NCT04624191

Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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)

Conditions

• Interstitial Lung Disease

Interventions

Type	Name	Description
OTHER	Saturation at home	Clinical benefit of taking saturation at home in interstitial lung disease

Timeline

• Start date: 2020-11-11
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2020-11-10
• Last updated: 2021-10-07

Locations

1 site across 1 country: Canada