Clinical trial NCT04624191: Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Saturometry at home
Quality of life
Heath care use
Physical activity level
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Fondation IUCPQ
First posted: 2020-11-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Oxygen dependent at rest

Primary outcomes:
measure: Quality of life by questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Health care use (phone calls, medical consultation)
timeFrame: 1 year
measure: Dyspnea score
timeFrame: 1 year
measure: Anxiety and depression score
timeFrame: 1 year
measure: Physical activity level
timeFrame: 1 year
measure: Energy expenditure
timeFrame: 1 year
Other outcomes:
measure: Acute exacerbation
timeFrame: 1 year
measure: Pulmonary function decline
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Institut universitaire de pneumologie et cardiologue de Québec - ULaval
name: Geneviève Dion, MD
role: PRINCIPAL_INVESTIGATOR
References: