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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03938324

Acronym

PiCASO

Enrollment

222

Registered

2019-05-06

Start date

2019-10-29

Completion date

2024-06-19

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALPiCASO Intervention Group

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.

BEHAVIORALSham Comparator: Attention Control Group

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

16 Years to 22 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Contacts

STUDY_DIRECTORAngel Barnes, BSN

Duke University School of Nursing

Participant flow

Participants by arm

Arm	Count
PiCASO Intervention Group 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.	147
Attention Control Group 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. Sham Comparator: Attention Control Group: 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.	75
Total	222

Baseline characteristics

Characteristic	PiCASO Intervention Group	Total	Attention Control Group
Age, Continuous	18.4 years STANDARD_DEVIATION 1.9	18.4 years STANDARD_DEVIATION 1.8	18.3 years STANDARD_DEVIATION 1.7
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants	22 Participants	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	134 Participants	199 Participants	65 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) Asian	5 Participants	6 Participants	1 Participants
Race (NIH/OMB) Black or African American	67 Participants	87 Participants	20 Participants
Race (NIH/OMB) More than one race	4 Participants	5 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants	18 Participants	7 Participants
Race (NIH/OMB) White	58 Participants	102 Participants	44 Participants
Region of Enrollment United States	147 Participants	222 Participants	75 Participants
Sex: Female, Male Female	93 Participants	138 Participants	45 Participants
Sex: Female, Male Male	54 Participants	84 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 147	0 / 75
other Total, other adverse events	0 / 147	0 / 75
serious Total, serious adverse events	0 / 147	0 / 75

Outcome results

Primary

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

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).