跳至主要内容
临床试验/NCT03332563
NCT03332563已完成不适用

Web-based Self-management of Adolescent Chronic Pain: National Implementation Project

Seattle Children's Hospital10 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
10
主要终点
Change in activity limitations

研究概览

简要总结

Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. The investigative team's prior studies demonstrate that technology-delivered pain self-management (WebMAP program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. In this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the WebMAP pain self-management program. Using a hybrid effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement WebMAP in the clinics following randomized usual care periods. Data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child age 10-17 years,
  • has chronic pain defined as pain present for at least 3 months, and
  • has access to a smartphone or web-enabled device (e.g., laptop, computer, iPad).

排除标准

  • non-English speaking,
  • presently in a psychiatric crisis,
  • cognitive impairments or intellectual disabilities (has to be able to complete surveys independently),
  • does not have access to a smartphone, computer, or internet, and
  • is unable to read at the 5th grade level.

研究组 & 干预措施

WebMAP Mobile

Experimental

Adolescent participants assigned to this arm will receive access to the WebMAP mobile program delivering cognitive-behavioral intervention for chronic pain. Parents of adolescents will receive access to cognitive-behavioral strategies for parents on the WebMAP parent web site.

干预措施: Cognitive-behavioral intervention for chronic pain (Behavioral)

Usual care

No Intervention

Participants assigned to this arm will receive usual care from the pain or specialty clinic during the non-exposure periods in the stepped wedge design.

结局指标

主要结局

Change in activity limitations

时间窗: Baseline to 3 month followup

The 9-item Child Activity Limitations Interview (CALI-9) will be completed on the online diary to rate perceived difficulty in completing 9 daily activities due to pain

次要结局

  • Change in pain intensity(Baseline to 3 month followup)
  • Patient's global impression of change(3 month followup)
  • Change in anxiety and depressive symptoms(Baseline to 3 month followup)
  • Change in pain-efficacy(Baseline to 3 month followup)
  • Change in insomnia severity(Baseline to 3 month followup)
  • Change in parent behavior(Baseline to 3 month followup)
  • Change in parent emotional distress(Baseline to 3 month followup)

研究者

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

Tonya Palermo

Professor, Anesthesiology and Pain Medicine

Seattle Children's Hospital

研究点 (10)

Loading locations...

相似试验

WebMAP Mobile Self-management of Adolescent Chronic... | 临床试验