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临床试验/NCT04624191
NCT04624191Unknown不适用

Clinical Impact of Home Oxygen Saturation Measurement in Patients With Interstitial Lung Disease: Quality of Live, Health Care Use, Score of Anxiety, Depression and Dyspnea and Physical Activity Level

Laval University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Quality of life by questionnaire

研究概览

简要总结

The use of saturometry at home is more and more widespread in patients suffering from interstitial pulmonary diseases (IPD), the patients seeing it as reassurance and a concrete way to follow the evolution of their disease. However, there are no studies evaluating the real clinical benefit of taking saturation at home in this population. In addition, clinical experience seems rather to demonstrate an increase in the anxiety level and the number of clinically unnecessary consultations related to the use of this measure.

The secondary objectives are to determine the impact of this measurement on: (1) the health care use (telephone calls, medical consultations and hospitalizations), (2) dyspnea score, (3) the anxiety and depression score (HADS score) and (4) the physical activity level. The exploratory objectives will be to determine if the measurement of saturation at home makes it possible to (1) predict the occurrence of acute exacerbations of fibrosis, (2) effectively predict the decline in respiratory function tests and (3) 1-year mortality. The investigator will also assess whether this measure makes it possible to screen patients with oxygen therapy needs at home. The investigator hypothesize that measuring oxygen saturation at home will lead to a significant deterioration in quality of life, an increase in the use of health care, a significant increase in the rate of anxiety and depression, dyspnea and a decrease in the physical activity level.

详细描述

Measurement tools

  1. Quality of life: King's Brief Interstitial Lung Disease
  2. Anxiety and depression score: HADS score
  3. Dyspnea score : UCSD questionnaire
  4. Physical activity level during 7 days: MoveMonitor by McRoberts
  5. Home base saturation: Nonin Ny vantagr 9590
  6. Disease evolution : complete lung function (plethymography, sprimoetry, DLCO), 6-minute walking test (following the ATS recommandation)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Fibrosing interstitial lung disease
  • •Saturation below 90% during the 6-minute walk test
  • •Clinically stable

排除标准

  • •Oxygen dependent at rest

研究组 & 干预措施

Intervention Group

Experimental

Intervention group participants will be asked to measure their oxygen saturation on a daily basis.

干预措施: Saturation at home (Other)

Control Group

No Intervention

Usual Care

结局指标

主要结局

Quality of life by questionnaire

时间窗: 1 year

Impact of home base saturometry on quality of life

次要结局

  • Health care use (phone calls, medical consultation)(1 year)
  • Dyspnea score(1 year)
  • Anxiety and depression score(1 year)
  • Physical activity level(1 year)
  • Energy expenditure(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geneviève Dion

Principal Investigator

Laval University

研究点 (1)

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