality associated with online completion of measures 
will be discussed with subjects and indicated in the consent/assent forms. Certain technical 
information automatically collected during the visit to that Web site, including the Internet domain 
and Internet address (IP address), the type of browser and operating system, and the date and 
time of access, will be stored in log files on the server and will not be made available to parties 
other than the system administrators at the URMC. This information will only be used for purposes 
related to troubleshooting system problems. Subjects will be assured that online data will be 
transmitted in a secure method to a server database in the study center at URMC. To access the 
online questionnaires, a unique login and password will be assigned and given to each subject at 
enrollment. Logging in will afford access to completing the questionnaire only. No person who has 
logged on with different logins and passwords will be able to view any other person’s responses to 
the questionnaires. All answers will be sent directly to the study center (URMC) database each 
time data are submitted; data will not be transmitted by any other means and cannot be retrieved 
by another person except the researchers in Rochester. In order to increase security, subjects will 
be counseled not to share these passwords with others, even those enrolled in the study. Data 
files will be backed up regularly. Project files and databases associated with the study will only be 
available to research personnel through the authorization of the PIs. In addition, study reports 
(such as aggregated data in progress reports) generated by the research team will provide total 
anonymity because no names or identifying information will be part of such reports. Participants 
and staff will be apprised of their rights and responsibilities under the Privacy Act of 1974, 
including penalties for violations. All staff involved with the research project will receive training on 
their function, roles, and responsibilities to protect and maintain privacy and confidentiality of 
research participants, and will complete NIH-approved training in this area. 
7.2 Benefits to Subjects.  
Although it is not automatically assumed that participants will benefit from study participation, the 
PI’s earlier pilot study indicates potential benefits for participants. We anticipate that peer leaders 
will benefit from participation in the intensive three-day sessions.  Leading the PLASMA program 
may provide peer leaders with opportunities to increase their knowledge and skills for effective 
asthma management and to develop and exercise leadership skills. Similarly, regular adolescent 
participants will have an opportunity to learn asthma self-management and build social networks 
with peers with the same illness. The camp will also provide participants with opportunities for 
entertainment and social experiences with asthma peers. The control group will attend an adult-
led camp and receive the same information from a healthcare professional. If proven effective in 
this multi-site study, the PLASMA program can be adopted by healthcare providers or third party 
payers (e.g., HMO or Medicaid) as a standard care program to address asthma morbidity and 
mortality among inner-city adolescents and to contain health care costs for this group. Moreover, 

Page 15 of 21 
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information gained through this study may benefit other adolescents with asthma who would 
receive a similar program in the future.   
Risk/benefit ratio. Risks to participants are reasonable in relation to anticipated benefits, with 
potential benefits far outweighing the risks. Because issues related to confidentiality will be 
scrupulously explained and managed, the primary concern is use of time. Anticipated benefits, 
including the peak flow meter and the program manual to keep, asthma self-management training 
and study incentives, are believed to be adequate compensation for the adolescents’ time. 
Moreover, peer leaders and participants may experience an altruistic benefit in participating in a 
study that may benefit other adolescents with asthma in the future. 
Self-reported (standardized questionnaires) and physiological (PEFR and Spirometry) data 
collected longitudinally (21 months) will capture systematic and dynamic processes by which the 
program modifies adolescents’ self-management behaviors and health outcomes. The long-term 
observation will also allow the investigators to examine the sustainability of the intervention. 
Inclusion of multiple cognitive factors (knowledge, attitude, self-efficacy, and outcome 
expectations) as mediators will allow us to demonstrate intricate interrelationships or mechanisms 
between the intervention and asthma outcomes including asthma control and quality of life in 
adolescents. This study will also systematically investigate the economic impact (e.g., healthcare 
utilization, prescription and indirect costs) of the intervention, which will offer invaluable data to 
policy makers who might consider adopting the intervention as a standard care for teens with 
asthma. Moreover, this multi-site study involving three cities representing the Northeastern, 
Eastern and Southern sections of the US will provide evidence of the generalizability of the 
intervention and its impacts, which could further accelerate the adoption and implementation of 
the program to address the serious health threats of asthma in inner-city adolescents and to 
contain economic costs to society.  
7.3 Alternatives to Participation 
There are no alternative courses of action should the subject elect not to participate in the study.  
8. CONFIDENTIALIATY OF DATA AND INFORMATION STORAGE  
To ensure confidentiality, subjects will be assigned an identification number, and they will be 
informed that all information will be held in confidence. Hardcopy data will be kept in a locked file 
cabinet in each site-PI’s office. Subject information connecting subject names with identification 
numbers will be locked in a separate file drawer in each site-PI’s office. Any printed subject 
information will be kept in the three site-PIs’ locked drawers and will be shredded immediately if 
not used. Subjects will be informed that their parents or guardians will not have access to their 
responses for any of the measures. Adolescents and parents will also be assured that forms will 
be destroyed safely upon completion of the study. Parents and adolescents will be informed that 
only the research team, University IRB members, grant sponsors and auditors from NIH will have 
access to their responses. All data from any parent or adolescent requesting withdrawal from the 
study will be destroyed at the time of the request. Only aggregated data without any personal 
identifiers will be reported in publications or presentations.  Only two documents, the informed 
consent form and the subject contact form, will contain participant’s identifying information. The 
informed consent form will be kept separate from the de-identified subject data, in paper form, 
accessible only to the essential study team. The contact form, containing the participant’s contact 
information (i.e., address and cell/phone numbers), will be needed by the study coordinator/peer 
leaders for follow-up visits for data collection.  
Informed consent documents, with identifying information (e.g.   subject’s name) and a link to the 
unique subject ID code, will be kept in a locked, secure location accessible only to the essential 
members of the study team. The contact information form, used by the study coordinator to 

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contact participants to arrange follow-up assessment visits will be stored separate from the 
research database on a password-protected secure server maintained by the University of 
Rochester School of Nursing IT Department.  
9. RESEARCH INFORMATION IN MEDICAL RECORDS 
N/A 
10. DATA ANALYSIS AND DATA MONITORING 
10.1 Planned Statistical Analysis: Analyses will be performed using SAS, and R 56 will be used as 
analysis software to ensure the validity and reproducibility of the results. We will perform 
descriptive statistics on each outcome measure to look for abnormality and outliers. If a measure 
is not normally distributed, transformation will be applied. We will identify and investigate outliers 
for sources of errors, and conduct preliminary analyses on data distribution and bivariate 
correlations to determine the appropriate statistical model as well as the final interpretation of the 
results. We will investigate missing data with pattern analysis for data missing completely at 
random (MCAR), missing at random (MAR) or missing not at random (MNAR), and use statistical 
methods appropriate for each type such as maximum likelihood and multiple imputation to impute 
missing values so full analysis can be performed with sensitivity. We will compute Cronbach’s 
alphas for psychometric measures, and assess construct validity using exploratory or confirmatory 
factor analysis when appropriate. The PLASMA and control groups will be compared on baseline 
data to determine any systematic differences; if any are found, analyses will include the variables 
as covariates in the model to adjust for the imbalances.  
Aim 1: A multi-site hierarchical three-level linear mixed-effects model, 26, 56, 57 where level 1 
represents repeated measures, level 2 = subject, and level 3 = site, will be used to analyze 
treatment differences and treatment-by-time interaction described in the following notation by 
Hedeker and Gibbons. 57 
Aim 2: The mediating effects will be examined mainly using the mediation methods of Baron & 
Kenny. 58 When found significant, a multiple mediation analysis 59 procedure will be used to further 
determine whether the effect of PLASMA on quality of life is mediated jointly by multiple 
exploratory outcomes. 
Aim 3: Moderating effects will be examined by multiple linear models and generalized linear 
models described in Berridge and Crouchley 56 or Chen and Peace  60 along with the above multi-
site hierarchical three-level linear mixed-effects models. 
Aim 4: This aim will be tested by applying the multi-site hierarchical two-level linear mixed-effects 
models described in the analysis for Aim 1, with level 1 representing longitudinal measurements 
and level 2 sites.  
Aim 5: The costs of services received during visits to a physician’s office, outpatient department, 
or ED will be estimated by taking the global relative value unit for each service CPT (Current 
Procedural Terminology) code multiplied by a standard conversion factor. 61 Hospital charges 
will be converted to costs using department-specific cost-to-charge ratio. 62 Medications and 
dosages prescribed will be captured; standard wholesale unit cost from the Pharmaceutical Red 
Book 63 will be used to estimate medication costs. To calculate lost productivity costs of a family 
with a sick teen, we will estimate total lost income related to each participant by multiplying total 
number of work hours missed by a parent’s hourly wage. Program costs will be estimated from 
the actual time peer and adult leaders spent in carrying out the program multiplied by hourly 
earnings, costs of equipment/ supplies, and overhead costs; program time will not include staff 
time for research-related tasks. We will estimate the average program cost per participant by 
study group, and include this estimate as one component of direct healthcare costs. The 

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medical or general Consumer Price Index 64 will be used to inflation-adjust costs to current year 
prices. 64 For each teen at each time-point, we will calculate total direct costs, direct costs by 
major category (office visit, hospitalization), indirect lost-productivity costs, and total direct and 
indirect costs. For withdrawals from follow-up, we will impute missing utilization and cost data 
assuming a linear trend in use and cost given prior experiences, where we will estimate 
weighted least square regression on log-transformed cost and obtain smearing-retransformed 
predictions. 65 For PLASMA and control groups separately, we will calculate the cost difference 
between each time point and baseline for each teen, assuming (s)he received “standard care” 
before treatment. Cost differences for each group will be modeled against follow-up points and 
individual covariates to estimate the independent impacts of each program on costs relative to 
standard care. 
10.2 Data and Safety Monitoring: The proposed project meets the NIH definition of a clinical 
trial and thus requires a Data and Safety Monitoring Plan. The Safety Monitoring Committee 
(SMC) will be established for the independent review of data. This study involves minimal risk 
because “the probability and magnitude of harm or discomfort anticipated in the research are not 
greater in and of themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests” (HHS.gov). Therefore, we 
will form the SMC. This independent committee will be charged with reviewing safety and trial 
progress and providing recommendations for study continuation and modification. The SMC 
comprises four PI-appointed members who are investigators and biostatisticians independent of 
the study protocol, as required by the NIH.  The names and affiliations of the board members are 
listed below. These individuals are not participating in this project and can provide objective 
feedback and recommendations to the investigators regarding any issues of data safety and 
monitoring. All have agreed to serve on the SMC for this study. The Committee Chair elected by 
the board members will lead the meetings and submit any reports to the NINR if necessary. The 
PI will provide written reports to the SMC on the current status of the trial, interim analyses, 
adverse events and problems encountered. If there are recommendations for consideration (e.g., 
changes in sample size, modifying outcomes) or amendments to the study protocol, the PI will 
provide a summary to the committee for review. The PI will be responsible for disseminating the 
SMC recommendations to participating clinical sites and the NINR.   
- 
James McMahon, PhD, Associate Professor, Biostatistician/clinical trial expert, University 
of Rochester School of Nursing 
- 
Jill Halterman, MD, MPH, Professor, Content/clinical trial expert, University of Rochester 
Medical Center, Department of Pediatrics 
- 
Elizabeth (Betsy) Tolley, PhD, Professor, Biostatistician, University of Tennessee Health 
Science Center, Biostatistics & Epidemiology Division, Preventive Medicine Department.  
- 
Maria Trent, MD, MPH, Associate Professor, Clinical trial expert, Division of General 
Pediatrics and Adolescent Medicine, Johns Hopkins School of Medicine.  
The SMC will meet annually (via video-conference). Each meeting will be divided into an open 
and closed session. Each meeting will be conducted by Roberts Rule of Order, and written 
summaries and recommendations will be sent to the PI.  Necessary changes to the study protocol 
will be communicated within 48 hours, and changes will be made expeditiously.  The open 
session will be attended by the members of the SMC and the study team (the PI, site-PIs, and 
study coordinators from each site). During the session, the PI will present general progress of the 
study, adverse events, subject accrual, protocol compliance, quality control and timeliness. The 
closed session will be attended by only the SMC members, who will discuss data presented 
during the open session and vote on recommendations.  

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NOTE: This application includes a clinical trial of a behavioral intervention that has already been 
registered in ClinicalTrials.gov (NCT01161225) during the PI’s earlier study in complying with 
registration and regulatory guidelines for this designation. The registered study protocol will be 
updated to reflect the current study design and outcomes.   
Investigator Time and Resources 
 
This IRB protocol is in partial fulfillment of Just-in-Time (JIT) notice requirements of the National 
Institutes of Health, National Institute of Nursing Research, in connection with NIH grant 
application R01 1R01NR014451 (Rhee, PI). The study will be conducted only on condition of 
grant award notification and funding, which will ensure sufficient investigator time and resources 
to conduct the study. Sufficient investigator and institutional resources have been verified by the 
School of Nursing grants management department and the Associate Dean for Research. 
 
 REFERENCES 
1. Morgan WJ, Stern DA, Sherrill DL, et al. Outcome of asthma and wheezing in the first 6 years 
of life. Am J Respir Crit Care Med. 2005;172:1253-1258. 
2. Bloom B, Cohen RA, Freeman G. Summary health statistics for U.S. children: National health 
interview survey, 2010. Vital Health Stat. 2011;10(250). 
3. Akinbami LJ, Schoendorf KC. Trends in childhood asthma: Prevalence, health care utilization 
and mortality. Pediatrics. 2002;110(2):315-322. 
4. Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the united 
states, 1980–2007. Pediatrics. March 2009;123(Supplement 3):S131-S145. doi: 
10.1542/peds.2008-2233C. 
5. William W. B. The national institutes of allergy and infectious diseases networks on asthma in 
inner-city children: An approach to improved care. J Allergy Clin Immunol. 2010;125(3):529-537. 
doi: 10.1016/j.jaci.2010.01.036. 
6. Busse WW, Mitchell H. Addressing issues of asthma in inner-city children. J Allergy Clin 
Immunol. 2007;119(1):43-49. doi: 10.1016/j.jaci.2006.10.021. 
7. Scott L, Morphew T, Bollinger ME, et al. Achieving and maintaining asthma control in inner-city 
children. J Allergy Clin Immunol. 2011;128(1):56-63. doi: 10.1016/j.jaci.2011.03.020. 
8. Calmes D, Leake BD, Carlisle DM. Adverse asthma outcomes among children hospitalized with 
asthma in california. Pediatrics. 1998;101(5):845-850. doi: 10.1542/peds.101.5.845. 
9. Fuhlbrigge AL, Guilbert T, Spahn J, Peden D, Davis K. The influence of variation in type and 
pattern of symptoms on assessment in pediatric asthma. Pediatrics. 2006;118(2):619-625. doi: 
10.1542/peds.2005-2963. 
10. Davis KJ, DiSantostefano R, Peden DB. Is johnny wheezing? parent-child agreement in the 
childhood asthma in america survey. Pediatr Allergy Immunol. 2011;22(1-Part-I):31-35. doi: 
10.1111/j.1399-3038.2010.01016.x. 
11. Kyngas H, Rissanen M. Support as a crucial predictor of good compliance of adolescents with 
a chronic disease. J Clin Nurs. 2001;10(6):767-774. 
12. Randolph C, Fraser B. Stressors and concerns in teen asthma. Curr Probl Pediatr. 
1999;29(3):82-93. 

Page 19 of 21 
Version Date: 09-25-2014 
 
13. Berg J, Tichacek MN, Theodorakis R. Evaluation of an educational program for adolescents 
with asthma. J Sch Nurs. 2004;20(1):29-35. 
14. Kyngas H. Support network of adolescents with chronic disease: Adolescents' perspective. 
Nurs Health Sci. 2004;6(4):287-293. 
15. Rhee H, Wenzel J, Steeves RH. Adolescents' psychosocial experiences living with asthma: A 
focus group study. J Pediatr Health Care. 2007;21(2):99-107. 
16. Cohen R, Franco K, Motlow F, Reznik M, Ozuah PO. Perceptions and attitudes of adolescents 
with asthma. J Asthma. 2003;40(2):207-211. 
17. Butler K, Cooper WO. Adherence of pediatric asthma patients with oral corticosteroid 
prescriptions following pediatric emergency department visit of hospitalization. Pediatr Emerg 
Care. 2004;20(11):730-735. 
18. Velsor-Friedrich B, Vlasses F, Moberly J, Coover L. Talking with teens about asthma 
management. J Sch Nurs. 2004;20(3):140-148. 
19. Balfour-Lynn L. Growth and childhood asthma. Arch Dis Child. 1986;61(11):1049-1055. 
20. Shadish WR, Cook TD, Campbell DT. Experiemental and Quasi-Experimental Designs for 
Generalized Causal Inference. Boston, MA: Houghton Mifflin Company; 2002. 
21. Ferguson L. External valdity, generalizability and knowledge utilization. J Nurs Scholarsh. 
2004;36(1):16-22. 
22. Laws RA, St.George AB, Rychetnik L, Bauman AE. Diabetes prevention research: A 
systematic review of external validity in lifestyle interventions. Am J Prev Med. 2012;43(2):205-
214. doi: 10.1016/j.amepre.2012.04.017. 
23. Akinbami LJ, LaFleur BJ, Schoendorf KC. Racial and income disparities in childhood asthma 
in united states. Discourse Processes. 2002;2(5):382-387. 
24. Halterman JS, Aligne CA, Auinger P, McBride JT, Szilagyi PG. Inadequate therapy for asthma 
among children in the united states. Pediatrics. 2000;105(1 Pt 3):272-276. 
25. Gupta RS, Carrión-Carire V, Weiss KB. The widening black/white gap in asthma 
hospitalizations and mortality. J Allergy Clin Immunol. 2006;117(2):351-358. doi: 
10.1016/j.jaci.2005.11.047. 
26. Roy A, Bhaumik DK, Aryal S, Gibbons RD. Sample size determination for hierarchical designs 
with different attrition rates. Biometrics. 2007;63:699--707. 
27. Rhee H, Belyea MJ, Hunt JF, Brasch J. Effects of a peer-led asthma self-management 
program for adolescents. Arch Pediatr Adolesc Med. 2011;165(6):513-519. doi: 
10.1001/archpediatrics.2011.79. 
28. National Heart, Lung, and Blood Institute. Expert panel report 3: Guidelines for the diagnosis 
and management of asthma. 2007. 
29. Mammen J, Rhee H. Concept analysis: Asthma self-management in adolescents. Pediatr 
Allergy Immunol Pulmonol. 2012;25(4):180-189. 
30. Rhee H, McQuillan B, Belyea MJ. Evaluation of a peer-led asthma self-management program 
and benefits of the program for adolescent peer leaders. Respir Care. 2012;57(12):2082-2089. 
31. Maticka-Tyndale E, Barnett JP. Peer-led interventions to reduce HIV risk of youth: A review. 
Eval Program Plann. 2010;33(2):98-112. doi: DOI: 10.1016/j.evalprogplan.2009.07.001. 

Page 20 of 21 
Version Date: 09-25-2014 
 
32. Becker CB, Bull S, Smith LM, Ciao AC. Effects of being a peer-leader in an eating disorder 
prevention program: Can we further reduce eating disorder risk factors?. Eat Disord. 2008;16:444-
459. 
33. Bruzzese JM, Bonner S, Vincent EJ, et al. Asthma education: The adolescent experience. 
Patient Educ Couns. 2004;55(3):396-406. 
34. Gebert N, Hummelink R, Konning J, et al. Efficacy of a self-management program for 
childhood asthma-a prospective controlled study. Patient Educ Couns. 1998;35(3):213-20. 
35. Lord A, St. Leger LH, Ridge DT, Elisha D. The value of asthma camps for young people in 
victoria, australia. Contemporary Nurse. 2001;11(2-3):133-141. 
36. Meng A, Tiernan K, Bernier MJ, Brooks EG. Lessons from an evaluation of the effectiveness 
of an asthma day camp. American Journal of Maternal Child Nursing. 1998;23(6):300-306. 
37. Robinson LD. Pediatric asthma self-management: Current concepts. Journal of the National 
Medical Association. 1999;91(8 Suppl):405-445. 
38. Song M, Happ MB, Sandelowski M. Development of a tool to assess fidelity to a psycho-
educational intervention. J Adv Nurs. 2010;66(3):673-682. doi: 10.1111/j.1365-
2648.2009.05216.x. 
39. Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of 
life in children with asthma. Qual Life Res. 1996;5(1):35-46. 
40. Okelo SO, Wu AW, Krishnann JA, Rand CS, Skinner EA, Diette GB. Emotional quality-of-life 
and outcomes in adolescents with asthma. J Pediatr. 2004;145(4):523-529. 
41. Raat H, Bueving HJ, de Jongste JC, Grol MH, Juniper EF, van der Wouden JC. 
Responsiveness, longitudinal-and cross-sectional construct validity of the pediatric asthma quality 
of life questionnaire (PAQLQ) in dutch children with asthma. Qual Life Res. 2005;14(1):265-272. 
42. Rhee H, Belyea MJ, Elward KS. Patterns of asthma control perception in adolescents: 
Associations with psychosocial functioning. J Asthma. 2008;45:600-606. 
43. Bartholomew LK, Gold RS, Parcel GS, et al. Watch, discover, think and act: Evaluation of 
computer-assisted instruction to improve asthma self-management in inner-city children. Patient 
Educ Couns. 2000;39(2-3):269-280. 
44. Austin JK, Huberty TJ. Development of the child attitude toward illness scale. J Pediatr 
Psychol. 1993;18(4):467-480. 
45. Rhee H, Belyea MJ, Cirzynski S, Brasch J. Barriers to asthma self-management in 
adolescents: Relationships to psychosocial factors. Pediatr Pulmonol. 2009;44(2):183-191. 
46. Bursch B, Schwankovsky L, Gilbert J, Zeiger R. Construction and validation of four childhood 
asthma self-management scales: Parent barriers, child and parent self-efficacy, and parent belief 
in treatment efficacy. J Asthma. 1999;36(1):115-128. 
47. Holden G, Wade SL, Mitchell H, Ewart C, Islam S. Caretaker expectations and the 
management of pediatric asthma in the inner city: A scale development study. Soc Work Res. 
1998;22(1):51-59. 
48. Bruzzese JM, Evans D, Mellins RB. Asthma self-management indices: Manual and 
instructions for the asthma: It’s a family affair I project. Unpublished report. 2011. 
49. Bruzzese J, Sheares BJ, Vincent EJ, et al. Effects of a school-based intervention for urban 
adolescents with asthma: A controlled trial. Am J Respir Crit Care Med. 2011;183:998--1006. 

Page 21 of 21 
Version Date: 09-25-2014 
 
50. Aguilar-Fernandez AJ, Villa-Asensi JR, Castro-Codesal M, Almeria-Gil E, Gonzalez-Alvarez 
MI, Romero-Andujar F. Concordance between the piko - 1 portable device and 
pneumotachography in measuring PEF and FEV(1) in asthmatic children. Allergol Immunopathol 
(Madr). 2009;37(5):244-248. doi: 10.1016/j.aller.2009.03.004 [doi]. 
51. Rothe T, Karrer W, Schindler C. Accuracy of the piko-1 pocket spirometer. J Asthma. 
2012;49(1):45-50. doi: 10.3109/02770903.2011.643522 [doi]. 
52. Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. European 
Respiratory Journal. 2005;26(2):319-338. 
53. Rhee H, Belyea MJ, Brasch J. Family support and asthma outcomes in adolescents: Barriers 
to adherence as a mediator. J Adolesc Health. 2010. 
54. Procidano ME, Heller K. Measures of perceived social support from friends and from family: 
Three validation studies. Am J Community Psychol. 1983;11(1):1-24. 
55. Ozer EJ, Weinstein RS, Maslach C, Siegel D. Adolescent AIDS prevention in context: The 
impact of peer educator qualities and classroom environments on intervention efficacy. Am J 
Community Psychol. 1997;25(3):289-323. 
56. Berridge BM, Crouchley R. Multivariate Generalized Liner Mixed Models using R. Boco Raton, 
FL: Chapman & Hall; 2011. 
57. Hedeker D, Gibbons RD. Longitudinal Data Analysis. New York: Wiley; 2006. 
58. Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological 
research: Conceptual, strategic and statistical considerations. J Pers Soc Psychol. 
1986;51(6):1173-1182. 
59. Preacher KJ, Hayes AF. Asympotic and resampling strategies for assessing and comparing 
indirect effects in multiple mediator models. Behavior Research Methods. 2008;40:879. 
60. Chen DG, Peace KE. Clinical Trial Data Analysis using R. Boca Raton, FL: Chapman & Hall; 
2010. 
61. Federal Register. Payment policies under the physician fee schedule and other revisions to 
part B for CY 2012: Department of health and human services, centers for medicare & medicaid 
services. 2011;42 CFR Parts 410, 414, 415 and 419. 
62. Finkler SA. The distinction between cost and charges. Annals of Internal Medicine. 
1982;96(1):102-109. 
63. Red Book. Red Book (Red Book Drug Topics): Pharmacy's Fundamental Referene / the 
Physicians' Desk Reference (PDR). ; 2010. 
64. US Department of Labor, Bureau of Labor Statistics. Consumer price index.  
65. Duan N, Manning WG, Morris CN, Newhouse JP. A comparison of alternative models for the 
demand for medical care. J Bus Econ Stat. 1983;1(2):115-126.