Peer i-Coaching for Activated Self-management Optimization in Adolescents and Young Adults With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Change in Self-management as Measured by the Partners in Health Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Diagnosed cognitive dysfunction
- •Need for English translator
研究组 & 干预措施
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.
干预措施: PiCASO Intervention Group (Behavioral)
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.
干预措施: Sham Comparator: Attention Control Group (Behavioral)
结局指标
主要结局
Change in Self-management as Measured by the Partners in Health Scale
时间窗: 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)
时间窗: 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).
次要结局
- 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)