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

• ClinicalTrials.gov Identifier: NCT03938324
• Recruitment Status: Enrolling by invitation
• First Posted: May 6, 2019
• Last Update Posted: October 31, 2019
• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH); National Institute of Nursing Research (NINR)
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: May 2, 2019
• First Posted Date: May 6, 2019
• Last Update Posted Date: October 31, 2019
• Actual Study Start Date: October 29, 2019
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 6, 2019)

• Change in Self-management as measured by the Partners in Health Scale [ Time Frame: baseline 3-, 6-, 9-, 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 (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).
• Change in Patient activation as measured by the Patient Activation Measure (PAM-13) [ Time Frame: baseline 3-, 6-, 9-, 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 and is scored on a 5-point Likert scale (range: 0-100 with higher scores indicating higher patient activation in self-management).

Original Primary Outcome Measures (submitted: May 2, 2019)

• Change in Self-management as measured by the Partners in Health Scale [ Time Frame: baseline 3-, 6-, 9-, 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 (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).
• Change in Patient activation as measured by the Patient Activation Measure [ Time Frame: baseline 3-, 6-, 9-, 12 months ]
  Patient Activation variable measured using the Patient Activation Measure: measures patient activation through self-reports of knowledge, skills, and confidence related to self-management of one's own health care. This 22-item self-report assesses confidence in self-management and understanding of health condition

• Change History: Complete list of historical versions of study NCT03938324 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 6, 2019)

• Change in Transition Readiness as measured by the Transition Readiness Questionnaire (TRAQ 20) [ Time Frame: baseline 3-, 6-, 9-, 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. The TRAQ scores produced include an overall score and a subscale score for each of the five subscales. The overall score and the subscale scores are calculated by taking the average score across the items in the questionnaire (or subscale). Each item is scored 1-5. Higher scores indicate more transition readiness
• Change in Health-related Quality of Life as measured by the Short Form Health Survey (SF12) [ Time Frame: baseline 3-, 6-, 9-, 12 months ]
  Health-related Quality of Life variable measured using the Short Form Health Survey (SF12): 12-item self-report that assesses physical and mental health related quality of life. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100 and were designed to have a mean score of 50. Higher scores indicate better physical functioning.
• Change in Emotional Health as measured by the Brief Symptom Inventory (BSI 18) [ Time Frame: baseline 3-, 6-, 9-, 12 months ]
  Emotional health variable measured using the Brief Symptom Inventory: 18-item self-report of emotional symptoms experienced over the previous 7 days. Subscales include depression, anxiety, and somatization. 5-point Likert scale, with three sub-scale scores and an overall global psychological distress score. Higher scores indicate more psychological distress.

Original Secondary Outcome Measures (submitted: May 2, 2019)

• Change in Transition Readiness as measured by the Transition Readiness Questionnaire [ Time Frame: baseline 3-, 6-, 9-, 12 months ]
  Transition readiness variable measured using Transition Readiness Questionnaire: 20-item self-report assessment of the ability to make appointments, manage medications, track health issues, talk with providers, and manage daily activities.
• Change in Health-related Quality of Life as measured by the Short Form Health Survey (SF12) [ Time Frame: baseline 3-, 6-, 9-, 12 months ]
  Health-related Quality of Life variable measured using SF12: 12-item self-report that assesses physical and mental health related quality of life.
• Change in Emotional Health as measured by the Brief Symptom Inventory [ Time Frame: baseline 3-, 6-, 9-, 12 months ]
  Emotional health variable measured using the Brief Symptom Inventory: 18-item self-report of emotional symptoms experienced over the previous 7 days. Subscales include depression, anxiety, and somatization.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions
• Official Title: Peer i-Coaching for Activated Self-management Optimization in Adolescents and Young Adults With Chronic Conditions
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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: None (Open Label)
Primary Purpose: Supportive Care

Condition

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

Intervention

• Behavioral: PiCASO 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.
• Behavioral: 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.

Study Arms

• Experimental: 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.
  Intervention: Behavioral: PiCASO Intervention Group
• 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.
  Intervention: Behavioral: Sham Comparator: Attention Control Group

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: May 2, 2019): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2024
• Estimated Primary Completion Date: June 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self-representation of gender identity

• Ages: 16 Years to 22 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03938324
• Other Study ID Numbers: Pro00102191; 1R01NR018379-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Duke University
• Study Sponsor: Duke University

Collaborators

• National Institutes of Health (NIH)
• National Institute of Nursing Research (NINR)

Investigators

• Study Director: Angel Barnes, BSN; Duke University School of Nursing

• PRS Account: Duke University
• Verification Date: October 2019