Effectiveness of a Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Level of empowerment
研究概览
简要总结
The transfer of young people with type 1 diabetes (T1D) to adult care occurs during a critical period of life, while many young people with T1D have unsatisfactory glycemic control. The preparation to take over responsibility for their health and self-care as well as increasing their participation in care are important aspects for strengthening people's own ability, an important component of person-centered care. STEPSTONES-DIAB aims to evaluate the effectiveness of a person-centred transition program for adolescents with T1D to empower them to become active partners in their care. The study is conducted at two hospitals in Stockholm, Sweden where 140 patients will be randomized to either a structured, person-centered transition program over a 2.5 -year period or to usual care. Outcome measures is empowerment, participation and responsibility in care, health status, glycemic control as well as the participants' experiences of care during transfer.
详细描述
Type 1 diabetes (T1D) is one of the most common chronic diseases in childhood. Each year, nearly 86 000 children around the world develop T1D. The annual mean incidence rates varies from 0.1-60/100000 with Sweden as one of the "top" incidence countries. Within diabetes care, most health care professionals agree that a lack of effective transfer from pediatric to adult care may contribute to insufficient continuity of health care and increased risk for adverse outcomes in young adults with T1D diabetes. In order to help the adolescent in the transitions to adulthood and adult care, transitions programs have been proposed as a complex intervention with the objective of maximizing lifelong functioning and potential through appropriate healthcare services. Therefore, research on transition and transfer, and on interventions that have the potential to improve both these clinical processes, is important.
Patient empowerment is recognized as an essential element of transition interventions. Through the promotion of patient empowerment the adolescents can become active partners in their care and have the knowledge and capacity to make decisions that affect their life and health status. The purpose of this study is to assess the effectiveness of a transition program for adolescents with type 1 diabetes within a randomized controlled trial. During the course of the study, participants will be part of a transition program or receive usual care before being transferred to adult care. The primary outcome is level of empowerment and secondary outcomes include health behavior as well as diabetes specific and transfer specific variables.
The investigators will assess the effectiveness of the transition program by comparing the level of empowerment (primary outcome) between the participants who received usual care and those who participated in the transition program. A higher level of empowerment from the group part of the intervention is expected. The economic evaluation entails an impact budget assessment and a cost-effectiveness analysis.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Swedish-speaking
- •Diagnosed with type 1 diabetes (one year duration)
- •Age: 16 years
排除标准
- •Conditions affecting cognitive abilities
- •If other diagnosis are present, type 1 diabetes must be the primary diagnosis
结局指标
主要结局
Level of empowerment
时间窗: Endpoint after 2.5 years from baseline
Gothenburg Young Persons Empowerment Scale (GYPES) will be used to assess the level of empowerment. This scale was developed by the researchers involved in this study and has been tested in a previous cross sectional study in order to determine its psychometric properties in adolescents with congenital heart disease and type 1 diabetes.The five subscales measure: (a) self-perceived level of understanding of their disease (knowledge and understanding); (b) the capacity patients have to handle their disease (personal control); (c) the effect their illness has on their lives and sense of self (identity); (d) the capacity to make decisions along with the healthcare professional (shared decision-making); and (e) the ability to share their experiences and help others who are going through a similar situation (enabling others). The total score ranges from 15 to 75 points, with a higher score reflecting a higher level of empowerment.
次要结局
- Health behavior(Change from baseline (16 year) to 18.5 year)
- Diabetes Burden(Endpoint after 2.5 years from baseline)
- HbA1c(Mean value during study period (16-18.5 year))
- Health Related Quality of Life(Endpoint after 2.5 years from baseline)
- Transition readiness(Change from baseline (16 year) to 18.5 year)
- General Quality of Life(Endpoint after 2.5 years from baseline)
- Diabetic ketoacidosis(From baseline (16 year) to 18.5 year)
- Hypoglycemic events(From baseline (16 year) to 18.5 year)
- Clinic attendance 1(During and six month after study period)
- Clinic attendance 2(Number of months between the last visit in pediatric care, pre-transfer and the first visit in adult care, post-transfer, assessed up to 2 years)