Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

Interstitial Lung Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624191
• Other study ID #: 2021-3417
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2021
• Source: Laval University
• Contact: Geneviève Dion
• Phone: 418-656-8711
• Email: geneviève.dion[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fibrosing interstitial lung disease

• Saturation below 90% during the 6-minute walk test

• Clinically stable

Exclusion Criteria:

• Oxygen dependent at rest

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Saturation at home
Clinical benefit of taking saturation at home in interstitial lung disease

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec	Québec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Fondation IUCPQ

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute exacerbation	Impact of home base saturometry on predict the occurrence of acute exacerbations of fibrosis.; Occurence: number of exacerbation of fibrosis during the year.	1 year
Other	Pulmonary function decline	Impact of home base saturometry on predict the decline in respiratory function tests, principally the forced vital capacity.	1 year
Other	Mortality	Impact of home base saturometry on 1-year mortality prediction	1 year
Primary	Quality of life by questionnaire	Impact of home base saturometry on quality of life	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical activity level	Impact of home base saturometry on physical activity level measure by accelerometer (McRoberts) and define by steps number.	1 year
Secondary	Energy expenditure	Impact of home base saturometry on energy expenditure (number of kilocalories burn by day), measure by accelerometer (McRoberts).	1 year