Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME) (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

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: Saturation at home

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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jany Harvey, M.Sc.; Phone Number: 5882 418-656-8711; Email: jany.harvey@criucpq.ulaval.ca
• Study Contact Backup: Name: Geneviève Dion; Phone Number: 418-656-8711; Email: geneviève.dion@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Recruiting
    • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
    • Contact: Jany Harvey, M.Sc.; Phone Number: 5882 418-656-8711; Email: jany.harvey@criucpq.ulaval.ca
    • Contact: Geneviève Dion, M.D. FRCPC; Phone Number: 5511 418-656-8711; Email: genevieve.dion@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Oxygen dependent at rest

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pulmonary function decline	Impact of home base saturometry on predict the decline in respiratory function tests, principally the forced vital capacity.	1 year
Mortality	Impact of home base saturometry on 1-year mortality prediction	1 year

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Fondation IUCPQ
• Investigators: Principal Investigator: Geneviève Dion, MD, Institut universitaire de pneumologie et cardiologue de Québec - ULaval

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Saturometry at home; Heath care use; Physical activity level
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 2021-3417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No