跳至主要内容
临床试验/NCT05894772
NCT05894772招募中不适用

Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study

The Hospital for Sick Children15 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
93
试验地点
15
主要终点
Acceptability

研究概览

简要总结

Pain is one of the most common symptoms of extreme stress in youth. Without treatment, short-term pain can last for months to years (called 'chronic pain'; CP), a problem already affecting 1 in 5 Canadian youth. The COVID-19 pandemic is one of the greatest threats to youth mental health seen in generations. CP in childhood can trigger a wave of mental health issues that last well into adulthood. In 2019, we learned that "access to pain care" is poor and a priority for youth with CP and their families. Unfortunately, COVID-19 has only made access more difficult. In 2020, we created an online "stepped care" program called the Power over Pain Portal for youth with CP. Stepped care is a promising way to improve access to CP care by tailoring care based on the symptoms each youth is experiencing. Like a ladder, youth start with one type of care and then "step up" or "step down" to more or less intense care depending on what they need. Over the past year, funded by CIHR, we worked with hundreds of youth and healthcare professionals across Canada to understand how the pandemic has affected pain and mental health. We also summarized all online pain self-management programs including peer support for youth to find the best resources to include in the Portal and will translate the portal content into French. Together with a diverse group of youth with CP, we have now co-designed the online Portal. The next step (focus of this grant) is to test the Portal with youth to ensure it can be implemented and is helpful. We will recruit 93 youth with CP waiting for specialist care at 11 CP clinics across Canada to use the Portal for 4 months. We will see how they use the Portal and if it helps to improve their pain and mental health. This study is important because it will allow us to understand how the Portal works in the real world before wide public release (English and French) to support all youth in Canada with CP with accessible, evidence-based pain care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Experience chronic pain
  • Speak and read English or French
  • Have access to internet / smartphone (or are willing to be loaned a study phone with a data plan)
  • Are on the waitlist of a tertiary care CP clinic in Canada
  • Intend to use the PoP Portal for at least 4 months
  • Have the capacity to consent

排除标准

  • Have moderate to severe cognitive impairments that may impact their ability to understand and use the PoP Portal or complete self-reported clinical outcome measures
  • Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality as assessed by the PoP Portal screening. Youth who have co-occurring clinically significant anxiety or depression that is currently being treated will be eligible if they meet other inclusion criteria.

结局指标

主要结局

Acceptability

时间窗: 16 weeks

Will be assessed using the Acceptability e-Scale administered at T2 and during the qualitative interview. Participants rate features of the portal on a scale from 1-5 with higher scores indicating higher acceptability.

Fidelity

时间窗: 16 weeks

Degree to which the PoP Portal and each intervention independently (WEBMap, iCanCope, iPeer2Peer) was used as intended. Will be characterized by intervention use analytics.

Adoption

时间窗: 16 weeks

Characterized via participant-level analytics of interactions with each feature. The benchmark will be \>60% of participants completing ≥ 1 portal intervention.

Portal Feasibility

时间窗: 16 weeks

Degree to which to PoP Portal could be used as intended. Will be assessed via monthly audit of support tickets and characterization of the severity of encountered issues.

Appropriateness

时间窗: 16 weeks

Perceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.

次要结局

  • Pain Intensity(16 weeks)
  • Pain Interference(16 weeks)
  • Anxiety(16 weeks)
  • Depression(16 weeks)
  • Insomnia(16 weeks)
  • Healthcare Utilization(16 weeks)
  • Health Related Quality of Life(16 weeks)
  • School Attendance(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Stinson

Senior Scientist

The Hospital for Sick Children

研究点 (15)

Loading locations...

相似试验