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
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
- Quality of life: King's Brief Interstitial Lung Disease
- Anxiety and depression score: HADS score
- Dyspnea score : UCSD questionnaire
- Physical activity level during 7 days: MoveMonitor by McRoberts
- Home base saturation: Nonin Ny vantagr 9590
- 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
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
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
Geneviève Dion
Principal Investigator
Laval University
