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

NCT03938324 | Completed Results DMC

• 2 other identifiers: Pro001021911R01NR018379-01
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  baseline, 3, 6, 9, and 12 months

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

  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).

  baseline, 3, 6, 9, and 12 months

Secondary Outcomes (3)

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

  baseline, 3, 6, 9, and 12 months

• 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

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

  baseline, 3, 6, 9, and 12 months

Study Arms (2)

PiCASO Intervention Group

EXPERIMENTAL

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.

Behavioral: PiCASO Intervention Group

Attention Control Group

SHAM COMPARATOR

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.

Behavioral: Sham Comparator: Attention Control Group

Interventions

PiCASO Intervention Group BEHAVIORAL

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.

PiCASO Intervention Group

Sham Comparator: Attention Control Group BEHAVIORAL

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.

Attention Control Group

Eligibility Criteria

• Age: 16 Years - 22 Years
• Gender Eligibility Details: Self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Diagnosed cognitive dysfunction
• Need for English translator

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Renal Insufficiency, Chronic; Lupus Erythematosus, Systemic; Neoplasms; Inflammatory Bowel Diseases; Diabetes Mellitus, Type 1; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pancreatic Diseases; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases

Results Point of Contact

• Title: Sharron Docherty, PhD
• Organization: Duke University

sharron.docherty@duke.edu

919-668-3836

Study Officials

• Angel Barnes, BSN

  Duke University School of Nursing

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: October 29, 2019
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)