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临床试验/NCT02435056
NCT02435056已完成不适用

Continuous Monitoring of Medication Overuse Headache in Europe and Latin America: Development and STAndardization of an Alert and Decision Support System

IRCCS National Neurological Institute "C. Mondino" Foundation0 个研究点目标入组 690 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
690
主要终点
Relapse Rate Follow up

研究概览

简要总结

Appropriate delivery of quality healthcare requires constant monitoring of the patient during follow up, particularly in the presence of chronic diseases. This approach can be further improved if leading edge tools supporting diagnosis, as well as prediction, identification and monitoring of adverse events are available. COMOESTAS aims to develop an innovative Information Communications Technology (ICT) system that allows patients with a chronic condition to receive continuous and personalized treatment. The whole system is based on an advanced, "all in one" Alerting and Decision Support System that follows patients from the diagnosis and supports the physician in managing the therapy, controlling relevant events impacting on patient safety and activating specific procedures if selected thresholds are exceeded. In the frame of chronic neurological disorders, Medication Overuse Headache (MOH) is a common condition and a major cause of disability. MOH is curable, but its outcome is hampered by a high risk of relapse. It is, therefore, a perfect example of a disorder that can benefit from an ICT-assisted approach developing innovative systems and services for monitoring chronic conditions. COMOESTAS goals will be achieved by improving and integrating the traditional paper headache diaries and calendars into an innovative ICT tool taking into account the complex issues that accompany this peculiar form of headache, which will make the patient a key node in the entire process.

详细描述

It will be a multicentre parallel group study. The two arms of the clinical protocol will be 1) classic approach to MOH and 2) Interactive Electronic Patient Record (IEPR)-based approach to MOH.

Each arm will last 12 months.

MOH will be diagnosed according to the 2006 MOH-R criteria of the International Headache Society as reported below:

A. Headache present on > 15 days/month.

B. Regular overuse for > 3 months of one or more acute symptomatic drugs:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Patients with MOH

排除标准

  • a current diagnosis of co-existent, significant and complicating medical or psychiatric illnesses
  • significant overuse of "pure" opioids (patients overusing combination drugs containing opioids are allowed), benzodiazepines, and barbiturates,
  • overuse of alcohol and other drugs of addiction,
  • current treatment with migraine prophylactic drugs
  • inefficacy of previous adequate detoxification programmes
  • inability to provide reliable information about medical history
  • pregnancy or breast feeding
  • inability to learn how to use paper or electronic diaries

结局指标

主要结局

Relapse Rate Follow up

时间窗: 6 month

Relapse Rate 6 months after withdrawal of patients with medication overuse. Relapse will be defined as use of ergotamine, triptans, opioids or combination analgesic medications on \> 10 days/month or use of simple analgesics or any combination of ergotamine, triptans, analgesics or opioids on \> 15 days/month during the previous month, with the exclusion of month +1.

次要结局

  • HURT scores(24 month)
  • Drop-outs(24 month)
  • Days with headache(6 month)
  • Days per month with migraine(6 month)
  • MOH patients/total number of headache(24 month)
  • Midas scores(24 month)

研究者

申办方类型
Other
责任方
Sponsor

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