Peer i-Coaching for Activated Self-management Optimization in Adolescents and Young Adults With Chronic Conditions
Phase: NA
Conditions: Sickle Cell Disease, Chronic Kidney Diseases, Systemic Lupus Erythematosus, Childhood Cancer, Inflammatory Bowel Diseases, Stem Cell Transplant, Organ Transplant, Diabetes Mellitus, Type 1, Cystic Fibrosis
Sponsor: Duke University

Peer i-Coaching for Activated Self-Management Optimization in 
Adolescents and Young Adults With Chronic Conditions
Document Date: March 11, 2019
NCT03938324

Peer i-Coaching for Activated Self-Management Optimization (PICASO) in Adolescents and Young 
Adults with Chronic Conditions 
Project Summary  
Increases in life expectancy in almost all childhood-onset chronic conditions (COCC) has brought unique 
challenges for adolescents and young adults (AYA) who struggle to deal with the associated disease burden, 
manage therapies, and thrive as they develop independent self-management skills, and become active and 
engaged patients.  The challenges that influence the lives of AYAs are largely adaptive, such as making 
lifestyle modifications, adhering to complex medication regimens, and learning to navigate the adult health 
system.  Adding to this complexity is the need for AYAs to progressively take over greater self-management 
responsibilities from parents. Promoting activated self-management is critically important given that this shift in 
health care management from parents and health care providers to the AYA is identified as key to successful 
adult outcomes. Peer support interventions are well-suited to address challenges theorized as critical to AYAs 
given the importance of peer relationships during this time. We propose a mixed-methods, five-year 
randomized controlled trial, that will include 225 AYAs (16-22 years) with COCCs, to test the Peer i-Coaching 
for Activated Self-Management Optimization (PICASO) versus an attention control group.  This novel, mobile 
health intervention utilizes an established telephone/text based secure interface to allow AYAs access 
knowledge, experience, and instrumental/emotional support from a trained peer coach (18-26 years), who has 
already developed independence and is an active self-manager.  We will determine the efficacy of PICASO on 
self-management, patient activation, transition readiness, health-related quality, and emotional health of life 
across 12 months. We will explore whether age, sex, race/ethnicity, chronic condition, and/or disease severity 
moderate the trajectory of PICASO effects on self-management, patient activation, coping, emotional health 
and health-related quality of life. Lastly, we will explore mechanisms of the PICASO impact by describing AYA 
experiences with the intervention.   
Project Narrative  
Promoting improved chronic condition self-management skills is critically important for adolescents and young 
adults with childhood onset chronic conditions transitioning to adult based care. Peer support interventions are 
well-suited to address challenges theorized as critical to adolescents and young adults given the importance of 
peer relationships during this time. We propose a mixed-methods, 5-year randomized controlled trial, that will 
include 225 AYAs (16-22 years) with childhood onset chronic conditions, to test the Peer i-Coaching for 
Activated Self-Management Optimization (PICASO) versus an attention control group. 

2. Specific Aims  
Statement of the problem: An increasing appreciation of the growing burden of chronic illness has led to calls 
for a shift in care models from curative, provider-centered care to adaptive, patient-centered self-management 
models.1 These models develop an individual’s capacity to engage actively in the work required to manage 
their condition. Applying this approach to the development of self-management skills for adolescents and 
young adults (AYAs) with chronic conditions is critical because of (a) growing numbers surviving into adulthood 
requiring transfer from pediatric to adult care services;2,3 (b) high rates of unsuccessful transfer to adult care 
due to poor preparation and low AYA activation;4,5 (c) knowledge that the transition to adulthood is a period of 
particular medical and psychosocial fragility in which their condition worsens and affective disorders 
increase;6,7 (d) general agreement that adolescence is a critical period for the development and activation of 
life-long chronic condition self-management skills;2,8-12 (e) knowledge that they have remained more dependent 
on their parents than their peers, and often lack independence in self-advocacy and self-care management.13,14  
The challenges that influence AYAs across this transition are largely adaptive, or those only the AYA can 
address, but for which they might not currently possess the capability15 (e.g., making lifestyle modifications, 
adhering to complex medication regimens,16 learning to navigate the adult health system). Adding to this 
complexity is the need for AYAs to progressively take over greater self-management responsibilities from 
parents as they prepare to transition from pediatric- to adult-based care systems. AYAs must navigate normal 
developmental transitions, develop independent self-management skills, and become active and engaged 
patients (patient activation), so that they can manage their health effectively and avoid the significant negative 
health outcomes that occur for many during this period. Promoting activated self-management, intrinsic 
motivation to actively manage their condition and related self-care, is critically important given that this shift in 
health management from parents and health care providers to the AYA is identified as key to successful adult 
outcomes.17-19 There is a lack of scalable, theoretically guided interventions that build the adaptive capacity of 
AYAs to develop and implement chronic condition activated self-management behaviors.14,20  
Peer support interventions are well-suited to address challenges theorized as critical to AYAs given the 
importance of peer relationships during this time.21 Qualitative studies have indicated that AYAs with a range of 
conditions are interested in peer support.22-26 Our systematic review of programs for AYAs with a peer support 
component found that most are not evidence-based, have not been rigorously evaluated, and few focus on 
adaptive skills required for activated self-management such as medication management, health care 
navigation, and symptom surveillance, critical to transition to adulthood and few can easily be disseminated 
across settings that serve AYAs with chronic conditions such as schools or medical home-modeled clinics.27 
Potential solution: To develop of chronic condition activated self-management skills, we designed and pilot 
tested a peer-based coaching intervention - Peer i-Coaching for Activated Self-Management Optimization 
(PICASO) - for AYAs with childhood onset chronic conditions.28,29 This novel, mobile health intervention utilizes 
an established telephone/text based secure interface to allow AYAs access knowledge, experience, and 
instrumental/emotional support from a trained peer coach who has already developed independence an active 
self-manager. Peers with shared experiences provide instrumental (e.g., health maintenance skills) and 
emotional support that likely lead to improvements in quality of life.30-33 Involving peers in supporting AYAs with 
chronic conditions to promote self-management and patient activation disrupts the typical over-reliance on the 
parent and health care provider that often impedes developing independence. Thus, we propose a five-year 
randomized controlled trial that will include 225 AYAs (16-22 years) with childhood onset chronic conditions to 
address these specific aims:    
Aim 1: Determine the efficacy of PICASO on primary outcomes (self-management, patient activation) and 
secondary outcomes (transition readiness, health-related quality of life, emotional health) across 12 months. 
Hypothesis: Compared to an attention control group, the PICASO group will report greater improvement in 
primary and secondary outcomes. 
Aim 2: Explore age, sex, race/ethnicity, chronic condition, and disease severity as moderators of trajectory of 
PICASO effects on self-management, patient activation, transition readiness, health-related quality of life and 
emotional health. Approach: Explore the moderating effects of patient characteristics on PICASO outcomes.  
Aim 3: Explore mechanisms of PICASO impact by describing AYA experiences with the intervention to 
characterize how they may be related to intervention components and contexts, with the goal of understanding 
intervention mediators and barriers to future large-scale implementation. Approach: Using mixed methods, 
qualitative interview data will be integrated with quantitative coaching data (e.g., coach/participant alliance).  
Long-term goals: Our next step is to take advantage of PICASO platform interoperability to conduct a 
pragmatic, multi-site, clinical trial. We aim to develop an efficient, generalizable, and scalable peer coach 
transition self-management product that will optimize AYA, parent, pediatric and adult chronic condition 
provider collaboration across care sites, venues, and transitions.  
 

3. Research Strategy
3.A.  Significance
Adolescent development, self-management, and patient activation. Adolescence and young adulthood, a 
phase in the life-course between 13 and 29 years34, is associated with significant biopsychosocial change and
brings negotiations of new statuses and abandonment of old ones. Family dependency decreases for 
adolescents and young adults (AYAs) as they gain new freedoms 
and are expected to accept greater responsibilities.35,36 Managing 
increased independence and establishing self-determination, or control 
over their own lives, are critical developmental tasks of adolescence. 
For AYAs living with a childhood onset chronic condition (COCC) (e.g., 
sickle cell disease, lupus) the stakes are higher as they must navigate 
the normal developmental transitions and also develop independent 
self-management skills and become active and engaged patients 
(patient activation), so that they can manage their health effectively and 
avoid the significant negative outcomes that occur for many during this 
period.7 To achieve this goal of developing more autonomous chronic 
condition self-management, the AYA must have both the opportunity to 
develop competency in the domains of self-management and be 
activated to take on these responsibilities. Growing evidence links 
patient activation levels to health outcomes. Self-management and 
patient activation are two concepts that together capture the set of 
critical skills and motivations needed for the AYA to become 
independent and effective managers of their chronic condition.
Given that the American Academy of Pediatrics supports medical 
transfer from pediatric to adult care as taking place between 18- to 21-
years of age37, for the purposes of this study, our population of focus 
is 16- to 22-years of age to capture the developmental period most 
imminently involved in planning for transition to adult care.20 While preparation should begin several years 
earlier, the cooperative program between the Maternal and Child Health Bureau and The National Alliance to 
Advance Adolescent Health, ‘Got Transition’38 (www.gottransition.org), which aims to improve transition to 
adult health care, has also recommended 16-22 years as the critical window in which AYAs must move into 
active transition preparation and are likely to require the highest level of support.
Self-management39 is the ability to manage the symptoms, treatments, lifestyle changes, and psychosocial, 
cultural and spiritual consequences of living with a chronic condition, and requires dynamic, daily 
engagement.40,41 For AYAs with COCC, self-management entails the ability to monitor their condition and 
develop cognitive, behavioral and emotional strategies to maintain optimal growth and development and 
preventative strategies to promote or maintain health.40 This daily work brings unremitting reminders of how 
AYAs are different from their peers.  In a review of 81 self-management interventions for 7 to 25 year-olds with 
a chronic condition,  most were aimed solely at medical management and lacked theoretical specification.42
Only five studies examined interventions for AYAs over 18 years of age, consistent with the significant absence 
of interventions for this age group. The literature on the medical transition from pediatric to adult health care 
providers, a distal outcome of AYAs developing self-management skills, focuses mainly on systems to help 
AYAs navigate the health care system, with few focused on the acquisition of self-management skills.20,27
Approximately 750,000 AYAs with COCC turn 18 years old each year in the U.S., and multiple medical 
organizations and national programs have indicated that improving the transition to adulthood for this 
vulnerable population is a priority.7,37,43-45 Yet, too often AYAs with chronic conditions are unprepared to take on 
components of self-management because the a) health care team has not provided them with adequate 
preparation46; b) parents are often afraid to allow the opportunity to practice self-management for fear of the 
AYA making a mistake47; and c) AYA is focused on other important developmental tasks and not motivated to 
become an activated, independent self-manager.48 Failure to develop independent self-management during 
this vulnerable time has significant negative consequences. For example, AYAs with diabetes often have 
worse metabolic control, AYAs with kidney transplants are at greater risk of losing their transplanted kidney 
due to noncompliance, and youth with a wide range of chronic conditions are unable to navigate the healthcare 
system and drop out of care. 7-12,49-51 Interventions are needed that change the status quo and disrupt the
dynamic between AYAs and parents/medical providers that result in AYAs being unprepared to become active 
partners in their own self-management. AYAs require guidance and ongoing support to promote motivation and 
engagement to become activated self-managers. 
Figure 1. Development of activated self-management 

Self-management competencies have been divided into four core components: 1) Knowledge; 2) 
Healthcare navigation/partnership in treatment; 3) Recognition and management of symptoms; and 4) 
Coping.52 In order to be a fully activated self-manager an AYA needs the requisite knowledge of their condition 
(1), and be able to activate the skills to manage their condition and maintain their health and well-being (2-4). 
Often, they may have strengths in one domain, and yet struggle in others.53 For example, an AYA with 
diabetes might have knowledge about how to deliver insulin (1) and cope with the social stress of having a 
chronic condition (4) but may still have poor overall self-management because they are not able to navigate 
the health system (2) or recognize a specific scenario in which they need to apply their knowledge (3). These 
competencies are often disease-agnostic and AYAs across conditions struggle to fully implement all four 
domains. They also tend to be tied to developmental experiences as opposed to chronological age.  For 
example, the 22-year-old who struggles with healthcare navigation has much in common with the 16-year-old 
who does not know how to make a doctor’s appointment. 
 
Patient activation is associated with positive outcomes among adults with chronic conditions including 
decreased ED visits, hospitalizations, and increased adherence.18,54,55  In order to be an activated self-
manager, AYAs must have self-management skills including those listed above (knowledge, healthcare 
navigation, recognition/management of symptoms, coping).14 Patient activation is the ability to act on the 
knowledge and effectively communicate and advocate for 
themselves within the health system. The Patient 
Activation Measure (PAM) is the only validated tool for 
measuring this construct and has been used across a 
range of chronic conditions to assess patient activation.56-
58 Patient activation has been divided into four  
stages of activation based on level of confidence and 
ability to act to address health (Table 1). Higher scores on 
the PAM are tied to these higher stages of patient 
activation. For AYA with chronic conditions, moving from 
stage 1 to 4 is a goal for becoming an independent, 
effective self-manager. Patient activation has been measured in a few studies of adolescent and young adults 
with chronic conditions,59,60 but in only one study was found to be significantly improved following participation 
in a text-messaging intervention with providers.19 Patient activation is distinct from self-management as it 
focuses on the specific approach to communication with providers and being motivated to participate in self-
management. For AYA with chronic conditions to become fully independent they must become activated to 
maintain their health as well as have the necessary self-management skills. 
 
Factors that influence development of activated self-management. The factors that shape the ability of an 
AYA to develop activated self-management include 1) individual characteristics, and 2) ecological features of 
their physical and social environment. Regardless of the etiology, symptoms, treatment regime or type of 
condition many AYAs with COCC face a common set of challenges and burdens.61 While it is often easier to 
focus on activated self-management within a particular condition, there is power in focusing on the common 
challenges related to the development of self-management faced by all AYAs and approaching this problem as 
a developmental challenge that is similar across conditions. This approach to examining the common features 
across conditions is often described as a non-categorical approach61,62 to the study of chronic condition self-
management and has gained acceptance to address the common developmental challenges. This non-
categorical approach to studying COCC has proved valuable as often the factors related to positive or negative 
outcomes are not directly related to the specific condition, but instead to other more general factors. 
 
Individual characteristics found to be important to the development of activated self-management 
include neurocognitive status, condition features (symptom burden, treatment burden, degree of impairment), 
age, gender, and psychosocial functioning. Neurocognitive status is particularly salient as individuals with 
intellectual disabilities are likely unable to become full independent self-managers and so modifications to their 
goals would be needed. While the development of self-management broadly is similar across conditions, there 
relevant features of each condition that must be considered as an individual AYA works towards independent 
self-management. More complex medication regimens may require more time to master and conditions 
requiring more medical specialists may require more organizational work to be able to effectively navigate the 
health system and partner with providers. Another important individual characteristic to consider is 
psychosocial function, which would include factors such as psychiatric conditions like depression or anxiety, as 
well as coping style, and educational attainment. 
 
From an ecological perspective the development of activated self-management skills is related to the 
environment in which an individual is situated. Relevant ecological factors include key features of the 
healthcare system in which an individual must seek care, as well as the relationship with parents and other 
Table 1. Patient activation stages 
Stage 
Summary  
Description 
1 
Disengaged & 
overwhelmed 
Does not feel able to take active role 
in health care 
2 
Becoming aware, but 
still struggling 
Lacks knowledge & confidence to take 
action 
3 
Taking action 
Beginning to take action but lacks 
confidence & support to change 
4 
Maintaining behavior & 
pushing further 
Learned to adopt new behaviors but 
may not maintain under stress 

social relationships, and socioeconomic factors. Access to care, proximity to care, relationships with providers, 
frequency of appointments, and the cost of care are all aspects of the health system that are relevant. For 
example, if an AYA loses insurance they will struggle with self-management because of a lack of resources 
and health care partners, even if they have the knowledge and appropriate skills and are coping well. To 
become independent self-managers AYAs must navigate the relationship with their parents or other care-
givers. Where AYA live and the degree of social support available are also relevant, as are financial factors 
such as insurance status, income, and financial stability. 
 
3.B. Theoretical Framework 
Self-Determination Theory and AYA self-management. While knowledge of the components of self-
management and stages of activation informed our ability to design an intervention that targets key concepts, 
systematically across levels, self-determination theory63 (SDT) assisted in framing the behavior change 
necessary for an AYA to become an activated self-manager. SDT specifies two types of motivation: extrinsic 
and intrinsic. Extrinsic, or controlled motivation, describes behavior that is a result of external sources or 
pressures.  Intrinsic, or autonomous motivation, describes behavior chosen freely that aligns with self-identity 
and values. Autonomous motivation has been shown to result in health behaviors sustained over longer 
periods of time, when compared to that of controlled motivation.64-66 Intrinsic motivation in SDT can be 
promoted by meeting three psychological needs: (a) autonomy (being in charge of one’s own choices), (b) 
competence (believing in one’s ability to attain goals and control outcomes), and (c) relatedness (feeling 
closely connected and supported by others). SDT-based health behavior models have been shown to be 
effective at promoting smoking cessation, weight loss, medication adherence, and other important health 
behavior outcomes.65,67,68 Providing AYAs with a supportive peer aligns with the promotion of relatedness, and 
allows for development of intrinsic motivation.  For example, motivational interviewing, when used by a trained 
peer-coach can foster intrinsic motivation to promote health.64 SDT has particular salience to interventions with 
AYAs with chronic conditions who need to take on increasing responsibility for their condition and generally 
lack the motivation to do so. SDT 
provides an empirically supported 
health behavioral framework to 
promoting the intrinsic motivation 
necessary for AYAs to acquire the 
activated self-management skills 
needed. 
 
Peer support is well suited to 
promote activated self-
management in AYAs through the 
provision of social support that can 
promote intrinsic motivation, following the Self-Determination Theory. Peer support through peer coaching has 
been most extensively studied in adults with diabetes33, and is now well-established as a tool to help adults 
develop self-management capacity.69 Co-I Fisher has extensive experience studying the effectiveness of peer 
support in improving adult chronic illness self-management through his global program of research ‘Peers for 
Progress’. His work has extended the evidence base for peer support interventions, helped establish peer 
support as an accepted, core component of health care, and promoted peer support programs and networks 
on a global scale (peersforprogress.org).33,70,71  Specifically, Fisher’s peer coaching model focuses on 
promoting healthy self-management behavior through focusing on 1) assistance in daily management, 2) social 
and emotional issues,72 3) linkages to clinical care, and having the coach available to support 4) ongoing self-
management.33 There is scant research utilizing peer coaches to deliver these four key features of peer 
support to promote the acquisition of self-management skills by AYA with COCC. Thus we developed and pilot 
tested our “Peer i-Coaching for Activated Self-Management Optimization (PICASO) for AYAs with COCC (see 
Section 3.D.2 Preliminary Studies).  
 
Reaching AYA through mobile devices is an established way to involve this often hard to engage 
population.73 Cell phone ownership has proliferated in recent years with approximately 93% of 18-29-year-
olds in the U.S. owning a smart phone. SMART phones are the main form of communication for AYAs74, and 
for those who use a cell phone, 91% use text messaging to communicate.75 Well-designed mobile-based, self-
management and healthcare navigation interventions have been shown to be an effective method for engaging 
AYAs with COCC.75,76 We employed an informatics-based platform, using a novel telephone/text-based 
interface to deliver the PICASO intervention. This platform has been used successfully in our randomized 
controlled pilot study with AYAs with COCC (see Section 3.D.2 Preliminary Studies),28 and has been deployed 
for parent to parent coaching77, and a range of commercial peer coaching programs developed by Co-I Patel, 
Table 2. Key functions of peer support align with activated self-management 
Components of 
Activated Self-
Management 
Four Key Functions of Peer Support 
Assistance 
in Daily 
Management 
Social & 
Emotional 
Support 
Linkage to 
Clinical & Comm 
Resources 
Ongoing 
Availability of 
Support 
Knowledge 
 
 
 
 
Navigate care system 
Partner with providers 
 
 
 
 
Recognition of 
symptoms 
Respond to symptoms 
 
 
 
 
Coping 
 
 
 
 
 

including the National Kidney Foundation and health system based peer coaching programs. Through the web-
based portal, the participant and peer coach can securely communicate via phone and text message. The 
software arranges a time for the two parties to speak, sends reminders for upcoming phone calls, and provides 
systematic tracking of phone- and text-based interactions.75,76,78 In order for an intervention to be broadly 
disseminated to AYA with chronic condition, it must utilized mobile technology to engage them and provide a 
convenient mechanism by which they can receive support. 
 
Summary of Significance 
AYAs with chronic conditions remain more dependent on their parents and health care providers than their 
healthy peers, and lack independence in activated self-management. This over-reliance on parents and health 
care providers often impedes developing the independence necessary for successful transition to young 
adulthood and adult health care services. There is a lack of scalable, theoretically guided interventions that 
build the capacity of AYAs to develop and implement chronic condition activated self-management behaviors. 
Non-directive peer coaching, delivered using an informatics-based platform, can promote intrinsic motivation 
and is well suited to promote activated self-management in AYAs through the provision of social support in a 
format well-designed for engaging AYA.  
 
3.C.  Innovation 
Our Peer i-Coaching for Activated Self-Management Optimization (PICASO) intervention is innovative in 
several important ways. 
 
1. First, it conceptually and practically couples self-management skill development with patient activation. 
Together, these two concepts synthesize the set of critical skills and motivations needed for the AYA to 
become engaged and effective managers of their chronic condition. 
 
2. Second the PICASO intervention is designed to promote the development of activated self-management by 
AYAs with COCC using nondirective peer coaching. This novel approach provides AYAs with the opportunity 
to develop intrinsic motivation and competence to take control of their healthcare within the nonjudgmental, 
nondirective environment established by a peer with a shared experience of living with a COCC.  
 
3. Third, PICASO uses a proven informatics technology interface (InquisitHealth Mentor 1:1™ Web Based 
Portal79) that harnesses mobile technology to allow AYAs to be able to access their peer coach by phone or by 
text. Use of mobile technology to deploy the intervention decreases engagement barriers, allows AYAs from 
rural and urban areas and with varying schedules to participate, and employs a communication format that 
aligns with AYAs preferences for interpersonal interaction. 
 
4. Fourth, PICASO’s technological innovation enhances scalability and allows for broad dissemination 
across settings that serve AYAs such as schools, camps, or medical clinics. InquisitHealth Mentor 1:1™ Web 
Based Portal has been deployed commercially across multiple settings for peer support.  
 
3.D.  Approach 
3.D.1 Overview. We propose a 5-year mixed-methods, randomized controlled trial that tests the Peer i-
Coaching for Activated Self-Management Optimization (PICASO) versus an attention control group in an 
academic health center setting.  
 
3.D.2. Preliminary Studies 
3.D.2.a. The investigators and environment are ideal because of proven content expertise, 
collaboration on preliminary data, and strong institutional support.  Co-PI Sharron Docherty is a nurse 
scientist, pediatric nurse practitioner, and has led inpatient, outpatient, and community-based studies of 
chronic condition self-management, intervention development, and interventions integrated with technology. 
She has expertise in mixed-methods, has led large multidisciplinary studies, and studies involving interviews 
with AYAs with chronic conditions, their parents and health care providers. Co-PI Gary Maslow is a child and 
adolescent psychiatrist and pediatrician with over 15 years of experience developing and implementing 
mentor-based peer support programs for AYAs with chronic conditions across academic medical centers. He 
has experience recruiting AYA for studies including recruiting 170 AYA with a range of chronic conditions from 
Duke pediatric clinics for a study examining positive youth development. Co-I, McLean Pollock is an 
epidemiologist and clinical social worker with over 10 years of experience as a children therapist working with 
at risk children and families. She has collaborated on several mixed-methods studies with her focus on the 
evaluation of the impact of interventions on child and family well-being. Co-I Edwin Fischer is a renowned 
public health researcher, clinical psychologist and the global director of Peers for Progress a program focused 
on accelerating the availability of best practices in peer support. He has led many large research studies 
focused on chronic disease prevention, management and quality of life in those with asthma, cancer, 
cardiovascular disease, smoking and weight management.  Co-I Susan Silva is a cognitive neuropsychologist 
and biostatistician, with expertise in the analysis of longitudinal data and moderator/mediator effects in multi-

center clinical trials. She served as the Statistical PI for the NIMH-sponsored Treatment for Adolescent 
Depression Study. Co-I Ashwin Patel is the Chief Medical Officer of InquisitHealth and the developer of the 
web-based peer support interface currently being deployed for several chronic conditions and has worked 
extensively with the Co-PIs to adapt the platform as part of pilot work. He is the PI of active NIH grants using 
this portal for peer support for diabetes self-management and to reduce asthma hospitalizations in children. 
Drs. Maslow and Docherty have worked together for over 10 years in the Duke Children’s Hospital and the 
Duke University School of Nursing’s P30 Center of Excellence in Adaptive Leadership for Cognitive/Affective 
Symptom Science and have co-authored manuscripts. Drs. Maslow and Fisher have published a review 
together of peer support interventions and have collaborated on a study of social support of adolescents in a 
summer camp setting. Dr. Silva has worked with the Dr. Docherty on several of the P30 projects and the 
preliminary study for the proposed study. 
 
3.D.2.b.  The PICASO was found to be feasible and acceptable and showed preliminary efficacy trends 
suggesting improvements in transition readiness and internal self-regulation.80  Using a randomized 
controlled trial with a 3-month waitlist control group, we piloted PICASO in four of the sub-specialty ambulatory 
care clinics at Duke Children’s Hospital. We enrolled 25 AYAs, 16 to 22 years, over a 9-month period 
(Intervention N=13; Wait-list control N=12) from four diagnostic categories: cancer (N=6), inflammatory bowel 
disease (N=6), lupus (N=7), sickle cell disease (N=6). The attrition rate at month 3, 23% in the intervention 
group and 25% in the wait-list control group, was consistent with that reported in other adolescent clinical 
trials.81-83  Reasons for withdrawal following randomization included: time constraints (n=3), medical crisis 
(n=1), unable to contact (n=1), and difficulty completing surveys due to low cognitive ability (n=1). Content 
analysis of post-intervention completion interviews supported high acceptability and satisfaction with PICASO. 
Themes with data samples included: Shared Experiences (e.g., “He was just..I can’t even explain it in 
words…but just he was also a fellow Hodgkin’s survivor so just kind of having that connection and just having 
someone there. He was very encouraging and that was very meaningful to me.”); Motivation Sharing (e.g., “I 
knew that I had this goal. She gave me motivation to get up and pursue it.”); Progress Towards Goals (e.g., “I 
definitely feel like we accomplished a lot. A lot in a little bit of time.”); Usefulness of Coaching (e.g., “I think that 
it’s something that every cancer patient needs because you know you’re just looking at having cancer and your 
like, okay I just got through this but life goes on after having cancer so this was really a big part of putting that 
into perspective.”). Clinically meaningful improvement for outcomes was defined as a median baseline to 
month 3 improvement per AYA of 5% or greater for the group. We found clinically meaningful improvement in 
transition readiness in the intervention group but not in the control group (median improvement 7.5% vs 3.9% 
respectively). Clinical improvement was also found in intentional self-regulation in both the intervention and 
waitlist control groups (median improvement 14.3% vs 12.5% respectively). A clinically meaningful 
improvement on the Patient Activation Measure (PAM) has been defined in previous studies as a 2-point or 
greater increase.54,55 Among the 19 participants (10 intervention, 9 controls) who completed the 3-month 
assessment, a clinically significant improvement was observed in five (50%) of those receiving the intervention 
and five( 55.6%) of those in the waitlist  control group. 
3.D.3 Experimental Approach 
3.D.3.a. Overview of aims, design, analyses, and timeline (Table 3).  
Aims 
Design & participants 
Analyses 
Aim 1: Test efficacy of 
PICASO versus attention 
control group on primary and 
secondary outcomes across 
12 months  
 
• Randomized controlled trial (RCT): 
• AYA PICASO intervention group (N=150) 
• AYA attention control group (N=75) 
• Primary Outcomes: self-management and patient 
activation  
• Secondary Outcomes: transition readiness, health-
related quality of life, emotional health  
• Assessments: baseline, 3,6,9,12 months 
Trajectory Analyses: Hierarchical mixed-
effect models for longitudinal data with a 
posteriori comparisons at each assessment 
point to compare the trajectory of change in 
each outcome across 12 months in the 
PICASO intervention group compared to the 
attention control group 
Aim 2: Explore moderating 
effects of AYA characteristics 
on primary and secondary 
outcomes across 12 months 
• Same design and participants as above 
• Candidate baseline moderators:  age, race/ethnicity, 
biological sex, type of chronic condition, and disease 
severity 
 
Exploratory Moderator Analyses: 
Trajectory analysis approach; Core trajectory 
model for each outcome as described in Aim 
1 plus inclusion of each candidate moderator 
and its two-way and three-way interactions 
Aim 3: Characterize user 
experiences with the 
intervention. 
• Purposive stratified sample from RCT 
• AYA PICASO intervention (n=50) 
• Post-intervention 
Mixed methods: 
Identify intervention responder typologies; 
identify themes  
 
3.D.3.b. Setting. The 12-month PICASO intervention will be tested at the Duke Children’s Health Center, a 
large multi-specialty ambulatory children’s hospital caring for over one thousand AYAs each year with a range 

of COCC. Co-PI Maslow has successfully recruited over 170 youth84 through the Duke Children’s Health 
Center for other studies and has dedicated support from each of the clinics that would serve as recruitment 
sites. Based on these and other prior recruitment efforts by both Co-PIs, we anticipate that 70-80% of youth 
approached will consent to participate with a 90% retention rate.47,85,86  
 
3.D.3.c. Description of study population. The usefulness of diagnostic groupings in studies of chronic 
condition self-management has been called into question since the landmark studies conducted by Stein,  
 Jessup and colleagues. 61,62,87 Since then, a range of studies on adaptation to COCC have supported the view 
that there is more variability within diagnostic groupings than between, suggesting that diagnosis is not a 
helpful categorization in the examination of adaptation.3,87-92  The only area in which differences are found is 
family interaction with the health system.62  Considering these findings, and our focus on outcomes that are not 
disease-oriented, we have adopted a modified noncategorical approach to defining the population. The list of 
chronic conditions included in this study is broad and includes conditions that require frequent hospital-based 
treatment (sickle cell disease, chronic kidney disease, systemic lupus erythematous), have specific daily 
management tasks and episodic periods of worsening/flares (type 1 diabetes, inflammatory bowel disease, 
severe asthma) and survivorship conditions in which participants have gone through some form of intense 
treatment and continue to deal with distressing symptoms and self-management tasks (stem cell 
transplantation, organ transplantation, childhood cancer survivor). For the purposes of peer coach matching, 
we created categories of chronic conditions based upon burden of condition attributed to chronicity and 
impairment (See Table 5). Peer coaches will be matched to AYAs based upon shared condition category.  
Eligibility criteria (detailed in Human Subjects and Clinical Trials Information Section 2.2) apply to participants  
in all Aims and are shown in Table 6. 
 
 
3.D.3.d. Outcome measures. Study outcomes are described in detail in Human Subjects and Clinical Trials 
Information Section 4.3. All outcomes have been piloted by our team and chosen based on the conceptual 
model, expert recommendations, and psychometrics. Response burden will be minimized with short 
instruments and online data entry via REDCap survey. Pilot testing confirmed completion times ranging from 
15-20 minutes. 
 
Primary outcome measures. The constructs of (a) self-management and (b) patient activation will be assessed 
at baseline, 3-, 6-, 9-, and 12-months post randomization. Self-management will be measured using the 
Partners in Health Scale (PIH)52,93,94, assessing chronic condition self-management knowledge, partnership in 
treatment, recognition and management of symptoms, and coping. Patient activation will be measured using 
the Patient Activation Measure (PAM)56-58. The PAM measures patient activation through self-reports of 
knowledge, skills, and confidence related to self-management of one’s own health care. 
 
Secondary outcome assessments. The following constructs will be assessed as secondary outcomes at 
baseline, 3-, 6-, 9-, and 12-months post randomization: (a) transition readiness, (b) health related quality of life, 
and (c) emotional health. Transition readiness will be measured by the Transition Readiness Assessment 
Questionnaire (TRAQ).95,96 The TRAQ assesses transition readiness in youth with COCC in domains of self-
advocacy (communication and use of resources in the community and school) and chronic disease self-
management (scheduling appointments, asking questions of health care providers, filling prescriptions). Health 
related quality of life will be measured using the Short-Form 12 (SF-12)97,98 which produces weighted 
subscales on physical and mental components of quality of life. Emotional health will be measured using the 
Brief Symptom Inventory (BSI)99-101 which assesses emotional symptom experience (depression, anxiety, 
somatization) over the previous week. 
 
3.D.3.e. Data management plan for all aims. Human Subjects and Clinical Trials Information Sections 3.1.b. 
& 3.3.3 detail data management and security. Briefly, all study data will be entered by participants and the 
Table 5. Sample  
Condition Category 
Diagnoses 
N 
Peer 
Coach 
1. Frequent 
Hospitalizations or ED 
visits 
Sickle Cell Disease; 
Chronic Kidney Disease, 
Lupus   
50 PICASO 
25 control 
4-5 
2. High daily 
management with 
intermittent flares  
Type 1 Diabetes Mellitus; 
Inflammatory Bowel 
Disease; Severe Asthma  
70 PICASO 
35 control 
5 -6 
3. Survivor of life-threat 
condition requiring 
ongoing symptom mgm   
Stem Cell Transplant, 
Organ Transplant, Cancer 
Survivor 
30 PICASO 
15 control 
3-4 
Total:  150 PICASO / 75-control     2:1 ratio 
12-15 
Table 6. Overview of eligibility criteria 
Inclusion 
1. AYA 16 to 22 years 
2. Childhood onset chronic condition from 1 of 3 
condition categories (see Table Y). 
3. Read and speaks English 
4. Access to internet via computer or Smart Phone 
4. Access to telephone (Smart Phone not required as 
text feature can be accessed via internet) 
Exclusion  
1. Diagnosed cognitive dysfunction 
2. Need for English translator 

study Clinical Research Coordinator (CRC) via REDCap data system residing on a Duke University RHEL 
Server. Leveraging a unique password system, only the Study Manager will be unblinded to study group in the 
data system.  Weekly reports will be reviewed to monitor enrollment, retention, safety, and missing data.  
 
3.D.4.a. Study Procedures by Specific Aim 
Aim 1: Determine the efficacy of the PICASO on primary outcomes (self-management, patient activation) and 
secondary outcomes (transition readiness, health-related quality of life, emotional health) across 12 months. 
Aim 2: Explore moderators of trajectory of PICASO effects on self-management, patient activation, transition 
readiness, health-related quality of life and emotional health across 12 months. 
 
Overview and design:  We will test the hypothesis that compared to an attention control group, the PICASO 
group will improve self-management and patient activation as well as improve secondary outcomes (transition 
readiness, HRQoL, emotional health) in a RCT over 12-months with 225 AYAs with COCC. The primary 
outcomes are the post-intervention scores on the Partners in Health Scale and the Patient Activation Measure.  
 
Recruitment plan: Our detailed Recruitment and Retention Plan is provided in Human Subjects and Clinical 
Trials Information Section 2.5; a brief summary follows. Participants will be recruited by the study CRC in 
partnership with the Duke Children’s Health Center ambulatory clinic staff (attending physicians, fellows, and 
nurse practitioners - see Letters of Support from Clinic Medical Directors). At the end of each week clinic staff 
and the CRC will review lists of AYAs scheduled for appointments the following week. Eligible AYA will be 
identified and flagged to be provided with basic information about the study by the clinic staff the following 
week.  If an AYA and parent/guardian (for those less than 18 years) express an interest in the study, the CRC 
will meet with them at the same appointment for study introduction. Once questions have been answered the 
informed consent process will be conducted by the CRC in a confidential manner. 
 
Randomization and data collection (detail in Human Subjects and Clinical Trials Information Section 4.2.a.7 & 
4.2.a.11):  On completion of baseline data collection, AYAs will be randomized using a stratified randomization 
with permuted block sizes of four to either the PICASO intervention (N=150) or attention control group (N=75). 
While stratifying on condition category, a 2:1 treatment allocation will be applied to ensure as an intervention 
sample size that is sufficient to provide robust findings and increase the precision of the outcome parameter 
estimates for the PICASO intervention. A RedCAP data base platform will be used to administer the 
randomization scheme prepared by the study statistician. 
 
Peer coach recruitment and training (details in Human Subjects and Clinical Trials Information Sections 4.3.a.): 
Peer coaches are young adults (18-26 years) with a COCC who have been identified by clinic staff (attending 
physicians, fellows, nurse practitioners) as having exemplary activated self-management skills and, based 
upon their interpersonal skills, having the potential to be trained as a peer coach. Those young adults who are 
recommended will undergo a screening process and interview by the study investigators (Maslow, Docherty, 
Pollock). If they express interest in training and employment as a peer coach they will be hired and trained 
following the training protocol described below.  We plan to employ 12- 15 peer coaches who represent the 
condition categories (see Table 5). Peer coaches will receive training from Co-I Pollock (Coach Supervisor) 
using a health and wellness curriculum designed by Dr. Pollock who is an Integrative Health Coach, and 
previously tested by the study investigators.28,29 Training is composed of a five-day program and ongoing semi-
monthly supervisory sessions. Training content includes a review of the coaching framework including social 
support and self-determination theories, motivational interviewing techniques and information about health 
behavior change. Training sessions focus on the coach-AYA relationship and use of motivational interviewing 
techniques. Various role-playing sequences are used throughout the training program to provide coaches with 
the opportunity to test their skills.  Semi-monthly supervisory sessions will be conducted with coaches and the 
research team including continued education and support. Supporting AYAs with a similar condition as oneself 
can be emotionally distressing at times, and both Gary Maslow, MD who is a licensed pediatrician and 
pediatric psychiatrist, and McLean Pollock, LCSW who is a licensed clinical social worker, can consult and 
refer coaches experiencing problems. 
 
Peer i-Coaching for Activated Self-Management Optimization (PICASO) (details in Human Subjects and 
Clinical Trials Information Sections 4.2.a.12-15): The PICASO intervention is a peer coaching intervention 
based upon self-determination theory.66,102,103 The intervention is delivered by young adults (18-26 years) with 
a COCC and trained using a tested curriculum that includes motivational interviewing techniques and the 
benefits of peer relationships over a shared experience such as a COCC. The peer coach supports the AYA to 
to identify their own goals and feel a sense of success in making change towards goals within a supportive 
environment. This peer-centric process involves goal-setting, the development of self-discovery and provides 
accountability for changes in health behavior.104 The peer coach elicits the AYA’s vision of optimal health and 
identifies the AYAs values; both necessary for behavior change. As the AYAs identify a vision of wellness and 

develop goals and action steps to progress towards that vision, the peer coach elicits the AYA’s intrinsic 
motivation and activates skill development in self-advocacy and communication and empowers the AYA to 
take leadership in managing their condition.  
 
Peer coaching is tailored to the AYA’s 
developmental level and designed to 
address the four key functions of peer 
support that have been found to be 
associated with increased self-
management:33 1) participation in daily 
management, 2) support for social and 
emotional issues, 3) linkage to clinical 
care, and 4) ongoing support. The 
peer coaches work consistently over 
time, using nondirective approaches, 
to guide the AYA to address goals 
around daily management, navigation 
of the health care system, 
communication with health care 
providers, and emotional coping. 
Figure 2 identifies characteristics of 
the AYA that are known to be related to the development of independent self-management. The intervention is 
designed to address a range of these characteristics and to have flexibility to support AYAs based on known 
variations. For example, the intervention can be tailored so that younger AYAs receive support targeting earlier 
stages of the development of activation and self-management. Each AYA will be matched with a coach, based 
on membership in 1 of 3 condition categories (see Table 5), who will provide support using the InquisitHealth 
Mentor 1:1™ Web Based Portal mobile telephone/text platform and the curriculum that guides them to assess 
AYA goals and provide support in addressing these goals.  
 
To enact the four key functions of peer support, the coaches develop a relationship over time with their 
assigned AYAs. The first phase of the intervention involves an assessment and goal setting call during which 
the peer coach learns about the AYA’s experience with their COCC, how they view their current self-
management skills and how they envision their ideal health in adulthood. Through this initial call the coach and 
AYA will identify specific goals to work towards their vision of health. Throughout the process of coaching, the 
coach and AYA identify action steps towards the health and self-management goals, draw upon the AYA’s 
strengths and existing skills, examine potential barriers to successful progression towards their goals and 
develop plans for addressing those barriers. The curriculum for the intervention is nondirective but allows 
coaches to help AYAs identify areas to work on within the four domains of self-management – knowledge, 
partnership in treatment, recognition/management of symptoms, and coping – as they relate to the AYA’s 
personal health goals and vision for their future. Table 1 provides examples of the ways in which a peer coach 
would provide support to an AYA participant utilizing a nondirective approach. 
 
Table 7. Components of peer support intervention, AYA challenges, and peer coach support 
Components of 
Peer Support 
Self-management 
challenge 
Standard medical 
system approach 
Nondirective peer coaching approach 
Daily 
Management 
Difficulty  
adhering to 
medication schedule 
Provider instructs when 
and how to take 
medication 
Coach helps explore daily routines; how medication 
schedules can link into daily routines; barriers to 
adherence 
Social/emotional 
support 
Following self-
management plan 
when with peers 
Altering therapy for 
flexibility (e.g. switching 
insulin pump in diabetes) 
Coach helps explore fears of being different than 
peers; provides emotional support; role plays plan to 
talk to friends about condition 
Providing 
linkage to 
clinical care 
Attending regular 
clinic appointments  
Clinic schedules 
appointments at regular 
intervals with reminders 
Coach explores navigation of clinic system; how to 
reach out to schedule appointments; developing 
differing relationships with adult-care team   
Providing 
ongoing support 
Consistently follow 
self-management 
plan over time 
Regular clinic visits with 
doctor and care team to 
monitor symptoms 
AYA speaks with coach on regular basis over time; 
coach provides support to help consistently follow 
self-management plan and cope with stressors. 
 

The peer coach will discuss daily management tasks (Key Function 1) during intake assessment and as part of 
the ongoing coaching process. The peer coach will also discuss the AYA’s healthcare team and their ability to 
navigate the healthcare system.  The peer coach will provide indirect linkage to clinical care by providing 
support to participants around goals related to healthcare navigation, while also communicating directly with 
the clinical team should the need arise. The circumstances by which the coach would share information with 
the clinical team are primarily related to safety concerns. The clinical team can also provide the coach with 
information regarding symptoms, treatments, and other relevant health information (Key Function 3). By 
providing support around daily management and the linkage to clinical care the peer coach promotes an 
increase in all the self-management domains and patient activation. 
 
The social and emotional support (Key Function 2) and ongoing support (Key Function 4) are critical 
components within PICASO. AYAs will identify goals and through the coaching process may choose to focus 
on the social consequences or emotional challenges of coping with a COCC. The coach will use the 
nondirective supportive tools gained in their training to promote active coping and to provide nondirective 
emotional support. This type of support is associated with positive coping and with lower rates of 
depression/anxiety in response to an emotional stressor.  In addition, the nondirective emotional support is 
expected to be related to the outcome of improved health-related quality of life.  
 
The peer coaching interactions will occur using the InquisitHealth Mentor 1:1™ Web Based Portal.79 This 
platform designed by InquisitHealth and deployed commercially across multiple settings in which peer support 
is activated,79 facilitates interactions using telephone and a web-based peer-support interface. This informatics 
technology interface has been used successfully in a preliminary study of AYA with COCC28,29, as well as for 
adults with chronic conditions.79  Through the software interface, the AYA and coach arrange times to speak 
according to the protocol schedule. They can exchange secure communication via phone and text messages, 
and coaches can send them monthly educational newsletters. The coaches will track the AYA’s progress over 
time using the InquisitHealth web-based software. This database includes progress on key health behaviors 
discussed and notes the coaches submit after each session. Peer coaches and AYA will communicate by 
phone and text twice weekly over the first 16 weeks of the active relationship building phase. This will be 
followed by 18 weeks of weekly communication in the goal-focused phase. Last, peer coaches will have twice 
monthly communication for the final 18 weeks of the maintenance phase. 
In general, calls last 20-30 minutes. During the first call, the coach and AYA have the opportunity to learn 
about one another’s experiences with living with a chronic condition. During subsequent calls, the coach 
focuses primarily on the specific sub-behavior elected by the AYA. The coaching process model described in 
figure 2, helps the coach guide behavior change, beginning with assessing the participant’s vision for the 
future, establishing focus, readiness to change, and then pursuit and maintenance of identified goals. As goal 
progress is made, the coach and AYA work to identify a new goal, or in the case of no progress, they discuss 
barriers and strategies, with an option to move on to another goal. Between sessions the coach and participant 
can exchange text messages including an update on progress towards a goal. At the end of the intervention 
the final call involves an opportunity for closure and for the coach and AYA to review progress on goals and 
future steps.  
 
Attention Control: Over 12 months the attention control group participants will receive a monthly electronic 
newsletter with educational content about COCC management and the differences between pediatric and adult 
health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to 
answer questions regarding content, and an opportunity to link them to other resources. If participants report 
health concerns they will be directed to contact their health care team.  
 
Treatment fidelity and protocol adherence: See Human Subjects and Clinical Trials Information Section 
4.2.a.13 and 4.3 for complete details on intervention fidelity, participant adherence, and adherence 
measurement. The NIH Treatment Fidelity Workgroup statement will guide our fidelity plan105 and Co-PI 
Docherty has experience implementing these guidelines in a previous RCT intervention with adolescents 
undergoing blood and marrow transplant.106 Fidelity will be enhanced by the InquistHealth Mentor1to1™ 
platform which enables masked, direct voice communication; facilitates continuity of relationship between the 
AYA and peer coach; and allows for the systematic tracking of phone- and text-based interactions. After the 
call, the platform facilitates scheduling upcoming calls, automates text message and e-mail reminders, and 
allows for user-initiated text messaging between calls. Since all calls are facilitated through the platform, the 
system automatically tracks call length and frequency, and records these interactions. AYA engagement will be 
tracked and quantified by the number of contacts and average length of contacts time per week. These two 
numbers will be aggregated and plotted for each AYA. Together with weekly content analyses of a random 
selection of two calls and text messages from each coach, we will monitor AYA engagement and during 
biweekly coach training sessions address problems that arise.  Fidelity will be assessed by examining peer 

coach engagement and content of the call recordings. Peer coach engagement will be evaluated using the 
aggregated number of contacts and length of contact time for each of the 12-15 coaches. This will allow us to 
assess the extent to which coaches are engaged and to explore the reasons for increases or decreases in 
engagement. These evaluations will be performed weekly and feedback given to the peer coaches at the 
biweekly training sessions so that adjustments to the content/direction of the calls and text messages may be 
made by the caoch at the subsequent call. A log will be kept of these assessments and any subsequent 
adjustments.  
 
Aim 1 and 2 Analysis Plan 
Descriptive statistics will be used to detail the sample characteristics of the (a) coaches and randomized AYAs 
and (b) detail the study outcomes for the AYAs at the five-assessment point (baseline, 3-, 6-, 9-, 12-months 
post randomization). Non-directional statistical tests will be performed, with the significance level set at 0.05 for 
each test. The significance level will not be adjusted for multiple outcomes and tests (see Power section 
below). Estimated effect sizes and their 95% confidence intervals (CI) will be reported to address magnitude of 
effect and clinical significance for the efficacy and moderator analyses (Aims 1 and 2, respectively). 
 
AYA Sample Characteristics. Chi-square/Fisher's Exact Tests for categorical variables and General Linear 
Models (GLM) for continuous measures will be used to test for group (PICASO vs attention control) differences 
in the baseline demographic and clinical characteristics as well as baseline outcome measures for the AYAs. A 
GLM approach, which calculates least square means to adjust for unequal sample sizes, will be used to test for 
between-group differences in the means for continuous measures. Any significant between-group difference in 
a baseline characteristic detected will be evaluated as a potential covariate in the efficacy analyses 
 
Aim 1 Efficacy Analyses. To test the efficacy of the PICASO compared to the attention control condition on the 
primary and secondary outcomes across the five assessment points (time), we will use a type of hierarchical 
mixed-effect model for longitudinal data known as random coefficients regression models (RRM) to evaluate 
group differences in the trajectory of change in each outcome across time. Fixed effects will be group, time, 
group-by-time, while random effects will be participant and participant-by-time. Potential covariates will be 
included as fixed effects and will be retained in the final model only if significant at the 0.05 level. When 
needed, the model will be fitted for any non-linear temporal effects observed. The assumption of data missing 
at random will be evaluated, and imputation for missing data will be applied when appropriate. Descriptive 
statistics will be used summarize the unadjusted and adjusted means at each assessment point. If there is a 
significant group-by-time interaction, a posteriori contrasts will be performed to compare the two groups at 
each time point. For each outcome, the primary analysis will an intention-to-treat (ITT) analysis in which all 
AYAs randomized will included in the analysis. Supplemental analyses will be conducted on those AYAs who 
complete the 12-month assessment. Both ITT and completers' results will be reported. 
 
Aim 2 Moderator Analyses. To explore whether age, biological sex, race/ethnicity, chronic condition, and/or 
disease severity moderate the trajectory of PICASO effects on the primary and secondary outcomes, the 
trajectory analysis approach described in Aim 1 will be used to evaluate the moderating effects of each 
candidate moderator on each outcome. Each candidate moderator will be evaluated separately by 
incorporating the variable (e.g., age) and its interaction with group and time as fixed effects in the model for 
each outcome. By definition107, a significant candidate moderator-by-group-by-time interaction would indicate 
that the variable moderates the effects of the PICASO compared to the control group over time. If a moderator 
interaction is significant at the 0.05 level, the RRM core model applied in Aim 1 will be fitted for subgroups of 
the moderator to better determine the differential trajectory of change from baseline to 12-month within each 
moderator subgroup. This analytic method will be applied in accordance with recommended approaches107,108 
for assessing moderator effects in trajectory and/or growth models. 
 
Aim 3: Explore mechanisms of PICASO impact by describing AYA experiences with the intervention and the 
InquisitHealth Mentor 1:1™ Web Based Portal.  Aim 3’s goal is to understand intervention mediators by 
characterizing how intervention components, as well as the unique case context of their use, may (a) target (or 
miss) within-case needs, (b) address variability across chronic condition and age contexts, and (c) impact 
patterns in outcome measures. Approach & goal: We will integrate findings from qualitative interviews with 
AYA outcomes.  This mixed methods analysis will provide insight into intervention mediators (mechanisms of 
action) and highlight how outcomes may be related to unique case contexts; both of which will lead to future 
intervention optimization through enhanced personalization, replicability, and scalability. 
 
Aim 3 Mixed Methods Analyses. We will explore AYA experiences with the PICASO using a mixed methods 
approach to characterize participants’ experiences with the intervention to understand mechanisms of action, 
how outcomes may be related to unique case contexts, and if barriers to broader implementation and 
dissemination are perceived. This knowledge will also guide future intervention optimization through enhanced 

personalization, replicability, and scalability.109-111 Interview transcripts will be analyzed using a content 
qualitative analysis technique that combines structural (e.g., intervention component, transition barriers) and 
magnitude coding (e.g., theme intensity) with inductive coding (e.g., variations in outcomes not captured by 
instruments).112  Drs. Docherty and Pollock will separately code 10 interviews, discuss the generated codes, 
and create an initial code book by consensus.  The code book will then be used by CRC coders for the next 10 
transcribed interviews (with Dr. Docherty coding each 5th interview), with further refinements made as needed.  
The final code book will be organized into categories used to generate themes of mechanistic and process 
elements.  The qualitative content analysis findings within each case will then be integrated with the relevant 
quantitative questionnaire- and informatics-based data.  A matrix will be constructed to display case findings 
(qualitative data in relation to quantitative data) in relation to every other case.  This will allow a cross-case 
comparative analysis, with the possibility of conducting an even wider range of theoretically driven analyses.113 
For example, case comparisons could be made by diagnostic category or mentor condition match.  Next, 
process tracing will be used to explore how particular case outcomes (e.g., self-management, coping, self-
esteem) may have been related to intervention components (e.g., goal selection, strategies).114,115  Dr. 
Docherty will use ATLAS.ti software to aid in coding and organizing transcribed interviews and field notes.   
 
3.C.8. Sample Size and Power Considerations 
A target sample size of 225 AYAs (PICASO: N=150; control: N=75) will be provide at least 80% statistical 
power to address the efficacy of PICASO compared to the attention control condition (Aim 1) and will provide 
sufficient heterogeneity to obtain reliable estimates of effect sizes for the exploratory moderator analyses. 
Using PASS software (NCSS LLC, Kaysville, UT), the sample size determination for the two primary outcomes 
was based on the following assumptions: (a) mixed-effects trajectory analyses using RRMs; (b) two-tailed tests 
with significance set at 0.05 per test; and (c) medium effects (Cohen d equivalent of 0.50); and (d) unstructured 
within-subjects correlation patterns over time. The significance level of 0.05 will not be adjusted for evaluating 
two primary outcomes. Although the mixed-effects models allow for data missing at random, the sample size of 
225 takes into account an attrition rate of up to 20% over time, and thus, should provide 80% power for both 
the ITT and completers’ analyses of the two primary outcomes.  
 
3.C.9. Methodological Considerations Relevant to a Robust, Unbiased, Reproducible Approach.  
     Intervention: Peer coaches will receive an initial five-day training on the process of coaching, which 
includes didactic sessions on the stages of coaching, motivational interviewing skill development, and 
opportunities to practice coaching skills. Practice sessions are observed by the coach supervisor, who 
developed the peer coaching curriculum, and feedback is provided in order to assess intervention fidelity. In 
addition, coaches receive ongoing, semi-monthly group supervision to provide ongoing training on the peer 
coaching process, facilitate additional practice sessions to advance skill development, troubleshoot coaching 
challenges, and maintain intervention fidelity. The coach supervisor also provide individual supervision as 
needed for coaches experiencing difficulties with the coaching process. During these sessions, the peer coach 
role plays a scenario that they may encounter with their participants with the supervisor in the role of the AYA. 
After the 10-minute practice, the supervisor and coach review the interaction and provide feedback on 
strengths and areas for improvement in order to implement coaching with fidelity. 
     Generalizability: We believe that the external validity of the proposed PICASO trial is very high. First, our 
approach to sampling using a modified noncategorical approach with a broad list of COCCs (sickle cell 
disease, chronic kidney disease, systemic lupus erythematous, type 1 diabetes, inflammatory bowel disease, 
severe asthma, stem cell transplantation, organ transplantation, and childhood cancer survivor, increases the 
likelihood that the results will be applicable across conditions most often experiencing self-management 
challenges during the critical window of transition. Our focus on outcomes that are not generally found to have 
disease-specific ramifications, also strengthens the external validity of the potential findings.  
      Replicability is an intervention strength.  Technology: As described in Innovation, replicability and 
scalability across future sites is ensured by the ability of InquisitHealth Mentor 1:1™ Web Based Portal to 
capture data directly from coaching sessions.  Our multidisciplinary research team assists in protecting against 
bias that may be inserted by virtue of disciplinary lenses.  
 
 
 
 
 
 
 
 
 

 
3.C.10.  Timeline 
See Human Subjects and Clinical Trials Information Section 4.2.a.13 for detailed description of timeline.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.C.11.  Future Steps 
Our next step is to take advantage of PICASO platform interoperability to conduct a pragmatic, multi-site, 
clinical trial. We aim to develop an efficient, generalizable, and scalable peer coach transition self-management 
product that will optimize AYA, parent, pediatric and adult chronic condition provider collaboration across care 
sites, venues, and transitions. The ultimate goal is to be broadly deploy this intervention in a range of settings 
that currently include AYA with COCC, but do not currently address self-management. Deployment of an 
evidence based peer support in these settings could provide thousands of youth with COCC the opportunity to 
develop self-management skills to successfully and safely transition to adult medical care and adulthood. 
 
 
 
 
 
 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Specific timeline 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Aims 1 & 2:  RCT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subcontracts finalized with 
programmers 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Web app finalized  
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Digital case report forms (ePRO) 
final 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DSMB formation & charter 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Regulatory documentation: IRB 
approval, human subjects 
training 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Registration on ClinicalTrials.gov 
 
 
X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Staff training 
 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Peer Coach Recruitment & 
Hiring 
X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator / team meetings 
X X X X X X X X X X X X X X X X X X X X 
Aim 1 randomization & all 
subject assessments  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     0-25% (n=62 cumulative) 
 
 
X X X X  
 
 
 
 
 
 
 
 
 
 
 
 
 
     26-50% (n=125 cumulative) 
 
 
 
 
 
 
X X X X  
 
 
 
 
 
 
 
 
 
     51-75% (n=187 cumulative) 
 
 
 
 
 
 
 
 
 
 
X X X X  
 
 
 
 
 
     76-100% (n=225 cumulative) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X  
 
 
 
Data collection complete 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
Data cleaning 
 
 
X X X X X X X X X X X X X X X X  
 
Database lock  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
Statistical analyses  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
Submit primary manuscript 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Progress reports to NIH 
 
 
 
X  
 
 
X  
 
 
X  
 
 
X  
 
 
X 
Data to DSMB; DSMB mtgs. 
 
 
X  
 
X  
 
X  
 
X  
 
X  
 
X  
X 
Update ClinicalTrials.gov 
 
 
 
X  
X  
X  
X  
X  
X  
X  
X  
X 
Submit grant application for 
multi-center pragmatic trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Aim 3: Participant experiences 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 3 accrual & subject 
assessments 
 
 
 
 
 
X X X X X X X X X X X X X  
 
Aim 3 data analysis 
 
 
 
 
 
 
 
 
X  
 
 
 
X  
 
 
X X  

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Huber M, Knottnerus JA, Green L, et al. How should we define health? BMJ (Clinical research 
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Stinson J, Kohut SA, Spiegel L, et al. A systematic review of transition readiness and transfer 
satisfaction measures for adolescents with chronic illness. International journal of adolescent 
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