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临床试验/NCT02538289
NCT02538289Unknown不适用

Hospital Without Dyspnea. Rationale and Design of a Multidisciplinary Intervention

Hospital General Universitario Gregorio Marañon2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Decrease the number of patients with advanced heart or chronic respiratory diseases who present chronic refractory dyspnea or irruptive dyspnea and do not receive adequate treatment.

研究概览

简要总结

Dyspnea is a symptom that is growing in incidence, as respiratory and heart diseases are becoming more frequent. Patients suffering from dyspnea have a significant disabling due to chronic refractory dyspnea and crisis of irruptive dyspnea. Although there are several tools that may produce an improvement of symptom intensity, they are underused.

详细描述

We sought to investigate whether if teaching interventions specifically addressed to medical staff improve the well-being of dyspneic patients. The MAIN GOAL of this study is to evaluate the effect of two talks (conveyed to doctors and nurses of Cardiology and Respiratory Medicine Departments) on the patient-perceived dyspnea. The contents of these talks will be prepared and supervised by Palliative Care specialists.

This is a four-staged study that includes a first observational phase (prevalence study of dyspnea) followed by intervention and a third phase that will determine the effect of this teaching intervention. The fourth phase consists in the elaboration of specific protocols for management of dyspnea.

A pharmacovigilance study of opioids will also take place.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

  • Hospital admission with dyspnea as main symptom
  • Acceptance of participation in the study
  • Diagnosis of Chronic Respiratory Disease
  • Diagnosis of Chronic Heart Failure
  • Chronic Refractory Dyspnea higher than 1/10 and Irruptive Dyspnea higher than 2/10 degree by Rating Numerical Scale

排除标准

  • Cognitive Impairment
  • Voluntary dropout.

结局指标

主要结局

Decrease the number of patients with advanced heart or chronic respiratory diseases who present chronic refractory dyspnea or irruptive dyspnea and do not receive adequate treatment.

时间窗: One month

Decrease the number of patients admitted to Cardiology or Respiratory Medicine departments who present chronic respiratory dyspnea or irruptive dyspnea.

次要结局

  • Determine the efficacy derived from a chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.(Three months)
  • Detect the prevalence of dyspnea in patients admitted to our hospital.(One month)
  • Describe the therapeutic tools (pharmacological and no pharmacological) employed for symptomatic treatment of dyspnea.(One month)
  • Evaluate the impact on dyspnea intensity associated with an implementation of educational talks addressed to medical staff in the management of dyspnea.(One year)
  • Number of patients that continue chronic treatment with opioids for chronic refractory dyspnea and irruptive dyspnea.(Three months)
  • Determine the intensity and functional impact of dyspnea in patients admitted to our hospital.(One month)
  • Determine the number of patients that present side effects derived from a chronic opioid treatment that require lowering dose or stopping treatment.(Three months)
  • Determine whether a specific educational talk would be affordable for dyspnea management(One month)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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