Development and Evaluation of an Internet-based Educational Program to Promote Self- Management for Teens With Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Disease-specific knowledge gained
研究概览
简要总结
In summary, there is a clear need to improve knowledge and self-management skills in adolescents with hemophilia. To date, there are no published accounts of self-management programs for this population. Evidence from other chronic diseases that affects teens suggests that by developing an interactive Internet-based program, the investigators can meet the educational needs of adolescents with hemophilia and improve their ability to manage their hemophilia. In the long-term, improved self-management should result in a smoother and more successful transition to adult care and improve patient outcomes.
详细描述
The overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Hemophilia Online" Internet intervention that will help adolescents with hemophilia to better understand and manage their disease independently. This program is modeled after Dr. Stinson's similar successful internet self-management program developed for youth with arthritis.
This program is being developed and evaluated using a sequential, phased approach. The first phase of this project has determined the self-management and transitional care needs of adolescents with hemophilia. Currently, in Phase 2A, we are developing the website with the content based on the findings from the Phase 1 needs assessment. We propose the current study to conduct usability testing (Phase 2B) to make sure it is easy to use and understand, and is efficient and satisfying to complete. Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3). This will enable us to determine an appropriate sample size for the future mixed controlled trial. Phases 2B and 3 are the focus of this proposal. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group. This randomized controlled trial controlled trial will include all interested pediatric hemophilia treatment centres across Canada.
We hypothesize that adolescents with hemophilia who complete the "Teens Taking Charge: Managing Hemophilia Online" Internet intervention will demonstrate: increased hemophilia specific knowledge, increased self-efficacy, improved health-related quality of life (HRQL) and decreased stress prior to transition to adult health care.
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
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 13-18
- •diagnosis of mild, moderate or severe hemophilia A or B
- •be able to speak and read English or French.
- •must have access to the Internet at home
排除标准
- •cognitive impairments
- •haematologist feels that they have a significant medical or psychiatric condition that will impact their participation
- •don't have access to the internet.
研究组 & 干预措施
Intervention (experimental) Group
干预措施: Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention (Other)
Control group
结局指标
主要结局
Disease-specific knowledge gained
时间窗: Immediately post-intervention - 8 weeks
assessed by pre and post-assessment of the "Hemophilia Knowledge Questionnaire". This novel tool will be developed by investigators based on core content deemed important by hemophilia care providers and be reviewed for face validity by the Hemophilia Care Teams in both study centers and by a National panel of reviewers prior to administration.
Disease-specific knowledge gained
时间窗: Baseline
assessed by pre and post-assessment of the "Hemophilia Knowledge Questionnaire". This novel tool will be developed by investigators based on core content deemed important by hemophilia care providers and be reviewed for face validity by the Hemophilia Care Teams in both study centers and by a National panel of reviewers prior to administration.
次要结局
- Health-related Quality of Life (HRQL)(Baseline and immediately post-intervention - 8 weeks)
- Self-efficacy (Generalised Self-Efficacy-Sherer Scale)(Baseline and immediately post-intervention - 8 weeks)
- Preparedness for Transition(Baseline and immediately post-intervention - 8 weeks)
- Impact of the program(Baseline and immediately post-intervention - 8 weeks)
研究者
Jennifer Stinson
Clinical Scientist
The Hospital for Sick Children