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临床试验/NCT04013529
NCT04013529
已完成
不适用

Connected Health to Decrease Opioid Use in Patients With Chronic Pain

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 40 人2018年8月31日
适应症Chronic Pain

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Pain
发起方
University of Pennsylvania
入组人数
40
试验地点
1
主要终点
Increased Mobility
状态
已完成
最后更新
4年前

概览

简要总结

The objective of this pilot study to evaluate if behavioral incentives applied at the VA Medical Center can appreciably increase participation in activities that promote mobility, and subsequently reduce pain severity and opioid use.

详细描述

Chronic pain is a highly prevalent and costly condition in the US. An estimated 88.5 million adults suffer from daily pain, resulting in estimated cost of $500- 635 biJlion due to lost productivity, and $261-300 billion in health care expenditures. To manage their chronic pain, 5 to 8 million Americans take an opioid medication daily. Yet , the risks associated with ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic effects. Opioids are not more effective in the treatment of chronic pain compared with non-opioid approaches. Current guidelines have adapted to the evidence, recommending opioid-sparing approaches for treating patients with chronic pain, and tapering for those on higher doses to safer levels of use. Tapering opioids, however, requires replacing them with effective non-opioid strategies. Improving mobility has been shown to improve pain and decrease medication use among patients chronically prescribed opiates. Concurrently, financial incentives and the use of behavioral incentives have been shown to promote mobility. Appreciating the gains in health outcomes that can be made with "connected health" approaches, we propose a novel pilot study designed to evaluate if technology enabled care (TEC) strategies and financial incentives can improve patient mobility in our chronic pain population, reduce pain and decrease opioid use . Our primary aim is to determine if chronic pain patients who receive TEC-enhanced treatment with financial incentives demonstrate increased participation in activities that promote mobility (physical therapy, yoga, tai chi) in comparison to patients receiving usual care. Secondary outcomes will include whether increased activity participation also reduces pain severity and opioid use, and improves function and increases the number of daily steps taken. The results of this pilot will enable us to determine what strategies are effective at increasing mobility and if these gains translate into reduced pain and decreased opioid use.

注册库
clinicaltrials.gov
开始日期
2018年8月31日
结束日期
2020年9月15日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Chronic non-malignant pain
  • High dose opioid therapy
  • Possession of activated cell phone with text messaging capabilities
  • Willingness to comply with study requirements

排除标准

  • Pain of malignant origin
  • Sensory impairments precluding use of text messaging and activity tracker
  • Physical disability precluding improvements in physical activity

结局指标

主要结局

Increased Mobility

时间窗: 12 weeks

steps per day measured by wearable step tracker at 12 weeks

Activity Participation

时间窗: 12 weeks

Stanford Exercise Questionnaire; min score = 0, max score = 180; higher scores = better outcome

次要结局

  • Physical Function(12 weeks)
  • Daily Opioid Use(12 weeks)
  • Pain Severity(12 weeks)

研究点 (1)

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