Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions (PiCASO)

Duke University

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Chronic Kidney Diseases; Organ Transplant; Stem Cell Transplant; Cystic Fibrosis; Childhood Cancer; Sickle Cell Disease; Inflammatory Bowel Diseases; Systemic Lupus Erythematosus

Treatments: Behavioral: Sham Comparator: Attention Control Group; Behavioral: PiCASO Intervention Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03938324

Pro00102191

1R01NR018379-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

Full description

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. The investigators 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. The investigators will determine the efficacy of PICASO on self-management, patient activation, transition readiness, health-related quality, and emotional health of life across 12 months. The investigators 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, the investigators will explore mechanisms of the PICASO impact by describing AYA experiences with the intervention.

Enrollment: 222 patients

Sex: All

Ages: 16 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AYA 16 to 22 years
• Childhood onset chronic condition from 1 of 3 condition categories
• Read and speaks English
• Access to internet via computer or Smart Phone
• Access to telephone (Smart Phone not required as text feature can be accessed via internet)

Exclusion criteria

• Diagnosed cognitive dysfunction
• Need for English translator

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

PiCASO Intervention Group

Experimental group

Description:

Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. 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.

Treatment:

Behavioral: PiCASO Intervention Group

Attention Control Group

Sham Comparator group

Description:

Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition 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:

Behavioral: Sham Comparator: Attention Control Group