Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: Saturation at home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibrosing interstitial lung disease Saturation below 90% during the 6-minute walk test Clinically stable Exclusion Criteria: Oxygen dependent at rest

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Intervention group participants will be asked to measure their oxygen saturation on a daily basis. | Other: Saturation at home<br>* Clinical benefit of taking saturation at home in interstitial lung disease<br>|
| No Intervention: Control Group<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life by questionnaire | Impact of home base saturometry on quality of life | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care use (phone calls, medical consultation) | Impact of home base saturometry on health car use as number and principal reason for : telephone calls, medical consultations and hospitalizations. | 1 year | 
| Dyspnea score | Impact of home base saturometry on dyspnea score with the University of California, San Diego Shortness of breath Questionnaire (UCSD) in a scale between 0 to 120 where 120 is the worst score. | 1 year | 
| Anxiety and depression score | Impact of home base saturometry on anxiety and depression score with the Hospital Anxiety and Depression Scale Questionnaire (HADs) in a scale between 0 to 42, where 42 is the worst score. | 1 year | 
| Physical activity level | Impact of home base saturometry on physical activity level measure by accelerometer (McRoberts) and define by steps number. | 1 year | 
| Energy expenditure | Impact of home base saturometry on energy expenditure (number of kilocalories burn by day), measure by accelerometer (McRoberts). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saturometry at home, Quality of life, Heath care use, Physical activity level