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

Not Applicable

Completed

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

Registration Number: NCT03938324

Lead Sponsor: Duke University

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 222

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Self-management as Measured by the Partners in Health Scale	baseline, 3, 6, 9, and 12 months	Self-management variable measured using the Partners in Health Scale (PIH): measures chronic illness self-management by assessing chronic condition self-management knowledge, partnership in treatment, recognition and management of symptoms, and coping. This 12 item self-report scale is scored on a 9-point Likert scale. The primary outcome is the overall score, which is the mean of the 12 items (possible range of 0 to 8, higher overall scores indicating better self-management).
Patient Activation as Measured by the Patient Activation Measure (PAM-13)	baseline, 3, 6, 9, and 12 months	Patient Activation variable measured using the Patient Activation Measure (PAM-13): measures patient activation through self-reports of knowledge, skills, and confidence related to self-management of one's own health care. This 13-item self-report assesses confidence in self-management and understanding of health condition. Each of the 13 items scored on a 5-point Likert scale. The primary outcome is an activation score derived from the 13 items (possible range of 0-100, higher scores indicating higher patient activation in self-management).

Secondary Outcome Measures

Name	Time	Method
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)	baseline, 3, 6, 9, and 12 months	Transition readiness variable measured using Transition Readiness Assessment Questionnaire (TRAQ 20): 20-item self-report assessment of the ability to make appointments, manage medications, track health issues, talk with providers, and manage daily activities. Each item is scored 1-5 on a Likert scale. The primary outcome is the overall score, calculated as the mean of the 20 items (possible range: 1 to 5, higher scores indicating more transition readiness).
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)	baseline, 3, 6, 9, and 12 months	Health-related Quality of Life variable measured using the Short Form Health Survey (SF12): 12-item self-report that assesses health related quality of life. The sum of the MCS items was transformed into T-scores for comparison to the US population (which has a mean of 50 and standard deviation of 10). The MCS T-scores have a range of 0 to 100, with higher scores indicating better mental health status.
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)	baseline, 3, 6, 9, and 12 months	Emotional health variable measured using the Brief Symptom Inventory: 18-item self-report of emotional symptoms experienced over the previous 7 days. Each item was scored with 0 to 4 Likert scale. The primary outcome was the global severity index score (GSI), an overall score derived by summing the scores of the 18 items (possible range: 0 to 72 with higher scores indicating greater psychological distress).