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临床试验/NCT03931694
NCT03931694已完成不适用

Evaluation of the Feasibility of an E-health Tool in the Follow-up and Characterization of Chronic Pain Patients.

University Hospital, Clermont-Ferrand13 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2019年2月6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
发起方
入组人数
113
试验地点
13
主要终点
Feasibility of the e-health tool

研究概览

简要总结

Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, Investigator has created e-DOL, a smartphone application for patients and a web platform for physicians. The purpose of this study is to evaluate the feasibility and clinical interest of an e-Health smartphone application for the characterization and follow-up of chronic pain patients..

详细描述

This first clinical study will assess the acceptability of the tool both by caregivers at the 13 pain clinics and by a panel of 300 patients followed for 6 months. Based on the results of the study (end 2019), investigator will improve the tool in a version 2.0, which will then be evaluated in a large impact study, measuring the intrinsic therapeutic effect of eDOL.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients with chronic pain
  • •patients with and regular users of a smartphone
  • •Non-opposition to participation in the study

排除标准

  • •Patient unable to understand or answer questionnaires

研究组 & 干预措施

All patients with chronic pain follow in pain clinic

干预措施: e-DOL (Device)

结局指标

主要结局

Feasibility of the e-health tool

时间窗: Once, up to 12 months

Feasibility evaluated by analysis of user acceptability (custom questionnaire: ease of use, utility...)

次要结局

  • Typology of patient responses(Up to 6 months)
  • Typology of patient responses(Weekly, up to 6 months)
  • impact of the eHealth tool(Once, Up to 12 months.)
  • impact of the eHealth tool(Once, up 12 months.)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (13)

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