NCT03938324 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2026-07-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change in Self-management as Measured by the Partners in Health Scale

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outcome · POSTED

Patient Activation as Measured by the Patient Activation Measure (PAM-13)

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outcome · POSTED

Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)

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outcome · POSTED

Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)

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outcome · POSTED

Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
gender Based: true
gender Description: Self-representation of gender identity
healthy Volunteers: false
maximum Age: 22 Years
minimum Age: 16 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Behavioral: PiCASO Intervention Group
label
PiCASO Intervention Group
type
EXPERIMENTAL
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.
intervention Names
Behavioral: Sham Comparator: Attention Control Group
label
Attention Control Group
type
SHAM_COMPARATOR

interventions

arm Group Labels
PiCASO Intervention Group
description
This 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. 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.
name
PiCASO Intervention Group
type
BEHAVIORAL
arm Group Labels
Attention Control 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.
name
Sham Comparator: Attention Control Group
type
BEHAVIORAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

Five year randomized controlled trial to test efficacy of behavioral intervention versus attention control group on primary and secondary outcomes across 12 months.

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 222
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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).
measure
Change in Self-management as Measured by the Partners in Health Scale
time Frame
baseline, 3, 6, 9, and 12 months
description
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).
measure
Patient Activation as Measured by the Patient Activation Measure (PAM-13)
time Frame
baseline, 3, 6, 9, and 12 months

secondary Outcomes

description
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).
measure
Change in Transition Readiness as Measured by the Transition Readiness Questionnaire (TRAQ 20)
time Frame
baseline, 3, 6, 9, and 12 months
description
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.
measure
Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF12) - Mental Component Summary (MCS)
time Frame
baseline, 3, 6, 9, and 12 months
description
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).
measure
Change in Emotional Health as Measured by the Brief Symptom Inventory (BSI 18)
time Frame
baseline, 3, 6, 9, and 12 months

Full study description

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.

Source references

references

citation
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
pmid
40243391
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice