Evaluation of the Digital Delivery of Person-centered Transitional Care to Empower Adolescents With Chronic Childhood-onset Diseases: The Digi-STEPSTONES Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Patient empowerment
研究概览
简要总结
Advances in medical care have extended the life expectancy of individuals with congenital and pediatric-onset diseases, leading to an increased need for effective transition programs as these individuals move from pediatric to adult healthcare. The STEPSTONES project in Sweden is designed to evaluate the effectiveness of a person-centered transition program to support teenagers with chronic conditions during this transition. The project's innovative digital adaptation, Digi-STEPSTONES, seeks to address challenges related to accessibility and continuity of care by delivering the program remotely. This study will assess the non-inferiority of the digital program compared to traditional, in-person care, focusing on outcomes such as patient empowerment, transition readiness, and quality of life. Additionally, the project will explore the implementation and scalability of the digital transition model across various chronic conditions. Preliminary studies have highlighted the importance of structured, person-centered care in improving empowerment and other outcomes in adolescents with chronic illnesses. The Digi-STEPSTONES project aims to provide crucial evidence for the digital delivery of transition programs, potentially enhancing the accessibility and effectiveness of care for young people with chronic conditions in Sweden.
详细描述
Medical and surgical advances have significantly increased the life expectancy of individuals with congenital and pediatric-onset diseases, often resulting in chronic conditions. Effective lifetime care is crucial, especially during the transition from pediatric to adult care. Transition is a process where adolescents with chronic conditions are prepared to manage their health and life as they move to adult healthcare environments. Transition programs are designed to assist in this preparation, and over the past decade, several randomized-controlled trials (RCTs) have demonstrated the effectiveness of such programs in improving outcomes like self-management, knowledge of the condition, clinic attendance, and satisfaction with care.
In Sweden, the STEPSTONES (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS) project is evaluating a person-centered transition program tailored for young individuals with chronic conditions. The project has focused on conditions like congenital heart disease and type 1 diabetes through RCTs and is now exploring a digital adaptation called Digi-STEPSTONES, which aims to deliver the transition program remotely to improve accessibility and continuity of care.
PURPOSE AND AIMS
The main goal of this project is to evaluate the effectiveness of a digitally delivered, person-centered transition program for adolescents with asthma/allergy and those who have undergone a solid organ transplant in a real-world setting. The specific objectives are:
- To investigate the non-inferiority of the digital delivery compared to in-person delivery.
- To evaluate the implementation process of the digital transition program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants:
- •Arm A - Literate and Swedish-speaking adolescents with asthma/allergy or went through a solid organ transplantation aged minimum 15 years. Their parents will be asked to fill out one questionnaire (proxy).
- •- Literate and Swedish-speaking adolescents with asthma/allergy or went through a solid organ transplantation aged minimum 15 years. Their parents will be asked to fill out one questionnaire (proxy).
- •Sample size calculation:
- •Arm A: approximately100 patients will be recruited consecutively. Arm B: the approximate sample for individuals who received the intervention in-person is of
排除标准
- 未提供
研究组 & 干预措施
Arm A
Arm A involves a pre-test/post-test design where individuals will participate in the digital delivery of the transition program.
干预措施: Stepstones transition program (Behavioral)
Arm B
Arm B is a historical comparison cohort that includes participants from two previous RCTs who received the intervention (the transition program) in-person.
干预措施: Stepstones transition program (Behavioral)
结局指标
主要结局
Patient empowerment
时间窗: At baseline T0 when the participant is 16 years with follow up at T1 when the participants are 18.5 years
Gothenburg Young Persons Empowerment Scale (GYPES)
次要结局
- Satisfaction with transition(18.5y)
- Transition readiness(At baseline T0 when the participant is 16 years with follow up at T1 when the participants are 18.5 years)
- Satisfaction with transition(18.5 year)