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临床试验/NCT04093921
NCT04093921已完成不适用

Ready for Change: a Telehealth, Motivational Enhancement Pre-habilitation Training to Increase Engagement in Children and Families Entering Intensive Interdisciplinary Pain Rehabilitation

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Length of stay

研究概览

简要总结

This is a randomized, motivational-interviewing-based intervention to improve readiness-to-change, or willingness to engage in a self-management approach to chronic pain, for patients referred to our intensive interdisciplinary pain rehabilitation day program.

详细描述

Readiness to change, or willingness to engage in a self-management approach to chronic pain and disability, is the most powerful predictor of children's success in intensive pediatric pain rehabilitation. Motivational Enhancement Therapy (MET) is an approach that has been effective in increasing readiness to change and treatment engagement for other behaviorally-oriented health interventions. However, MET has never been systemically employed in the context of treating pediatric chronic pain and disability.

This demonstration project seeks to test the effects of a novel telehealth intervention using motivation enhancement therapy to improve patient and parent engagement in, and outcomes of, an intensive interdisciplinary day hospital program for children with complex chronic pain conditions and associated disability, the Pediatric Pain Rehabilitation Center (PPRC). The intervention, PPRC-Prep, is a 4 week MET-based telehealth intervention that will be offered to families of children with refractory chronic pain conditions awaiting admission to the PPRC at Boston Children's Hospital at Waltham. Families approved for and awaiting PPRC admission will be randomized to receive PPRC-Prep along with usual care or to a comparison group receiving treatment as usual. Study aims include assessing the feasibility and acceptability of the intervention along with measuring its potential to increase readiness to engage in a self-management approach assessed at time of admission to the PPRC using established measures of readiness to change, pain acceptance, and committed action. Investigators will also evaluate the effects of PPRC-Prep on program length of stay and on reductions of disability and pain at PPRC discharge and short-term (8-week) follow up through comparison of families who undergo PPRC-prep with families who do not undergo PPRC-prep. Demonstrating the feasibility and preliminary effectiveness of PPRC-Prep will enable the study team to establish this as a routine component of our approach to care for children with complex, refractory chronic pain and disability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

盲法说明

Those providing care at the PPRC will not know which study arm their patients were in.

入排标准

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

入选标准

  • Patient age 8-18 at enrollment
  • Presence of chronic pain condition for > 3 months with moderate or severe disability
  • Accepts referral to PPRC and awaiting admission

排除标准

  • Non-English speaking
  • No access to device with telehealth capability

结局指标

主要结局

Length of stay

时间窗: PPRC discharge [within 6 months of baseline]

length of stay in PPRC program (in weeks)

Pain stages of change questionnaire for adolescents (PSOCQ-A)

时间窗: at PPRC follow up (1 year post discharge)

readiness to change/embrace pain self-management. 13 item scale with total scores ranging from 13-65. Domain with highest score is considered current stage of change.

Chronic Pain Acceptance Questionnaire total score

时间窗: At PPRC admission [typically within 3 months of baseline]

Measure of readiness to change/engage in pain self-management. 20 item questionnaire, will use total score. Range 0-120. HIgher scores indicate more pain acceptance.

Functional disability inventory (FDI) total score

时间窗: at PPRC follow up (4-8 weeks post discharge)

level of pain related functional disability, ranges from 0-60 with higher scores indicating more disability

Readiness Rulers

时间窗: During and at end of the intervention, for the treatment group only

Motivational interviewing based ratings of willingness, importance, awareness and confidence related to adopting a self-management approach to pain

Modified Adolescent Treatment Engagement Questionnaire

时间窗: At end of intervention, 4 weeks from baseline

Level of engagement in treatment. Scores 0-40 higher scores indicate more engagement.

Treatment satisfaction inventory

时间窗: At end of intervention, 4 weeks from baseline

Participant satisfaction with treatment. 13 items range 13-65, higher scores = more satisfaction

次要结局

  • Pain intensity(1 year post-treatment)
  • Functional disability inventory (FDI) total score(at PPRC follow up (1 year post discharge))
  • Committed action questionnaire total score(At PPRC admission [typically within 3 months of baseline])
  • Committed action questionnaire(At PPRC discharge [within 6 months of baseline])
  • Parental pain catastrophizing(At treatment admission and discharge, following intervention/control period)
  • Adult responses to child pain - protect subscale(At treatment admission and discharge, following intervention/control period)
  • Parental fear of pain questionnaire(At treatment admission and discharge, following intervention/control period)

研究者

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

Deirdre Logan

Director of psychology services in pain medicine

Boston Children's Hospital

研究点 (2)

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