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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 人开始时间: 2018年8月31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
40
试验地点
1
主要终点
Increased Mobility

研究概览

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.

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 (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

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

研究组 & 干预措施

Control

Placebo Comparator

Participate in technology-enabled care without regret lottery

干预措施: Way to Health technology enhanced care (Behavioral)

Experimental

Experimental

Participate in technology-enabled care with regret lottery

干预措施: Regret lottery (Behavioral)

Experimental

Experimental

Participate in technology-enabled care with regret lottery

干预措施: Way to Health technology enhanced care (Behavioral)

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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