Clinical trial NCT03938324: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2019-05-06
Enrollment: 222
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Self-management as measured by the Partners in Health Scale
timeFrame: baseline 3-, 6-, 9-, 12 months
measure: Change in Patient activation as measured by the Patient Activation Measure (PAM-13)
timeFrame: baseline 3-, 6-, 9-, 12 months
Secondary outcomes:
measure: Change in Transition Readiness as measured by the Transition Readiness Questionnaire (TRAQ 20)
timeFrame: baseline 3-, 6-, 9-, 12 months
measure: Change in Health-related Quality of Life as measured by the Short Form Health Survey (SF12)
timeFrame: baseline 3-, 6-, 9-, 12 months
measure: Change in Emotional Health as measured by the Brief Symptom Inventory (BSI 18)
timeFrame: baseline 3-, 6-, 9-, 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Angel Barnes, BSN
role: STUDY_DIRECTOR
References: